Protein Polymer Technologies, Inc. Announces FDA Jurisdiction Designation For Injectable Urethral Bulking Agents

    SAN DIEGO, Oct. 14, 1997 -- Protein Polymer Technologies, Inc. (Nasdaq: PPTI) announced today that its hydrogel-based injectable urethral bulking agent for the treatment of urinary incontinence will be reviewed by the Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH).  Urinary incontinence is a debilitating condition that affects an estimated 10 million women in the United States alone.  A significant number of these women suffer from intrinsic sphincter deficiency, where the muscular valve controlling urine flow at the base of the bladder is no longer able to stay completely closed.
    PPTI's proposed hydrogel product is based on a biocompatible recombinant protein polymer designed for injection as a solution through a fine needle into the sphincter and surrounding tissues to increase their bulk.  As the liquid reaches body temperature, it quickly forms a pliable, long-lasting hydrogel, which is expected to enable the sphincter to fully close while still allowing voluntary voiding of urine.  PPTI believes its product technology will provide distinct advantages to both the surgeon and patient compared to currently available treatments.
    The FDA's decision to review PPTI's product as a device is important since it supports the Company's position that products based on its polymer technology should be classified for FDA regulation according to their function in the body rather than the method used to make their component materials. Although PPTI's polymers are novel engineered proteins made using recombinant DNA technology, they are designed to have specific material properties which improve upon the function of traditional natural and synthetic polymers now used in a variety of medical devices.
    PPTI has completed candidate product screening in animals for the urethral bulking agent application and is now pursuing formal preclinical studies for submission to the FDA to obtain approval for subsequent human clinical studies.  Concurrent with the selection of a final product candidate, the Company is completing preparation for operations under FDA's GLP regulations. Such operations are designed to assure the validity and reproducibility of preclinical and clinical test data that demonstrates the safety and efficacy of medical devices.
    Protein Polymer Technologies, a San Diego-based biotechnology company, has developed a proprietary biomaterials technology platform and targeted multiple medical applications for product development.  Products based on its technology will be commercialized through partnerships with leading medical product companies.  PPTI's hydrogel technology has many uses, including cosmetic/reconstructive surgery and drug delivery.  The Company is developing surgical adhesives and sealants in collaboration with Ethicon, Inc., a Johnson & Johnson company, to replace and augment the use of sutures and staples. Other targeted applications include coatings for traditional medical devices, scaffolds for wound healing and tissue engineering, and surgical adhesion barriers.
    This press release may contain forward-looking statements that are based on management's expectations.  Actual results could differ materially from those expressed here; further, the Company is not obligated to comment specifically on those differences.  Risks associated with the Company's activities include scientific and product development uncertainties, competitive products and approaches, continuing collaborative partnership interest and funding, regulatory testing and approvals, and manufacturing scale-up.  The reader is encouraged to refer to the Company's 1996 Annual Report and filings with the Securities and Exchange Commission, copies of which are available from the Company, to further ascertain the risks associated with the above statements.