FDA Accepts For Review SangStat's Application For Market Clearance of its Cyclosporine; Additional Trials Further Support Bioequivalence Between SangStat's Cyclosporine and Novartis' Neoral.

MENLO PARK, Calif.--(BUSINESS WIRE)--January 24, 1997--SangStat, The Transplant Company, (Nasdaq:SANG), announced today that the U.S. Food and Drug Administration (FDA) has accepted for review its application for market clearance of its proprietary formulation of CYCLOSPORINE. The Company filed an application for market clearance of its Neoral-bioequivalent CYCLOSPORINE with the FDA on November 27, 1996. Neoral is the leading formation of cyclosporine, an immunosuppressive drug used in human organ transplantation to prevent graft rejection. Worldwide sales of Novartis' cyclosporines in 1995 are reported at $1.2 billion.

SangStat's application for market clearance of its CYCLOSPORINE was filed as an Abbreviated Antibiotic Drug Application (AADA), under Section 507 of the Federal Food, Drug and Cosmetic Act. "We are very pleased that our AADA submission was accepted for review by the FDA," said Philippe Pouletty, M.D., Chairman and CEO.

Furthermore, SangStat has now completed five human trials with its proprietary CYCLOSPORINE formulation in a total of 119 volunteers and patients. The pivotal bioequivalence trials submitted in the AADA demonstrated SangStat's CYCLOSPORINE to be bioequivalent to Neoral in healthy volunteers under both fasted (36 subjects) and fed (21 subjects) conditions. However, the FDA has not yet reviewed these data. The Company subsequently confirmed bioequivalence in two additional healthy volunteer trials in 38 subjects (African Americans and females) and its first patient trial in 24 kidney transplant recipients. In each of these trials the incidence, severity or frequency of side effects was similar between the two products. The company continues to plan and conduct trials in different populations of organ transplant recipients, and expects to present the results of these trials at upcoming transplant and regulatory meetings.

Under current FDA regulations and policy, a cyclosporine formulation that is shown to be bioequivalent to Neoral may be approved without the need to duplicate safety and efficacy trials. If the FDA approves SangStat's CYCLOSPORINE based on bioequivalence to Neoral, SangStat intends to market its formulation as a therapeutic substitute for Neoral.

"We look forward to working with the agency to address any issues that may arise during the review process in a timely fashion," said Hana Berger Moran, Ph.D., Senior V.P. Regulatory Affairs & Quality Assurance. "However, our policy is to not publicly comment on any interim events such as minor or major deficiency letters or modification of the file to the FDA as long as we believe the Company can ultimately gain a market approval."

In the United States and Europe there are more than 200,000 transplant recipients requiring daily immunosuppressive therapy for the rest of their lives, the majority of whom take cyclosporine. Sandimmune, the original formulation of cyclosporine, was introduced by Sandoz Ltd. (now Novartis AG) in the United States in 1983. Neoral, an improved formulation of cyclosporine with increased bioavailability, was launched first in Europe in 1994 and then in the United States in September 1995. Currently, the Company estimates that the majority of all newly transplanted patients are started on Neoral, and more than 70% of European and 50% of U.S. transplant recipients have been initiated on or converted to Neoral. This number continues to grow. Neoral and Sandimmune are marketed by Novartis AG with 1995 worldwide sales reported at $1.2 billion.

SangStat is a specialty pharmaceutical company applying a disease management approach to improve the outcome of organ transplantation. The Company has a total of 12 monitoring and therapeutic product and product candidates to address the pre-transplant, acute care and chronic phases of transplantation. Products in development include THYMOGLOBULIN (exclusive marketing and development rights from Pasteur Merieux Connaught "PMC" for the U.S. and Canada) to treat graft rejection, CYCLOSPORINE and AZATHIOPRINE for chronic immunosuppressive therapy and ALLOTRAP 2702 to promote graft acceptance following transplantation. Monitoring products include PRA-STAT and CROSS-STAT (both marketed in the U.S. and Europe) and are designed to improve donor/recipient compatibility. Other products in development include monitoring products intended to guide post-transplant therapy such as THYMOSTAT for THYMOGLOBULIN treatment optimization; CELSIOR (exclusively licensed from PMC) which is an organ preservation solution; and drug candidate XE-9 which is in early development for xenotransplantation. XENOJECT is a platform technology in the discovery phase for replacing antibody therapy with small synthetic drugs. SangStat is located in Menlo Park, California, and operates THE TRANSPLANT PHARMACY, a comprehensive pilot pharmacotherapy management program, and wholly-owned subsidiaries, SangStat Atlantique S.A., SangStat's European base of operations in Nantes, France and SangStat Canada Ltd. in Mississauga, Ontario, Canada and XenoStat, Inc., in Menlo Park, California.

This press release contains forward-looking statements that involve risks and uncertainties. Forward-looking statements reflect the Company's current views with respect to future events. Actual results may vary materially and adversely from those anticipated, believed, estimated, or otherwise indicated. Important factors common to the FDA drug review and approval process could cause actual results to differ materially with regard to the approvability of SangStat's CYCLOSPORINE. These factors include, without limitation, (1) that data obtained from clinical trials are subject to varying interpretations, and there can be no assurance that the FDA (or an FDA panel of experts) will agree with the Company's assessment of clinical trial results; (2) that there can be no assurance that the agency will not issue new guidelines, guidance documents, policies, or regulations or otherwise have new, different or previously unknown requirements that may materially affect the approvability of the product; and (3) that there can be no assurance of FDA approval of the product. Other factors that could cause actual results to differ materially include, without limitation, uncertainty related to the manufacturing of commercial quantities of CYCLOSPORINE on commercially favorable terms, market acceptance and potential litigation. For a discussion of factors that might result in different outcomes, see the section under the caption "Risk Factors" beginning on page 30 of the 1995 Annual Report to Stockholders, the Company's quarterly reports and other documents filed with the Securities and Exchange Commission.

CONTACT: Maree Wall

V.P. Corporate Communications

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