Showing posts with label Idenix pharmaceuticals. Show all posts
Showing posts with label Idenix pharmaceuticals. Show all posts
Thursday, August 16, 2012
IDX184 suffers setback in clinical trial....
Posted 8/16/12 on MarketWatch.com. Ouch. This makes Novartis look almost prescient in it's restructuring of it's relationship to Idenix. BMS-094, PSI-938 and IDX184 all share the same chemical structure - even if the cardiac event is unrelated to BMS-094 (hard to tell) I think the market will be wary regarding nucs sharing this structure.
Idenix plunges 30% on HCV drug setback 08/16 10:43 AM
BOSTON (MarketWatch) -- Shares of Idenix Pharmaceuticals (IDIX:$5.93,00$-2.38,00-28.64%) plunged 30% to $5.96 Thursday on news that the U.S. Food and Drug Administration has partially halted a Phase II clinical trial for its drug IDX184 over safety concerns. Idenix has been testing the product for the treatment of the hepatitis C virus, or HCV. The FDA placed a 'partial hold' on the trial pending the evaluation of reports that one of the patients taking the treatment had suffered a severe cardiac event. The FDA has also requested that Idenix provide additional patient data to help the agency with its evaluation. IDX184 belongs to a newer class of HCV drugs known as nucleotides. Earlier this month, shares of rival Bristol-Myers Squibb (BMY:$31.95,00$0.07,000.22%) slid almost 10% after the company announced it had suspended a Phase II study of its HCV nucleotide agent due to concerns that a patient had developed heart failure.
Tuesday, June 19, 2012
Idenix hep C polymerase inhibtor shows promise in mid-stage study...
Posted 6/19/2012 on the Chicago Tribune website. Not a whole lot of info in this bare-bones press release, but it looks like Idenix's HCV polymerase inhibitor IDX184 is faring pretty well, at least with an n=31 in this mid-stage clinical trial in combo with P/R. More info to follow as soon as I can dig some up.
Idenix hep C drug shows promise in mid-stage study
Reuters
4:34 p.m. CDT, June 19, 2012
(Reuters) - Idenix Pharmaceuticals Inc said interim data from a mid-stage trial on its experimental hepatitis C drug showed promise, sending its shares up 12 percent.
The drug, IDX184, was given to 31 patients in combination with the standard hep C treatments pegylated interferon and ribavirin.
Nine patients received the combination therapy for 12 extended weeks and were checked four weeks later for signs of the virus in the blood to determine if there was a sustained virologic response, or SVR.
All four patients in the 100 mg arm and four out of five patients in the 50 mg arm achieved a sustained virologic response four weeks after the completion of treatment.
Patients who did not have undetectable levels of virus at 4 weeks and 12 weeks automatically entered the 36-week combination therapy extended treatment phase which is ongoing, the company said.
Idenix shares rose 12 percent to $10.45 in extended trade, after closing at $9.37 on Tuesday on the Nasdaq.
(Reporting by Shailesh Kuber in Bangalore; Editing by Saumyadeb Chakrabarty)
Tuesday, March 20, 2012
The Street.com: EASL Gives Wall Street's Privileged Investors Sneaky Preview to Key Hep C Data
Article posted on The Street.com on 3/20/12. Spring is in the air, and that means that one of the most important meetings in HCV drug development - EASL - is right around the corner. The Street author Adam Feuerstein is none too pleased on EASL's rather elitist approach to disseminating important data ahead of time to only a chosen, privileged few. He's right - and he's also right that EASL's attempt at keeping this data embargoed until the actual start of the conference is pert near impossible. The time has come for reform and revolution. I'd be right there on the front lines, but there's too much good stuff on TV.
EASL Gives Wall Street's Privileged Investors Sneaky Preview to Key Hep C Data
By Adam Feuerstein 03/20/12 - 10:45 AM
Update: After this column was published, EASL announced a delay in the release of research abstracts for the International Liver Congress to Tues. March 27.
BARCELONA (TheStreet) -- Investing in hepatitis C drug stocks is a suckers bet this week because the European Association for the Study of the Liver, better known as EASL, has rigged the game so that Wall Street's privileged investors get a sneak peek at new clinical data ahead of an important and closely followed conference next month.
