SangStat Files Marketing Clearance Application for CYCLOSPORINE with FDA; CYCLOSPORINE is the Leading Immunosuppressive Drug for Transplantation.

MENLO PARK, Calif.--(BUSINESS WIRE)--Dec. 2, 1996--SangStat, The Transplant Company(TM) (NASDAQ: SANG), announced today the filing of its application for market clearance of the company's proprietary CYCLOSPORINE formulation with the U.S. Food and Drug Administration (FDA). This application includes the results of the Company's pivotal bioequivalence trials showing that SangStat's CYCLOSPORINE formulation is bioequivalent to branded cyclosporine, as defined by current FDA policy for generic drugs. Eli Lilly and Company has agreed to manufacture the finished commercial supply of SangStat's CYCLOSPORINE product candidate for the anticipated worldwide market. SangStat retains the exclusive commercial rights worldwide. Cyclosporine is the leading immunosuppressive drug used in human organ transplantation to prevent graft rejection. It is currently marketed by Sandoz Ltd. in different formulations with 1995 worldwide sales reported at $1.2 billion.

Philippe Pouletty, M.D., Chairman and CEO said, "We are very proud to be filing for approval of our CYCLOSPORINE, SangStat's first therapeutic drug application. Assuming approval, we believe SangStat's CYCLOSPORINE can be a key player in the growing transplantation market."

"The marketing application for SangStat's CYCLOSPORINE is called an AADA, an abbreviated antibiotic drug application, and is currently regulated under Section 507 of the Food, Drug and Cosmetic Act," said Hana Berger Moran, Ph.D., V.P. Regulatory Affairs and Quality Assurance. "The application must contain evidence that the generic drug is bioequivalent to the reference listed drug. The drug's bioavailability and pharmacokinetics i.e.; absorption rate, blood concentration and persistence in the bloodstream should be demonstrated to be equivalent according to defined regulatory policy. An AADA must also contain information on chemistry, manufacturing, controls, documentation and labeling."

SangStat recently completed pivotal bioequivalence trials demonstrating that SangStat's CYCLOSPORINE formulation is bioequivalent to branded cyclosporine, as defined by current FDA policy for generic drugs. Eli Lilly manufactured the exhibit batch used in SangStat's pivotal CYCLOSPORINE bioequivalence trials. Eli Lilly will fill and finish bulk CYCLOSPORINE, provided by SangStat, for subsequent commercial sale and distribution worldwide by SangStat upon approval for marketing.

Under current FDA regulations and policy, generic drugs can be approved based on a demonstration of bioequivalence to a FDA-approved reference drug without the need to duplicate the safety and efficacy trials conducted on the reference listed drug. If the FDA accepts for filing and subsequently approves SangStat's CYCLOSPORINE based on bioequivalence to the reference listed drug, SangStat's formulation will receive an "AB" rating in the FDA's list of approved drugs. This rating would signify that SangStat's CYCLOSPORINE is therapeutically equivalent to, and interchangeable with, the reference listed drug.

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.

SangStat is a biopharmaceutical 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(R) (exclusive marketing and development rights from Pasteur Merieux Serums et Vaccins "PMsv" for the U.S. and Canada) to treat graft rejection, CYCLOSPORINE and AZATHIOPRINE for chronic immunosuppressive therapy and ALLOTRAP(R) 2702 to promote graft acceptance following transplantation. Monitoring products include PRA-STAT(R) and CROSS-STAT(R) (both marketed in the U.S. and Europe), and product candidate TYP-STAT(TM) all designed to improve donor/recipient compatibility. Other monitoring products in development are intended to guide post-transplant therapy; CELSIOR(R) (exclusively licensed from PMsv) is an organ preservation solution; and drug candidate XE-9 is in early development for xenotransplantation. XENOJECT(TM) platform technology also is in the discovery phase for replacing antibody therapy with small synthetic drugs. SangStat is located in Menlo Park, California, and operates The Transplant Pharmacy(TM), a comprehensive pharmacotherapy management program, and wholly-owned subsidiaries, XenoStat Inc., in Menlo Park, Calif., SangStat Atlantique S.A. in Nantes, France and SangStat Canada Ltd. in Mississauga, Ontario, Canada.

This press release contains forward-looking statements that involve risks and uncertainties. The Company's actual results may differ significantly from the results discussed in the forward-looking statements. Factors that might cause such a difference include, but are not limited to, those risks associated with the company's ability to obtain FDA's acceptance of its CYCLOSPORINE AADA filing for review, regulatory approval for its CYCLOSPORINE, manufacturing of commercial quantities of CYCLOSPORINE on commercially favorable terms, and potential litigation associated with intellectual property claims of third parties. 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.

CONTACT: SangStat

Maree Wall, 415/328-0300 ext. 131

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