GlaxoSmithKline on Tuesday issued an update of the various compounds in its research pipeline, and noted that it expects to file for approval of at least three of these compounds in 2005. In a presentation in London to investors, GSK executives said that its compounds in development to treat central nervous system disorders, a therapy area that represents 20 percent of the compnay's R&D pipeline, have shown significant progress, but are in early stage trials.
GSK also highlighted its drugs expected to see filings and/or approvals in 2005 include:
*Entereg to accelerate gastrointestinal recovery following abdominal surgery. The FDA has accepted an NDA for Entereg. The FDA action date is April 25, 2005.
*Trexima for migraine. Trexima is expected to provide superior efficacy when combined with naproxen sodium. Filing is expected in the first half of 2005.
*Requp/Adartrel for the treatment of restless leg syndrome, the third most common cause of sleep disturbance. GSK expects to gain U.S. approval for Requp/Adartrel for the treatment of RLS in the first half of 2005.
GSK has 148 projects in clinical development, including 90 new chemical entities (NCEs) - an 80 percent increase since the merger of Glaxo Wellcome and Smithkline Beecham.
A complete listing of all compounds in the GSK research pipeline is available at www.gsk.com