EASL's International Liver Congress, taking place April 18-22 in Barcelona, is the must-follow medical meeting of the spring. Gilead Sciences, Bristol-Myers Squibb, Abbott, Idenix Pharmaceuticals, Vertex Pharmaceuticals and Merck are among the companies rolling out new clinical data on experimental hepatitis C therapies.
But if you want an advance look at potentially market-moving hepatitis C drug data, you'll have to be an EASL member or a registered attendee of the EASL meeting -- a group which includes hedge fund and mutual fund portfolio managers and sell-side analysts, all of whom can pay for early access.
EASL plans to selectively distribute hepatitis C drug research abstracts to these folks on Thursday. The same documents will not be made available to the public. That means a select group of investors will have access to potentially stock-moving clinical data while a majority of investors will be kept in the dark.
Journalists registered to cover the EASL meeting will also be granted early access to hepatitis C research abstracts but they are barred by EASL's restrictive embargo rules from writing about any new data until the start of the April meeting.
EASL's abstract distribution policy is misguided, unfair and quite frankly unworkable. Smarter medical and scientific groups like the American Society of Clinical Oncology (ASCO) realized years ago that trying to compartmentalize research abstracts was futile. Information cannot be selectivity disclosed and expected not to leak, especially information that will weigh on the market valuations of biotech and drug firms involved in new hepatitis C drug research.
That's why most medical and scientific groups made research abstracts freely available to everyone in advance of major conferences.
Jacqui Sisto, an EASL spokesperson, explained via email that selective disclosure of research abstracts "ensures the integrity of the International Liver Congress." Really? EASL appears to be corrupting its most important meeting, not making it more honest.
Wednesday, February 1, 2012
Analysts weigh in on takeover odds of Achillion and Idenix...
Posted on Weds from Market Watch.com : It drives me nuts when 'nucs', the popular shortened term for 'nucleoside analogs', is spelled 'n-u-k-e-s' instead. We're talking drug development, not nuclear arms proliferation in unstable Middle East nations. Probably a good indicator I need something else to take out my frustrations on.
An article here from Market Watch talking to several analysts about possible mergers of Achillion and Idenix. No doubt that the slack of easing sales of Incivek and Victrelis will definitely be picked up by the 2nd and 3rd generation molecules, especially if developers can manage an interferon-free regimen. The HCV drug development space is incredibly hot right now, and with an estimated 170 million people infected, successful drugs are probable cash cows for many years to come.
Feb. 1, 2012, 12:01 a.m. EST
Achillion, Idenix could miss hep-C merger bonanza
By Val Brickates Kennedy, MarketWatch
BOSTON (MarketWatch) -- Investors tantalized by a recent string of lucrative takeover offers for hepatitis C drug-developers shouldn’t assume that an eye-popping bid for Idenix Pharmaceuticals and Achillion Pharmaceuticals is just around the corner, according to biotech analysts.
Both Idenix were put in play earlier this month by news that Bristol-Myers Squibb intends to buy Inhibitex Inc for $2.5 billion in cash.The offer represents a dazzling 163% premium over Inhibitex’s pre-bid closing price.
Bristol’s bid also comes on the heels of two other lucrative takeovers in the hepatitis C virus, or HCV, arena. In October, Roche announced it was paying a stunning 256% premium, or $230 million, for tiny Anadys Pharmaceuticals. That was followed by Gilead Sciences’s whopping $11 bid for Pharmasset Inc., which carried an 89% premium.
Rumors have since swirled that other Big Pharma players are likewise eyeing the HCV space. And that speculation has helped push up Idenix shares by a hefty 80% and Achillion shares by 45% since the beginning of the year.
At stake is a market filled with a backlog of under-treated HCV patients that many analysts believe could reach $10 billion a year within the next five years.
But here’s the kicker -- because the new HCV drugs can actually cure the disease, their demand will likely drop over time after the backlog of patients is treated. Despite this, most analysts agree the market should be able to coast along at the $10 billion level for at least ten years. And because time is of the essence, companies with HCV drug candidates in mid-to-late stage development have been considered the hottest takeover targets.
Of the two companies, Idenix’s stock has seen the most action largely because its lead drug candidate hails from a highly-touted class of drugs called nucleotides, or “nukes.” Both Inhibitex’s and Pharmasset’s lead drug candidates are nukes, which is what made them particularly attractive acquisitions.
