Medivir moves to strengthen its HCV portfolio...

Press release dated 9-5-12 on the Medivir AB website. Medivir bolstered it's HCV portfolio by purchasing anti-HCV related preclinical research compounds from Novadex Pharmaceuticals. This purchase includes IP and prodrug technologies as well in hopes that it could be applied to both HCV protease inhibtors and nucleoside analogs to give a boost to the pharmacokinetic properties. Medivir already has TMC-435 in collaborative development with Janssen Pharaceuticals, now in Phase III clinical trials. 

Medivir acquires preclinical antiviral programs including hepatitis C and prodrug technologies

05-Sep-12 Stockholm, Sweden—Medivir AB (OMX: MVIR), announced today that it has acquired preclinical research stage assets from Novadex Pharmaceuticals AB. The acquisition includes intellectual property and prodrug technologies in order to further strengthen Medivir’s hepatitis C platform and know how.

The acquired portfolio of research stage antiviral programs includes novel nucleotide polymerase inhibitors that have been identified and developed. It also includes prodrug technologies which could be applied to both protease inhibitors and nucleoside analogues to enhance their overall pharmacokinetic properties.

“We are very pleased to be able to make these additions to the Medivir R&D portfolio, which will further strengthen our pipeline and capabilities in the antiviral disease area. There are several synergies with the Medivir anti-viral projects and prodrug approaches which we aim to explore” comments Charlotte Edenius, Medivir’s EVP of Research and Development

The transaction value, which consists of up-front payment as well as future potential milestone payments, is not disclosed.

For more information about Medivir, please contact:

Medivir Direct: +46 8 440 6550 or:
Rein Piir, EVP Corporate Mobile: +46 708 537 292
Affairs & IR
M:Communications medivir@mcomgroup.com
Europe: Mary-Jane Elliott, +44(0)20 7920 2330
Amber Bielecka, Hollie Vile

About Medivir

Medivir is an emerging research-based pharmaceutical company focused on infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company’s key pipeline asset is simeprevir (TMC435), a novel protease inhibitor in phase III clinical development for hepatitis C that is being developed in collaboration with Janssen Pharmaceuticals.

In June 2011, Medivir acquired the specialty pharmaceutical company BioPhausia. and today Medivir has a broad product portfolio with prescription pharmaceuticals in the Nordics.

Medivir’s first product, the unique cold sore product Xerese®/Xerclear®, is launched in collaboration with GlaxoSmithKline to be sold OTC under the brand name ZoviDuo in Europe, Japan and Russia.

Medivir’s IPO was in 1996 and currently the company has around 180 employees.

For more information about Medivir, please visit the Company’s website: www.medivir.com

JID: 'Chronic Hepatitis C Virus Infection Increases Mortality From Hepatic and Extrahepatic Diseases: A Community-Based Long-Term Prospective Study'

I reference this study entitled 'Chronic Hepatitis C Virus Infection Increases
Mortality From Hepatic and Extrahepatic Diseases: A Community-Based Long-Term
Prospective Study' from the "Journal of Infectious Diseases" all the time in conversation and seem to get a good discussion going. I'm hoping for the same outcome on the Internet, thus this post. This is a HUGE cohort study from China (n = 23,820). Grant it, the 'n' representative of the HCV seropositive population is rather small (1095) compared to the seronegative population (19,636), and the population is of Eastern descent, but even given the sampling and ethnic disparity, there are compelling conclusions here which bear further study. Most notably, that having replicating Hepatitis C virus results in not only greater hepatic-related mortality, but extra-hepatic as well. Replicating virus = inflammation of all types. This gives compelling fuel to treatment advocates arguments that, barring contraindications and other special cases, Hepatitis C-positive patients should be considered for treatment now vs 'warehousing' for drugs that might/might not make it to market in the future. Hopefully further prospective and retrospective data based on the conclusions here will shed more light on this controversial subject. 

Investing Daily.com: Hepatitis C Drug Companies and All-Oral Treatment - A $20 Billion Market

Posted 8/28/12 on Investing Daily.com. Author and investor Jim Finks takes a look at the current HCV Drug Development space. Of note is the projected $20 billion worldwide HCV drug market which he feels will greatly be increased from the current $5 billion if drugs with better tolerability and efficacy make it to market, coupled with the benefit of interferon-free regimens for some patients.    

