FDA Grants Expedited Development Status to Cypros Pharmaceutical Sickle Cell Anemia Crisis Drug; Patient Recruitment Begins in Phase III Sickle Cell Trial of Cordox.

CARLSBAD, Calif.--(BW HealthWire)--Dec. 14, 1998--Cypros Pharmaceutical Corp. (AMEX:CYP) announced today that it has been notified by the Food and Drug Administration (the "FDA") that the company's drug for the treatment of sickle cell anemia crisis, Cordox(TM), has been granted expedited development status.

The designation is reserved for drugs whose development, evaluation and marketing are considered a higher priority because they treat life-threatening or severely debilitating diseases for which no adequate therapies are available. Both of the company's late stage drugs, Cordox and Ceresine(TM), now have received expedited development status. The company also announced that patient recruitment has begun in its Phase III trial of Cordox in sickle cell anemia crisis patients.

Cordox(TM) is being developed by the company for several ischemic indications including bypass surgery, heart transplant and sickle cell crisis. The drug is a natural sugar phosphate which provides metabolic energy to blood deprived (ischemic) tissues. Sickle cell anemia is a genetic disorder characterized in its most severe form by multiple ischemic events which are extremely painful and result in progressive organ failure and reduced lifespan.

Cordox(TM) is believed to reduce the ischemic damage associated with the disease by both direct action on the ischemic tissue and by improving blood flow. The drug may affect the clinical course of the patient in addition to reducing pain. Current treatments for sickle cell crisis treat the symptoms and do not reduce the organ and tissue damage which is associated with the morbidity and mortality in these patients.

Commenting on the announcement, Paul J. Marangos, the company's chief executive officer, stated: "We are very pleased that both of our lead development state drugs, Cordox and Ceresine, now have been granted expedited development status. This select status assures a close working relationship with the regulatory authorities and can translate to a substantial reduction in the time it takes to get these drugs approved. We are pleased to be developing two drugs that meet such a high medical need."

Cypros Pharmaceutical is engaged in the development and marketing of drug products for the hospital market. The company is pursuing a diversified strategy of marketing approved drugs and developing small molecule therapeutics that protect cells from ischemic injury.

The company currently has three products on the market, Glofil, Inulin and Ethamolin(R) and expects to launch two new burn and wound care products in the next year, Neoflo(TM) and Sildaflo(TM). The company is developing Cordox(TM) and Ceresine(TM) in various cardiovascular and cerebrovascular indications and is in a Phase III trial of Cordox in sickle cell anemia crisis patients.