SAN DIEGO, Jan. 27 /PRNewswire/ -- 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.
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.
SOURCE Protein Polymer Technologies, Inc.
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Company News On-Call:
http://www.prnewswire.com/comp/721876.html or fax,
800-758-5804, ext. 721876
CONTACT:
J. Thomas Parmeter, President, or Laura
Sarno, Director, Tissue Augmentation Products, both of Protein
Polymer Technologies, Inc., 858-558-6064, info@ppti.com
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