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SangStat files 510(k) for CROSS-STAT: earns milestone payment.

MENLO PARK, Calif.--(BUSINESS WIRE)--Jan. 16, 1995--SangStat, The Transplant Company (NASDAQ:SANG), announced Monday that it has filed for FDA 510(k) market clearance for SangStat's CROSS-STAT pre-transplant monitoring product.

SangStat also said an additional milestone payment of $375,000 from Baxter Healthcare Corp. was due upon the filing. Baxter licensed the product from SangStat as part of a 1993 agreement, including PRA-STAT, recently introduced in Europe and the United States.

CROSS-STAT, developed by SangStat for crossmatch testing, is an ELISA assay for detection of transplant candidate antibodies. The crossmatch test detects if a transplant candidate expresses harmful antibodies against a potential donor. Test results are intended to guide selection of a particular recipient for the donor organ.

Typically, an organ is allocated to a recipient only if the crossmatch test for that candidate is negative, i.e., the patient does not have anti-donor antibodies.

Baxter has exclusive worldwide rights to market three SangStat pre-transplant monitoring products. SangStat has previously received $5.6 million in licensing fees and milestone payments and expects to receive certain milestone payments and royalties based on net sales of the products.

SangStat has sole rights to manufacture the products for Baxter. Baxter has also purchased a $3.75 million equity interest in SangStat. These products will be distributed worldwide by the Baxter affiliate Nextran.

The first pre-transplant monitoring product in this group PRA-STAT received market clearance in September 1994 following the 510(k) filing in April. Philippe Pouletty, M.D., president and chief executive officer of SangStat, said, "The CROSS-STAT filing for market clearance on our second pre-transplant product demonstrates that SangStat is building its transplant franchise and continues to deliver on milestones."

A clinical study demonstrated high correlation and superior reproducibility when CROSS-STAT was compared to microlymphocytotoxicity for detection of donor specific antibodies to recipient HLA antigens.

Results of the controlled, blinded study comparing CROSS-STAT and microlymphocytotoxicity conducted in 4 different transplant laboratories in the United States and Europe showed greater than 90% agreement on the presence of HLA antibodies and equivalent sensitivity by the two methods.

CROSS-STAT, PRA-STAT and TYP-STAT (in development) for predicting compatibility between organ donors and recipients are based on the core molecules in the graft immune response, human leukocyte antigens (HLA).

The company's proprietary soluble HLA (sHLA) technology utilizes the sHLA present in serum or plasma to perform histocompatibility testing by ELISA. This methodology offers significant potential advantages over conventional microlymphocytotoxicity methods which require viable cells and subjective interpretation of results by microscopic analysis.

SangStat is a biopharmaceutical company dedicated to the development, manufacturing and marketing of a broad range of therapeutic and monitoring products for organ transplantation. Of SangStat's 11 products and product candidates, one is an in-licensed, commercially proven drug, three are currently available for clinical or research use and several others are at an advanced stage of development.

SangStat's drug candidates include THYMOGLOBULIN to treat graft rejection, CYCLOSPORINE for chronic immunosuppressive therapy and ALLOTRAP to promote graft acceptance following transplantation.

THYMOGLOBULIN (exclusive marketing and development rights for the United States and Canada from Pasteur Merieux Serums et Vaccins "PMsv") is being distributed under the Emergency Drug Release (EDR) program in Canada where an NDS for market approval has been filed. It is in a pivotal Phase III clinical trial in the United States.

The second drug candidate, CYCLOSPORINE, is in early development, and ALLOTRAP is in early Phase II clinical trials in France. Monitoring products include PRA-STAT (marketed in the United States and Europe) and candidates CROSS-STAT and TYP-STAT to improve donor/recipient compatibility.

Other product candidates, QUANTSTAT, TRANSTAT and sHLA-STAT Class I are intended to guide post-transplant therapy; CELSIOR (exclusively licensed from PMsv) is an organ preservation solution; and drug candidate XE-9 is in early development for xenotransplantation.

SangStat is located in Menlo Park, and operates wholly-owned subsidiaries XenoStat Inc., Menlo Park, SangStat Atlantique S.A. in Nantes, France and SangStat Canada, Ltd. in Mississauga, Ontario, Canada.

CONTACT: SangStat Medical Corp., Menlo Park

Maria Straatmann, 415/328-0300 x126
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