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  EASL 47th Annual Meeting
April 18th - 22nd 2012
Barcelona, Spain
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Gilead, Bristol Hep C Drug Data Arrives at EASL: 100% Cure Rate with Bristol's phase II study of daclatasvir plus Gilead's GS-7977 in patients with genotypes 1, 2, and 3: SVR4 (early cure) rate in the genotype 1 patients: 100%. In genotype 2/3 patients, the SVR4 rate was 91%.
  Gilead, Bristol Hep C Drug Data Arrives at EASL: 100% Cure Rate with Bristol's phase II study of daclatasvir plus Gilead's GS-7977 in patients with genotypes 1, 2, and 3: SVR4 (early cure) rate in the genotype 1 patients: 100%. In genotype 2/3 patients, the SVR4 rate was 91%.

EASL: Once Daily GS-7977 Plus Ribavirin in HCV Genotypes 1-3: The ELECTRON Trial - (04/21/12)

EASL: Potent Viral Suppression With the All-Oral Combination of Daclatasvir (NS5A Inhibitor) and GS-7977 (Nucleotide NS5B Inhibitor), +/- Ribavirin, in Treatment-Naive Patients With Chronic HCV GT1, 2, or 3 (100% SVR gt1, 91% gt2) - (04/19/12)

EASL 47th Annual Meeting
Barcelona, Spain
April 18th - 22nd 2012

BARCELONA (TheStreet) -- Finally, highly anticipated data from studies of all-oral hepatitis C therapies under development by Gilead Sciences and Bristol-Myers Squibb have been released this morning at the European Association for the Study of Liver Disease (EASL) annual meeting.

Here are the headline EASL data most important to investors:

Gilead's "Electron" study of GS-7977 plus ribavirin which enrolled 25 treatment naive, genotype 1 patients: SVR4 (early cure) rate of 88%

Bristol's phase II study of daclatasvir plus Gilead's GS-7977 in patients with genotypes 1, 2, and 3: SVR4 (early cure) rate in the genotype 1 patients: 100%. In genotype 2/3 patients, the SVR4 rate was 91%.

Snap judgments: Strong data, particularly from the Bristol daclatasvir study. Anytime you cure 100% of patients, that's very good. Gilead's Electron study results appear to meet Wall Street's expectations for what's considered a strong cure rate.

TheStreet contributor and healthcare investor Nathan Sadeghi-Nejad is in Barcelona at the EASL conference and reports back that the says the hedge fund crowd around the Gilead poster broke into high fives when the data were announced.

In a tweet from EASL, Sadeghi writes, "Consensus here is 'thrilled.' Buysiders and sellsiders alike. I don't see any big flaws. GILD management glowing."

Gilead also announced results from a second mid-stage study, dubbed "Quantum", using the same GS-7977 and ribavirin combination. The SVR4, or early, cure rate of 59% was not as robust as the Electron result.

Why the disparity between the strong Electron results and weaker Quantum results using the same treatment regimen? Electron enrolled easier to treat patients -- 44% had the IL28B "CC" genetic variant of the hepatitis C virus which is known to respond better to treatment. By comparison, only 16% of the patients in the Quantum study carried the "CC" genetic variant.

Wall Street reactions are starting to come in:

ISI Group biotech analyst Mark Schoenebaum says Bristol's daclatasvir plus GS-7977 study is the "best case" with an SVR4 rate of 100%, "it obviously doesn't get any better than this," he writes in an email to clients.

Schoenebaum also says Gilead's Electron results were "better than expected."

J.P. Morgan biotech analyst Geoff Meacham, with a nod to his time in Barcelona, calls the Gilead data "Muy Robusto."

More details and updates from the EASL conference on the way.

--Written by Adam Feuerstein in Boston.


Collaboration on Hepatitis Drugs Lags: BMS & Gilead

NY Times Published: April 19, 2012

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.

A machine purifying a drug at a Gilead Sciences laboratory in California.

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."

Norbert W. Bischofberger, executive vice president for research and development at Gilead, said his company wanted to wait several months for data on other treatment options before deciding what path to take.

"We told them it's too early to jump wildly into this collaboration," he said.

Both executives spoke separately by telephone from the International Liver Congress in Barcelona, Spain, where data on the drug combination was presented.

Gilead and Bristol are among the leaders of one of the most heated races in the pharmaceutical industry - to develop an all oral treatment for hepatitis C, a liver-damaging virus that infects three million to four million Americans.

New pills introduced last year by Vertex Pharmaceuticals and Merck have sharply improved the cure rate, to about 60 to 80 percent. But those drugs must still be used alpha interferon, which is injected weekly for up to a year and can cause flulike symptoms.

