Archive for the ‘Inhibitex’ Category

Feb
15

Hep C drug deal frenzy can’t be slowed by growing doubts

Posted under Achillion Pharmaceuticals, Biocryst, Blog, Companies, Diagnostics, Funding, Hepatitis C, Idenix Pharmaceuticals, Inhibitex, Medical Devices, Medical Supply, Pharmaceuticals, Pharmasset, Startups, Universities, Videos by John Carroll

At the BIO CEO & Investor Conference in New York yesterday, Achillion CEO Michael Kishbauch wrapped up his remarks on the biotech's hepatitis C programs by making it clear that he was angling for a clean buyout for a premium that would "put a silly grin on all our faces." A merger of equals, he made clear, was not his first choice. And he is actively in pursuit of a deal.

Kishbauch has made no secret of his delight that Achillion is positioned at one of the busiest intersections in the R&D world. Captivated by the megablockbuster prospects of a next-gen oral therapy that can quell the hep C virus without the use of interferon injections, which trigger a hornet's nest of adverse effects for many patients, investors have been bidding up the value of Achillion's stock ($ACHN) as well as Idenix ($IDIX), the two independent biotechs which are furthest down the pipeline after the big acquisitions of Pharmasset ($VRUS) and Inhibitex ($INHX).

Kichbauch's theory, widely held in the industry, is that a few key cocktail treatments that can quickly knock down the virus and keep it in check will relatively soon be able to divvy up a $20 billion marketplace. And he believes Achillion holds the ticket for any company looking for the inside track on that drug race.

Bloomberg isn't letting anyone forget, either. In the latest iteration of the spotlight now trained on hepatitis C, the business news service once again stirs the pot of takeover speculation, quoting Raghuram Selvaraju, an analyst with Morgan Joseph TriArtisan, as a believer in the common view that buyouts for Achillion and Idenix are inevitable.

"I don't think either of these companies will remain independent very long," Selvaraju said in a telephone interview. "I think we'll see both of them out of there by the end of the year."

Looking for further proof? Shares of BioCryst ($BCRX) spiked 17% this morning on its release touting positive preclinical results for BCX5191, a hepatitis C drug that supposedly has rung all the key bells: Signs of potent pan-genotype antiviral activity in its in vitro and in vivo work.

Normally, preclinical results don't warrant much attention in the biotech world. But that was before Pharmasset was acquired for close to $11 billion. The overheated response, though, is earning some frowns in the Big Pharma world. Moncef Slaoui, GlaxoSmithKline's ($GSK) R&D chief, has now joined Sanofi's ($SNY) Chris Viehbacher in voicing doubts about the sums being paid for risky experimental programs. Time will tell whether the hep C buyout frenzy has already peaked, or whether the speculators can still cash in.

- read the Bloomberg article
- here's the release from BioCryst

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Feb
03

Gilead shares surge as hep C drug scores a cure for big patient population

Posted under Blog, Bristol-Myers Squibb, Companies, Diagnostics, Funding, Gilead Sciences, Hepatitis C, Inhibitex, Medical Devices, Medical Supply, Pharmaceuticals, Pharmasset, PSI-7977, Startups, Universities, Videos by John Carroll

Gilead Sciences ($GILD) received its first bonus from the monster $10.8 billion deal to acquire Pharmasset ($VRUS) after CSO Norbert Bischofberger told analysts yesterday evening that PSI-7977 combined with ribavirin cured a group of genotype 1 hepatitis C patients after four weeks of therapy. The analysts already knew that the same treatment had performed well for genotypes 2 and 3, and promising data on the more-common genotype 1 pool added some significant luster to one of the most closely watched programs underway in the industry.

During its quarterly earnings call, Bischofberger told analysts that there were no detectable signs of the hepatitis C virus in patients after they had been taking the oral treatment for close to a month. The data supports Gilead's belief that 7977 is on a fast track to an approval that can swiftly gain blockbuster returns as it races against a bevy of rivals anxious to get to the market with an all-oral regimen that can eliminate the injections now needed to treat patients.

"It looks like Gilead will race ahead and continue to lead because its drug 7977 continues to support potential 100 percent cure rates," RBC Capital Markets' Michael Yee tells Bloomberg. "The data disclosed in genotype 1, an important population for which there was no good data yet, continues to show they can support a multibillion-dollar drug franchise with 7977."

Gilead's shares popped about 5% in overnight trading as word of the data began to spread. Hopes for an all-oral hepatitis C drug have inspired a string of deals in the field. Soon after Gilead acquired Pharmasset, Bristol-Myers Squibb ($BMY) stepped up with a $2.5 billion deal to buy Inhibitex ($INHX), giving it a horse in the big race to the FDA.