Hepatitis C Drug Companies and All-Oral Treatment: A $20 Billion Market

by JIM FINK on AUGUST 28, 2012
in STOCKS TO WATCH

Last week I wrote about 3 Stock Plungers and only liked the future prospects of one of the stocks: Idenix Pharmaceuticals (NasdaqGM: IDIX). My main reason for thinking a sustainable stock rebound is possible was because it’s a top-ten holding of value-investing legend Seth Klarman, who owns a 9.2% stake in the company (10 million shares) at an average purchase price of $8 per share (30% higher than the stock’s current price of $6.15). Klarman’s Baupost Group has bought shares in Idenix for five consecutive quarters.

This begged the question why Klarman is so enamored with Idenix. I couldn’t get an interview with Klarman to ask him and Baupost Group’s 2011 shareholder letter (dated Jan. 31, 2012) doesn’t mention Idenix — even though Klarman started buying the stock in Q2 2011. Consequently, I needed to research Idenix myself.

Hepatitis C Virus is a Global Killer
I discovered that the Idenix investment story is all about the market opportunity for treating Hepatitis C, a virus that infects the liver and is life-threatening – slowly destroying the liver over 20-30 years (resulting in cirrhosis or cancer). For those that are unsure, the liver is a vital organ that we cannot live without.

There is no vaccine for Hepatitis C, so the number of people who will get infected (e.g., sexual intercourse, tattoos, blood transfusions/dialysis, sharing dirty needles, mother/child) is predictable and not likely to go down. Furthermore, the body does not develop immunity from experiencing the disease, so people can get infected multiple times. In other words, the market demand for Hepatitis C drug cures is high and long-lasting. Below are some facts about Hepatitis C:

Worldwide, 180 million people are infected and 350,000 die each year.
In the U.S., 3.2 million people are infected, between 32,000 and 110,000 are newly infected each year, and 15,000 to 20,000 die each year.
75% of infections are curable, but up to 75% of all infected people don’t realize that they have the disease because they don’t look or feel sick – until it is too late.

Annual global sales of Hepatitis C drugs is currently $5 billion, but analysts project that new drug treatments with fewer side effects and oral application could generate a worldwide market opportunity of $20 billion.

The U.S. Centers for Disease Control and Prevention (CDC) recently recommended that all baby boomers born between 1946 and 1964 (76 million people aged 47 to 67) be tested for Hepatitis C infection.

Treating Hepatitis C with Interferon Injections is Unpleasant
Prior to 2011, the standard treatment for Hepatitis C was a combination of immune-boosting peginterferon injections – offered by Merck (NYSE: MRK) and Roche Holding AG (OTC Markets: RHHBY) — and ribavirin anti-viral pills (ribavirin patent has expired, so generic versions are available from several companies). Course of treatment was long at 48 weeks and costs $15,000 to $30,000, the cure rate was only 46% and there were severe side effects (e.g., flu-like symptoms, anemia, depression).

Treating Hepatitis C with Protease Inhibitors Is Better But Still Requires Interferon
Then, in May 2011, the Food & Drug Administration (FDA) approved two new Hepatitis C drugs called “protease inhibitors” that promise much higher cure rates (75%) and shorter treatment protocols (half as long at 24 weeks). Both of these drugs are taken orally in pill form but only work in conjunction with the standard peginterferon injections and ribavirin treatment. The two new drugs are:

Victrelis by Merck, which has a 66% cure rate, costs between $26,400 and $48,400 per course of treatment, and requires 12 pills per day.

Incivek by Vertex Pharmaceuticals (NasdaqGS: VRTX), which has a 79% cure rate, costs $49,200 per course of treatment, and requires 6 pills per day.

Based on the higher cure rate and simpler dosing from Incivek, it should come as no surprise that Incivek is outselling Victrelis 3-to-1.

Treating Hepatitis C with All-Oral Nucleotide Drugs is the Holy Grail

But Vertex’s dominance with Incivek could be short-lived because other drug companies are working on new Hepatitis C drugs called “nucleotides” that offer the holy grail of therapy: pill-only treatment that does not require the peginterferon/ribavirin injection albatross.

