SangStat Receives Positive FDA Action Letter for CYCLOSPORINE; Bioequivalence Review Completed.

MENLO PARK, Calif.--(BW HealthWire)--Feb. 12, 1998--SangStat, The Transplant Company(R) (NASDAQ:SANG), announced today that it has received correspondence from the U.S. Food and Drug Administration (FDA) indicating that the Agency has completed its review of the Company's CYCLOSPORINE marketing application. An application for marketing Sang-35, SangStat's proprietary CYCLOSPORINE product candidate, was submitted to the FDA in November, 1996 as a bioequivalent formulation to Neoral(R) for the prevention of rejection in organ transplant recipients.

The receipt of this action letter, called a Minor Deficiency letter, indicates that the FDA has completed its review of the CYCLOSPORINE abbreviated antibiotic drug application (AADA) including the Company's responses to key questions during the review process. Prior to potential final product approval, the Office of Generic Drugs (OGD) requires responses to a short list of questions which SangStat intends to respond to within the next 2-3 weeks. Importantly, the remaining issues raised in this letter are not related to the bioequivalence trials.

The bulk cyclosporine drug substance used in SangStat's application, supplied by Gensia Sicor, received FDA approval in July, 1997. A pre-approval inspection of the finished product manufacturing facility was deemed not necessary by the FDA.

Philippe Pouletty, M.D., SangStat's Chairman and CEO said, "We are very pleased that the FDA has completed its review of the application and issued this key action letter for CYCLOSPORINE. Achieving this milestone is another significant accomplishment for SangStat." He continued, "Subject to providing satisfactory responses to all questions the FDA may have, we look forward to receiving US market clearance for CYCLOSPORINE as a bioequivalent product to Neoral and launch."

Cyclosporine is the leading immunosuppressive drug used in transplantation to prevent graft rejection. Cyclosporine is marketed by Novartis Ltd. in different formulations as Sandimmune(R) and Neoral with estimated worldwide sales of $1.3 billion in 1997. In the U.S. 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.

In December 1997, Amgen signed an agreement with SangStat for the exclusive commercial rights to SangStat's CYCLOSPORINE for market approval and distribution in select countries in the Asia Pacific rim (Australia, New Zealand, China and Taiwan). SangStat intends to market directly its products, subject to regulatory approvals, in North America and Europe and seek well-established companies, like Amgen, as partners for marketing CYCLOSPORINE in other territories around the world.

SangStat is a specialty pharmaceutical company applying a disease management approach to improve the outcome of organ transplantation. SangStat has a total of 12 monitoring and therapeutic product and product candidates to address the pre-transplant, acute care and chronic phases of transplantation. SangStat is in Menlo Park, California, and operates The Transplant Pharmacy(R), 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, California.

This press release contains forward-looking statements that involve risks and uncertainties. Forward-looking statements reflect SangStat'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 review and approval process could cause actual results to differ materially with regard to the approvability and possible market acceptance of SangStat's finished CYCLOSPORINE drug product. These factors include, without limitation:

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(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 SangStat's assessment of
     clinical trial results or proposed labels;

(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 products;

(3)  that there can be no assurance that final labeling can be agreed
     upon in a timely manner;

(4)  that there can be no assurance that any manufacturing or control
     issues will be adequately resolved to the FDA's satisfaction;

(5)  that there can be no assurance that any future questions relating
     to the FDA's review of the AADA can be adequately answered to
     FDA's satisfaction; and

(6)  that there can be no assurance of FDA approval of the product.

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Other factors that could cause actual results to differ materially include, without limitation, uncertainty related to the current or future manufacturing of commercial quantities of CYCLOSPORINE on commercially favorable terms, adequate and continuous supply of bulk CYCLOSPORINE drug substance, market acceptance, profitability, competition and potential litigation. For a discussion of other factors that might result in different outcomes, see SangStat's 1996 Annual Report, in particular "Risks Associated With CYCLOSPORINE" set forth therein, and the Company's filings on Form 10-K and 10-Q with the Securities and Exchange Commission. -0-

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