The Motley Fool comments on the next generation of Hepatitis C drug therapy...

The Motley Fool's take on the future of HCV drug development, buyouts and partnerships. Once the fodder for small biotechs, Big Pharma has their eye on the marketplace. That means plenty of action in the coming months in the quest to usurp Telaprevir's crown.

Gunning for the Leaders

By Brian Orelli
October 31, 2011

Merck's (NYSE: MRK ) Victrelis and Vertex Pharmaceuticals' (Nasdaq: VRTX ) Incivek have been on the market for only five months, and the threats to unseat them keep coming.

Data on some of the next-generation hepatitis C drugs will be presented at the end of this week, when the annual meeting of the American Association for the Study of Liver Diseases kicks off. Add in top-line data that's been released recently and expected results in the next few months, and the hepatitis C space is looks like it'll get really crowded, really quickly.

The biotech front-runner
Pharmasset (Nasdaq: VRUS ) has grabbed most of the spotlight. The company has a drug, RG7128, partnered with Roche, but most of the focus has been on PSI-7977 that it owns in its entirety. The company will present data at the meeting including results using PSI-7977 as a monotherapy. Reducing or eliminating peginterferon, which must be used with Incivek and Victrelis, is a goal of every next-generation hepatitis C regimen because of nasty side effects with peginterferon.

Achillion Pharmaceuticals (Nasdaq: ACHN ) will make multiple presentations at the meeting, with its phase 2 compound, ACH-1625, being the most interesting. Idenix Pharmaceuticals has a pair of presentations at the meeting.

No shortage of pharma competition
Unfortunately for the smaller biotechs, Big Brother is interested in the space as well.

Earlier this month, Abbott Labs (NYSE: ABT ) said it has a drug combination that might be able to deliver cure rates as high as 90% without peginterferon. Don't write off the others just yet, though. It was a fairly small trial, and the data from more patients might not be as impressive.

Bristol-Myers Squibb (NYSE: BMY ) recently presented data for one of its compounds, BMS-790052. In a phase 2 trial, 83% of patients taking the two highest doses of BMS-790052 had undetectable viral levels 24 weeks after treatment, compared with just 25% who took just peginterferon alfa and ribavirin. But the results with BMS-790052 required adding it to peginterferon and ribavirin.

The upside to pharma's interest
Fortunately for biotechs, combination treatments are likely to be key to ridding patients of the virus. Resistance issues are common, but they can be avoided by combining medications that attack the virus in different ways.

No doubt Roche's acquisition of Anadys earlier this month was driven by its desire to get a hold of Anadys' hepatitis C treatment, setrobuvir. While we might see more acquisitions in the works, partnerships -- especially non-exclusive ones -- could be the best solution for both sides. Pharmasset has used the double-dipping strategy making pacts with both Johnson & Johnson (NYSE: JNJ ) and Bristol-Myers to combine their hepatitis C treatments with PSI-7977.

The problem with non-exclusive pacts is that they may not provide biotechs with much cash to fund their own development. On the other hand, if a biotech doesn't make too many of them, it could lead to a takeout offer.

Which combo is the combo?
It's hard to know which combination will eventually win out. When you start adding multiple drugs to each other, there's bound to be side-effect issues that aren't a problem when they're used individually. Hepatitis C is a little less life-threatening than HIV, so the FDA will demand a cleaner side-effect profile than they have for cocktails that treat HIV.

And while finding the most potent combination is important, it's useful only if they complement each other's resistance issues; knocking the virus down to undetectable levels in 100% of the patients isn't particularly useful if the virus just rebounds once it mutates in a way to avoid the drugs' inhibitory properties.

Rather than trying to guess which company will eventually profit, buying a basket of hepatitis C drugmakers might be the best move. If a combo treatment is going to eventually work, why not a combination of investments?

Biotica nominates cyclophilin inhibitor BC556 for development....

Biotica Technology Limited announces development of cyclophilin inhibitor BC556 for treatment of chronic Hepatitis C. Biotica claims to offer an advantage with a high barrier to resistance, low potential for drug interactions and PK suitable for once-daily dosing.

PRESS RELEASE
Oct. 31, 2011, 12:09 p.m. EDT
Biotica nominates drug candidate, BC556, a cyclophilin inhibitor to treat Hepatitis C
Cyclophilin inhibition provides a high barrier to viral resistance in combination therapy


LONDON, Oct 31, 2011 (BUSINESS WIRE) -- Biotica Technology Limited (Biotica), a privately-held biotechnology company that discovers and develops polyketide therapeutics, today announces the nomination of its drug candidate, BC556, a cyclophilin inhibitor to treat Hepatitis C virus (HCV) infection. BC556 offers many benefits over existing treatments and, in combination with drugs acting by other mechanisms, offers the potential of an interferon-free regimen for treatment of HCV infection.

BC556 is a highly potent inhibitor of HCV replication across viral genotypes, its pharmacokinetic profile is consistent with once-daily oral dosing and the compound exhibits a very high barrier to selection of viral resistance. As in HIV therapy, successful treatment of HCV is likely to involve combination of drugs acting by different mechanisms. BC556 benefits from reduced interaction with drug transporters and metabolizing enzymes responsible for drug-drug interactions, and therefore is a suitable compound for combining with other drugs in a treatment cocktail. BC556 was selected from Biotica's new Sangamide class of cyclophilin inhibitors. Sangamides are analogs of the naturally-occurring polyketide Sanglifehrin A, produced using Biotica's proprietary polyketide engineering technology.

"It is our strong belief that only a combination therapy, as in the treatment of HIV, will offer patients a fully-efficacious treatment for hepatitis C,'' commented Edward Hodgkin, Biotica's CEO. "As such, Biotica will develop and commercialise BC556 in combination with other drugs with the aim to provide a therapy with a high barrier to resistance, pan-genotype efficacy, oral dosing, and without the side effects seen with interferon-based therapy.''

- Ends -

Notes to editors

About Biotica Technology Limited

Biotica is a privately-held biotechnology company that discovers and develops polyketide therapeutics. It has a growing pipeline of novel therapeutic programs supported by clinical validation. These include nPT-mTOR (unique rapamycin analogs), nPT-CyP (cyclophilin inhibitors for HCV) and nPT-ery (anti-inflammatory erythromycin analogs partnered with GlaxoSmithKline). All of Biotica's projects employ its proprietary novoPT(TM) technology, which enables it to select from the many known polyketides with biological activity and make a range of derivatives that are either difficult or impossible to make by medicinal chemistry methods. For additional information visit www.biotica.com .

About Hepatitis C

Hepatitis C virus infection (HCV) is a chronic blood-borne infection which attacks the liver with potentially fatal effects. The World Health Organisation estimates that up to 170 million people worldwide are infected with HCV, making the virus a health concern of global magnitude. Vaccines for HCV are not available and the infection is only curable in certain patients.

The current standard of care (SoC) treatment for HCV is the well-established combination therapy of interferon-alpha (a protein therapeutic immune stimulant) and ribavirin (a broad spectrum anti-viral). This protocol has serious side effects and shortfalls in efficacy. SoC only achieves a sustained clearance and virological response (SVR) rate of 45% in HCV genotype 1 (the predominant genotype of the virus in Western countries). In addition, the chronic side effects of the treatment (fatigue, influenza-like symptoms, etc.), present compliance issues for patients over the 48-week course. Indeed, the severity of the side effects is such that 60 to 80 percent of patients are forced to reduce dosing, or cease treatment entirely. It is noteworthy that a recent report of US Veterans [State of Care for Veterans with Chronic Hepatitis C, Nov 2010] states that up to 100,000 patients are delaying HCV treatment awaiting better therapies in development that offer greater efficacy and better side-effect profiles.

SOURCE: Biotica Technology Limited

Incivek sales drive Vertex 3rd quarter profit...

$420 million in net product revenues for Incivek in the third quarter helped Vertex record a record net income or $221 million sending shares up almost 2% today, this despite a recent rumored stall in the sales trajectory for Incivek. The company also gives an update to it's HIV/HCV co-infection trial (an exceptionally under-served part of the population), potential BID dosing, a 12 week study of TVR + P/R in patients with the 'CC' variation near the IL28B gene and it's quad therapy trial looking at it's VX-222 polymerase inhibitor + P/R

CAMBRIDGE, Mass., Oct 27, 2011 (BUSINESS WIRE) -- ---Continued strength in launch of INCIVEK for hepatitis C; submissions of KALYDECO(TM) (VX-770, ivacaftor) approval applications complete-

Vertex Pharmaceuticals Incorporated /quotes/zigman/79675/quotes/nls/vrtx VRTX +1.81% today reported consolidated financial results for the quarter ended September 30, 2011 and provided an update on the launch of INCIVEK(TM)(telaprevir) tablets and its development programs evaluating potential new medicines.

The company reported total revenues of approximately $659 million, including approximately $420 million in net product revenues for INCIVEK in the third quarter. Vertex recorded net income of approximately $221 million, or $1.02 per diluted share, on a GAAP basis and approximately $151 million, or $0.70 per diluted share, on a non-GAAP basis for the quarter. Vertex ended the quarter with a cash position of approximately $659 million.

Vertex also today provided an update on ongoing and planned clinical trials for its broad pipeline of potential new treatments for hepatitis C, cystic fibrosis, rheumatoid arthritis, epilepsy and influenza. In addition to INCIVEK, Vertex has seven other potential medicines in clinical development.

"Our continued progress with the launch of INCIVEK together with our global approval applications for KALYDECO highlight Vertex's strengths in moving innovative science from the lab to people with serious diseases," said Matthew Emmens, Chairman, President and Chief Executive Officer of Vertex. "As we enter 2012, we expect to have more than a dozen ongoing clinical trials across our broad and diverse pipeline, which we believe may lead to additional new medicines to support our future growth."

"More than 17,000 people with hepatitis C have started treatment with INCIVEK since its approval in May, underscoring the strength of the launch," said Nancy Wysenski, RN, Executive Vice President and Chief Commercial Officer. "We are focused on further broadening the number of doctors using INCIVEK and are continuing to work with the hepatitis C community to increase awareness and screening and to help ensure patients are able to get the support they need."

Recent Progress and Upcoming Milestones

Hepatitis C

INCIVEK Now Available in Multiple Countries

-- In the third quarter, Vertex announced the availability of INCIVEK for people in Canada who have chronic genotype 1 hepatitis C. INCIVEK is the first medicine marketed in Canada by Vertex.

-- Vertex's collaborator, Janssen, announced in September that the European Commission approved telaprevir in Europe, where it is being marketed by Janssen as INCIVO(R). INCIVO is now available in the U.K., Germany, France and Sweden. Also in the third quarter, Vertex's collaborator Mitsubishi Tanabe Pharma announced the approval of telaprevir in Japan, where it will be marketed by Mitsubishi as TELAVIC(R).