Perhaps in the forefront of all-oral Hepatitis C treatment is Gilead Sciences (NasdaqGS: GILD), which in November 2011 acquired biotech company Pharmhasset in a monstrous $10.8 billion all-cash deal. Pharmhasset’s Hepatitis C drug in Phase III trials is called PSI-7977 and could be on the market by 2014. According to Gilead, PSI-7977 is “way ahead of everybody else” and promises a cure in only 8-to-12 weeks of treatment. However, news in February that patients experience a relapse of Hepatitis C symptoms after stopping treatment with PSI-7977 caused Gilead’s stock price to suffer its largest one-day drop in 11 years. Since February, Gilead has recovered to all-time highs, which suggests investors have concluded that PSI-7977 will remain the core treatment for Hepatitis C – perhaps in combination with other drugs — despite the relapse issue.

Gilead’s drug may be best, but it won’t be the first all-oral treatment on the market because Roche Holdings is expected to offer an all-oral drug cocktail possibly consisting of setrobuvir (obtained in its acquisition of Anadys Pharmaceuticals in October 2011), danoprevir (purchased from InterMune (NasdaqGS: ITMN) in October 2010), and Merck’s Victrelis.

With Bristol-Myers Squibb’s (NYSE: BMY) abandonment of the Hepatitis C drug (BMS-986094) acquired from Inhibitex for $2.5 billion and the FDA clinical hold on Idenix’s Hepatitis C drug (IDX-19368) pending additional safety data, the path to riches in Hepatitis C treatment is proving to be a tortuous one. Other drug companies in the race for Hepatitis C drug treatments or vaccines include:

Achillion Pharmaceuticals (NasdaqGS: ACHN)
Abbott Laboratories (NYSE: ABT)
Dynavax Technologies (NasdaqCM: DVAX)
Peregrine Pharmaceuticals (NasdaqCM: PPHM)
Inovio Pharmaceuticals (NYSE: INO)
Medivir AB (OTC Markets: MVRBF) –  in partnership with Johnson & Johnson (NYSE: JNJ)

Achillion is a Prime Takeover Candidate
Of all of these companies, the best speculative buy right now may be Achillion. It is a pure-play on Hepatitis C with two promising drugs under development (one protease inhibitor and one NS5). There are no FDA clinical holds on Achillion’s drug pipeline like there are on Idenix and Achillion’s small market cap of $481 million makes the company an easily digestible acquisition for big boys like Gilead, Roche, Merck, or Abbott.

Furthermore, I have a soft spot for Achillion because it is located in New Haven, Connecticut (where I lived for four years) and is in partnership with my alma mater, Yale University. Good things happen to people and companies associated with a top-notch educational institution like Yale.

miR-122 inhibitor SPC3649 successfully inhibits HCV replication in chimps...

Posted 8/30/12 on Texas Biomed.org. Texas Biomedical Research Institute scientists in collaboration with Denmark's Santaris Pharma A/S have successfully inhibited HCV replication in chimpanzees using SPC3649, a DNA-based drug developed from Santaris's proprietary LNA ('Locked Nucleic Acid') technology. SPC3649 inhibits a host-based RNA molecule microRNA122 (miR-122) which HCV uses to replicate.  The drug is currently in phase II trials in humans and looks particularly compelling because of it's lack of any known side effects. 

Attacking the Silent Killer

Texas Biomed scientists have demonstrated that a new and novel class of drug targeting hepatitis C infections successfully inhibited replication of the virus in the liver of chimpanzees. The drug is now in phase two human clinical trials.

The drug was developed by the biopharmaceutical firm Santaris Pharma A/S in Denmark using its proprietary nucleic acid chemistry called “locked nucleic acid” or LNA. The drug, known as SPC3649, is a DNA-based drug that captures a small RNA molecule in the liver, called microRNA122 (miR-122) that is required for hepatitis C virus (HCV) replication.

“Our collaboration with Santaris Pharma proved that the drug worked exceptionally well in treating HCV infections in chimpanzees,” said Texas Biomed’s Robert E. Lanford, Ph.D., of the Department of Virology and Immunology. He was the lead author on the study appearing in the journal Science in January 2010.

One of the novel aspects of this drug is that it targets a host factor, miR-122, required by the virus, rather than directly targeting the virus itself. This helped prevent antiviral resistance, a major problem with therapies that directly target the virus.  Remarkably, this drug continued to work for several months after administration of the last dose.

