FDA Delays Cadence Drug Review: BioBuzz

SAN DIEGO, Calif. ( TheStreet) --Another U.S. Food and Drug Administration drug review -- delayed.

This time, it's Cadence Pharmaceuticals ( CADX), which said Friday that FDA is pushing back review of its intravenous acetaminophen by three months. The new approval decision date is now Feb. 12, 2010.

Last week, the FDA also delayed by three months a review of a restless leg syndrome drug by GlaxoSmithKline ( GSK) and Xenoport ( XNPT). The FDA has had difficulty meeting drug approval review deadline this year, in part because of staffing shortages but also because of the agency's renewed focus on drug safety.

Cadence is developing its intravenous acetaminophen for use in hospitalized patients. The drug's U.S. and Canadian marketing rights was licensed from Bristol-Myers Squibb ( BMY), which already sells the drug in Europe.

Gilead Benefits From New HIV Treatment Rules

Earlier this week, the European AIDS Clinical Society revised its HIV treatment guidelines, calling on doctors to start treating newly diagnosed HIV patients earlier.

The new European recommendation calls for doctors to begin treating HIV patients when their CD4 counts (a key measure of immune system health) fall to 500. In the past, doctors waited until CD4 counts fell to 350 before beginning treatment. The change comes on the heels of mounting clinical evidence from large studies showing that earlier treatment benefits HIV patients.

The new guidelines are a boon to drug companies that sell HIV medicines, and none will benefit more than Gilead Sciences ( GILD), given its market-leading HIV drug franchise. Earlier treatment starts for newly diagnosed HIV patients will translate into more HIV patients starting therapy with Gilead's Atripla or Truvada, and for longer durations.

It’s expected that HIV treatment guidelines in the U.S. will be changed similarly soon, and in fact, may be even more liberal in terms of starting HIV therapy early.

The positive financial impact to Gilead's bottom line is a bit hard to measure, but Sanford Bernstein analyst Geoff Porges estimates that the company's 2012 worldwide revenue and earnings would increase by 7% and 8%, respectively, if treatment guidelines both in Europe and the U.S. were boosted to the CD4 500 level.

This earnings boost is worth a minimum of $4 a share to Gilead, Porges estimates. If treatment guidelines become even more liberalized, meaning that the recommendation becomes treating all HIV patients upon diagnosis regardless of CD4 count, the boon to Gilead's business would be worth $9 a share, he says.

-- Reported by Adam Feuerstein in Boston

Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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