“I don’t think Idenix’s stock’s bid too high,” said Wedbush Securities analyst Duane Nash, who tracks Idenix. “But the caveat is that acquisitions generally take longer than most people anticipate.”
While Wedbush currently has Idenix’s fair market value listed at $15 a share, Nash believes that Idenix could fetch a takeout price of between $20 and $25 a share. The stock closed at $13.39 on Tuesday.
William Blair analyst Katherine Xu, meanwhile, said she believes Idenix’s current takeout range is probably between $15 and $20 a share. Xu currently has a price target of $10 on the stock.
Xu added that she could be raising her target into the mid-to-high teens if and when U.S. regulators give the green light to an Idenix’s clinical trial that has been placed on partial hold over safety concerns. The decision is expected within the next few weeks.
“I doubt people will take it out before the hold is removed,” she said.
But analysts also point out that Novartis AG’s roughly 30% equity stake in Idenix could hinder a takeover bid, especially as the Swiss pharmaceutical giant reportedly has options to some key drug candidates. Meanwhile, JMP Securities analyst Liisa Bayko thinks that investors have overvalued Idenix’s nuke drug candidate, which she says isn’t as potent as those being developed by Inhibitex and Pharmasset. Because of this, Bayko has a sell rating on the stock.
As for Achillion, the reason its shares haven’t been bid up as high as Idenix’s is largely because its lead drug candidate is a protease inhibitor, a class of drugs that includes Merck & Co.’s Victrelis and Vertex Pharmaceuticals’s Incivek, which were both launched last year. Several other drug developers already have protease inhibitors in their pipelines.
Xu said that while she currently has Achillion’s price target at $15 a share, its takeout range is probably between $15 and $20. The stock closed at $11.09 on Tuesday.
“I think it’s still undervalued at the moment,” she said.
Wells Fargo Securities analyst Brian Abrahams said that even though Achillion’s lead drug candidate isn’t a nucleotide, that doesn’t mean it isn’t an attractive acquisition target.
“Certainly nucleotides are an exciting class but they’re not the only class we believe will be used in HCV treatment,” said Abrahams, adding that doctors will be looking to use the drugs in combination to get the best results.
An article here from Market Watch talking to several analysts about possible mergers of Achillion and Idenix. No doubt that the slack of easing sales of Incivek and Victrelis will definitely be picked up by the 2nd and 3rd generation molecules, especially if developers can manage an interferon-free regimen. The HCV drug development space is incredibly hot right now, and with an estimated 170 million people infected, successful drugs are probable cash cows for many years to come.
Feb. 1, 2012, 12:01 a.m. EST
Achillion, Idenix could miss hep-C merger bonanza
By Val Brickates Kennedy, MarketWatch
BOSTON (MarketWatch) -- Investors tantalized by a recent string of lucrative takeover offers for hepatitis C drug-developers shouldn’t assume that an eye-popping bid for Idenix Pharmaceuticals and Achillion Pharmaceuticals is just around the corner, according to biotech analysts.
Both Idenix were put in play earlier this month by news that Bristol-Myers Squibb intends to buy Inhibitex Inc for $2.5 billion in cash.The offer represents a dazzling 163% premium over Inhibitex’s pre-bid closing price.
Bristol’s bid also comes on the heels of two other lucrative takeovers in the hepatitis C virus, or HCV, arena. In October, Roche announced it was paying a stunning 256% premium, or $230 million, for tiny Anadys Pharmaceuticals. That was followed by Gilead Sciences’s whopping $11 bid for Pharmasset Inc., which carried an 89% premium.
Rumors have since swirled that other Big Pharma players are likewise eyeing the HCV space. And that speculation has helped push up Idenix shares by a hefty 80% and Achillion shares by 45% since the beginning of the year.
At stake is a market filled with a backlog of under-treated HCV patients that many analysts believe could reach $10 billion a year within the next five years.
But here’s the kicker -- because the new HCV drugs can actually cure the disease, their demand will likely drop over time after the backlog of patients is treated. Despite this, most analysts agree the market should be able to coast along at the $10 billion level for at least ten years. And because time is of the essence, companies with HCV drug candidates in mid-to-late stage development have been considered the hottest takeover targets.
