FDA Grants Fast Track Designation for Cordox, Cypros Pharmaceutical's Bypass Surgery Drug.

CARLSBAD, Calif.--(BW HealthWire)--Sept. 21, 1999--

Cypros Pharmaceutical Corp. (AMEX:CYP) announced today that it has been informed by the U.S. Food and Drug Administration (FDA) that the company's Cordox(TM) drug has been granted fast track designation for the treatment of acute ischemic complications associated with coronary artery bypass grafting (CABG) surgery.

The fast track (facilitated development) designation was granted because Cordox(TM) has the potential to address an unmet medical need since no suitable alternative therapy for this indication currently exists. This designation permits the FDA to expedite the development and review of a potential new drug application for Cordox(TM) in CABG surgery patients who are at increased risk of complications. Cordox(TM) now has facilitated development status in both the CABG and sickle cell anemia crisis indications.

Cordox(TM), a natural intermediate of anaerobic energy generation, is currently being evaluated in a Phase III clinical trial in sickle cell anemia patients and has recently completed Phase II clinical evaluation in CABG patients. Fast track status for Cordox(TM) in the CABG indication was granted for the reduction of acute ischemic complications such as heart failure, atrial fibrillation, acute myocardial infarction and death, all of which are associated with CABG. Existing clinical data indicates that Cordox(TM) can reduce the damage done to the heart during the ischemic period of the bypass procedure when blood flow to the heart is completely interrupted. There are almost 400,000 CABG procedures performed per year in the U.S. and over 750,000 procedures employing heart bypass, a substantial portion of which are at increased risk of complications.

"This is now the third facilitated development designation Cypros has received from the FDA; sickle cell anemia and CABG for Cordox(TM) and traumatic brain injury for Ceresine(TM), commented Paul Marangos, the company's chairman and chief executive officer. "This underscores our mission to develop drugs to treat serious, unmet medical needs with the ability to improve acute care therapy in a fundamental manner. Receipt of fast track status prior to NDA submission can result in a facilitated development path. We are pleased to have all our development programs under this regulatory designation."

Cypros Pharmaceutical Corp. is engaged in the development and marketing of acute care drug products for the hospital market. The company employs a diversified strategy of marketing approved drugs and developing small molecule therapeutics that protect cells from ischemic injury. The company's two cytoprotective drugs, Cordox(TM) and Ceresine(TM), are in late stage clinical trials for a variety of ischemic indications including sickle cell anemia, coronary artery bypass grafting surgery and brain injury.

Visit the Cypros Pharmaceutical Web site at http://www.cypros.com.

This news release contains forward-looking statements, which involve risks and uncertainties. Such statements are subject to certain factors, which may cause the company's plans to differ. Factors that may cause such differences include, but are not limited to, the risks discussed in the company's Form 10-K for the fiscal year ended July 31, 1998 and the Risk Factors section of the company's Registration Statement No. 333-25661.