The other novel aspect was the use of a DNA based therapy in what is called antisense technology. Antisense was supposed to be one of the “magic bullets” along with siRNA technology, but thus far no one has gotten them to work when systemically administered. Thus, this proof-of-concept study suggests that the LNA technology might also prove useful in using DNA based antisense drugs to treat many other diseases such as AIDS, cancer, and inflammatory diseases.

The study was conducted under a sponsored research grant to Texas Biomed. The primate studies were performed at Texas Biomed’s Southwest National Primate Research Center, which is supported by the National Institutes of Health.

HCV infections affect 170 million people worldwide and may progress over years to end-stage liver disease, including cirrhosis and liver cancer. In the United States, 4 percent of the adult population is chronically infected with HCV. The only U.S. FDA-approved therapy is pegylated-interferon and ribavirin, which is highly toxic, requires 48 weeks of treatment, and works in less than half of patients who are able to complete the full course of treatment. HCV infection is the leading reason for liver transplantation in the U.S, and HCV associated liver cancer is the most rapidly increasing cause of cancer death in the U.S.

Because it provides a high barrier to resistance, the new therapy could potentially replace interferon in future drug cocktails. “This antiviral could be used alone in long-term therapy to treat disease progression,” Lanford said. The new therapy may also be good to use after liver transplantation, because it may help suppress the replication of HCV in the new liver. The therapy has no known toxic or adverse reactions, and this is critical in the transplant setting.

In the study, four chimpanzees chronically infected with HCV were treated with the new antiviral drug. The two animals that received the higher dose had a reduction in virus levels in the blood and liver of approximately 350-fold. Additional surprising findings were the lack of antiviral resistant mutants and the fact that the therapy continued to work for several months after dosing stopped. An additional benefit of the drug was the reduction of total serum cholesterol by up to 45%, due to inhibition of the normal function of miR122 in cholesterol and fatty acid metabolism.

The new study was a critical proof of concept that the LNA technology could work for HCV. It proved that miR-122 is essential for HCV replication in an animal infected with HCV. Previously the role of miR-122 in HCV replication had only been shown in tissue culture. A second advance was the finding that LNA therapy could work against an important human disease in the chimpanzee model, suggesting that the new technology could be applied to other diseases.

Achillion Pharmaceuticals HCV pipeline suddenly looking attractive...

Posted 8/29/12 on Business Week.com. Achillion Pharmaceuticals, once regarded as an also ran by Big Pharma suddenly looks sexy again as clinical holds and pipeline failures stymie drug development with Idenix and BMS. Rumors of a takeover has made Achillion stock surge in the past couple of days. The HCV drug development space continues to be one of the most dynamic in pharma, there is definitely no shortage of spills and thrills. 

Achillion Deal Looming as Hepatitis Drugs Fail: Real M&A

By Ryan Flinn and Will Robinson on August 29, 2012

Achillion Pharmaceuticals Inc. (ACHN), the developer of hepatitis C treatments that was passed over by potential acquirers in the last year, is poised to draw renewed interest after setbacks by rival drugmakers.

Bristol-Myers Squibb Co. (BMY) last week said it was abandoning an experimental hepatitis C pill it obtained through its February purchase of Inhibitex Inc. after one patient died and others were hospitalized while taking the drug in a study. This week, Idenix Pharmaceuticals Inc. said U.S. regulators halted its study of a similar therapy, marking the second hold on clinical trials for the company this month.

With the market for new hepatitis C treatments projected to reach $20 billion by 2020 and Achillion facing no delays in two drugs under development, Piper Jaffray Cos. and William Blair & Co. say the $481 million company could gain fresh attention as a takeover candidate for Merck & Co. (MRK), Roche (ROG) Holding AG and Vertex Pharmaceuticals Inc. (VRTX) A suitor could pay a premium of as much as 79 percent to Achillion’s stock price and still acquire the New Haven, Connecticut-based company for less than its peak market value earlier this year, when takeovers and merger speculation spurred a surge in hepatitis C drugmakers’ shares.

“The frenzy has been taken out of the space, but I still think Achillion is very attractive” because its therapies have the potential to be the best of their type, Ted Tenthoff, a New York-based analyst for Piper Jaffray, said in a telephone interview. “We expect the wave of consolidation to continue. Achillion is clearly a target.”