Of the two companies, Idenix’s stock has seen the most action largely because its lead drug candidate hails from a highly-touted class of drugs called nucleotides, or “nukes.” Both Inhibitex’s and Pharmasset’s lead drug candidates are nukes, which is what made them particularly attractive acquisitions.
“I don’t think Idenix’s stock’s bid too high,” said Wedbush Securities analyst Duane Nash, who tracks Idenix. “But the caveat is that acquisitions generally take longer than most people anticipate.”
While Wedbush currently has Idenix’s fair market value listed at $15 a share, Nash believes that Idenix could fetch a takeout price of between $20 and $25 a share. The stock closed at $13.39 on Tuesday.
William Blair analyst Katherine Xu, meanwhile, said she believes Idenix’s current takeout range is probably between $15 and $20 a share. Xu currently has a price target of $10 on the stock.
Xu added that she could be raising her target into the mid-to-high teens if and when U.S. regulators give the green light to an Idenix’s clinical trial that has been placed on partial hold over safety concerns. The decision is expected within the next few weeks.
“I doubt people will take it out before the hold is removed,” she said.
But analysts also point out that Novartis AG’s roughly 30% equity stake in Idenix could hinder a takeover bid, especially as the Swiss pharmaceutical giant reportedly has options to some key drug candidates. Meanwhile, JMP Securities analyst Liisa Bayko thinks that investors have overvalued Idenix’s nuke drug candidate, which she says isn’t as potent as those being developed by Inhibitex and Pharmasset. Because of this, Bayko has a sell rating on the stock.
As for Achillion, the reason its shares haven’t been bid up as high as Idenix’s is largely because its lead drug candidate is a protease inhibitor, a class of drugs that includes Merck & Co.’s Victrelis and Vertex Pharmaceuticals’s Incivek, which were both launched last year. Several other drug developers already have protease inhibitors in their pipelines.
Xu said that while she currently has Achillion’s price target at $15 a share, its takeout range is probably between $15 and $20. The stock closed at $11.09 on Tuesday.
“I think it’s still undervalued at the moment,” she said.
Wells Fargo Securities analyst Brian Abrahams said that even though Achillion’s lead drug candidate isn’t a nucleotide, that doesn’t mean it isn’t an attractive acquisition target.
“Certainly nucleotides are an exciting class but they’re not the only class we believe will be used in HCV treatment,” said Abrahams, adding that doctors will be looking to use the drugs in combination to get the best results.
Monday, December 5, 2011
BioMedReports.com on Idenix... everything you wanted to know and then a little bit more...
For those of you who love to indulge themselves with HCV drug development minutia (meaning nerds like me) here is a nice investment piece from Proactive Investors.com, specifically a Biomed report on Idenix.
When it comes to Idenix, who are you betting with?
Mon 3:45 pm by M.E. Garza
Even if you're late to the break-out party, Idenix Pharmaceuticals (NASDAQ:IDIX) is still an intriguing market mover worth watching.
On Thursday, we told our subscribers that shares of Idenix had seen over $200K worth of insider buying during the month of November- making it one of the most purchased stocks by insiders in biotech. By Friday, the stock broke out and led all gainers in healthcare after shares traded as high as $8.51 before closing 8% higher at $8.22 +0.62.
Idenix Pharmaceuticals, Inc.
7.60 -0.62 (-7.54%)
Shares of Idenix Pharmaceuticals hit new highs after 1,221,246 traded hands (148% of the daily average). Still, it appears a growing number of traders are starting to feel that IDIX shares are now overbought as 5.2M of the stocks 56.5M shares are now positioned to the short side. With Idenix now priced more than 25% above its average consensus analyst price target, who could blame them? Still, there is more to this equation.
Investors who are long the stock may be a little on edge after the 42.73 % Daily Short Sale Volume on Friday. This figure was calculated using the daily aggregate reported share volume of executed short sale trades during regular trading hours and the daily aggregate reported share volume of all executed trades during regular trading hours. That being said, the shorts have approximately six days to cover their positions, so if any important news or developments are announced during that time we could see some heavy covering.
As we look at the BioMedReports FDA Calendar and World Wide Regulatory Catalyst Tracker for hints of any pending news, we see several listed milestones which are supposed to take place in the short term and could come into play to catch shorts off-guard.