- here's the story from Bloomberg
- here's the report from TheStreet

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Jan
24

Vertex outlines its survival plan for next-gen hep C combo

Posted under Blog, Companies, cystic fibrosis, Diagnostics, Funding, Hepatitis C, Inhibitex, interferon, Medical Devices, Medical Supply, Merck, Pharmaceuticals, Startups, telaprevir, Universities, vertex, Videos, VX-222 by John Carroll

At the beginning of 2011, Vertex ($VRTX) was basking in the limelight of blockbuster success. Its hepatitis C drug was headed for approval, offering a game-changing approach to the disease, and was the clear favorite in a brewing market showdown with Merck's ($MRK) rival therapy. Vertex went on to win that battle but lost the war for the affection of the industry analysts, who were seduced by the interferon-free promises of the relatively puny Pharmasset ($VRUS), Inhibitex ($INHX) and others. The big M&A deals that followed with Bristol-Myers Squibb ($BMY) and Gilead ($GILD) shunted Vertex off to the sidelines.

But as Vertex CEO Jeff Leiden makes clear in his interview with Xconomy, the upstart biotech has a few promising experimental treatments up its sleeve. Vertex is making the case that it is fully prepared to compete in the new race to develop cocktail therapies that will offer a "cure" without all the ugly side effects linked to interferon. But it doesn't have much time, as analysts are zeroing out telaprevir's revenue as new drugs muscle into the market.

Game plan #1: Grab solid proof of concept data on a combo of telaprevir, VX-222 and ribavirin in the first quarter and then hustle into a pivotal study straightaway. "If we can do that, it will be a very exciting result. If you take that regimen into pivotal trials, now we're talking about 2014 to finish those trials," Leiden tells Luke Timmerman.

Game plan #2: The jewels in the pipeline were licensed from Alios just before the bidding war broke out for the hepatitis C drug developers. And an initial trial judging both the safety as well as early efficacy of these early-stage compounds will be crucial to regaining some of the lost hype around the company's prospects.

"I really like the way we've positioned ourselves because we have the component parts," Leiden says. "We have the best protease inhibitor, we have a non-nuc polymerase inhibitor (VX-222), and two different nucleotide polymerase inhibitors (ALS-2200 and ALS-2158)."

But with potential competitors further ahead in the clinic, Vertex's R&D team will have to play its best game. One slip in this race could give competitors a big lead that Vertex may not recover from easily. Significantly, though, Vertex also has a promising new drug for cystic fibrosis in the pipeline which is an odds-on favorite for near-term approval.

- here's the story from Xconomy

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Jan
19

Bristol-Myers reports interferon-free cures in small PhII hep C study

Posted under Blog, Bristol-Myers Squibb, Companies, Diagnostics, Funding, Hepatitis C, Inhibitex, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

While Bristol-Myers Squibb ($BMY) was dealt a setback today on the diabetes front, investigators were reporting progress with a new combination approach to hepatitis C that's raising hopes for an interferon-free approach to treating hepatitis C. In a small Phase II study, four of 11 patients who hadn't responded to standard therapy and were treated only with the experimental antivirals daclatasvir and asunaprevir were effectively cured of hepatitis C. And the four included both of the patients with the HCV genotype 1b.

"This study was the first study to demonstrate the possibility that hepatitis C can be cured (defined as sustained virologic response 48 weeks post-treatment or SVR48) without the use of interferon," BMS reported. "The study also demonstrated that 100 percent (10 out of 10) of these difficult-to-treat patients dosed with quadruple therapy containing daclatasvir and asunaprevir in combination with PEG-Interferon alfa and ribavirin achieved" a cure.

Finding a way to cure hepatitis C with an oral combination regimen that excludes interferon--a therapy commonly linked to fatigue and flu symptoms--has become one of the Holy Grails of biotechnology. That quest inspired BMS to pay $2.5 billion for Inhibitex ($INHX) as rivals compete to conquer a rapidly growing market.

Of course, with only a handful of patients in the Phase II study BMS still has a long ways to go before it offers pivotal data. But with proof of principle data in hand, it just leaped forward in the race to the FDA.

- read the press release
- here's the Bloomberg report

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Archive for the ‘Inhibitex’ Category

Hep C drug deal frenzy can’t be slowed by growing doubts

Gilead shares surge as hep C drug scores a cure for big patient population

Vertex outlines its survival plan for next-gen hep C combo

Bristol-Myers reports interferon-free cures in small PhII hep C study