Phase 3b Study of INCIVEK Dosed Twice Daily

-- Vertex is currently conducting a Phase 3b clinical trial to evaluate twice-daily dosing of INCIVEK (1,125 mg; BID) compared to three-times-daily dosing of INCIVEK (750 mg; q8h) in combination with Pegasys(R) (pegylated-interferon alfa-2a) and Copegus(R) (ribavirin) for people with chronic genotype 1 hepatitis C. Sustained viral response (SVR, or viral cure) data from OPTIMIZE are expected as early as the second half of 2012, which could support the submission of a supplemental New Drug Application (NDA) for twice-daily dosing of INCIVEK by the end of 2012.

Phase 3b CONCISE Study Underway Evaluating 12-week Regimens of INCIVEK Combination Treatment

-- Earlier this week, Vertex announced the start of a Phase 3b trial to evaluate the potential for treatment with INCIVEK(TM) combination therapy to be shortened to 12 weeks in people with genotype 1 chronic hepatitis C who have the 'CC' variation near the IL28B gene. Approximately one-third of people with hepatitis C have the 'CC' genotype, which has been associated with higher sustained viral response (SVR, or viral cure) rates and faster response to interferon-based treatment. The trial is expected to include approximately 350 people with genotype 1 chronic hepatitis C who have not previously been treated and people who have relapsed after at least one prior course of treatment with pegylated-interferon and ribavirin alone.

Enrollment Complete in All-Oral Arms of Phase 2 ZENITH Study of INCIVEK and VX-222

-- Vertex completed enrollment in the third quarter in the two, all-oral three-drug treatment arms of the ongoing Phase 2 ZENITH clinical trial evaluating response-guided regimens of Vertex's lead investigational hepatitis C virus polymerase inhibitor, VX-222, dosed in combination with INCIVEK and ribavirin. The all-oral, three-drug treatment arms are evaluating a twice-daily, interferon-free regimen of INCIVEK (1,125 mg), VX-222 (400 mg) and ribavirin in people with genotype 1a or 1b chronic hepatitis C. Vertex expects to obtain end-of-treatment data from the all-oral arms of the study in early 2012.

-- Two four-drug (quad) arms of the study are also fully enrolled and are evaluating response-guided four-drug combinations of VX-222 (400 mg or 100 mg; BID), INCIVEK (1,125 mg; BID), pegylated-interferon and ribavirin.

-- Earlier this year Vertex announced interim data from ZENITH and expects to provide additional data from the four-drug arms at the upcoming Liver Meeting in November.

Multiple INCIVEK and VX-222 Presentations at the Liver Meeting in November

-- At the 2011 Liver Meeting, being held in San Francisco, November 4-8, Vertex expects to present clinical data from multiple studies of INCIVEK and VX-222. New data, including sustained viral response (SVR, or viral cure) results from the ZENITH study, will be presented for the first time. Additionally, new data from a Phase 2 study evaluating INCIVEK combination treatment in people co-infected with genotype 1 chronic hepatitis C virus (HCV) and human immunodeficiency virus (HIV), will be presented at the meeting.

Phase 3b HCV-HIV Co-infection Trial to Begin This Year

-- Based on data from a Phase 2 trial of INCIVEK combination treatment in people co-infected with HCV and HIV, Vertex plans to initiate a Phase 3b trial of INCIVEK in people co-infected with HCV and HIV by the end of 2011. The trial is expected to enroll approximately 150 people and will be designed to provide safety and efficacy data to support registration of INCIVEK for the treatment of HCV-HIV co-infection as early as 2013. All patients in this trial will receive INCIVEK combination treatment. Vertex's collaborator Tibotec also plans to conduct a similar trial in Europe, which will provide additional safety and efficacy data in people co-infected with HCV and HIV. Tibotec expects to begin enrollment in this study in early 2012.

First Phase 2b Study of INCIVEK in People with Hepatitis C Following a Liver Transplant

-- By the end of 2011, Vertex expects to initiate the first Phase 2b clinical study of INCIVEK combination treatment in people who have recurrent hepatitis C following a liver transplant. The 2-part trial will evaluate approximately 80 people.

Phase 1 Trials to Begin for ALS-2200 and ALS-2158

-- Vertex and Alios plan to advance ALS-2200 and ALS-2158 into clinical development beginning later this year. The first Phase 1 study is expected to begin by year-end for ALS-2200, followed by a study of ALS-2158 in early 2012. The studies will evaluate healthy volunteers followed by people with hepatitis C. The goal of these studies is to generate safety, pharmacokinetic and viral kinetic data to support the potential evaluation of either or both compounds in all-oral treatment regimens for hepatitis C.

Additional information on INCIVEK, including important safety information, appears at the end of this release.

Cystic Fibrosis (CF)

U.S. and E.U. Applications for Approval of KALYDECO (VX-770, ivacaftor) Complete

-- Last week, Vertex submitted an NDA to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for KALYDECO, Vertex's cystic fibrosis transmembrane conductance regulator protein (CFTR) potentiator. Vertex requested Priority Review from the FDA and has received agreement from the EMA for accelerated assessment of KALYDECO in Europe.

Phase 2 Combination Trial of KALYDECO and VX-809 Enrolling Patients in Part 2

-- Vertex today announced the start of the second part of a Phase 2 clinical trial to evaluate combination regimens of KALYDECO and VX-809, a CFTR corrector, in people with the most common mutation in CF, known as F508del. Part Two of this trial will evaluate dosing of VX-809 alone for four weeks followed by dosing of KALYDECO and VX-809 in combination for four weeks. The study is expected to evaluate multiple dose levels of VX-809, including doses higher than those studied in the first part of the trial. The study is expected to enroll approximately 100 people with CF who have one copy or two copies of the F508del mutation. Similar to Part One, the primary goals of the second part of the trial are to evaluate safety and tolerability and the effect of the combination of KALYDECO and VX-809 on CFTR function as measured by sweat chloride. Lung function will be measured as a secondary endpoint. Patient screening for this study is underway.

KALYDECO and VX-809 Presentations at the North American Cystic Fibrosis Conference

-- Nine abstracts were accepted for presentation at the 2011 North American Cystic Fibrosis Conference (NACFC), being held in Anaheim, CA, November 3-5. Complete 48-week data from the Phase 3 ENVISION study of KALYDECO in children ages 6 to 11 years will be presented for the first time, as will data from a subset of patients in the open-label PERSIST extension study who had completed 48 weeks of treatment (placebo or KALYDECO) in one of the KALYDECO Phase 3 trials (STRIVE or ENVISION). Data from the first 12 weeks of the rollover study in patients who completed the STRIVE study and entered PERSIST will be presented at the meeting. In addition, complete data from the first part of the Phase 2 study combining KALYDECO and VX-809 will be presented for the first time.

Additional Studies of KALYDECO Planned for 2012

-- Pediatric Study: Vertex remains on track to initiate a Phase 2 study of KALYDECO dosed as monotherapy in children ages 2 through 5 in 2012. This will be the first study to evaluate a pediatric formulation of KALYDECO in children with the G551D mutation as young as two years of age.

-- Other CFTR Mutations: Also in 2012, Vertex plans to begin evaluation of KALYDECO monotherapy in people with certain other gating mutations (not G551D) and in mutations that result in some residual function of the defective CFTR protein on the cell surface. Vertex is in discussions with global regulatory agencies regarding the design of these studies and intends to provide additional information upon the initiation of the first study in these additional mutations.

First Study of VX-661 Planned for First Quarter of 2012

-- In addition to the ongoing Phase 2 study of KALYDECO and VX-809, Vertex also plans to begin Phase 2 development of VX-661, another CFTR corrector, in the first quarter of 2012. VX-661 is expected to be evaluated as monotherapy followed by dosing of VX-661 in combination with KALYDECO in people with two copies of the F508del mutation.

Rheumatoid Arthritis

350-patient Phase 2b Study of VX-509 To Begin by Early 2012 for Rheumatoid Arthritis

-- In September, Vertex announced data from a Phase 2 proof-of-concept clinical trial of the oral JAK3 inhibitor VX-509 in people with moderate to severe rheumatoid arthritis (RA). Based on these data, Vertex plans to begin a six-month Phase 2b study of VX-509 in RA by early 2012. This study will evaluate once-daily (QD) and twice-daily (BID) doses of VX-509 in combination with methotrexate, a commonly prescribed disease-modifying antirheumatic drug (DMARD) for RA that is frequently used in combination with other RA medicines. The study is expected to enroll approximately 350 people with moderate to severe RA.

Epilepsy

400-patient Phase 2b Study of VX-765 To Begin by Year-end for Epilepsy

-- Earlier this year, Vertex announced results from a Phase 2 study of VX-765 in people with treatment-resistant epilepsy. Based on these results, Vertex plans to initiate an additional Phase 2 study to evaluate longer dosing of VX-765 in approximately 400 people with treatment-resistant epilepsy. The trial is expected to begin by the end of this year.

Influenza:

Phase 1 Development Underway for VX-787

-- In September, Vertex began clinical development of VX-787 in a Phase 1 study in healthy volunteers. VX-787 is an investigational medicine that is designed to treat influenza A, including recent H1 (pandemic) and H5 (avian) influenza strains. VX-787 is the first of a new class of molecules that aims to treat influenza in a way that is distinct from neuraminidase inhibitors, the current standard of care for the treatment of influenza, and from other previous approaches to the treatment of influenza.

-- Phase 1 development in healthy volunteers is ongoing, and Vertex plans to begin evaluation of VX-787 in influenza infection as part of a Phase 2a proof-of-concept trial in mid-2012.

Third Quarter Financial Results

"Our financial performance in the third quarter was driven by the successful launch of INCIVEK, enabling Vertex to be profitable and cashflow positive in the first full quarter after INCIVEK was available," said Ian Smith, Executive Vice President and Chief Financial Officer. "We remain committed to reinvesting in our broad pipeline and to the creation of significant earnings, which we believe will deliver the greatest value for patients, the company and shareholders."

Total Revenues: Total revenues for the quarter ended September 30, 2011 were $659.2 million, compared with $23.8 million in total revenues for the third quarter of 2010. The increase in total revenues is primarily a result of INCIVEK net revenues of $419.6 million and $200.0 million in milestone revenues earned from Vertex's collaborator Janssen in the third quarter.

INCIVEK Revenues: For the quarter ended September 30, 2011, Vertex reported $419.6 million in net revenues of INCIVEK, which were recorded on an ex-factory basis and reflect the first full quarter of INCIVEK sales following approval on May 23, 2011. Net revenues of INCIVEK for the second quarter of 2011 were $74.5 million.

Cost of Product Revenues: Cost of product revenues for the quarter ended September 30, 2011 was $35.3 million, which principally reflects royalty expenses owed to third parties on the sale of INCIVEK.