Many companies are trying to develop combinations of pills - similar to those used to treat H.I.V. - that would eradicate the virus without the need for interferon.

Results from several companies presented at the Barcelona conference have given doctors confidence that this will indeed be possible, with the first such combinations reaching the market perhaps by 2014.

Dr. Melissa Palmer, who was a practicing liver specialist until last fall, said that the trials were small and patients were usually not followed long enough to see if they were truly cured.

"It's going to be important to wait a longer time to see if these results are sustainable," said Dr. Palmer, who is now a consultant to investors.

Nonetheless, investors were busily predicting from the Barcelona data which companies will capture the billions of dollars a year in possible sales. Besides Gilead and Bristol, some mentioned Abbott Laboratories, which also presented strong preliminary data.

Gilead, a leader in drugs for AIDS, paid $11 billion a few months ago to acquire Pharmasset, based on very preliminary data on its hepatitis drug, now called GS-7977. Subsequent data was not as good and Gilead's stock sank.

But the data announced on Thursday appeared to restore confidence in 7977. Shares of Gilead gained 12 percent to $52.25. Shares of Bristol rose 1 percent to $33.93.

All 29 of the patients with the strain of the virus that is most common in the United States had no detectable virus in their blood four weeks after finishing 24 weeks of treatment with GS-7977 and Bristol's pill, daclatasvir. The figure was 28 out of 30 patients with two other virus strains. Each pill was taken once a day.

Doctors usually wait 12 to 24 weeks after finishing treatment to declare a cure, since there can be relapses.

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.


Gilead, Bristol Put Profits Ahead of Best Care for Hep C Patients


BARCELONA (TheStreet) -- The most effective new therapy for hepatitis C -- two pills that could cure nearly every patient treated -- may never see the light of day because the developers of these new medicines, Bristol-Myers Squibb and Gilead Sciences seem unable to work together.

Apparently, profits are more important than best patient care.

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.

"Given the strong SVR4 [early cure] data from the combo trial of daclatasvir (DCV) + GS-7977, and in the interest of advancing the science and for the benefit of patients, we were interested in a Phase III collaboration. Unfortunately Gilead was not interested," said Bristol spokeswoman Cristi Barnett.

Gilead spokeswoman Amy Flood responded, "That's not the case. There are a number of new data sets at EASL and we need to evaluate and understand all of them. We're going to do that, and look at the best option or options for proceeding as quickly as possible to advance the best all-oral regimen."

EASL Secretary General Mark Thursz wants to see the two companies work together.

"The combination of daclatisvir and GS-7977 has shown positive results at Phase II. EASL is disappointed that development of this combination has been halted as daclatisvir and GS-7977 promised to deliver a highly effective oral regimen that we hoped would be available to HCV patients soon," said Thursz.

Gilead may have $11 billion worth of reasons for not wanting to hook up with Bristol, as in the money spent by the company to acquire Pharmasset this year and gain control of GS-7977. Gilead spent outrageously to buy Pharmasset in an attempt to dominate the future of Hep C treatment in much the same way it already dominates the HIV market.

Gilead needs to justify that $11 billion and deliver profits and returns to its shareholders. Collaborating with Bristol would more than likely dilute Gilead's Hep C profits, which helps explain why Gilead isn't exactly thrilled to push ahead with the daclatasvir GS-7977 combination.

Instead, Gilead would prefer to combine GS-7977 with GS-5885, another drug it owns 100% that belongs to the same NS5A inhibitor class as daclatasvir. But a lot of work remains to be done on GS-5885; it may not be as safe or as effective as daclatasvir. It could also take longer for this all-Gilead combination to reach the market, which means Hep C patients in need of treatment will suffer.

Bristol is in a similar situation. Without access to GS-7977, the company is likely to move ahead with a combination of daclatasvir and INX-189, which belongs to the same nucleoside, or "nuc" class of drugs as GS-7977. Bristol acquired INX-189 when it bought Inhibitex for $2 billion earlier this year.

Bristol still has a lot of work to do with the daclatasvir-INX-189 combination before it can move into phase III studies, which also potentially means Hep C patients will be waiting longer.

Idenix Pharmaceuticals is also working on a regimen combining an NS5A inhibitor with a nuc, but those clinical studies are well behind Bristol and Gilead.

Regardless of who's to blame in this Bristol-Gilead spat, Hep C patients in need of convenient and potent new cures are being hurt. It remains to be seen if leading Hep C doctors, patient advocacy groups or medical societies like EASL will object and pressure the companies to move daclatasvir and GS-7977 into phase III studies as soon as possible.

Drug companies always say patients come before profits, but that feels like nothing more than an empty slogan today.

--Written by Adam Feuerstein in Boston.