News (Updated
April 26, 2009)
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Gilead Sciences shares
gain ground after HIV treatments drive 1st-quarter profit boost
On Wednesday April 22,
2009, 12:25 pm EDT
The stock gained $3.36, or
7.7 percent, to reach $47.09 in afternoon trading. Shares have traded between
$35.60 and $57.63 over the last 52 weeks.
The Foster City, Calif.-based
company surprised Wall Street with profit of 63 cents per share, beating the
59-cents-per-share estimate of analysts polled by Thomson Reuters.
The company also backed
its 2009 outlook.
The bulk of the revenue
again came from HIV drugs. Truvada sales rose 23 percent to $590.4 million, and
Atripla sales climbed 57 percent to $509.9 million. Atripla is made from a
combination of three older drugs:
"Looking forward, we
expect modest market growth driven by increased diagnosis and treatment rates as
well as market share gains," BMO Capital Markets analyst Jason Zhang said
in a note to investors.
He reaffirmed a
"Outperform" rating and raised his outlook for HIV treatment sales at
Meanwhile, Thomas Weisel
Partners analyst M. Ian Somaiya reaffirmed a "Overweight" rating
following the financial results. He said several factors, including a potential
inventory restocking and lack of patients seeking and receiving financial
assistance bode well for the company's growth outlook.
"This suggests that
Pharmasset ends
development of lead drug candidate over concerns for hepatitis B patients
On Monday April 20, 2009,
8:23 am EDT
PRINCETON, N.J. (AP) --
Pharmasset Inc. said Monday it is ending development of its most advanced drug
candidate, clevudine, over concerns of severe muscle weakness in hepatitis B
patients.
Pharmasset said it made
the decision to end the late-stage Quash studies voluntarily, following
discussions with an independent monitoring board and the Food and Drug
Administration. The company is maintaining its focus on a separate hepatitis C
program with its partner Roche.
Both hepatitis B and C are
liver conditions. The decision was made based on the rate of South Korean
patients with muscle weakness, or myopathy, side effects.
"Although the number
of cases of myopathy in the Quash trials was low and the severity was mild, more
severe reports from other trials and post marketing surveillance led us to
believe the risk benefit ratio for clevudine was insufficient to continue
development," said Chief Medical Officer Dr. Michelle Berrey in a
statement.
Pharmasset said it will
continue collecting safety data and monitoring patients after the study is
discontinued, though it won't submit the results to the FDA for approval.
"While we are
obviously disappointed with the outcome, we believe the decision to stop dosing
is an appropriate one," said Chief Executive Schaefer Price in a statement.
With the loss of clevudine,
the company's next most advanced drug candidate is Racivir, an HIV treatment in
midstage development. The developing hepatitis C treatment R7128 is set for
midstage development.