Research and Development (R&D) Expenses: R&D expenses for the quarter ended September 30, 2011 were $189.1 million, including $18.7 million in stock-based compensation expense, compared to $170.4 million, including $17.0 million in stock-based compensation expense, for the third quarter of 2010. These expenses reflect the company's continued investment in its research and development pipeline, including preparation for the initiation of multiple clinical trials planned to begin by early 2012.

Sales, General and Administrative (SG&A) Expenses: SG&A expenses for the quarter ended September 30, 2011 were $110.7 million, including $10.8 million in stock-based compensation expense, compared to $48.9 million, including $6.8 million in stock-based compensation expense, for the third quarter of 2010. This increase reflects the expansion of the company's commercial organization to support both INCIVEK and KALYDECO and costs related to the commercial launch of INCIVEK.

GAAP and Non-GAAP Net Income (Loss) Attributable to Vertex: For the quarter ended September 30, 2011, the company's GAAP net income attributable to Vertex was $221.1 million, or $1.02 per diluted share, compared to a GAAP net loss attributable to Vertex for the quarter ended September 30, 2010 of $209.0 million, or $1.04 per diluted share.

The non-GAAP net income attributable to Vertex for the quarter ended September 30, 2011 was $151.2 million, or $0.70 per diluted share, compared to a non-GAAP net loss of $174.6 million, or $0.87 per diluted share, for the quarter ended September 30, 2010. The non-GAAP net income for the third quarter of 2011 and the third quarter non-GAAP net loss for the third quarter of 2010 excludes stock-based compensation expense, restructuring expense (credit), any revenues and expenses related to certain September 2009 financial transactions, any intangible asset impairment charge, net of tax, and items related to Vertex's collaboration with Alios. The increase in the third quarter 2011 non-GAAP net income attributable to Vertex resulted principally from increased revenues related to the sale of INCIVEK.

Cash Position: At September 30, 2011, Vertex had $658.7 million in cash, cash equivalents and marketable securities, compared to cash, cash equivalents and marketable securities at June 30, 2011 of $593.5 million.

This section contains forward-looking guidance about the financial outlook for Vertex Pharmaceuticals.

Vertex is today reiterating its guidance for 2011 total operating expenses, excluding cost of revenues, stock-based compensation expense and intangible asset impairment charge, of $960 to $980 million, as provided on July 28, 2011.

Go here for the full press release.

Abbott Announces Positive Data from Mid-Stage Trial of Hepatitis C Therapy...

Although it's still early in the clinical trial process, the news gets better and better with Direct Acting Antivirals as we head toward AASLD. This press release from Abbott focuses on Abbott's ABT-450 and one of two Abbott polymerase inhibitors, ABT-333 or ABT-072. Interim data points toward shortening therapy down to 12 weeks with ribavirin but sans interferon. Abbott doesn't specifically go into adverse events in this press release, which is a question everyone will likely be asking at the conference.

Abbott Announces Positive Data from Mid-Stage Trial of Hepatitis C Therapy

pharmpro.com

Oct 24 2011
Abbott on Friday announced interim data from mid-stage trials of its experimental hepatitis C drug combination that suggested patients could achieve a viral cure without use of interferon and that the duration of therapy could be about half as long as conventional therapies. Abbott’s Richard Gonzales, who will take over as CEO of the company's new presecription drug business following its split, commented that the therapy could "dramatically change the treatment landscape" for the disease, adding that "we’re on track to show patient cure rates in the 90 percent range."

In the trials, 44 previously untreated patients with hepatitis C were given ritonavir with Abbott's ABT-450 and one of two Abbott polymerase inhibitors, ABT-333 or ABT-072, and ribavirin for 12 weeks. All patients who remained in the studies achieved an early virologic response at 12 weeks, and of the 10 patients to date who were tested 24 weeks after completing the treatment course, nine had achieved a sustained virologic response, the company said. Abbott plans to present more detailed data on these and other trials of the drug regimen next year.


"While early, these results are unprecedented in that very high cure rates are being achieved ... with only 12 weeks of interferon-free therapy," Gonzalez commented. Abbott noted that the FDA has given fast track status to the regimen and indicated that it could reach the market by 2015. In addition, the drugmaker speculated that the treatment regimen could go on to capture $2 billion in annual sales.


Shares in Pharmasset, which is developing a similar therapy that includes two drugs versus Abbott’s four components, dipped 15 percent on the news. Investors had expected that Pharmasset’s treatment would not face competition from another therapy that doesn’t use interferon, commented Leerink Swann analyst Howard Liang. "We are seeing there is another way of achieving a regimen without interferon that looks like it will be competitive," he said, adding that "it will eventually all boil down to who has the better data."


However, Brean Murray Carret & Co. analyst Brian Skorney noted that "the two-drug combination has a better chance of a very clean safety profile. I continue to believe Pharmasset’s [therapy] will be better." Pharmasset will present new data on the therapy next month at the American Association for the Study of Liver Disease annual meeting.

Boehringer Ingelheim BI 201335 and BI 207127 data to be presented at AASLD...

BI releases it's oral and poster presentation coverage for AASLD. Hot on the list will be SOUND-C2, a phase IIb study looking at an interferon-free combo regimen of BI's polymerase inhibitor BI 2071287 and protease inhibitor BI 201335 both with and without ribavirin.


Boehringer Ingelheim announces new data from hepatitis C virus portfolio

Published on October 22, 2011 at 12:58 AM

Boehringer Ingelheim announced today that new data from its hepatitis C virus (HCV) portfolio will be presented in scientific sessions at The Liver Meeting® 2011, the 62nd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), taking place November 4 - November 8 in San Francisco, CA. The abstracts are published online at www.aasld.org.

Key data presented will include a week 12 interim analysis of SOUND-C2, a Phase IIb study evaluating an interferon-free combination of its protease inhibitor BI 201335 and its polymerase inhibitor BI 207127 - with and without ribavirin in treatment-naïve HCV infected patients. In addition, SILEN-C1 and SILEN-C3 data will further assess the efficacy and safety of BI 201335 in treatment-naïve HCV-infected patients, in combination with pegylated interferon alfa-2a and ribavirin (PegIFN/RBV).

SOUND-C2
In SOUND-C2, 362 treatment-naïve patients with chronic genotype-1 HCV infections were randomised into five interferon-free treatment arms, each with 120mg BI 201335 once daily (QD) but with different dosings of BI 207127 and ribavirin as follows:
• 120 mg QD BI 201335 combined with 600 mg TID (thrice daily) BI 207127 and RBV for 16 weeks
• 120 mg QD BI 201335 combined with 600 mg TID BI 207127 and RBV for 28 weeks
• 120 mg QD BI 201335 combined with 600 mg TID BI 207127 and RBV for 40 weeks
• 120 mg QD BI 201335 combined with 600 mg BID (twice daily) BI 207127 and RBV for 28 weeks
• 120 mg QD BI 201335 combined with 600 mg TID BI 207127 for 28 weeks (no RBV)
The interim results will provide early virological response rates for all treatment arms of the novel interferon-free combination of BI 201335/BI 207127/ribavirin and are due to be presented by Stefan Zeuzem, M.D., Chief of the Department of Medicine and Professor of Medicine at the Johann Wolfgang Goethe University Hospital in Frankfurt, Germany and lead investigator of the study.

SILEN-C1
In SILEN-C1, 429 treatment-naïve patients with chronic genotype-1 HCV infections were randomised to the following treatment groups:
• Placebo
• BI 201335 120 mg QD with 3 days lead-in (LI) of PegIFN/RBV
• BI 201335 240 mg QD/LI
• BI 201335 240 mg QD without LI
In each arm, BI 201335 or placebo were given for 24 weeks together with PegIFN/RBV for 24 or 48 weeks. Results presented at AASLD will include an analysis of sustained virological response across different baseline factors, including difficult to treat HCV cases.

SILEN-C3
In SILEN-C3, 159 treatment-naïve genotype-1 patients were randomised to the following treatment groups:
• BI 201335 120mg QD for 12 weeks with 3 days lead-in of PegIFN/RBV
• BI 201335 120mg QD for 24 weeks with 3 days lead-in of PegIFN/RBV
In each arm, PegIFN/RBV was given for 24 or 48 weeks. Results presented at AASLD will provide an analysis of 12 versus 24 weeks of treatment with BI 201335.
Titles for accepted abstracts are below and full results and conclusions for these abstracts will be shared at AASLD at the times specified.
• Virologic response to an interferon-free regimen of BI 201335 and BI 207127, with and without ribavirin, in treatment-naïve patients with chronic genotype-1 HCV infection: Week 12 interim results of the SOUND-C2 study
(Poster LB-15. Zeuzem, et al. November 7, 8:00 a.m. - 5:30 p.m. PT)

Oral presentations
• SILEN-C3: Treatment for 12 or 24 weeks with BI 201335 combined with peginterferon alfa-2a and ribavirin (P/R) in treatment-naïve patients with chronic genotype-1 HCV infection
(Abstract 39. D. Dieterich, et al. November 6, 4:15 p.m. - 4:30 p.m. PT)
• Treatment with the second generation HCV protease inhibitor BI 201335 results in high and consistent SVR rates - results from SILEN-C1 in treatment-naïve patients across different baseline factors
(Abstract 226. M.S. Sulkowski, et al. November 8, 8:45 a.m. - 9:00 a.m. PT)
• High sustained virologic response following interferon-free treatment of chronic HCV GT1 infection for 4 weeks with HCV protease inhibitor BI 201335, polymerase inhibitor BI 207127 and ribavirin, followed by BI 201335 and PegIFN/ribavirin - the SOUND-C1 study
(Abstract 249. S. Zeuzem, et al. November 8, 11:15 a.m. - 11:30 a.m. PT)

Poster presentation
• Characterization of HCV NS3 variants that emerged during virologic breakthrough and relapse from BI 201335 phase 2 SILEN-C1 study
(Poster 1339. G. Kukolj, et al., November 7, 8:00 a.m. - 5:30 p.m. PT)
The results from the HCV portfolio at AASLD underscore the promise of the company's pipeline as Boehringer Ingelheim continues to focus on the real-world challenges faced by HCV patients globally.
Boehringer Ingelheim is continuing its long heritage in virology and is dedicated to developing new medicines for HCV patients. BI 201335 and BI 207127 are being investigated with the goal of improving cure rates for more HCV patients, including those traditionally difficult to treat.

Clinical Care Options presents "Resistance in Hepatitis C"

A new CCO CME is online, this one taking a looks at Hepatitis C resistance in the era of the Direct Acting Anitivirals. Faculty includes Stephane Zeuzem MD, Stephane Chevaliez Pharm.D, Ph.D and Paul Pockros MD. Registration to CCO required.

Click here for the CME module

Merck releases 24 week Boceprevir interim Phase IIb data in HIV/HCV co-infected patients...

