SOURCE: Penwest Pharmaceuticals Co. Press Release

Penwest Pharmaceuticals Co. announced that for the first time the U.S. Food and Drug Administration (FDA) has approved a new drug application (NDA) for a product that uses Penwest's PROSOLV®. The drug was developed by MOVA Pharmaceutical Corporation and is a sodium levothyroxine dosage form indicated for the treatment of hypothyroidism and the suppression of thyroid stimulating hormone. MOVA will market the product as Levo-T® in eleven tablet dosages ranging from 25 mcg to 300 mcg. Penwest expects MOVA to launch the product over the next few months.

Stephen J. Berte, Jr., Penwest's Senior Vice President, General Manager - Excipients, said, "This first NDA approval for a drug using PROSOLV in the U.S. is an important milestone for the acceptance of our technology by pharmaceutical companies. PROSOLV, which had double-digit revenue growth in 2001, is a significant driver of our excipient business and continues to demonstrate its flexibility and effectiveness. Our PROSOLV technology is an important ingredient for direct compression manufacturing, which lowers production costs and provides tablets with content uniformity that has traditionally been achievable only through more expensive processes such as wet granulation. Therefore, as the pharmaceutical industry looks to formulate lower dose, higher potency drugs, we believe PROSOLV is well-positioned in the U.S. We also anticipate two additional marketing approvals of drugs containing PROSOLV in the U.S. during 2002."

Jose E. Casellas, Vice President Corporate Business Development of MOVA Pharmaceutical, commented, "PROSOLV enabled MOVA to develop our Levo-T product with the content uniformity that is essential in ensuring proper efficacy of the drug, and PROSOLV's direct compression techniques reduce our production costs and allow us to avoid manufacturing challenges typically associated with low-dose drugs. We believe we will have the advantage of a clearly differentiated and superior medicine."

Penwest is engaged in the research, development and commercialization of novel drug delivery technologies. Based on its experience in developing and manufacturing ingredients for orally administered pharmaceutical products, Penwest has developed its proprietary TIMERx® controlled release delivery and PROSOLV® High Functionality Excipient technologies, which can be applied to a broad range of drugs.