FDA accepts for review SangStat's application for market clearance of THYMOGLOBULIN; THYMOGLOBULIN is a market leader in Europe for transplantation.

MENLO PARK, Calif.--(BW HealthWire)--Feb. 20, 1997--SangStat, The Transplant Company(TM) (NASDAQ:SANG) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review its application for market clearance of THYMOGLOBULIN(R).

The application includes the positive results of SangStat's U.S. pivotal Phase III trial showing that successful reversal of acute graft rejection was more frequent, significantly, in the THYMOGLOBULIN than in the control treated adult kidney transplant patients (87.8% vs. 76.3%). These data, however, have not yet been reviewed by the FDA.

The company filed a product license application (PLA) for THYMOGLOBULIN with the FDA's Center for Biologics Evaluation and Research (CBER) in January 1997. SangStat's application for market clearance of its CYCLOSPORINE, an abbreviated antibiotic drug application (AADA), was also recently filed and accepted for review by the FDA.

Philippe Pouletty, M.D., chairman and CEO said, "We are very pleased that both our THYMOGLOBULIN PLA and CYCLOSPORINE AADA submissions have now been accepted for review for market clearance by the FDA."

In the U.S. SangStat is seeking marketing approval for use of THYMOGLOBULIN for treatment of acute graft rejection episodes in kidney transplant recipients. The regulatory approval process for a biological product involves the submission of an Establishment License Application (ELA) for the manufacturing process and facility, while the product characteristics, non-clinical and clinical data, are submitted in a PLA.

In August 1996, a supplement to an approved ELA to provide for the manufacturing process and facility for THYMOGLOBULIN was submitted and accepted for filing by the FDA.

"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."

THYMOGLOBULIN is a pasteurized, rabbit anti-human thymocyte immunoglobulin which induces immunosuppression as a result of T-cell depletion. Common side effects of polyclonal antibody therapy include, among others, fever, infections, leukopenia and thrombocytopenia. These side effects are often transient. THYMOGLOBULIN is contraindicated in patients with an allergy to rabbit proteins.

THYMOGLOBULIN has been approved in 39 countries, used in more than 30,000 patients worldwide and is a market leader in Europe for the treatment and prevention of acute graft rejection episodes in transplant recipients. SangStat acquired an exclusive license from Pasteur Merieux Connaught (PMC), a subsidiary of Rhone Poulenc S.A., to market this drug in the United States and Canada.

Subject to approval, Pasteur Merieux Connaught will be the manufacturer of commercial supplies of THYMOGLOBULIN for distribution in the United States. THYMOGLOBULIN is manufactured and marketed outside North America by IMTIX, the Pasteur Merieux Connaught transplantation division.

SangStat has filed a New Drug Submission (NDS) and is generating revenues through the distribution of THYMOGLOBULIN in Canada under the Emergency Drug Release (EDR) program, which permits the distribution of certain products before final regulatory approval. In the United States, SangStat has provided THYMOGLOBULIN for compassionate use to more than 50 patients.

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(R) 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 are designed to improve donor/recipient compatibility.

Other products in development include monitoring products intended to guide post-transplant therapy such as THYMOSTAT(TM) for THYMOGLOBULIN treatment optimization; CELSIOR(R) (exclusively licensed from PMC) which is an organ preservation solution; and drug candidate XE-9 which is in early development for xenotransplantation. XENOJECT(TM) is a platform technology in the discovery phase for replacing antibody therapy with small synthetic drugs.

SangStat is located in Menlo Park and operates THE TRANSPLANT PHARMACY(TM), a comprehensive pilot pharmacotherapy management program, and wholly owned subsidiaries, SangStat Atlantique S.A., SangStat's European base of operations in Nantes, France, SangStat Canada Ltd. in Mississauga, Ontario, Canada and XenoStat Inc., in Menlo Park, Calif.

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 or THYMOGLOBULIN. 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 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 any product; and (3) that there can be no assurance of FDA approval of any product. Other factors that might cause actual results to differ materially include, without limitation, uncertainty related to the manufacturing of commercial quantities of CYCLOSPORINE and THYMOGLOBULIN on commercially favorable terms, market acceptance and potential litigation. For a discussion of factors that might result in different outcomes, see the company's Registration Statement on Form S-3 filed on Jan. 24, 1997, in particular "Risks Factors" set forth therein, and the company's annual and quarterly reports filed with the Securities and Exchange Commission.

CONTACT: SangStat, Menlo Park

Maree Wall, 415/328-0300 x131

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