Twenty-four week interim Phase IIb results looking a Boceprevir + PR in HIV/HCV co-infected patients. Results at week 24 show 70.5% (n=43/61) of patients receiving bocepreivr + PR were undetectable compared to 34.4%(n=11/32) of patients receiving just PR alone. This represented a treatment difference of 36.1%, according to the press release. Not much is said about the HIV regimen patients were on, other than it didn't include AZT or any of the 'D' drugs. Because boceprevir is a strong inhibitor of CYP3A4/5 and is partly metabolized by CYP3A4/5, drug-drug interactions with HIV antivirals are a real possibility. Merck also announced a trial in co-infected subjects who had failed previous therapy in conjunction with the French National Agency for Research on AIDS and Viral Hepatitis (ANRS) as well as a Phase III coinfection study in collaboration tithe the AIDS Clinical Trials Group (ACTG).

Interim Phase IIb Data for Merck's VICTRELIS(TM) (boceprevir) in Patients Coinfected with Chronic Hepatitis C and HIV-1 Presented at the Infectious Diseases Society of America (IDSA) 2011 Annual Meeting

BOSTON, Oct 20, 2011 (BUSINESS WIRE) -- Merck, known as MSD outside of the United States and Canada, today announced results from a 24-week interim analysis of an ongoing 48-week Phase IIb clinical study evaluating the investigational use of VICTRELIS(TM) (boceprevir), the company's first-in-class, oral hepatitis C virus (HCV) NS3/4A protease inhibitor, in combination with peginterferon alfa and ribavirin for the treatment of chronic HCV genotype 1 infection in adult patients coinfected with HIV-1. All patients in the study were new to treatment for chronic HCV, on an optimized antiretroviral regimen and had stable HIV-1 disease. The interim analysis showed that at week 24 of treatment, 70.5 percent (n=43/61) of patients receiving VICTRELIS in combination with peginterferon alfa-2b and ribavirin had undetectable hepatitis C virus (HCV-RNA) compared to 34.4 percent (n=11/32) of patients receiving peginterferon alfa-2b and ribavirin alone, a treatment difference of 36.1 percent. These interim results are being presented for the first time in a late-breaker oral presentation at the Infectious Diseases Society of America (IDSA) 2011 annual meeting in Boston. Final results from the study are expected in 2012.

"We are encouraged by these interim results with VICTRELIS in combination therapy in this difficult-to-treat patient population," said Roger J. Pomerantz, M.D., F.A.C.P., senior vice president, Infectious Diseases, Merck Research Laboratories. "Helping patients who are dealing with both chronic hepatitis C and HIV-1 is a critical issue in infectious diseases today, and Merck is committed to evaluating VICTRELIS in these patients. In addition to this ongoing Phase IIb study in patients new to HCV treatment, we are collaborating with the French National Agency for Research on AIDS and Viral Hepatitis (ANRS) on an ongoing Phase II study in patients who failed previous HCV treatment. We also plan to begin a Phase III coinfection study for VICTRELIS in combination therapy later this year in collaboration with the AIDS Clinical Trials Group (ACTG), which is funded by the U.S. National Institute of Allergy and Infectious Diseases."

Indications and usage for VICTRELIS

VICTRELIS was approved by the U.S. Food and Drug Administration (FDA) on May 13 for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.

The following points should be considered when initiating VICTRELIS for treatment of chronic hepatitis C infection:

-- VICTRELIS must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin.

-- VICTRELIS efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors. VICTRELIS in combination with peginterferon alfa and ribavirin has not been studied in patients documented to be historical null responders (less than a 2 log HCV-RNA decline by treatment week 12) during prior therapy with peginterferon alfa and ribavirin. The clinical studies included patients who were poorly interferon responsive. Patients with less than 0.5 log HCV-RNA decline in viral load at treatment week 4 with peginterferon alfa plus ribavirin alone are predicted to have a null response (less than a 2 log HCV-RNA decline by treatment week 12) to peginterferon alfa and ribavirin therapy.

-- Poorly interferon responsive patients who were treated with VICTRELIS in combination with peginterferon alfa and ribavirin have a lower likelihood of achieving a sustained virologic response (SVR), and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin.

Key interim results

One hundred (100) adult patients with previously untreated HCV genotype 1 infection and stable HIV-1 disease (HIV-RNA less than 50 copies/mL; CD4 cell counts equal to or greater than 200 cells/mm(3)) were randomized into the study. Two patients randomized to the treatment arm receiving VICTRELIS in combination with peginterferon alfa-2b (P) and ribavirin (R) did not receive VICTRELIS. Thus, the interim analysis was based on 98 patients who received at least one dose of study drug: 64 patients in the arm receiving VICTRELIS plus P/R, and 34 patients in the control arm receiving P/R alone. All patients treated in the study received a 4-week lead-in with P/R alone followed by VICTRELIS plus P/R or placebo plus P/R for 44 weeks, for a total treatment duration of 48 weeks.

Preliminary safety data for VICTRELIS in combination therapy in HCV/HIV coinfected patients demonstrated a profile similar to that previously observed in patients with HCV mono-infection. There were no unexpected trends in HIV-RNA levels or CD4 cell counts.

The most common clinical adverse events with a difference of equal to or greater than 10 percent for the treatment arm receiving VICTRELIS plus P/R compared to the P/R control arm, respectively, were: neutropenia (13 vs. 3 percent), dysgeusia (bad taste) (25 vs. 15 percent), vomiting (25 vs. 15 percent), pyrexia (34 vs. 21 percent), headache (28 vs. 12 percent) and decreased appetite (30 vs. 18 percent) [median days on study, 211 vs. 166, respectively]. Serious clinical adverse events occurred in 8 percent and 21 percent of patients in the two treatment arms, respectively. Dose modification for any study drug due to a clinical adverse event occurred in 19 percent and 21 percent of patients, respectively, and study discontinuation due to a clinical adverse event occurred in 14 percent and 9 percent of patients, respectively.

About the Phase IIb coinfection study

The primary objective of this ongoing randomized, multicenter, double-blinded for VICTRELIS, Phase IIb study is to compare the efficacy of VICTRELIS 800 mg three times daily in combination with peginterferon alfa-2b (P) 1.5 mcg/kg weekly plus ribavirin (R) 600 to 1,400 mg daily to therapy with P/R alone in adult patients coinfected with chronic HCV genotype 1 and HIV-1. Patients were randomized in a 2:1 ratio to the treatment arm with VICTRELIS plus P/R or the P/R control arm, respectively. Patients were stratified by cirrhosis (yes/no) and baseline HCV-RNA (less than 800,000 IU/mL vs. equal to or greater than 800,000 IU/mL). The majority of patients were non-cirrhotic (95 percent), white (82 percent) and male (69 percent), with a median age of about 43 years. Most patients had high HCV-RNA (88 percent) at baseline and HCV genotype 1a infection (65 percent).

Antiretroviral regimens for HIV-1 that included non-nucleoside reverse transcriptase inhibitors (NNRTIs), zidovudine, stavudine or didanosine were not permitted. Patients with detectable HCV-RNA and less than a 2 log HCV-RNA decline at treatment week 12 or detectable HCV-RNA at treatment week 24 were considered treatment failures and discontinued all treatment.

Important safety information about VICTRELIS

All contraindications to peginterferon alfa and ribavirin also apply since VICTRELIS must be administered with peginterferon alfa and ribavirin. Because ribavirin may cause birth defects and fetal death, VICTRELIS in combination with peginterferon alfa and ribavirin is contraindicated in pregnant women and in men whose female partners are pregnant. Avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to therapy; have monthly pregnancy tests; and use two or more forms of effective contraception, including intrauterine devices and barrier methods, during treatment and for at least 6 months after treatment has concluded. Systemic hormonal contraceptives may not be as effective in women while taking VICTRELIS.

VICTRELIS is contraindicated in coadministration with drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events. VICTRELIS also is contraindicated in coadministration with potent CYP3A4/5 inducers where significantly reduced boceprevir plasma concentrations may be associated with reduced efficacy. Drugs that are contraindicated with VICTRELIS include: alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's Wort (hypericum perforatum), lovastatin, simvastatin, drosperinone, Revatio(R) (sildenafil) or Adcirca(R) (tadalafil) (when used for the treatment of pulmonary arterial hypertension), pimozide, triazolam, and midazolam (orally administered).

Anemia has been reported with peginterferon alfa and ribavirin therapy. The addition of VICTRELIS to peginterferon alfa and ribavirin is associated with an additional decrease in hemoglobin concentrations. The addition of VICTRELIS may result in a worsening of neutropenia associated with peginterferon alfa and ribavirin alone. Complete blood count (with white blood cell differential counts) must be conducted in all patients prior to initiating VICTRELIS combination therapy. Complete blood counts should be obtained pretreatment, and at treatment weeks 4, 8 and 12, and should be monitored closely at other time points, as clinically appropriate. If a patient has a serious adverse reaction potentially related to peginterferon alfa and ribavirin therapy, the peginterferon alfa and/or ribavirin dose should be reduced or discontinued. VICTRELIS must not be administered in the absence of peginterferon alfa and ribavirin. Dose reduction of VICTRELIS is not recommended.

The most commonly reported adverse reactions (greater than 35 percent) in clinical trials in adult patients receiving the combination of VICTRELIS with peginterferon alfa-2b and ribavirin were fatigue, anemia, nausea, headache and dysgeusia. Of these commonly reported adverse reactions, fatigue, anemia, nausea, and dysgeusia occurred at rates greater than or equal to 5 percent above the rates for peginterferon alfa and ribavirin alone in either clinical study. The incidence of these adverse reactions in previously untreated patients who received VICTRELIS combination therapy compared with peginterferon and ribavirin alone were: fatigue (58 vs. 59 percent), anemia (50 vs. 30 percent), nausea (46 vs. 42 percent), dysgeusia (35 vs. 16 percent), respectively. The incidence of these adverse reactions in previously treated patients who received VICTRELIS combination therapy compared with peginterferon and ribavirin alone were: fatigue (55 vs. 50 percent), anemia (45 vs. 20 percent), nausea (43 vs. 38 percent), dysgeusia (44 vs. 11 percent), respectively.

VICTRELIS is a strong inhibitor of CYP3A4/5 and is partly metabolized by CYP3A4/5. The potential for drug-drug interactions must be considered prior to and during therapy.

Please see U.S. prescribing information at: http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf .

Merck's global commitment to advancing hepatitis therapy

Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. In hepatitis C, company researchers developed the first approved therapy for chronic HCV in 1991 and the first combination therapy in 1998. In addition to ongoing studies with VICTRELIS, extensive research efforts are underway to develop additional innovative oral therapies for viral hepatitis treatment.

About Merck

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

Forward-Looking Statement

This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.

The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2010 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( www.sec.gov ).

