J&J and Bristol-Myers ally on another potential hep C blockbuster

Posted under Blog, Bristol-Myers Squibb, Companies, Diagnostics, Funding, Gilead Sciences, Hepatitis C, Janssen, Johnson & Johnson, Medical Devices, Medical Supply, Medivir, Pharmaceuticals, Pharmasset, Pipeline, R&D, Startups, TMC435, Universities, Videos by john

Just a few months after Johnson & Johnson joined R&D forces with Bristol-Myers Squibb on an interferon-free combo for hepatitis C, the two companies have broadened their development pact to include another one-two interferon-free punch targeted at the virus. And Medivir, a Swedish company partnered with J&J's ($JNJ) Janssen R&D Ireland on one of the key ingredients, saw its stock price pop this morning as it spread the news.

The two research powerhouses will conduct a drug-drug interaction study on J&J's TMC435 with BMS-986094 (formerly INX-189), a hep C treatment Bristol-Myers ($BMY) nabbed with its $2.5 billion buyout of Inhibitex back in February. And as they study the future potential of that combo they say they'll be ready to push immediately into a late-stage study of a TMC435/daclatasvir if their mid-stage study this year goes well.

BMS-986094 is a nucleotide polymerase NS5B inhibitor, like Gilead's ($GILD) closely watched 7977, which inspired the $10.8 billion buyout of Pharmasset. The protease inhibitor TMC435 blocks an enzyme the virus needs to replicate while BMS-986094 takes a different route to quell hep C. The prospects of a blockbuster business awaiting any developer which can market an interferon-free product has triggered a host of collaborations and buyouts as companies scramble to develop the most effective cocktail therapy that can work for a broad cross section of patients.

"We see the expanded clinical collaboration as a strong validation of TMC435, especially as we know of no other competing protease inhibitors running interferon-free combination trials with other direct-acting antivirals externally," which include polymerase inhibitors, noted Hans Jeppsson, an analyst at Danske Bank, according to a report in Bloomberg.

"This represents one of several strategies to explore TMC435 in interferon free regimens; a development we believe will be an important advancement in the HCV field for patients," said Medivir R&D chief Charlotte Edenius in a statement.  

- here's the press release
- get the report from Bloomberg

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Fresh woes for Gilead as two more hep C patients relapse in small 7977 study

Fresh woes for Gilead as two more hep C patients relapse in small 7977 study

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

The news that two more hepatitis C patients had relapsed after they stopping taking an experimental medication in a tiny study wouldn't normally be the cause for considerable angst in the biotech world. But when the patients relapsed after taking a drug Gilead ($GILD) paid $10.8 billion to acquire, an overexcited group of investors tends to sit up and take notice.

That's what happened yesterday afternoon as news spread that a total of eight of nine patients taking GS-7977 have now relapsed, up from the six reported last month. All eight were in a hard-to-treat group and shared the most common genotype for the disease. Lead investigator Edward Gane told the Conference on Retroviruses and Opportunistic Infections that the news likely indicated that at the very least, that treatment refractory group will need more than a standard round of therapy or an added drug in their anti-viral cocktail. 

"It's clear the treatment options for this very difficult to treat group will either be longer duration of 7977 plus ribavirin, or alternatively, the addition of another direct acting antiviral," Gane told the conference, according to a report in Bloomberg. And Reuters reported that Gane added that pivotal-stage trials of GS-7977 "should establish that interferon-free treatment is not a dream. It's a reality that should be here within the next five years."

The reason Gilead was willing to pay such a premium for Pharmasset ($VRUS), which owned the treatment, was that in two other groups with less common genotypes, 7977 had wiped out all signs of the virus among half the patients who had been followed up after the study. And the prospect of curing hepatitis C without the need for interferon, which causes a host of nasty side effects, is tantalizing developers with the prospect of a multibillion-dollar blockbuster. Gilead's new data is likely to remind investors, though, that there's no simple, de-risked clinical pathway to follow.

Gilead's shares have slid 18% since it noted the initial six relapses.

- here's the Bloomberg story
- read the story from Reuters

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UPDATED: Gilead disappoints with relapse data in oral Hep C study

Posted under Blog, Companies, Diagnostics, Funding, Gilead Sciences, Hepatitis C, Medical Devices, Medical Supply, Pharmaceuticals, Pharmasset, Startups, Universities, Videos by Ryan McBride

Thorny data now threaten what some industry commentators have called a market bubble for all-oral regimens against hepatitis C. Gilead Sciences ($GILD) revealed that certain patients who had not responded to prior treatments relapsed after taking a combo of the company’s prized GS-7977--acquired in the company’s $11 billion buyout of Pharmasset ($VRUS)--and the anti-viral ribavirin.

Given the drugmakers’ feeding frenzy for oral Hep C drugs like 7977, Gilead’s disappointing data are likely to be intensely scrutinized and potentially temper expectations for next-generation drugs for the liver-damaging disease. In this morning’s release, the company said 6 out of 10 patients with the genotype 1 form of the disease in the company’s “Electron” study had viral relapses within four weeks of wrapping up 12 weeks of treatment on the 7977/ribavirin combo.

These data are setback because Gilead spent a big premium to acquire Pharmasset and its all-oral drug regimen against Hep C, which doesn’t require patients to take injections of interferon, which is associated with causing flu-like symptoms and other side effects. Bristol-Myers Squibb ($BMY), of course, made a similar bet on in this field in its $2.5 billion buyout of Inhibitex ($INHX) last month. The wisdom of these deals has been in question, and now the skeptics have some fuel for their arguments against such risky bets on assets that haven’t been proven in all three phases of clinical trials typically needed to seek market approval.

“These data answer an important question about the use of GS-7977 and ribavirin for the treatment of genotype 1 null responder patients, suggesting that additional direct acting antivirals may be necessary to effectively treat this patient population,” Norbert Bischofberger, Gilead's chief scientist, said in a statement. “We will continue to explore a number of therapeutic approaches to address this significant unmet medical need, including combinations with other oral antivirals.”

Gilead's stock had sunk by 15% as of early this afternoon. Its bad news appears to have benefitted others in the race to advance interferon-free Hep C cocktails such as Vertex ($VRTX), which also markets the Hep C drug Incivek, as well as Achillion Pharmaceuticals ($ACHN) and Idenix Pharmaceuticals ($IDIX). There's been lots of speculation that Achillion and Idenix are likely to be the next Hep C drug developers to be acquired, and Gilead's data appear to emphasize the belief that it could take multipe drugs in cocktails to wipe out the disease without interferon. 

- here's the release
- check out Bloomberg's article  
- see the WSJ's report

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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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