Monday, August 7, 2000
While European regulators may be following the precautionary
principle when it comes to GMOs, with drugs, they sometimes take a more laissez
faire approach than their U.S. counterparts. This appears to be the case with
two drugs being developed by Shire Pharmaceuticals Group plc: Reminyl galantamine
for Alzheimer's disease and Lambda lanthanum carbonate to treat hyperphosphatemia
in dialysis patients.
Shire (LSE:SHP; SHPGY, Andover, U.K.) and partner Janssen Pharmaceutica
Products LP (Beers, Belgium) received an approvable letter last week from the
FDA for Reminyl, an acetylcholinesterase inhibitor. Reminyl is approved in Europe,
with European launches anticipated in the fourth quarter.