(Adds CEO comments on healthcare reform, research spending)
By Ransdell Pierson
May 31 (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 impressive
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 or shared drug needles, the
virus invades the liver and can steadily destroy the organ over
decades. It is the most common reason for liver transplants in
the United States.
Data from the mid-stage trial combining Gilead’s GS-7977 and
Bristol’s daclatasvir showed a 100 percent response rate in
previously untreated patients with the most common form of
hepatitis C.
Shares of Gilead jumped 11 percent on April 19 when the data
were released, showing the profound benefits of combining its
7977 — acquired through Gilead’s $11 billion purchase of
Pharmasset — with daclatasvir.
At the time, Bristol said Gilead had balked at further
collaboration on the combination under study, which was begun
while 7977 was owned by Pharmasset.
The results of the mid-stage study were accomplished without
interferon, an injected drug that causes flu-like symptoms and
other side effects that often lead patients to discontinue or
delay treatment, or ribavirin, an older antiviral drug that is
also currently part of all treatment regimens.
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.
In other remarks at the Sanford Bernstein meeting on
Thursday, Andreotti said he expects some form of U.S. healthcare
reform to emerge, even if the U.S. Supreme Court rules against
extensive reforms approved by Congress and signed into law by
President Obama.
The High Court is expected next month to render a decision
on the sprawling legislation, which would greatly expand
healthcare coverage to uninsured Americans but require bigger
fees and rebates from drugmakers and medical device makers.
Andreotti said the enacted reforms “started out on the right
foot” but became too complicated for Bristol-Myers and the
American people.
The Bristol-Myers CEO said he expects rapidly declining
sales of Plavix, a blood-clot preventer which has long been the
company’s longtime biggest product, due to loss of U.S. patent
protection earlier this month and ensuing competition from a
number of cheaper generics. The pill, sold in partership with
French drugmaker Sanofi, had revenue last year of more
than $7 billion — making it one of the world’s top-selling
medicines.
Despite expected plunging sales of Plavix, Andreotti said
Bristol-Myers has no plans to “downsize” its research spending,
having already closed down many company facilities in previous
cost-cutting efforts.
Bristol-Myers will adjust future R&D; spending in accordance
with company performance, and expects significant sales gains to
come from Asia but not from Europe, Andreotti said.
(Reporting By Ransdell Pierson; Additional reporting by Bill
Berkrot; Editing by Maureen Bavdek and Gunna Dickson)
