Bristol urges combo study with Gilead hepatitis drug

By Ransdell Pierson

Thu May 31, 2012 12:14pm EDT

(Reuters) - Bristol-Myers Squibb Co renewed its call for biotechnology company Gilead Sciences Inc to test one of its hepatitis C drugs in late-stage trials alongside Bristol's own promising medicine, following stellar results from a mid-stage trial that combined the experimental products.Bristol's daclatasvir is from a new class of drugs known as NS5A inhibitors. Gilead's GS-7977 is a nucleotide polymerase inhibitor. Both are designed to block enzymes essential to replication of the hepatitis C virus.

Bristol-Myers Chief Executive Lamberto Andreotti, speaking on Thursday at the Sanford Bernstein Strategic Decisions Conference in New York, said patients and both drugmakers stand to benefit if combined Phase III trials of the two medicines are pursued.

"We have a different point of view about whether to enter Phase III (trials) with that combination," Andreotti said. "We believe for both patients and companies, it is better to move forward" in the short term.

But Andreotti said Gilead instead seemed intent on looking "in-house" -- focusing instead on combinations of its own products. Gilead officials could not immediately be reached to comment.
Andreotti said there was a "huge unmet need" for better treatments among an estimated 170 million to 180 million people worldwide believed to be infected with the virus. Transmitted by blood transfusions, sexual contact and shared drug needles, the virus invades the liver and can steadily destroy the organ over decades. It is the biggest reason for liver transplants in the United States.

Shares of Gilead jumped 11 percent on April 19 when data from a mid-stage trial were released and showed profound benefits of combining its GS-7977 -- acquired through Gilead's $11 billion purchase of Pharmasset -- with Bristol's daclatasvir.

At the time, Bristol said Gilead had balked at further collaboration on the combination under study, which began when 7977 was owned by Pharmasset.

Data from the mid-stage study combining 7977 and daclatasvir showed a 100 percent response rate in previously untreated patients with the most common form of hepatitis C.

Instead of working with Bristol-Myers, Gilead is forging ahead with a study of 7977 in combination with its own experimental NS5A inhibitor. In the meantime, Bristol-Myers is testing daclatasvir with a drug similar to 7977 that it acquired with its $2.5 billion purchase of Inhibitex, as well as with other experimental drugs in its development pipeline.

(Reporting By Ransdell Pierson; Additional reporting by Bill Berkrot; Editing by Maureen Bavdek)

http://www.reuters.com/article/2012/05/31/us-bristolmyers-gilead-idUSBRE84U0WC20120531