Gensia Go-Ahead For Geomatrix Nifedipine

Gensia has completed pilot pharmacokinetic studies which have resulted in the selection of a suitable formulation of Geomatrix nifedipine for development as a generic version of Pfizer's $1 billion-plus Procardia XL product. Gensia believes it has shown bioequivalence with its formulation and plans to file an Abbreviated New Drug Application in the USA in the first quarter of 1995.

If scale-up is successful, this is a significant development as Pfizer has always maintained that generics companies will have trouble mimicking the delivery of Procardia XL's Alza-developed GITS system. Rhone-Poulenc Rorer will manufacture the product for clinical studies as well as for commercialization if it gains regulatory approval. Geomatrix nifedipine is the first product to be developed by Gensia under its agreement with the Genta-Jago joint venture. Gensia has rights in North America, while Genta-Jago retains rights elsewhere.