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.
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