Drug Development
Joe Truitt, Achillion’s chief commercial officer, said it wasn’t appropriate to comment on the company’s development plans, including the possibility of a takeover.

“We’ll make the best strategic options as they come to us, but for right now, we’re developing our drugs and getting them into combinations and making them available to patients,” Truitt said in a phone interview.

Today, shares of Achillion rose 3.5 percent to $6.86 at 9:45 a.m. in New York, the second-biggest gain among 116 stocks in the Nasdaq Biotechnology Index.

Hepatitis C is a viral infection that can cause liver damage and is estimated to affect 180 million people worldwide, according to the National Institutes of Health. Rising deaths among so-called baby boomers from the infection prompted U.S. health officials to declare in May that all of those born from 1946 to 1964 are at risk and should be tested.

Achillion is among several companies racing to develop hepatitis C cures that would replace the standard year-long injectable treatment that can cause flu-like symptoms.

Four Classes
There are four new classes of drugs under development to cure hepatitis C. Each work in different ways to stop the virus from replicating, and can be effective against one or several subtypes of the disease.

Drugmakers such as Abbott Laboratories (ABT), Achillion, Bristol- Myers, Gilead Sciences Inc. (GILD), Merck and Vertex have been testing these therapies, either alone or together, with varying degrees of success. The promise of a market that Achillion Chief Executive Officer Michael Kishbauch estimates will grow to $20 billion by 2020 spurred at least three acquisitions since October.

The biggest deal was Gilead’s $10.8 billion acquisition of Pharmasset Inc., announced in November, which came a month after Roche agreed to buy Anadys Pharmaceuticals Inc. for about $230 million. Bristol-Myers followed in January by announcing its $2.5 billion purchase of Inhibitex.

Fresh Look
Achillion’s Kishbauch said in November that the company was in “advanced discussions” with potential partners or acquirers. Its shares then reached a five-year high of $12.38 in February on takeover speculation before falling (ACHN) 46 percent since then as no deal materialized.

Now, with Bristol-Myers stopping development of the drug it bought from Inhibitex, and Idenix (IDIX) halting testing of a similar therapy, Achillion could attract a fresh look from companies seeking hepatitis treatments to use on their own or in combination with their existing therapies, said Liisa Bayko, a Chicago-based analyst with JMP Securities LLC.

Achillion is testing two types of drugs. By combining several classes of these new hepatitis C drugs, doctors may be able to limit the virus’ ability to infect, mimicking the strategy that a decade earlier helped turn HIV from a killer disease to a controlled one.

During the first quarter, Achillion will be reporting on how effective its two therapies work in combination. Good data could entice competitors to bid, Bayko said.

‘Well-Positioned’
“By the first quarter of next year, we could be a very different company,” Achillion’s Truitt said. “If that combination data comes through, then we really have a commercially viable, competitive combination that will put everybody on notice.”

“We’re pretty optimistic for Achillion,” Bayko said in a phone interview. “They’ll be well-positioned to be a candidate to be taken out, because right now, there are very few options if you want to get involved in hep C, in terms of combinations that are more advanced that are still in clinical development.”

Bayko said that while she expects a suitor to wait for the data on the drugs before making an offer, Achillion still could fetch as much as $10 a share if a company bid for it now, 51 percent more than its closing price yesterday.

Piper Jaffray’s Tenthoff said Achillion could lure suitors such as Merck, Roche and Vertex as they seek to compete against Gilead, which is seen by analysts as having the most promising hepatitis C drug. Gilead is poised to start testing two of its therapies together in a single pill this year, putting it on track to request U.S. regulatory approval for the drug in 2014.

Gilead Bid
Ronald Rogers, a spokesman for Merck, said the company doesn’t comment on speculation when asked whether the Whitehouse Station, New Jersey-based drugmaker was interested in Achillion, while an e-mail to Basel, Switzerland-based Roche’s media relations office wasn’t returned. Megan Pace, a spokeswoman for Cambridge, Massachusetts-based Vertex, declined to comment.

Even Gilead could seek to acquire Achillion as a way to remove a potential competitor and bolster its position, said Peter Kolchinsky, co-founder and general partner at RA Capital Management LLC, which oversees $300 million, including Achillion shares.

