news flash................
Tuesday July 7, 9:32 am Eastern Time
Company Press Release
FDA Grants Expedited Review Status to Cypros
Pharmaceutical Corporation's Head Injury Drug, Ceresine
CARLSBAD, Calif.--(BW HealthWire)--July 7, 1998--Cypros Pharmaceutical Corp.
(AMEX:CYP - news) announced today that it has been notified by the Food and Drug
Administration (the ''FDA'') that the company's drug, Ceresine(TM), for the treatment of acute head
injury, has been granted expedited development status.
Special provisions delineated under Subpart E of the Code of Federal Regulations are designed to
expedite the development, evaluation and marketing of drugs for the treatment of life-threatening or
severely debilitating diseases. The decision to grant Ceresine(TM) expedited review status followed
FDA evaluation of the company's data and its clinical plan for developing Ceresine(TM) to treat
acute head injury, up to the filing of the New Drug Application.
Ceresine(TM) is in late-stage clinical development by the company for the treatment of severe head
injury patients. The drug has a novel mechanism of action which employs the reduction of lactic acid
accumulation in the brain. Lactic acid accumulates in ischemic or injured brain tissue and results in cell
death due to cessation of energy production and reduced pH (increased acidity). Although several
drug candidates from other firms have recently failed in head injury clinical trials, Ceresine(TM)
represents the first attempt at employing this metabolic approach to brain injury. Clinical studies
conducted by the company have shown that Ceresine(TM) dramatically reduces lactic acid build-up
in head injury patients. Head injury is the leading cause of death of Americans under the age of 35.
Zofia E. Dziewanowska, M.D., Ph.D., the company's senior vice president of Drug Development,
made the following comments, ''The expedited review mechanism represents a most desirable
relationship between the Company and the regulatory authorities. The mutual goal is to speed the
development of potentially promising drugs for currently untreatable, life-threatening diseases. It
assures close and rapid interactions with the Agency as the Ceresine(TM) project moves forward.
We are very pleased that Ceresine(TM) has joined the ranks of this very select group of high priority
drugs.''
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); is preparing to launch two
proprietary, extended-release wound-care products; and, is developing its two lead drugs,
Cordox(TM) and Ceresine(TM), for a variety of ischemic disorders.
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, 1997 and the Risk Factors section of the company's
Registration Statement No. 333-25661.
Contact:
Cypros Pharmaceutical Corporation
Paul J. Marangos, 760/929-9500
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