Penwest Pharmaceuticals Co announced that Nifedipine XL, which it has licensed to Merck, SA. Industrias Quimicas, has been approved by regulatory authorities in Brazil for marketing there in 30 mg and 60 mg dosage forms. The companies expect that Merck will begin commercialization of the drug under the brand name Cronodipin in early 2002.

Nifedipine XL is a controlled release version of nifedipine using Penwest's TIMERx oral drug delivery technology. The product is indicated for the treatment of hypertension and angina.

Tod R. Hamachek, Chairman and Chief Executive Officer of Penwest, said, "We are pleased by the international acceptance of our technology and of Nifedipine XL. This is our first entrance into the South American market. Nifedipine products are marketed in Europe through our collaboration with Sanofi-Sythelablo, and is being registered in Israel through a separate licensing agreement. In addition, Penwest and Mylan Pharmaceuticals jointly developed a 30 mg version of Nifedipine XL, a generic version of Procardia XL, which received U.S. regulatory approval. The internationalization of our product portfolio is an important part of our strategy and we will continue to pursue opportunities for Nifedipine XL."