UPDATE: J&J, Gilead Sign Deal For Combination HIV Therapy
June 28 2011 - 3:21PM
Dow Jones News
Gilead Sciences Inc. (GILD) and Johnson & Johnson (JNJ)
agreed to develop a new combination HIV drug, and are in talks to
further expand their partnership on drugs for the virus causes
AIDS.
The companies plan to develop a single-tablet combination of
J&J's Prezista drug with Gilead's experimental drug
cobicistat.
Prezista, which has been on the market since 2006, is a
so-called protease inhibitor designed to treat HIV infection and is
taken with the drug Norvir, in combination with other
antiretroviral agents.
Gilead has been testing cobicistat as a "boosting agent" to
enhance blood levels of certain other HIV drugs. The companies plan
to combine Prezista with cobicistat in a single table that can be
taken once daily.
J&J will be responsible for the formulation, manufacturing,
registration, distribution and commercialization of the combination
drug worldwide. Gilead will retain sole rights to manufacture,
develop and commercialize cobicistat as a stand-alone product and
for use in combination with other agents.
Gilead will receive a flat royalty as a percentage of net sales
of the combination product, if it reaches market, minus the supply
price of the cobicistat active ingredient contained in those net
sales, said spokeswoman Erin Rau.
In addition, J&J and Gilead are negotiating terms for the
development and commercialization of a single-tablet regimen
combining several components: Prezista, Gilead's Emtriva and
Gilead's experimental drugs GS 7340 and cobicistat.
Piper Jaffray analysts said the new deal was a modest positive
for J&J as it builds a franchise in HIV medications. They said
it's difficult, however, to assess the financial impact on J&J
until the negotiations on the single-tablet regimen are complete
and terms are disclosed.
For Gilead, the deal further extends the company's dominance in
HIV therapies, according to Lazard Capital Markets analyst Joel
Sendek. Gilead's HIV drug Atripla had sales of $2.93 billion for
2010, while Truvada sales were $2.65 billion.
The moves would expand a partnership between J&J and Gilead
formed in 2009. Under that deal, the companies developed a
combination of Gilead's Truvada HIV drug and J&J's Edurant.
Earlier this year, Gilead re-submitted an application for U.S.
Food and Drug Administration approval of the Truvada-Edurant
combination, after the FDA said the initial application didn't
contain sufficient information. An FDA decision is expected by
mid-August. The FDA approved Edurant as a stand-alone drug in
May.
Shares of Gilead rose 2.3% to $41.10, while J&J was up 1.3%
at $66.09 in recent trading.
-By Peter Loftus, Dow Jones Newswires; +1-215-982-5581;
peter.loftus@dowjones.com
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