Please see Prescribing Information for VICTRELIS at http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf and Medication Guide for VICTRELIS at http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_mg.pdf .

SOURCE: Merck


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Roche Pharmaceuticals buys Anadys Pharmaceuticals in $230 million deal...

Looks like Roche is gearing itself up for the HCV Wars by potentially bolstering it's long-standing presence in HCV with Anadys's non-nuc Setrobuvir, which currently in Phase II clinical trials.

Roche to Acquire Anadys Pharmaceuticals
Oct 20, 2011
By: Rich Whitworth
ePT--the Electronic Newsletter of Pharmaceutical Technology


In a deal worth approximately $230 million, Roche has signed an agreement to acquire Anadys Pharmaceuticals according to a Roche press release issued Oct. 17, 2011. Citing aims to bolster future treatment options for hepatitis C, the merger will see Roche fully acquiring Anadys at a share price of $3.70 in an all-cash transaction.

Anadys, a US-based company, develops oral, small-molecule therapeutics for the hepatitis C virus (HCV), the most advanced of which is a direct-acting antiviral compound (Setrobuvir, a non-nucleoside polymerase inhibitor) that is being evaluated in Phase II studies in combination with Roche’s pegylated interferon (Pegasys) and ribavirin (Copegus).

Also in development at Anadys is an oral, small-molecule inducer of innate immunity. Currently in Phase I trials, it may prove useful for treating HCV as well as other chronic infections and oncology, another strong focus for Roche.

“This acquisition augments our already strong HCV portfolio. Our aim is to offer physicians and hepatitis patients a powerful combination of therapies that bring us closer to a cure, even without the use of interferon. Anadys’ compounds provide additional modes of action that could lead to interferon-free treatment regimens without viral resistance,” said Jen-Jacques Garaud, global head of Roche Pharma research and early development.

Steve Worland, president and CEO of Anadys, said, “With Roche’s considerable capabilities and experience in HCV, we believe this acquisition provides the best chance of success for the new potential treatments to reach patients.”

Anadys added in its own press statement that Anadys’ directors and executive officers have agreed to tender their own shares in the offer, which is expected to close in the fourth quarter of 2011.

Forbes article - "The Hepatitis C Wars: What Docs Say About The Newest Meds"

(Forbes article by Ed Silverman on the 'DAA Wars' and how HCV providers view Invicek vs Victrelis. Interesting insight, but the most compelling aspect to this is whether the reconfigured Rx data from IMS for the last two weeks of September will confirm a stall in the growth of both products)

The Hepatitis C Wars: What Docs Say About The Newest Meds

By Ed Silverman

Over the past several days, there has been a great deal of confusion about the extent to which physicians are embracing the new Incivek hepatitis C drug that is sold by Vertex Pharmaceuticals. The reason is that IMS Health, the market research firm that tracks prescriptions, has to restate mail-order activity for the drug for the last two weeks of September.

The uncertainty sent Vertex stock gyrating because the initial data suggested prescriptions had stopped growing. Investors are now waiting for IMS to release an update. Meanwhile, we thought it might be interesting to provide a different sort of look at how Incivek is faring along with its equally new rival, Victrelis, which is sold by Merck and Roche.

A survey conducted in August of 80 physicians – 29 gastroenterologists, 25 hepatologists, and 26 infectious disease specialists – finds that Incivek is edging out Victrelis in various ways, according to Decision Resources, which queried the doctors. The latest survey, by the way, was run three months after the meds launched and updates an earlier effort that was conducted one month after launch.

The survey found that a widening gap in physician satisfaction between the two treatments. One month after launch, 36 percent of the docs were satisfied with Victrelis and this rose to 48 percent after three months. Among those physicians prescribing Incivek, 40 percent were satisfied one month after product launch and this jumped to 55 percent after the three-month mark.

Interestingly, the average number of patients being treated was slightly lower three months after launch, although the percent of docs using both meds increased significantly. Both drugs have high recognition – 36 percent of the docs were able to cite either the brand or generic name for Victrelis; the figure was 34 percent for Incivek. And two-thirds reported receiving patient requests for the drugs.

Meanwhile, more than two thirds of the docs have begun using either med, compared with more than one half of physicians at one month after the launches. However, Decision Resources notes that most docs have prescribed both brands, suggesting they are still experimenting. So far, 29 percent say it it too soon to know whether they are satisfied with Incivek; the number was 27 percent for Victrelis.

Another nugget: most Americans with hepatitis C have genotype 1, which is the hardest to treat. The survey found that infectious disease specialists have more genotype 1 patients undergoing active treatment compared to two months earlier; Victrelis share among hepatologists is higher compared to gastroenterologists; and gastroenterologists view shorter duration of treatment and managed care access as significantly more important when choosing a drug compared to the other specialties.

Overall, the main benefit of this new class of hepatitis C treatments is the improvement in sustained viral load or SVR, according to the docs surveyed. While Incivek beat Victrelis on higher SVR, shorter duration and simpler protocol, the perception of superior efficacy was countered by concerns with rash, according to Decision Resources. “While it’s too soon to tell, Victrelis may fill a niche for patients who prefer it’s side effect profile,” the firm reports.

Anadys Announces Positive 12-Week Data for Setrobuvir in Phase 2b Hepatitis C Study

Positive interim (12 week) Phase IIb data for Anadys's non nuc Setrobuvir + p/r in both treatment naive and non-responders to previous P/R. Looks to be comparable to P/R in side effect profile, except for the amount of rash (39%) (98% mild to moderate)

Anadys Announces Positive 12-Week Data for Setrobuvir in Phase 2b Hepatitis C Study

- Strong Antiviral Response in Prior Partial Responders and Relapsers - Favorable Safety Data with AE Profile Comparable to Control Group - High Barrier to Resistance Confirmed --Conference Call at 8:00 AM EDT Today

SAN DIEGO, Oct. 13, 2011 Anadys Pharmaceuticals today released interim antiviral response and safety data from an ongoing Phase IIb study of setrobuvir in combination with pegylated interferon and ribavirin (P/R) in genotype 1 hepatitis C patients. Setrobuvir is the Company's direct-acting antiviral being developed for the treatment of chronic hepatitis C, or HCV.

"We are pleased with today's data, which we believe demonstrate a compelling profile for setrobuvir in significantly more patients," said Steve Worland, Ph.D., President and CEO of Anadys. "The antiviral response in patients who had failed prior treatment is a particularly encouraging benchmark of setrobuvir's potency and high barrier to resistance. Coupled with a favorable safety profile to date, we believe today's data position setrobuvir as a very attractive agent to be included in future DAA combination regimens."

78% of treatment-naive patients and 76% of patients who had responded inadequately to, or relapsed after, prior treatment with P/R had undetectable virus at week 12 (cEVR) while receiving setrobuvir plus P/R, compared to 56% and 44%, respectively, for patients who received placebo plus P/R. 71% of treatment-naive patients who received setrobuvir plus P/R had undetectable virus at week 8 and met the initial response-guided criteria for shortening treatment in this study to 28 weeks from the traditional 48 weeks for treatment with P/R alone.

29% of patients who had no appreciable response to prior treatment with P/R (null responders) achieved cEVR with setrobuvir plus P/R, and the percentage of patients with undetectable virus continued to climb in this hard-to-treat population to 36% at week 18. No prior null responders received placebo plus P/R in this trial.

The viral breakthrough rate through 12 weeks on setrobuvir plus P/R was low in both treatment-naïve patients (2.9%) and patients who had responded inadequately to, or relapsed after, prior treatment with P/R (3.6%). The Company believes this low incidence of viral breakthrough exhibited to date in a larger patient population further characterizes setrobuvir's high barrier to resistance.

Setrobuvir has been generally well-tolerated in the study. Safety data for patients receiving setrobuvir plus P/R, and comparison to the control group that received placebo plus P/R, are being reported through a time period that reflects a median dosing duration of 19 weeks. The rate of discontinuing treatment in the study due to adverse events has been similar in patients receiving setrobuvir plus P/R (5.6%) or P/R alone (5.9%). The profile of adverse events has been similar between the setrobuvir and control groups, with reported adverse events being typical for patients treated with interferon and ribavirin. In the setrobuvir group, 39% of patients (84/215) developed a rash while 22% (15/68) of patients in the control group developed a rash. 98% of the rashes in the setrobuvir group were mild or moderate (grade 1 or grade 2), compared to 93% in the control group. There were no Grade 4 rashes in either group. The incidence of rash in the setrobuvir group is consistent with prior reports of rash due to interferon and ribavirin through 19 weeks of treatment.



Proportion of patients with undetectable virus at Week 12 (cEVR)
setrobuvir + P/R placebo + P/R
--------------------- ---------------------
Treatment-naive patients 78% 56%
----------------------------------- --------------------- ---------------------
Treatment-experienced patients
prior partial responder or relapser 76% 44%
prior null responder 29% ---
----------------------------------- --------------------- ---------------------




Phase 2b Protocol Design

283 patients were dosed in this study. Patients received either setrobuvir 200 mg twice a day (bid) in combination with Pegasys® (peginterferon alfa-2a) and Copegus® (ribavirin, USP) (P/R) with a loading dose of setrobuvir 800 mg bid on day 1, or placebo plus P/R. Patients who had a prior null response to P/R, defined as less than a 1 log10 decline in viral load at week 4 or less than a 2 log10 decline at week 12 during prior treatment, were not randomized to receive placebo. All other patients were stratified by IL28B genotype (CC/non-CC) between setrobuvir and placebo groups. The interim antiviral response data is being reported as the proportion of patients with undetectable virus (< 15 IU/mL) using the Roche COBAS HCV TaqMan assay. The primary endpoint of the study is Sustained Virological Response 24 weeks after patients conclude all treatment, known as SVR24. In addition to the interim data released today, data through 24 weeks of dosing are expected around year-end. The study is being conducted at sites in the United States, Canada, Australia and New Zealand.

Treatment-Naive Group

102 treatment-naive patients received setrobuvir plus P/R

36 treatment-naive patients received placebo plus P/R

Treatment-naive patients who achieved undetectable levels of virus by Week 8 and maintain undetectable levels of virus are scheduled to conclude all treatment at Week 28

For treatment-naive patients with detectable virus at Week 8, treatment with setrobuvir or placebo and P/R is scheduled to continue through Week 48

Treatment-Experienced Group (including prior null responders)

82 patients who were partial responders during, or relapsers after, a prior course of therapy with P/R alone received setrobuvir plus P/R

32 corresponding patients received placebo plus P/R

31 prior null responder patients received setrobuvir plus P/R

All treatment-experienced patients are scheduled to be treated for 48 weeks

About Setrobuvir

Setrobuvir is an HCV RNA polymerase inhibitor that belongs to a chemical class referred to as non-nucleosides. Setrobuvir has a well-characterized safety database in which more than 350 subjects have received the agent to date. Setrobuvir has received Fast Track Status from the FDA for the treatment of chronic hepatitis C. Earlier this year, Anadys announced a cross-company clinical trial agreement with a large, commercial-stage biopharmaceutical company to study setrobuvir in combination with another DAA in healthy volunteers.

