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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report: January 27, 2000
PROTEIN POLYMER TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
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Delaware 0-19724 33-0311631
(State or other jurisdiction of (Commission (IRS Employer Identification No.)
incorporation or organization) File Number)
10655 Sorrento Valley Road
San Diego, California 92121
(Address of Principal Executive Offices) (Zip Code)
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(619) 558-6064
(Registrant's telephone number, including area code)
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Item 5. Other Events.
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The Registrant issued the press release, filed as Exhibit 99.1 hereto,
on January 27, 2000.
Item 7. Financial Statements and Exhibits.
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Exhibit Number Description of Document
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99.1 Press Release of the Registrant dated January 27, 2000.
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SIGNATURE
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Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Date: February 3, 2000 PROTEIN POLYMER TECHNOLOGIES, INC.
By: /s/ J. Thomas Parmeter
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J. Thomas Parmeter
Chief Executive Officer
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INDEX TO EXHIBITS
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Exhibit Number Description of Document Page Number
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99.1 Press Release of the Registrant dated January 27, 2000. 4
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Exhibit 99.1
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FOR IMMEDIATE RELEASE
CONTACTS:
J. Thomas Parmeter
President
Laura Sarno
Director, Tissue Augmentation
(858) 558-6064
[email protected]
PROTEIN POLYMER TECHNOLOGIES AND FEMCARE ESTABLISH STRATEGIC ALLIANCE TO
COMMERCIALIZE FEMALE URINARY INCONTINENCE PRODUCT IN EUROPE AND AUSTRALIA
SAN DIEGO, January 27, 2000 -- Protein Polymer Technologies, Inc. (NASDAQ-PPTI),
today announced that a strategic alliance has been formed with Femcare Ltd. for
the commercialization in Europe and Australia of its urethral bulking agent for
treatment of female stress urinary incontinence. Femcare is a British-based
developer and international marketer of surgical products for gynecological and
urological applications. PPTI's urethral bulking agent is in clinical testing in
the United States as a treatment for stress urinary incontinence, a common
problem experienced by many women over the age of forty that tends to become
progressively worse over time.
In the alliance, PPTI will provide Femcare with technical assistance and the
incontinence product for Femcare's clinical testing and regulatory approvals in
Great Britain, continental Europe, and Australia. It is anticipated that women
clinically treated in Great Britain will be incorporated into PPTI's projected
application to the U.S. Food and Drug Administration for approval to market the
product in the U.S. In addition, Femcare will pay PPTI a $1 million license fee
and a royalty on the revenues generated from the sale of the product. PPTI also
will be responsible for providing the product to Femcare for commercial sale.
PPTI's urethral bulking agent has been specifically designed to address the
shortcomings in biocompatibility, ease of use, and durability associated with
both existing treatments and those known to be under development. The Company's
product is based on a patented new biomaterial having unique properties created
by combining specific features of natural silk and human elastin into a new rDNA
protein formulation. The material has been designed to be far less susceptible
to absorption by the body as compared to collagen or other materials that are
derived from natural tissues. Once injected, PPTI's product forms a solid
implant and, as a result, is expected to enable patients to remain "dry" longer
than patients treated with other product formulations.
According to the U.S. Department of Health and Human Services Agency for Health
Care Policy and Research (1996), urinary incontinence, the involuntary loss of
urine, affects approximately 13 million Americans, mostly women. It is generally
recognized as one of the major causes of institutionalization of the elderly.
The European market is estimated to be very similar in size and composition to
the U.S. market. The direct cost of caring for people with incontinence has been
estimated to be over $16 billion per year.
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Stress urinary incontinence (SUI) is the most common type of incontinence and is
caused by failure of the urethral sphincter to prevent urine flow, particularly
associated with physical activity. Treatments range from non-invasive behavioral
training to abdominal surgery.
Urethral bulking agents currently approved by the FDA are only for treatment of
a subclass of SUI in which the urethral sphincter is unable to close
(approximately 15% of the potential patient population). These products,
formulations of solid particles suspended in a liquid or gel carrier, are
injected into the urethral tissues at the base of the bladder to increase the
physical bulk of the sphincter, thus sealing the urethra to prevent involuntary
urine leakage. However, the effectiveness of these treatments decreases with
time and multiple injection procedures are required to maintain patient
benefits.
PPTI's urethral bulking agent will be tested in women suffering from all types
of SUI. It has been developed to be an alternative to surgery that can be
administered in an office-based procedure under local anesthesia. The product is
unique in that it is injected as a fluid that quickly transforms to a solid gel
within the urethral tissues. The Company believes this feature will offer
significant advantages over preformed products that are difficult to inject or
implant, and over particle-based products where the injected volume decreases
over time as the carrier liquid dissipates and/or as particle migration may
occur.
Protein Polymer Technologies, Inc., is a San Diego-based company focused on
developing products to improve medical and surgical outcomes. From its inception
in 1988, PPTI has been a pioneer in protein design and synthesis, developing an
extensive portfolio of proprietary biomaterials. These genetically engineered
biomaterials are high molecular weight proteins, processed into products with
physical and biological characteristics tailored to specific clinical
performance requirements. Targeted products include urethral bulking agents for
the treatment of stress urinary incontinence, dermal augmentation products for
cosmetic and reconstructive surgery, surgical adhesives and sealants, scaffolds
for wound healing and tissue engineering, and depots for local drug delivery.
Femcare, Ltd. is an UK company based in Nottingham. Founded in 1982 by Dr.
Marcus Filshie and others, Femcare's initial objective was to manufacture and
market the Filshie Clip for Female Sterilization. Based on the success of these
early efforts, Femcare received the Queen's Award for Export in 1987, and in
1999, the company became the female sterilization market leader in the Western
world. During the past 18 years Femcare has expanded its product line and
geographical business base. Currently, Femcare markets its products in 40
countries world wide, and has developed products for male sterilization and
female urology. A new Urology division has been created to extend the company's
success in gynecology to urological applications, in particular female stress
urinary incontinence. Based upon PPTI's urethral bulking agent, Femcare will
utilize its existing customer base and its extensive distribution network as the
basis for introducing the product into Europe and Australia.
This press release contains forward-looking statements that are based on
management's views and 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 raising adequate capital to continue operations 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 1998 Annual Report Form 10-KSB, and recent 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.
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