For example, one of those catalysts involves an announcement made in early August, in which Idenix stated that it had selected IDX719 as the lead candidate for its NS5A program. The NS5A program is another focus of Idenix’s Hepatitis C virus (HCV) discovery efforts. The company states that it has identified NS5A compounds with multi-genotypic activity and favorable pharmacokinetics. Two candidates have been selected for preclinical development, their website as well as a recently filed SEC document indicate that the company plans to file an IND.
IDX719 showed potent activity and broad genotypic coverage in preclinical studies. The planned Investigational New Drug application remains on track, and the Company expects to submit regulatory filings by year-end 2011 and begin the clinical program in early 2012.
Idenix shares are trading much higher than their levels of support at the 50-day ($6.02) and 200-day moving averages ($5.05). Both of those averages have moved 1.82% higher and 2.38% higher over the past week, and shares are now trading 59% higher than when we told our readers (on October 18th) that Hepatitis C drug developers were seeing shares rise after Swiss drugmaker Roche agreed to buy Anadys Pharmaceuticals (Nasdaq:ANDS) for $230 million. IDIX shares were then priced at $5.51 per share.
Idenix is engaged in the discovery and development of drugs for the treatment of human viral diseases. Like shares of Achillion Pharmaceuticals (NASDAQ:ACHN) and Inhibitex (NASDAQ:INHX), IDIX shares have continued to climb much higher in the last couple of months.
Idenix has a robust pipeline focused on agents for advance treatment of hepatitis C. As we mentioned, they have an ongoing HCV development and discovery program building a critical mass of candidates in three different classes of drugs, including: nucleoside polymerase inhibitors, non-nucleoside polymerase inhibitors and protease inhibitors.
Its pipeline products include: IDX375, a lead clinical candidate from its HCV non-nucleoside polymerase inhibitor discovery program, IDX136, a novel macrocyclic HCV protease inhibitor being developed as oral formulation for the treatment of Hepatitis C, IDX316, a novel macrocyclic HCV protease inhibitor being developed as oral formulation for the treatment of Hepatitis C. etc. The company co-developed and co-launched the licensed hepatitis B drug candidate, Telbivudine. The firm has collaborations with Novartis Pharma AG, ViiV Healthcare, GlaxoSmithKline plc, Sareum Ltd, Galapagos nv, Microbiologica Quimica e Farmaceutica, Ltda., Institut Pasteur, National Center for Scientific Research (CNRS), and others.
From a financial perspective, in the firm's November 10Q filing, management stated "We believe that our current cash, cash equivalents and the expected royalty payments associated with product sales of Tyzeka®/Sebivo® will be sufficient to sustain operations into at least the second quarter of 2012." In mid November, Idenix announced the pricing of an underwritten registered public offering of 9,393,416 shares of its common stock at a public offering price of USD 6.50 per share. All of the shares were sold by Idenix.
Prior to that, in early April, Idenix Pharmaceuticals, Inc. announced the pricing of an underwritten registered public offering of 18,310,000 shares of its common stock at a public offering price of USD $2.80 per share.
As reported by the Motley Fool when shares rose on Friday, IDX184 is Idenix's greatest hope for a future blockbuster and the drug candidate is currently in phase 2b trials. "The oral drug is designed to enhance the efficiency of other medications. Idenix doesn't have a big-name partner for the endgame yet and might end up arm-in-arm with J&J or Bristol-Myers."
Disclosure: None
When it comes to Idenix, who are you betting with?
Mon 3:45 pm by M.E. Garza
Even if you're late to the break-out party, Idenix Pharmaceuticals (NASDAQ:IDIX) is still an intriguing market mover worth watching.
On Thursday, we told our subscribers that shares of Idenix had seen over $200K worth of insider buying during the month of November- making it one of the most purchased stocks by insiders in biotech. By Friday, the stock broke out and led all gainers in healthcare after shares traded as high as $8.51 before closing 8% higher at $8.22 +0.62.
Idenix Pharmaceuticals, Inc.