Conference Call Webcast and Slides

Anadys will hold a conference call and webcast today, October 13, 2011 at 8:00 a.m. Eastern Daylight Time to discuss interim antiviral response and safety data from an ongoing Phase IIb study of setrobuvir in combination with P/R. A live webcast of the call, including accompanying slides, will be available online at www.anadyspharma.com . A telephone replay with slides will also be available approximately one hour after completion of the call. To access the telephone replay, dial 888-286-8010 (domestic) or 617-801-6888 (international), passcode 21814367. The webcast and telephone replay will be available through October 27, 2011.

Safe Harbor Statement

Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such forward-looking statements include, but are not limited to, references to (i) the belief that the interim data described in this press release, coupled with a very favorable safety profile to date, position setrobuvir as a very attractive agent to be included in future DAA combination regimens, (ii) Anadys' belief that the low incidence of viral breakthrough exhibited to date further characterizes setrobuvir's high barrier to resistance, and (iii) setrobuvir's potency and adverse event profile based on the interim data reported in this press release. Such statements involve known and unknown risks, uncertainties and other factors, which may cause Anadys' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. For example, the results of preclinical and early clinical studies may not be predictive of future results, and Anadys cannot provide any assurances that setrobuvir will not have unforeseen safety issues, will have favorable results in ongoing or future clinical trials or will receive regulatory approval. In addition, Anadys' results may be affected by competition from other biotechnology and pharmaceutical companies, its effectiveness at managing its financial resources, its ability to enter into transactions around its product candidates, its ability to successfully develop and market products, difficulties or delays in its non-clinical studies or clinical trials, difficulties or delays in manufacturing its clinical trials materials, the scope and validity of patent protection for its products, regulatory developments and its ability to obtain additional funding to support its operations. Risk factors that may cause actual results to differ are more fully discussed in Anadys' SEC filings, including Anadys' Form 10-Q for the quarter ended June 30, 2011. All forward-looking statements are qualified in their entirety by this cautionary statement. Anadys is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

Pegasys® and Copegus® are registered trademarks of Hoffman-La Roche Inc.

SOURCE Anadys Pharmaceuticals, Inc.

Copyright (C) 2011 PR Newswire. All rights reserved

Transgene considers change study design after 3 patients develop interferon-related blood disorders in dosing with TG4040.

Article posted today from Bloomberg on 3 patients in Transgene vaccine trial (TG4040) that developed blood disorders normally associated with interferon. TG4040 was given with peg-inf and RBV in their clinical trial - it's not clear whether the blood disorders were due to the vaccine or the interferon component of the therapy.

Transgene Says 3 Patients in Hepatitis Trial Had Blood Disorders
October 11, 2011, 1:57 PM EDT

Oct. 11 (Bloomberg) -- Transgene SA said three patients in a mid-stage trial for its TG4040 vaccine to treat chronic hepatitis C developed blood disorders, prompting the biotechnology company to propose changing the study’s design.

One patient suffered aplastic anemia and two others developed thrombocytopenia, including one with neutropenia, after interferon therapy and not during direct treatment with TG4040, said Transgene, whose biggest shareholder is the French family headed by Alain Merieux, in an e-mailed statement today. TG4040 is used in combination with pegylated interferon alpha and ribavirin in the study, which included 154 people.

“A possible relationship with TG4040 cannot be today formally ruled out and is under active investigation,” the company, based near Strasbourg, France, said in the statement. “The company has decided to submit an amendment to the study design so as to avoid further exposing patients to possible similar adverse events.”

No such side effects occurred in an early-stage trial involving 39 patients who hadn’t received treatment for the disease, Transgene said. These severe events are possible though rare with the standard treatment alone, the company said.

A voicemail message left for Elisabetta Castelli, a Transgene spokeswoman, wasn’t immediately returned after business hours.

Aplastic anemia is a condition in which bone marrow doesn’t produce enough new blood cells. Thrombocytopenia is a decrease in platelets, a component of blood that aids clotting, and neutropenia is a decrease in neutrophils, the most common type of white blood cell.

Hepatitis C is caused by a virus that leads to chronic disease in 75 percent to 85 percent of those infected, according to the U.S. Centers for Disease Control and Prevention in Atlanta. About 170 million people carry the virus worldwide, the CDC said on its website.

--Editor: Kristen Hallam, Chris Staiti

To contact the reporter responsible for this story: Andrea Gerlin in London at agerlin@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

Inovio Pharmaceuticals and VGX International to Advance Therapeutic Hepatitis C and Hepatitis B Synthetic Vaccines into Clinical Studies

New partnership to develop a therapeutic HCV vaccine - Inovio and VGX will own both the vaccine and the delivery system to administer it

BLUE BELL, Pa., Oct. 10, 2011 /PRNewswire via COMTEX/ -- Inovio Pharmaceuticals, Inc. a leader in the development of synthetic vaccines against cancers and infectious diseases, announced today that it has entered into a product development collaboration agreement with its affiliate, VGX International Inc. to co-develop Inovio's SynCon® therapeutic vaccines for hepatitis B and C infections.

Under the terms of the agreement, VGX International will receive marketing rights for these vaccines in Asia, excluding Japan, and in return will fully fund IND-enabling and initial phase I and II clinical studies. Inovio will receive payments based on the achievement of clinical milestones and royalties based on sales in the licensed territories and retains all commercial rights in all other territories.

The first product to enter clinical testing will be a synthetic multi-antigen hepatitis C virus (HCV) vaccine covering genotypes 1a and 1b and targeting the antigens NS3/4A, which includes HCV nonstructural proteins 3 (NS3) and 4A (NS4A), as well as NS4B and NS5A proteins. The vaccine will be delivered with Inovio's CELLECTRA® delivery device. IND-enabling toxicology tests will be conducted in 1H 2012, with the intent being to initiate a phase I clinical study in late 2012. The target population for the vaccine clinical trials will be HCV infected individuals.

Supporting this product development advancement are positive preclinical results from Inovio's novel SynCon® vaccine targeting NS3/4A, which were published in the journal Molecular Therapy in the paper, "Hepatitis C Virus NS3/NS4A DNA Vaccine Induces Multi-epitope T Cell Responses in Rhesus Macaques Mimicking Human Immune Responses." Following immunization, rhesus macaques mounted strong HCV-specific T cell immune responses strikingly similar to those reported in patients who have cleared the virus on their own. The responses included strong NS3-specific interferon- (IFN-) induction, robust CD4 and CD8 T cell proliferation, and induction of polyfunctional T cells. The study was funded in part by a $2.8 million PA CURE grant received by Inovio and its collaborators in 2010 to develop this multi-antigen synthetic HCV vaccine.

"Hepatitis B and C are a major global health problem, with about 470 million people infected worldwide. As a development leader of synthetic vaccines, we are pleased to collaborate with our affiliate VGX International to advance our global, multi-antigen HCV vaccine into the clinic. This latest development is an integral part of Inovio's multi-pronged approach to develop our therapeutic hepatitis vaccine pipeline," stated Dr. J. Joseph Kim, President and CEO.
Inovio has an ongoing open label Phase II clinical study with ChronTech Pharma AB to test the effect of a DNA vaccine (ChronVac-C®) encoding for NS3/4A protein (genotype 1a) administered by Inovio's MedPulser® electroporation delivery device followed by the standard of care (SOC) drug treatment using interferon and ribavirin. In an earlier phase I study, 5 of 6 participants (83%) who received the vaccine along with SOC cleared the virus. SOC drug treatment alone in patients infected with HCV genotype 1 results in clearance of the virus in 40-50% of patients. Interim results from this phase II study are expected in 2012.

Inovio previously announced a research collaboration with ChronTech Pharma AB and Transgene S.A. to test the immunogenicity of a DNA/electroporation prime - MVA boost approach against HCV by combining two promising, previously studied clinical candidates. A Phase I clinical study is anticipated to start in Q4 2011.

Under the same agreement, Inovio and VGX International will also co-develop Inovio's SynCon® therapeutic vaccine for hepatitis B virus.

Pharmasset expands PSI-7977 ELECTRON trial for treatment of HCV...

Pharmasset expands it's ELECTRON trial by adding two interferon-free arms and modifying another one. The changes include a PSI-7977 monotherapy arm (!!!) for Tx-naive genotype 1 patients; a PSI-7977 + RBV arm in Tx-experienced GT 2/3 patients and modifying a treatment arm for null responders by adding an interferon-free PSI-7977 + RBV arm. This announcement caused investors to flee Vertex Pharmaceuticals, which saw a 7% slide today.

press release

Oct. 10, 2011, 6:45 a.m. EDT

Pharmasset Announces Further Expansion of ELECTRON Trial in Hepatitis C

--**Added PSI-7977 monotherapy arm in treatment-naive patients with HCV GT1
--**Added PSI-7977/RBV arm in treatment experienced patients with HCV GT2/3
--**Modified previously-announced treatment regimen in HCV GT1 prior null responders to explore IFN-free regimen of PSI-7977/RBV


PRINCETON, N.J., Oct. 10, 2011 /PRNewswire via COMTEX/ -- Pharmasset, Inc. announced today the addition of two treatment arms to the ELECTRON trial of PSI-7977, a nucleotide analog polymerase inhibitor, for the treatment of chronic hepatitis C (HCV). The rapid and consistent antiviral effects and high barrier to resistance demonstrated with PSI-7977 to date provided the rationale for additional exploratory regimens in this setting. The protocol amendment adds one arm exploring 12 weeks of PSI-7977 monotherapy in treatment naive patients with HCV genotype 1 (GT1), and one arm of PSI-7977 and ribavirin (RBV) in treatment-experienced patients with HCV genotype 2 (GT2) or genotype 3 (GT3). In addition, the previously announced arm in HCV GT1 patients with a prior "null" response to an interferon (IFN) containing regimen, which was planned to assess PSI-7977/IFN/RBV, has been modified to an IFN-free 12-week regimen of PSI-7977/RBV.

"We look forward to reporting SVR12 results from Part 1 and interim data from the PSI-7977 monotherapy arm of ELECTRON on Sunday, November 6th, 2011 at the upcoming 2011 American Association for the Study of Liver Diseases (AASLD) annual meeting. The preliminary results to be discussed at AASLD led us to expand the study to add an arm of PSI-7977 monotherapy for HCV GT1," said Michelle Berrey, MD, MPH, Pharmasset's Chief Medical Officer. "We and others continue to explore the potential of PSI-7977 for IFN-free and monotherapy treatment regimens in a broader group of individuals living with HCV of all genotypes and regardless of their response to prior treatment."

