Protein Polymer Technologies Receives Important Notice Of Allowance From
U.S. Patent Office; Second Patent Issued In 1997
SAN DIEGO, Nov. 6, 1997 -- Protein Polymer Technologies, Inc.
(Nasdaq: PPTI) announced today that it received a notice of allowance from the
US Patent and Trademark Office (USPTO) for broad composition of matter claims
based on its core protein engineering technology. The U.S. patent is expected
to issue within the next 6 months. PPTI currently has six issued U.S. patents,
two of which issued this year, two USPTO notices of allowance, and fifteen
other patent applications pending. Corresponding patent applications have been
filed in major international markets. Many of the issued patents and pending
applications relate to inventions that build upon, or which are components of,
the broad proprietary position established by these newly allowed claims.
"Composition of Matter" Patent. The allowed claims cover recombinantly
produced proteins that consist of relatively short sequences of amino acids
found to be repeated in natural proteins. These "repeat units" are used by
PPTI scientists as building blocks for creating "protein polymers" that have
unique materials properties due to the repetition of these sequences
throughout the polymer molecules. Silk and collagen are but two of the many
natural proteins whose valuable properties result from such repeat units.
The protein polymers PPTI creates, however, are not found in nature.
Rather, these "designer" proteins isolate, amplify and combine properties
found in natural proteins. The value of PPTI's proprietary technology platform
is based on its capability to create new proteins with new performance
properties for use in products designed to improve medical and surgical
outcomes.
Protein polymers are made using recombinant DNA technology to create
synthetic genes which direct host cells, typically bacteria, to produce the
protein designed by PPTI's scientists. By using a genetic template to direct
the production process, high molecular weight polymers are created with an
exquisite degree of control over their composition and properties. Such
control is required in the natural production of proteins which sustain life,
but has been unobtainable using traditional methods of polymer synthesis.
Genetic "Methods" Patent. The synthesis and manipulation of DNA
required to create synthetic genes encoding "protein polymers" is covered
under U.S. Patent No. 5, 641, 648, which was issued to the Company in June
1997. In addition, related patent applications claiming methods useful in
preparing synthetic repetitive DNA are pending. Prior to these inventions,
scientists had not been successful in creating genes that would express high
molecular weight proteins of repetitive amino acid sequences. Cells have
built-in mechanisms to prevent multiple identical sequences of DNA encoding
proteins from being maintained. Instead proteins are normally created with
variation in their repeated amino acid segments to maintain genetic stability
of the corresponding DNA.
"Silk & Elastin" Protein Polymers. One example of the usefulness of the
technology was in the creation of a family of protein polymers combining
repeat units from silk and elastin, another structural protein which provides
elasticity to animal tissues including skin, blood vessels and lungs. These
unique biomaterial compositions are covered in U.S. Patent No. 5,606,019,
which was issued to the Company in February 1997. The Company's current
product development efforts, based on this family of polymers, have a wide
range of applications in large markets, including medical device coatings and
soft tissue bulking agents, particularly for the treatment of stress urinary
incontinence.
Protein Polymers capable of Enzymatic cross-linking. The technology also
has been used in the development of polymers that are capable of being cross-
linked by enzymes normally found in the body. Enzymatic cross-linking is, for
example, the method used by the body to form blood clots, and is the mechanism
underlying fibrin sealants which are marketed in Europe and Japan and under
development for use in the United States. Although capable of sealing tissues
to prevent the loss of blood, these blood-derived products set-up slowly and
have low bond strength. PPTI has created protein polymers that incorporate
more of the sites for enzymatic cross linking than are present in the natural
protein substrate, fibrin. These polymers set up more quickly, with much
higher bond strength, than fibrin sealant products.
PPTI has received a notice of allowance from the USPTO for its
patent application covering this enzymatic cross-linking technology. The U.S.
patent is expected to issue within the next few months. The allowed claims are
not limited to compositions for use in tissue adhesives or sealants, and
should be useful in a number of PPTI's targeted product applications,
particularly in enhancing the tissue regeneration process.
"Thus far, this has been an outstanding year for PPTI's patent portfolio.
This latest notice of allowance is for broad claims that significantly extend
the protection of our powerful technology platform used to create unique
protein polymers, and fortifies our pioneering position in the field of
biomaterials" said J. Thomas Parmeter, President and Chief Executive Officer
of Protein Polymer Technologies, Inc. "Our strategic and layered approach to
intellectual property protection covers both protein and DNA compositions, the
recombinant DNA methods used to create the genes which express the proteins,
methods for purifying the protein compositions, and products which are based
on the protein compositions. We believe an exceptionally strong proprietary
position has been established that will protect our commercial interests well
into the future."
Protein Polymer Technologies, a San Diego-based biotechnology company, has
developed a number of different classes of biocompatible polymers that enable
cell growth, promote the regeneration of tissue, bond to synthetic surfaces
and resorb into tissue at controlled rates. Targeted applications include
tissue adhesives and sealants, soft tissue augmentation, wound healing,
contact lens coatings, surgical adhesion barriers and drug delivery vehicles.
PPTI's lead products are being developed in collaboration with Ethicon, a
Johnson & Johnson company, for use as a new generation of surgical adhesives
and sealants to replace or augment the use of sutures and staples.
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 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.
For more information on these and other issued patents, visit
PPTI's
online Patents page. |