Gensia Inc. said Wednesday that it selected a formulation formanufacturing scale-up on a product it believes can achieve an ABequivalent rating (generic equivalency) to Procardia XL, a Pfizer Inc.drug used to treat chronic cardiovascular disease.The product, Geomatrix nifedipine, is the first compound beingdeveloped by the San Diego company's collaboration with Genta Jago,a joint venture between Genta Inc., of San Diego, and Jagotec AG ofSwitzerland. If scale-up efforts are successful, Gensia plans to beginpivotal studies in the fourth quarter, and hopes to submit anabbreviated new drug application in the first quarter of 1995.Also Wednesday, Gensia said it signed an agreement with Rhone-Poulenc Rorer Inc. to manufacture the product for pivotal studies, aswell as commercialization, if the product is approved. Procardia XLhas U.S. sales of $1.2 billion in 1993, Genta said.Genta Jago is developing six products, and is planning to start fivemore this fall, though not all of them are AB rated, William Bliss,Genta's president, told BioWorld. _ Jim Shrine
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