In addition to previously announced interferon-free studies of PSI-7977 by Bristol Myers Squibb and Tibotec, The National Institute of Health (NIH) recently initiated an interferon-free 24 week study of PSI-7977 400mg QD with and without ribavirin, in 60 treatment naive patients with HCV genotype 1 (GT1) in the US.

About ELECTRON

ELECTRON is an exploratory study of PSI-7977 for the treatment of chronic HCV infection. Part 1 of the trial is evaluating 12-week regimens of interferon-free PSI-7977 400mg QD with ribavirin (RBV), and three abbreviated duration peginterferon (Peg-IFN) regimens of 4, 8, or 12 weeks in treatment-naive patients with HCV GT2 or GT3. The primary endpoint of the trial is the safety and tolerability of PSI-7977 400mg QD and RBV for 12 weeks, administered with or without Peg-IFN. On May 11, 2011, Pharmasset announced the completed enrollment of Part 1 of ELECTRON:

PSI-7977 400 mg with Peg-IFN and RBV for 12 weeks (GT2/3)

PSI-7977 400 mg with RBV for 12 weeks, Peg-IFN weeks 1-8 only (GT2/3)

PSI-7977 400 mg with RBV for 12 weeks; Peg-IFN weeks 1-4 only (GT2/3)

PSI-7977 400 mg with RBV for 12 weeks (GT2/3)

In Part 2 of ELECTRON, a 5th cohort was added to explore PSI-7977 monotherapy in treatment naive patients with HCV GT2 or GT3:

PSI-7977 400 mg monotherapy for 12 weeks (n=10 GT2/3)

Following on the previously reported 100% SVR12 in treatment-naive subjects with HCV GT2/3 (PROTON), a 6th cohort was added to ELECTRON to explore an 8-week duration of PSI-7977Peg-IFN/RBV. The previously announced 7th cohort in HCV GT1 patients with a prior "null" response to Peg-IFN, has been modified to an interferon-free 12-week regimen of PSI-7977/RBV.

PSI-7977 400 mg with Peg-IFN/RBV for 8 weeks (n=10 GT2/3 treatment-naive)

PSI-7977 400 mg with RBV for 12 weeks (n=10 GT1 null)

In Part 3 of ELECTRON, two additional IFN-free regimens will be explored in treatment-naive patients with HCV GT1 and in treatment-experienced patients with HCV GT2 or GT3.

PSI-7977 400 mg monotherapy for 12 weeks (n=25 GT1 treatment-naive)

PSI-7977 400 mg with RBV for 12 weeks (n=25 GT2/3 treatment-experienced)

About Pharmasset

Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is the development of oral therapeutics for the treatment of hepatitis C virus (HCV) infection. Our research and development efforts are focused on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication. We currently have three clinical-stage product candidates advancing in trials in various populations. Our pyrimidine, PSI-7977, an unpartnered uracil nucleotide analog, is currently under study in five Phase 2b trials, including abbreviated duration interferon and interferon-free regimens, in subjects with all HCV genotypes. Our purine, PSI-938, an unpartnered guanosine nucleotide analog, is in QUANTUM, a Phase 2b interferon-free trial of PSI-7977 and PSI-938 in subjects with all HCV genotypes. Mericitabine (RG7128) continues in three Phase 2b trials and one interferon-free trial being conducted through a strategic collaboration with Roche.

ContactRichard E. T. Smith, Ph.D.VP, Investor Relations and Corporate CommunicationsOffice: +1 (609) 865-0693

Forward-Looking Statements

Pharmasset "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release that are not historical facts are "forward-looking statements," that involve risks, uncertainties, and other important factors, including, without limitation, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving our product candidates, the risk that our collaboration with Roche will not continue or will not be successful, and the risk that any one or more of our product candidates will not be successfully developed and commercialized. For a discussion of risks, uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended September 30, 2010 and our Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission.

SOURCE Pharmasset, Inc.

Copyright (C) 2011 PR Newswire. All rights reserved

Positive Phase 2a data for Biotron's first-in-class HCV p7 inhibitor BIT225...

Positive Phase 2a data for Biotron's first-in-class HCV p7 inhibitor BIT225

Biotron shares soar 34% on Hepatitis C Phase 2a positive results
Monday, October 10, 2011 by John Phillips

Biotron Limited (ASX: BIT) has received some strong support in the first couple of hours of market open today, with the stock trading 34% higher at $0.13 after announcing some positive trial results.

Preliminary analysis of trial data confirms that BIT225, an orally administered, small molecule drug, has good antiviral activity against HCV.

Patients receiving BIT225 in combination with interferon and ribavirin (the current standard of care for treating HCV) had greater reductions in HCV levels than patients receiving standard of care treatment alone.

Biotron said that patients receiving the 400 mg dose of BIT225 showed the greatest levels of virus reduction, with an improvement of ~1 log (a measure of the amount of reduction of the virus in the blood of patients) over standard of care treatment at the completion of the dosing phase with BIT225.

This is a significant improvement over and above the standard of care treatment in this patient group.

Twenty four patients who had passed a stringent screening process were randomly assigned to receive either 400 mg or 200 mg BIT225, or placebo (ratio of 1:1:1), for the first 28 days of their standard treatment with interferon and ribavirin.

The trial was undertaken at the Siriraj Hospital, Bangkok, Thailand.

All patients were infected with genotype 1 HCV, which is the most common type of HCV and the most resistant to current treatment.

BioTrends Research Group report on provider perceptions and use of Incivek and Victrelis...

New research from BioTrends Research Group on HCV provider perceptions and use of both Incivek and Victrelis. Consistent with my perceptions in the field, there is a wide gap between use of Incivek vs Victrelis, with Incivek taking a large lead. Not mentioned in this report is an emerging trend of some providers starting a second wave of 'warehousing' for the second generation of HCV Direct Acting Antivirals (DAAs), mostly for patients that are F0-F1 and are null responders to previous Peg + P/R therapy or genotype 2/3 nonresponders.

PRESS RELEASE
Oct. 6, 2011, 3:12 p.m. EDT
Hepatitis C Landscape is Changing as the New Protease Inhibitors are Adopted into Clinical Practice

Vertex's Incivek is outperforming Merck/Roche's Victrelis on many of the most important attributes and differences between physician specialties are beginning to emerge according to a new report by BioTrends Research Group


EXTON, Pa., Oct 06, 2011 (BUSINESS WIRE) -- Three months after the launch of Vertex's Incivek (telaprevir) and Merck/Roche's Victrelis (boceprevir), results from the second wave of research conducted by BioTrends Research Group indicate strong interest and high demand for triple therapy with the new protease inhibitors.

In LaunchTrends(R): Incivek and Victrelis, Wave 2 BioTrends surveyed a total of 80 physicians (gastroenterologists, hepatologists, and infectious disease specialists) and conducted in-depth qualitative interviews with a subset of the respondents about their current perceptions, early experience and anticipated future use of these products. In addition, feedback around patient type, product satisfaction, patient influence, obstacles to use, and promotional activities is captured.

With expectations running high in the months leading up to the launch of the protease inhibitors, the level of awareness and familiarity with these products remains strong. Now more than two thirds of surveyed physicians have initiated trial with Incivek or Victrelis compared to more than one half of physicians at one month post-launch. Most physicians report that they have prescribed both brands suggesting that physicians continue to be in trial mode. Trial rates do vary by physician specialty and in addition, after three months of experience, specialty differences in preference and usage are now emerging.

The majority of surveyed physicians report seeing either a Victrelis or Incivek representative. Representatives for both products were given strong performance ratings on their overall disease state and product knowledge. There were slight variations in messages being delivered with counter-detailing largely centered on the side effect profile of the competitor drug.

Physicians report a high number of eligible patients yet to be started on the new protease inhibitors. Both newly diagnosed patients as well as patients who had either failed prior treatment or who were untreated and awaiting the approval of Incivek and Victrelis are fueling patient starts. Although the protease inhibitors are only indicated for genotype 1 patients, approximately one-third of the respondents report that they would consider these agents for genotype 2/3 patients as well. While both products have increased market share by about 50 percent at three months compared to one month post launch, the gap between the products has widened with Incivek continuing to take the lead. Market share projections in the next six months suggest that Incivek will retain a significant share advantage although the surveyed physicians indicate that the projected gap will narrow.

With the recent European approval of telaprevir under the brand name INCIVO(R), preceded by the approval of boceprevir (VICTRELIS(TM)) in July, the protease inhibitors are poised to address a significant unmet global need for better treatments for genotype 1 chronic-HCV. The impact of the products in the EU countries will be closely monitored and reported on in a Treatment Trends HCV (EU) to be published in 2012.

About LaunchTrends

LaunchTrends(R): Incivek and Victrelis is a series of three post-launch syndicated reports designed to track the uptake of Merck's Victrelis and Vertex's Incivek at one month, three months and six months following launch. LaunchTrends(R) assesses trial and use of new products, barriers to use, reasons to use, typical patient types, line of therapy, product perceptions, promotional efforts/messages and product satisfaction.

About BioTrends Research Group, LLC

BioTrends Research Group, LLC provides syndicated and custom market research to pharmaceutical manufacturers competing in clinically evolving, specialty pharmaceutical markets. For information on BioTrends publications and research capabilities, please contact us at (610) 363-3872 or www.bio-trends.com .

About Decision Resources Group

Decision Resources Group is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources Group at www.DecisionResourcesGroup.com .

All company, brand, or product names contained in this document may be trademarks of their respective holders.

SOURCE: BioTrends Research Group, LLC

Vertex to Present New Data from Hepatitis C Development Program at AASLD Annual Meeting

Vertex to Present New Data from Hepatitis C Development Program at AASLD Annual Meeting

- Late-Breaker Presentations Include Phase 2 Data from INCIVEK-Based Combination Regimen in HIV/HCV Co-Infection and Short Duration Treatment with a Four-Drug Regimen Including INCIVEK and VX-222 -


CAMBRIDGE, Mass., Sep 30, 2011 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated VRTX +4.67% today announced that abstracts from its hepatitis C program, including two late-breaking posters from studies of INCIVEK(TM) (telaprevir) tablets and VX-222, were accepted for presentation at The Liver Meeting(R), the 62nd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, November 4-8, 2011.

New data, including sustained viral response (SVR, or viral cure) results, from a Phase 2 study evaluating short durations of 12- and 24-week regimens of VX-222 in combination with INCIVEK (in-SEE-veck), pegylated-interferon and ribavirin in people with genotype 1 chronic hepatitis C who were new to treatment will be presented for the first time. Additionally, new data from a Phase 2 study evaluating INCIVEK combination treatment in people co-infected with genotype 1 chronic hepatitis C and human immunodeficiency virus (HIV) will be presented at the meeting. All people in this study were new to hepatitis C treatment.