“Gilead could solidify its supremacy if it had Achillion’s drugs, each best in its respective class based on what we know so far,” Kolchinsky said in an interview. “Acquiring Achillion would also be a wise defensive move for Gilead, keeping it from falling into a competitor’s hands or from becoming an independent low-cost competitor.”

Safety Concerns
Cara Miller, a spokeswoman for Foster City, California- based Gilead, said the company (GILD) doesn’t comment on market speculation.

Brian Skorney, an analyst with Brean Murray Carret & Co. in New York, says Achillion won’t be a takeover target soon because it has “a lot more to prove” with clinical data next year. Other companies that developed hepatitis C treatments like Pharmasset and Inhibitex proved their drugs were effective before they were bought, and the only remaining question about their products was safety, he said.

The safety problems that challenged the drug Bristol-Myers bought from Inhibitex and the regulatory holds that Idenix faces show how much risk is still left in the market for hepatitis C treatments, said Les Funtleyder, a fund manager focused on the health-care industry at New York-based Poliwogg.

“What’s that phrase, ‘Once burned, twice shy?’” Funtleyder said in a phone call. “If someone was to repeat what happened to Bristol, shareholders would start to ask questions about management’s judgment.”

Cheaper Now
Still, after the drop in Achillion’s stock this year, a buyer would be taking on the risk of the therapies potentially failing at a lower price tag.

During the past 12 months, acquirers that announced deals for biomedical companies paid 65 percent more than the target’s average 20-day stock price in transactions greater than $500 million, according to data compiled by Bloomberg. A bidder for Achillion could offer a premium of as much 79 percent to yesterday’s stock price and still get the drugmaker for less than its record market value of $863 million in February.

The market for treating the viral infection is too big to be dominated by Gilead alone, so large drugmakers may have the appetite to acquire a company such as Idenix or Achillion once they produce sufficient data on the safety and effectiveness of their drugs, said Y. Katherine Xu, a New York-based analyst at William Blair. Kelly Barry, a spokeswoman for Cambridge, Massachusetts-based Idenix, didn’t return a voicemail message and e-mail sent after business hours about whether the company has been approached by suitors.

“Both Idenix and Achillion, their strategy is to sell themselves,” Xu said. “Timeline-wise, these two used to be similar, but now Achillion may be a little bit ahead.”

To contact the reporters on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net; Will Robinson in New York at wrobinson11@bloomberg.net.

To contact the editors responsible for this story: Sarah Rabil at srabil@bloomberg.net; Reg Gale at rgale5@bloomberg.net.

Idenix suffers another FDA-mandated clinical hold...

Posted 8/27/12 on Fierce Biotech.com. Idenix suffers another setback as the FDA puts its NS5B inhibitor, IDX19368 on clinical hold as the fallout from the AE's from BMS-094 continue. Both IDX184 and IDX19368 are in the same class of nucs as the ill-fated BMS-094 and share the same active metabolite. Idenix CEO Ron Renaud feels there is enough differentiation between BMS-094 and the Idenix compounds to put safety concerns to rest, but the company is doing its due diligence in terms of ensuring the safety of the patients enrolled in its trials. The clinical holds certainly slow down the development of Idenix's nucs, but hopefully Mr. Renaud is right and the Idenix compounds still hold market potential. 

Idenix plunges after FDA puts another hep C treatment on hold

August 27, 2012 | By John Carroll

Idenix already faces a partial clinical hold on its top hepatitis C program. Now the FDA has stepped in to add a clinical hold on its preclinical therapy IDX19368, another nucleotide polymerase inhibitor, or "nuc," in the pipeline. The biotech ($IDIX) also spelled out some added safety checks for its lead hep C treatment, which the company says can be completed in a matter of weeks. But its shares swiftly plunged on the fresh round of troubling news.

"Based on our discussions with the FDA, we understand the clinical hold is a precautionary decision made by the FDA in light of the adverse events seen with BMS-986094," said Idenix CEO Ron Renaud. "Both IDX184 and IDX19368 fall into the same broader class of NS5B inhibitors, and share the same active metabolite as BMS-986094. However, there are many attributes of our compounds, particularly the prodrug approach, that we believe favorably differentiate the toxicity profiles from that of BMS-986094."

