Protein Polymer Technologies and Femcare Establish Strategic Alliance
To Commercialize Female Urinary Incontinence Product in Europe and Australia
SAN DIEGO, Jan. 27 -- Protein Polymer Technologies,
Inc. (OTC Bulletin Board: 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.
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 a 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.
