NEWS OFTHEWEEK PHARMACEUTICALS
MERCK ADVANCES LICENSING AGENDA Deal with Lundbeck lands a late-stage compound for sleep disorders
M Gilmartin
ERCK AND H. LUNDBECK
A/S have signed a joint development and commercialization agreement under which Merck will gain exclusive U.S. rights to Lundbeck's gaboxadol, a GABA-Areceptor agonist currendy in Phase III clinical trials for sleep disorders. Under the agreement, Merck will make an up-front payment of $70 million to Lundbeck and a total of as much as $200 million in milestone payments. Merck anticipates filing a New Drug Application with FDA between late-2006 and mid-2007. Lund-
beck, which specializes in psychiatric medicine, will copromote gaboxadol and will receive a share of U.S. sales of the drug. Industry analysts applaud the move as a sign that Merck, which suffered two late-Phase III trial failures in 2003, is serious about expanding its portfolio through licensinglate-stage drug candidates. WithZcjcorCsimvastatinXMerck's $5 billion-per-year cholesterol-reducing drug, corning off patent in June, andalate-stagepipeline dominated by low-profit-margin vaccines, Merck will look to gaboxadol for growth, comments David
RISK ASSESSMENT
VACCINES'LINK TO AUTISM UNCLEAR Researchers present conflicting evidence over role of preservative
T
H E R E HAS BEEN A L O N G -
running debate in the US. over whether vaccines routinely given to infants contribute to the development of autism. In particular, some people believe that thimerosal—sodium ethylmercurithiosalicylate—until recently used as a preservative in most pediatric vaccines, may cause autism. On Feb. 9, researchers presented findings on the subject to the Immunization Safety Review Committee of the Institute of Medicine (IOM). The information did not resolve the dispute. Epidemiologists showed data indicating that thimerosal in vac-
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cines is harmless. However, the toxicologists and a chemist presented findings showing that it is biologically plausible for thimerosal in vaccines to cause autism. The researchers seemed to agree that U.S. autism rates rose dramatically in the 20 years or so before 2000, a period in which mercury exposure to infants from thimerosal nearly tripled, primarily because many more childhood vaccines were developed. In 2001, IOM issued a report saying that, although current evidence neither proves nor disproves a link between thimerosal and autism, exposure to the preserva-
Moskowitz, a stock analyst at Friedman, Billings, Ramsey Group. Analysts warn, however, that the $2 billion U.S. market for prescription sleep disorder drugs, now dominated by Sanofi-Synthelabo's Ambien (zolpidem tartrate) with a 65% share, is getting crowded. Sepracor's Estorra (eszopiclone) and Pfizer/Neurocrine's indiplon are both in Phase III clinical trials. An extendedrelease version of King Pharmaceutical's Sonata (zaleplon) is in Phase II trials. At a recent meeting with analysts, Merck CEO Raymond V Gilmartin emphasized the company's plan to pursue licensing and external alliances as opposed to mergers or acquisitions to advance its pipeline. The firm, which has notable alliances with GenPath Pharmaceuticals for cancer, Amrad for respiratory disease, and Neurogen for pain, completed 40 deals last year, compared with 10 in!999.-RICKMULLIN
tive should be reduced. As aresult, drug firms removed thimerosal from most pediatric vaccines. Anders P Hviid, biostatistician at the State Serum Institute in Copenhagen, told IOM that he had found no connection between autism rates and thimerosal exposure among about 467,000 Danish children born between 1990 and 1996. But Boyd E. Haley professor of chemistry at the University of Kentucky presented evidence that autistic children have more difficulty excreting mercury than normal children. This could explain why mercurymay stay in their bodies long enough to interfere with normalbrain development, he said. "vaccine maker Aventis Pasteur says in a statement: "The hypothesis of any danger {from thimerosal] is not established or supported by either clinical or experimental evidence." The IOM committee will issue a report in about three months.-BETTE HILEMAN HTTP://WWW.CEN-ONLINE.ORG
