Wednesday, April 25, 2012

GS-7977/BMS-790052 - Will Bristol-Myers Squibb and Gilead collaborate?

Over at Pharmalot journalist Ed Silverman today wrote about - the European Association for the Study of the Liver - discussing the all oral combination of Gilead's  GS-7977 and Bristol-Myers Squibbs' daclatasvir. No doubt you read the interim results on the two drug combo which  resulted in 100% SVR in genotype 1 treatment-naive patients, view the data here or here.

However there seems to be a dark cloud looming over the groundbreaking results, please know this blogger isn't qualified to discuss any pharmaceutical company, although I do understand that the two drug companies Bristol-Myers Squibb and Gilead haven't yet agreed to collaborate on the all oral promising combination.  The details and finger pointing would be best left up to the journalists. Here are a few articles on the subject.

Pharma Buzz And The Big Liver Meeting

But which drugmakers generated the most buzz? Not surprisingly, there was something of a horse race between Gilead and Bristol-Myers, which have a joint venture and hope to be the first to market with an oral hepatitis C treatment. As the chart indicates, they dominated investor chatter on Facebook, Twitter and online that was picked up by Semantelli, a market research firm that tracks social media in the pharma world and provides us with a weekly buzz installment.
There was talk about their venture, since Gilead has not committed to Phase III, suggesting the biotech may swap one of its own formulations for daclatasvir.

Continue Reading....

Excerpt-The Street
Gilead, Bristol Put Profits Ahead of Best Care for Hep C Patients

The new Hep C therapy at issue here combines Bristol's daclatasvir with Gilead's GS-7977. Each is a single pill administered once a day. The results from this new therapy are nothing short of spectacular -- an early cure rate of 100% for genotype 1 patients and 91% of genotype 2/3 patients, according to data from a mid-stage study announced Thursday at the European Association for the Study of Liver Disease (EASL) meeting.  
A 100% cure rate for genotype 1 patients! Obviously, results can't get better than that. 
You'd think there'd be a rush to move the combination regimen of daclatasvir and GS-7977 into a larger, confirmatory phase III trial, but you'd be mistaken. Amazingly, this most promising new treatment for hepatitis C patients may actually be discontinued because Bristol and Gilead can't work together. 
Good luck understanding why Bristol and Gilead can't come together to help Hep C patients. The companies can't even agree on the fact that the two companies are not agreeing.

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Excerpt-Seeking Alpha
Vertex Is Ready To Rise On INCIVEK Success

There is one problem facing Gilead and Bristol, though. The cure for their Hepatitis C drug depends on both drugs from both companies. The companies are far from having decided to collaborate and it seems to many that this particular cure may never reach the market, putting Vertex back in the leading position in curing Hepatitis C. An ideal situation would have these large companies working together for the sake of those inflicted. However, the industry does not work like that and if Bristol and Gilead are not able to come to terms, it may mean sufferers have nowhere else to look beside INCIVEK.

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Excerpt-New York Times
Collaboration on Hepatitis Drugs Lags

A combination of two pills proved extremely effective in treating hepatitis C in a small trial, raising hopes among researchers that the disease will be curable without an injected drug that has debilitating side effects.
But the combination might not find its way to the market because one pill is owned by Gilead Sciences and the other by Bristol-Myers Squibb. The companies have not agreed to collaborate, to the chagrin of some doctors.
“The only appropriate motivation should be what is the best and fastest way to get cures, not what is best for the shareholders,” said Dr. Scott Friedman, chief of liver diseases at the Mount Sinai School of Medicine in New York, who was not involved in the trial.
Dr. Douglas J. Manion, a senior vice president for Bristol-Myers, said his company was “keen” on working with Gilead but that “thus far, they have been unwilling to engage in that collaboration.”Dr. Bischofberger said that before deciding whether to work with Bristol on a larger trial, Gilead wanted to wait a few months for data showing whether the same two drugs would work with only 12 weeks of treatment instead of 24.

He said he also wanted to see whether Gilead could improve results of using GS-7977 with ribavirin, a drug that is part of the existing treatment.

A combination of GS-7977 with ribavirin, which is generic, would be far less expensive than a combination with daclatasvir, he said, because new hepatitis drugs are expected to cost tens of thousands of dollars for a course of treatment.

A combination with ribavirin would also mean that Gilead would not have to split revenues with Bristol, making it easier to recoup the money it spent to buy Pharmasset.

Dr. Bischofberger said that once both 7977 and daclatasvir won approval, doctors could use them together, so patients would not be shortchanged if the companies did not collaborate.

Continue Reading....

Excerpt-The Street
Grading hep C stocks exiting EASL confab

As if that weren't enough excitement, Gilead also generated some drama at the meeting -- and elicited a "patients-not-profits" rebuke from my colleague Adam Feuerstein -- when word got out that the company had refused an offer from Bristol-Myers to collaborate on further development of GS-7977 and daclatasvir. Although Gilead insists it hasn't made a final decision, I'm guessing management will try to combine GS-7977 with GS-5885, an early-stage drug candidate in the same NS5A class as daclatasvir. Obviously, Gilead wants to keep all the profits from a highly potent, all-oral hepatitis C therapy for itself.  
In GS-7977, Gilead appears to control a strong, future "backbone" for any next-generation hepatitis C regimen. I have mixed feelings about Gilead's apparent desire to deny Bristol-Myers access to the drug and therefore prevent a daclatasvir-GS-7977 regimen from reaching the market. Patients and their advocates will probably be justifiably upset that such this apparently highly effective regimen won't be developed further. I understand that. Interestingly, physicians I spoke with at the meeting didn't care either way. That surprised me; I would have expected more complaints. 
As an investor, I don't fault Gilead for angling to maximize profits -- I've never subscribed to the biotechnology industry's cloying "patients first" rhetoric. However, the move does increase the company's clinical risk in hepatitis C. Even though initial GS-5885 data look clean, a problem could still emerge and daclatasvir is far more established. Essentially, management is betting that the promise (and eventually, the reality) of an "all Gilead" HCV regimen outweighs additional R&D expenses and near-term clinical risks.

Continue Reading....

Please sign the online petition urging Gilead and BMS to collaborate on the promising new treatment for hepatitis C.

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