Gensia Inc. said problems with its initial scale-up formulation ofGeomatrix nifedpine will force the company to delay filing anabbreviated new drug application (ANDA) with the FDA for at leastseveral months.
The company's stock (NASDAQ:GNSA) dropped 13 percentMonday to close at $4.12.
The San Diego-based Gensia had planned to file the ANDA in thefirst half of this year for the drug, which is designed as a treatmentfor hypertension and angina. The product is a combination ofGensia's Geomatrix technology of controlled drug delivery andnifedipine, which is a generic form of New York-based Pfizer Inc.'sProcardia XL.
Daniel Burgess, Gensia's chief financial officer, said the company isworking with its partner, Boehringer Mannheim PharmaceuticalsCorp., to modify the formulation.
Last October, Gensia signed a $64.5 million agreement withBoehringer Mannheim, of Gaithersburg, Md., to develop Geomatrixnifedipine. Under the agreement, Boehringer Mannheim paid Gensia$10 million in cash and made a $10 million equity investment.
Payment of the additional $44.5 million is based on Gensiaachieving certain milestones related to Geomatrix nifidepine,including filing the ANDA.
Burgess said the delay of the ANDA will postpone and reducepayments from Boehringer Mannheim, but he declined to providedetails.
The Geomatrix nifedipine problems surfaced when commercial-scalequantities of drug were manufactured for the pivotal studies neededto support the ANDA. Rhone-Poulenc Rorer, of Collegeville, Pa., ismanufacturing the product for Gensia.
In pilot studies, the formulation developed for Geomatrix nifedipineshowed it was bioequivalent to Procardia XL, but Burgess said testsof the product for the pivotal trials indicated it did not meetbioequivalency standards. _ Charles Craig
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