Idenix's FDA woes were triggered by the abrupt failure of BMS-094, a once sizzling-hot hep C treatment which raised alarms after one patient died and 8 others in a study were hospitalized, just 8 months after Bristol-Myers Squibb paid $2.5 billion to acquire Inhibitex. Bristol ($BMY) announced on Thursday that it was writing off $1.8 billion and scrapping the drug entirely. Idenix added today that BMS is lending a hand in resolving the holds.

Idenix also reported that it has lined up ethocardiograms for 50 patients enrolled in its IDX184 study. A few done so far have not revealed any safety concerns and the developer says that it should be able to complete this process in a few weeks.

A lingering concern for Idenix, though, is whether the company can regain the glow that had enveloped it after some big deals in the hepatitis C space made the company a prime takeover target, with analysts speculating about the prospect for a big premium. The Cambridge, MA-based company has been among the leaders in the mad scramble to advance new "nucs" and NS5A inhibitors that can be combined with ribavirin into an all-oral regimen with megamarket potential.

Idenix shares plunged 40% on news of the partial hold 11 days ago. This morning the stock plunged another 16% in premarket trading. Both of these programs are unpartnered, which leaves Idenix holding the bag now for any long-term loss in value.

BMS formally suspends development of BMS-094...

Posted 8/23/2012 on Fox Business.com.  BMS formally suspends development of nucleoside inhibitor BMS-094/INX-189 due to possible heart and kidney toxicity. One subject died, nine were hospitalized and two remain so at the time of press. The cause of the events has not yet been identified. Ramifications have already been felt through the HCV drug development space, with Idenix's IDX184 clinical trial, a nucleoside inhibitor similar in structure to BMS-094, put on partial clinical hold by the FDA. The FDA hinted in it's letter to Idenix that there were possibilities of similar actions to other nucs in development as well.

Bristol-Myers Discontinues Development of Hepatitis C Drug
Published August 23, 2012

Dow Jones Newswires

Bristol-Myers Squibb Co. (BMY) said Thursday it has discontinued the development of a drug intended to treat the liver disease hepatitis C in the interest of patient safety, after a patient died and others were hospitalized.

Bristol-Myers earlier this month voluntarily suspended a Phase 2 study of BMS-986094, which was formerly known as INX-189, a nucleotide polymerase inhibitor, or "nuke." The initial case of heart failure, which was the basis for halting the study, subsequently resulted in death, the company said Thursday.

Bristol-Myers said it is working with the U.S. Food and Drug Administration and clinical study investigators to conduct ongoing and close follow-ups of all the study's patients. To date, nine patients have been hospitalized, including the initial patient, and two remain hospitalized.

The company said the cause of these unexpected events, which involve heart and kidney toxicity, hasn't been definitively established.

Bristol-Myers decision to halt the study earlier this month raised questions about the experimental drug's potential and the $2.5 billion price tag Bristol paid earlier this year to buy the company that developed it. The suspension was considered a significant setback for the drug maker--already grappling with weak sales of its Plavix anticlotting drug that lost patent protection in May--in the race to develop new hepatitis C treatments.

Bristol-Myers as well as other companies such as Gilead Sciences Inc. (GILD) and Abbott Laboratories (ABT) has been looking to bring the first all-oral hepatitis C regimen to market, hoping to tap what is expected to be a multibillion-dollar market for such a therapy.

To strengthen its hepatitis C position, Bristol-Myers in February shelled out $2.5 billion to buy Inhibitex Inc. at a whopping 163% premium. Bristol was lured primarily by Inhibitex's nuke for hepatitis C, though it did acquire other potential treatments for infectious disease in the deal.

Treatments for hepatitis C are considered lucrative because the disease is prevalent in large sections of the global population. The virus, which can be transmitted sexually or through use of shared needles and at tattoo parlors, affects some 170 million people world-wide.

Separately, Synergy Pharmaceuticals Inc. (SGYP) said it has agreed to acquire the assets related to shingles treatment FV-100 from Bristol-Myers. FV-100 was developed by Inhibitex.

Shares were up by 10 cents to $32.25 after hours. The stock has fallen 8.8% since the start of the year.

-Write to Nathalie Tadena at nathalie.tadena@dowjones.com

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