7.60 -0.62 (-7.54%)
Shares of Idenix Pharmaceuticals hit new highs after 1,221,246 traded hands (148% of the daily average). Still, it appears a growing number of traders are starting to feel that IDIX shares are now overbought as 5.2M of the stocks 56.5M shares are now positioned to the short side. With Idenix now priced more than 25% above its average consensus analyst price target, who could blame them? Still, there is more to this equation.
Investors who are long the stock may be a little on edge after the 42.73 % Daily Short Sale Volume on Friday. This figure was calculated using the daily aggregate reported share volume of executed short sale trades during regular trading hours and the daily aggregate reported share volume of all executed trades during regular trading hours. That being said, the shorts have approximately six days to cover their positions, so if any important news or developments are announced during that time we could see some heavy covering.
As we look at the BioMedReports FDA Calendar and World Wide Regulatory Catalyst Tracker for hints of any pending news, we see several listed milestones which are supposed to take place in the short term and could come into play to catch shorts off-guard.
For example, one of those catalysts involves an announcement made in early August, in which Idenix stated that it had selected IDX719 as the lead candidate for its NS5A program. The NS5A program is another focus of Idenix’s Hepatitis C virus (HCV) discovery efforts. The company states that it has identified NS5A compounds with multi-genotypic activity and favorable pharmacokinetics. Two candidates have been selected for preclinical development, their website as well as a recently filed SEC document indicate that the company plans to file an IND.
IDX719 showed potent activity and broad genotypic coverage in preclinical studies. The planned Investigational New Drug application remains on track, and the Company expects to submit regulatory filings by year-end 2011 and begin the clinical program in early 2012.
Idenix shares are trading much higher than their levels of support at the 50-day ($6.02) and 200-day moving averages ($5.05). Both of those averages have moved 1.82% higher and 2.38% higher over the past week, and shares are now trading 59% higher than when we told our readers (on October 18th) that Hepatitis C drug developers were seeing shares rise after Swiss drugmaker Roche agreed to buy Anadys Pharmaceuticals (Nasdaq:ANDS) for $230 million. IDIX shares were then priced at $5.51 per share.
Idenix is engaged in the discovery and development of drugs for the treatment of human viral diseases. Like shares of Achillion Pharmaceuticals (NASDAQ:ACHN) and Inhibitex (NASDAQ:INHX), IDIX shares have continued to climb much higher in the last couple of months.
Idenix has a robust pipeline focused on agents for advance treatment of hepatitis C. As we mentioned, they have an ongoing HCV development and discovery program building a critical mass of candidates in three different classes of drugs, including: nucleoside polymerase inhibitors, non-nucleoside polymerase inhibitors and protease inhibitors.
Its pipeline products include: IDX375, a lead clinical candidate from its HCV non-nucleoside polymerase inhibitor discovery program, IDX136, a novel macrocyclic HCV protease inhibitor being developed as oral formulation for the treatment of Hepatitis C, IDX316, a novel macrocyclic HCV protease inhibitor being developed as oral formulation for the treatment of Hepatitis C. etc. The company co-developed and co-launched the licensed hepatitis B drug candidate, Telbivudine. The firm has collaborations with Novartis Pharma AG, ViiV Healthcare, GlaxoSmithKline plc, Sareum Ltd, Galapagos nv, Microbiologica Quimica e Farmaceutica, Ltda., Institut Pasteur, National Center for Scientific Research (CNRS), and others.
From a financial perspective, in the firm's November 10Q filing, management stated "We believe that our current cash, cash equivalents and the expected royalty payments associated with product sales of Tyzeka®/Sebivo® will be sufficient to sustain operations into at least the second quarter of 2012." In mid November, Idenix announced the pricing of an underwritten registered public offering of 9,393,416 shares of its common stock at a public offering price of USD 6.50 per share. All of the shares were sold by Idenix.
Prior to that, in early April, Idenix Pharmaceuticals, Inc. announced the pricing of an underwritten registered public offering of 18,310,000 shares of its common stock at a public offering price of USD $2.80 per share.
As reported by the Motley Fool when shares rose on Friday, IDX184 is Idenix's greatest hope for a future blockbuster and the drug candidate is currently in phase 2b trials. "The oral drug is designed to enhance the efficiency of other medications. Idenix doesn't have a big-name partner for the endgame yet and might end up arm-in-arm with J&J or Bristol-Myers."
Disclosure: None
Monday, October 31, 2011
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?
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?
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