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www.fdanews.com/articles/84587-gsk-profits-up-in-2005-company-plans-cervarix-filings-in-u-s-eu

GSK PROFITS UP IN 2005; COMPANY PLANS CERVARIX FILINGS IN U.S., EU

February 15, 2006

GlaxoSmithKline's (GSK) profits rose 16 percent to $11.2 billion last year on strong vaccine, diabetes and asthma drug sales growth, the firm reported.

While pharmaceutical sales increased 8 percent in 2005, sales of Wellbutrin and Paxil declined on generic competition, the firm said in its recent earnings report. For 2005, sales of antidepressant Wellbutrin (bupropion HCl) fell 2 percent while sales of antidepressant Paxil (paroxetine HCl) fell 42 percent.

Sales of asthma drug Advair (fluticasone propionate/salmeterol xinafoate) increased 22 percent, while sales of diabetes drug Avandia (rosiglitazone maleate) grew 18 percent. Vaccine sales rose 15 percent, led by diphtheria and tetanus vaccine Infanrix. U.S. vaccine sales were particularly strong, rising 26 percent, aided by flu vaccine Fluarix and tetanus, diphtheria and whooping cough vaccine Boostrix.

GSK said it plans to file applications for HPV/cervical cancer vaccine Cervarix in the European Union in March and in the U.S. by the end of the year. The firm also will file applications to market Cervarix in other non-U.S. markets in March. In addition, GSK said it expects to start clinical trials in the next few weeks on its experimental H5N1 avian flu vaccine.

Merrill Lynch analyst Gregory Gilbert said it was "encouraging" that GSK was on track to file Cervarix as planned, because it suggests that Cervarix will launch shortly after Merck's HPV/cervical cancer vaccine Gardasil.

GSK said it expects seven products to be approved and launched this year. The firm also plans to file applications for another seven products in 2005, including an extended-release version of epilepsy and bipolar drug Lamictal. Eight products are set to enter Phase III clinical testing this year, doubling its total late-stage product pipeline, GSK said. In late January, GSK received the FDA go-ahead to market a OTC version of Roche's weight-loss drug Xenical (orlistat).