"INCIVEK combination therapy has successfully increased viral cure rates and shortened total treatment time for the majority of people with hepatitis C who are being treated for the first time, but we have more to do," said Peter Mueller, Ph.D., Chief Scientific Officer and Executive Vice President of Global Research and Development at Vertex. "Our ongoing research is aimed at further improving treatment for hepatitis C by exploring the use of INCIVEK among those in critical need of more effective medicines and evaluating combinations, including some without interferon, that may offer higher cure rates and shorter treatment times."

The accepted abstracts are now available on the AASLD website at https://www.aasld.org/lm2011 .

INCIVEK Oral Presentations

1. #31: "Efficacy and safety of telaprevir-based regimens in cirrhotic patients with HCV genotype 1 and prior peginterferon/ribavirin treatment failure: subanalysis of the REALIZE Phase III study." November 6, 2011, 3:00 p.m. PDT.

2. #32: "Predictors of virologic response with telaprevir-based combination treatment in HCV genotype 1-infected patients with prior peginterferon/ribavirin treatment failure: post-hoc analysis of the Phase III REALIZE study." November 6, 2011, 3:15 p.m. PDT.

3. #35: "Retreatment with telaprevir/Peg-IFN/RBV after a short exposure to telaprevir in Phase I studies: interim results from a Phase IIIb rollover trial (C219)." November 6, 2011, 4:00 p.m. PDT.

4. #248: "Follow-up of SVR Durability and Viral Resistance in Patients with Chronic Hepatitis C Treated with Telaprevir-Based Regimens: Interim Analysis of the EXTEND Study." November 8, 2011, 11:00 a.m. PDT.

Vertex Late-Breaking Poster Presentations

1. #LB-8: "Telaprevir Combination with Peginterferon Alfa-2a/Ribavirin in HCV/HIV Coinfected Patients: 24-Week Treatment Interim Analysis." November 7, 2011.

2. #LB-14: "VX-222/telaprevir in Combination with Peginterferon Alfa-2a and Ribavirin in Treatment-naive Genotype 1 HCV Patients Treated for 12 Weeks: ZENITH Study, SVR12 Interim Analysis." November 7, 2011.

Vertex Poster Presentations

1. #943: "Projections Using Decision-Analytic Modeling of Long-Term Clinical Value of Telaprevir for the Treatment of HCV Patients who had Failed Prior Peginterferon/Ribavirin Treatment." November 6, 2011.

2. #1328: "Summary of Clinical Virology Findings from Clinical Trials of Telaprevir." November 7, 2011.

3. #1331: "Different likelihood of achieving SVR on a telaprevir-containing regimen among null responders, partial responders and relapsers irrespective of similar responses after a peginterferon/ribavirin 4-week lead-in phase: REALIZE study subanalysis." November 7, 2011.

4. #1368: "Impact of anemia and ribavirin dose reduction on SVR to a telaprevir-based regimen in patients with HCV genotype 1 and prior peginterferon/ribavirin treatment failure in the Phase III REALIZE study." November 7, 2011.

5. #1369: "Impact of insulin resistance on virologic response to a telaprevir-based regimen in patients with HCV genotype 1 and prior peginterferon/ribavirin treatment failure: post-hoc analysis of the REALIZE Phase III study." November 7, 2011.

6. #2105: "Sustained Virologic Response Rates and Viral Resistance Profiles Were Similar in Patients Treated with a Telaprevir-Based Regimen Regardless of Liver Fibrosis Stage." November 8, 2011.

About INCIVEK

INCIVEK is an oral medicine that acts directly on the hepatitis C virus protease, an enzyme essential for viral replication. INCIVEK was approved by the U.S. Food and Drug Administration (FDA) in May 2011 and by Health Canada in August 2011 for people with genotype 1 chronic hepatitis C with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver). INCIVEK is approved for people who are new to treatment, and for people who were treated previously but who did not achieve a sustained viral response or viral cure (relapsers, partial responders and null responders).

INCIVEK (750 mg) is given as two 375 mg tablets three times daily for 12 weeks in combination with pegylated-interferon and ribavirin. Each monthly package of INCIVEK contains four weekly boxes that include daily blister strips. After the first 12 weeks, all patients stop receiving INCIVEK and continue treatment with pegylated-interferon and ribavirin alone for an additional 12 weeks or 36 weeks of treatment. With INCIVEK combination therapy, more than 60 percent of people treated for the first time, as well as those who relapsed after previous therapy, are expected to complete all treatment in 24 weeks. All other patients receive a total of 48 weeks of treatment.

Rash and anemia are the most serious side effects associated with INCIVEK, which led to treatment discontinuation in about 1 percent of people in clinical studies. The most common side effects reported with INCIVEK combination treatment include fatigue, itching, nausea, diarrhea, vomiting, anal or rectal problems, and taste changes.

Vertex developed telaprevir in collaboration with Tibotec BVBA and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir in North America where it is being marketed under the brand name INCIVEK (in-SEE-veck). Through its affiliate, Janssen, Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. In September 2011, telaprevir was approved in the European Union and Switzerland. Telaprevir is known as INCIVO(R) in Europe. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries. In September 2011, telaprevir was approved in Japan and will be known as Telavic(R).

About VX-222

VX-222 is an oral medicine in development that is a non-nucleoside inhibitor of the HCV NS5B polymerase. VX-222 is being evaluated in a Phase 2 study in combination with INCIVEK and ribavirin, with and without pegylated-interferon. Vertex retains worldwide commercial rights to VX-222.

IMPORTANT SAFETY INFORMATION

Indication

INCIVEK(TM) (telaprevir) is a prescription medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (lasting a long time) hepatitis C genotype 1 infection in adults with stable liver problems, who have not been treated before or who have failed previous treatment. It is not known if INCIVEK is safe and effective in children under 18 years of age.

Important Safety Information

INCIVEK should always be taken in combination with peginterferon alfa and ribavirin. Ribavirin may cause birth defects or death of an unborn baby. Therefore, a patient should not take INCIVEK combination treatment if she is pregnant or may become pregnant, or if he is a man with a sexual partner who is pregnant. Patients must use two forms of effective birth control during treatment and for the 6 months after treatment with these medicines.

INCIVEK and other medicines can affect each other and can also cause side effects that can be serious or life threatening. There are certain medicines patients cannot take with INCIVEK combination treatment. Patients should tell their healthcare providers about all the medicines they take, including prescription and non-prescription medicines, vitamins and herbal supplements.

INCIVEK can cause serious side effects including rash and anemia. The most common side effects of INCIVEK include itching, nausea, diarrhea, vomiting, anal or rectal problems, taste changes and tiredness. There are other possible side effects of INCIVEK, and side effects associated with peginterferon alfa and ribavirin also apply to INCIVEK combination treatment. Patients should tell their healthcare providers about any side effect that bothers them or doesn't go away.

Please see full Prescribing Information for INCIVEK including the Medication Guide, available at www.INCIVEK.com .

INCIVEK(TM) is a trademark of Vertex Pharmaceuticals Incorporated.

PEGASYS(R) and COPEGUS(R) are registered trademarks of Hoffmann-La Roche.

About Hepatitis C

Hepatitis C is a serious liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver.(1) Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.(1)Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.(1)

Unlike HIV and hepatitis B virus, chronic hepatitis C can be cured.(2) However, approximately 60 percent of people do not achieve SVR,(3,4,5)or viral cure,(6) after treatment with 48 weeks of pegylated-interferon and ribavirin alone. If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.(7,8)

More than 170 million people worldwide are chronically infected with hepatitis C.(6) In the United States, nearly 4 million people have chronic hepatitis C and 75 percent of them are unaware of their infection.(9)Hepatitis C is four times more prevalent in the United States compared to HIV.(9)The majority of people with hepatitis C in the United States were born between 1946 and 1964, accounting for two of every three people with chronic hepatitis C.(10)Hepatitis C is the leading cause of liver transplantations in the United States and is reported to contribute to 4,600 to 12,000 deaths annually.(11,12)By 2029, total annual medical costs in the United States for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion.(9)

Special Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including statements regarding Vertex's aim to further improve treatment for hepatitis C by exploring the use of INCIVEK among those in critical need of more effective medicines and evaluating combinations that may offer higher cure rates and shorter treatment times. While the company believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, future scientific, clinical, competitive or other market factors may adversely affect the potential for INCIVEK-based therapies and the other risks listed under Risk Factors in Vertex's annual report and quarterly reports filed with the Securities and Exchange Commission and available through Vertex's website at www.vrtx.com . Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

About Vertex

Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives.

Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases.

Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada.

(VRTX-GEN)

(1) Centers for Disease Control and Prevention. Hepatitis C Fact Sheet: CDC Viral Hepatitis. Available at: http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf . Accessed March 21, 2011.

(2) Pearlman BL and Traub N. Sustained Virologic Response to Antiviral Therapy for Chronic Hepatitis C Virus Infection: A Cure and So Much More. Clin Infect Dis. 2011 Apr;52(7):889-900.

(3) Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001;358:958-965.

(4) Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-982.

(5) McHutchison JG, Lawitz EJ, Shiffman ML, et al; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009;361:580-593.

(6) Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.

(7) Morgan TR, Ghany MG, Kim HY, Snow KK, Lindsay K, Lok AS. Outcome of sustained virological responders and non-responders in the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) trial. Hepatology. 2008;50(Suppl 4):357A (Abstract 115).

(8) Veldt BJ, Heathcote J, Wedmeyer H. Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Annals of Internal Medicine. 2007; 147: 677-684.

(9) Institute of Medicine of the National Academies. Hepatitis and liver cancer: a national strategy for prevention and control of hepatitis B and C. Colvin HM and Mitchell AE, ed. Available at: http://www.iom.edu/Reports/2010/Hepatitis-and-Liver-Cancer-A-National-Strategy-for-Prevention-and-Control-of-Hepatitis-B-and-C.aspx . Updated January 11, 2010. Accessed March 21, 2011.

(10) Pyenson B, Fitch K, Iwasaki K. Consequences of hepatitis C virus (HCV): Costs of a baby boomer epidemic of liver disease. Available at: http://www.natap.org/2009/HCV/051809_01.htm . Updated May 2009. Accessed March 21, 2011. This report was commissioned by Vertex Pharmaceuticals, Inc.

(11) Volk MI, Tocco R, Saini S, Lok, ASF. Public health impact of antiviral therapy for hepatitis C in the United States. Hepatology. 2009;50(6):1750-1755.

(12) Davis GL, Alter MJ, El-Serag H, Poynard T, Jennings LW. Aging of hepatitis C virus (HCV)-infected persons in the United States: A multiple cohort model of HCV prevalence and disease progression. Gastroenterology. 2010;138:513-521.

SOURCE: Vertex Pharmaceuticals Incorporated


Vertex Pharmaceuticals Incorporated
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or
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