| November
21 , 2005
BioMimetic Therapeutics Announces
FDA Approval of GEM 21S® Growth-factor
Enhanced Matrix for the Treatment
of Periodontally-related Bone Defects
- First Recombinant Growth Factor
Approved for Use in Periodontal Applications
-
Franklin, Tenn. – November
[xx], 2005 - BioMimetic Therapeutics,
Inc. announced today that it has received
approval from the U.S. Food and Drug
Administration (FDA) for its lead
product, GEM 21S®. The first BioMimetic
product to be PMA approved by the
FDA, GEM 21S is a fully synthetic
regeneration system for the treatment
of periodontal bone defects and associated
gingival recession. GEM 21S is composed
of the tissue growth factor, recombinant
human Platelet-Derived Growth Factor
(rhPDGF-BB), and a synthetic bone
matrix, Beta-tricalcium phosphate
(_-TCP). It is the first totally synthetic
product combining a purified recombinant
growth factor with a synthetic bone
matrix to be approved by the FDA for
human application.
“GEM 21S is an innovative new
treatment and an important therapeutic
advancement for patients who suffer
from severe bone loss associated with
periodontal disease,” commented
Samuel E. Lynch, DMD, DMSc, president
and chief executive officer of BioMimetic.
“Approval of GEM 21S is the
culmination of over a decade of scientific
research by multiple investigational
teams. These extensive studies have
demonstrated the significant therapeutic
potential of this technology to stimulate
bone and periodontal regeneration
leading to earlier resolution of periodontal
lesions, and thereby offer a significant
new option for clinicians and patients.”
“With this approval,”
Dr. Lynch continued, “BioMimetic
has taken another step forward in
the development of the Company. We
are in the position to immediately
launch the product with our distribution
partner Osteohealth, and have commercial
supply ready for shipment. We hope
to have the product in the hands of
dentists, periodontists, and oral
and maxillofacial surgeons within
the coming two weeks. Additionally,
this FDA approval, confirming the
bone regenerative properties of the
rhPDGF-BB technology, allows us to
aggressively focus our efforts on
the development of other product candidates
for the treatment of orthopedic and
sports injury conditions in bone,
cartilage, ligaments and tendons.”
Under the exclusive agreement with
Osteohealth Company, a division of
Luitpold Pharmaceuticals, Inc. which
is a group company of Sankyo Co.,
Ltd., Osteohealth is responsible for
the worldwide marketing, sales, distribution,
and post-approval development of GEM
21S for additional indications including
the repair or reconstruction of cranio-maxillofacial
osseous defect indications. As part
of the agreement, BioMimetic will
receive license fees, royalties, and
marketing assistance and milestone
payments, and will be the sole source
manufacturer of GEM 21S.
The combination of the two components
of GEM 21S are key to the overall
effectiveness of the product. The
rhPDGF-BB provides the biological
stimulus for tissue repair by stimulating
the proliferation and in-growth of
osteoblasts, cells responsible for
the formation of bone, while the _-TCP
provides the framework or scaffold
for new bone growth to occur. In recognition
of the unique treatment modality provided
by GEM 21S, the FDA has established
it as a first-in-class compound in
its treatment category.
Beyond GEM 21S, the Company has established
a pipeline of orthopedic product candidates
that are being developed to stimulate
tissue healing/regeneration in bone,
cartilage, ligaments and tendons.
GEM 21S Clinical Trial Results
GEM 21S approval was based on results
from a pivotal 180 patient double-blind,
randomized, controlled multicenter,
pivotal clinical trial involving subjects
who required surgical intervention
to treat periodontal bone defects.
Patients were studied for six months
following implantation of the product.
The study assessed both soft-tissue
attachment levels and bone regeneration,
which was determined radiographically.
The results of the study demonstrated
that GEM 21S treatment led to statistically
significant benefits in bone growth
and accelerated tissue attachment
level gain compared to the control
group that received the _-TCP plus
buffer, without the addition of the
growth factor. Additionally, the study
revealed no evidence of either local
or systemic adverse effects resulting
directly from placement of GEM 21S.
GEM 21S Information
GEM 21S is a prescription device.
No specialized training is required
for the use of the GEM 21S device
beyond that required to perform periodontally-related
grafting procedures. Clinicians are
referred to the GEM 21S package insert
for additional information, or to
www.osteohealth.com.
Periodontal Disease
Currently there are over two million
periodontal surgeries performed every
year in the United States with nearly
one-quarter of all adults over age
65 having severe periodontal disease.
Periodontal disease results from infection
and inflammation of the gum tissue
adjacent to the tooth, and commonly
leads to loss of bone and ligament
structures supporting the tooth. A
major goal of periodontal therapy
continues to be regeneration of the
attachment structures of teeth, including
bone, periodontal ligament and cementum,
which have been destroyed by periodontal
diseases or trauma. Attempts to regenerate
the bone and adjacent structures in
periodontal defects have historically
met with only modest and unpredictable
success. Thus, clinicians have continued
to seek more predictable regenerative
therapies that are less technique
sensitive, lead to faster tissue regeneration,
and are applicable to the broad array
of periodontal defects encountered
daily by clinicians. Clinical studies
conducted by BioMimetic demonstrated
that GEM 21S stimulates healing of
periodontally-related bony defect.
About BioMimetic Therapeutics
BioMimetic Therapeutics, Inc. is an
emerging leader in the development
and commercialization of recombinant
protein-based products for the treatment
of orthopedic and sports injury indications,
including bone, cartilage, tendon
and ligament. BioMimetic has established
a multi-product pipeline based upon
its core expertise in the development
of convergent drug-device combinations
for use in tissue engineering applications.
Forward-looking Statements
This press release contains "forward-looking
statements" within the meaning
of the Private Securities Litigation
Reform Act of 1995. These forward-looking
statements are based on the current
intent and expectations of the management
of BioMimetic Therapeutics. These
statements are not guarantees of future
performance and involve risks and
uncertainties that are difficult to
predict. BioMimetic’s actual
results and the timing and outcome
of events may differ materially from
those expressed in or implied by the
forward-looking statements because
of risks associated with our unproven
preclinical and clinical development
activities, regulatory oversight,
intellectual property claims, litigation
and other risks. Except as required
by law, BioMimetic undertakes no obligation
to update any forward-looking or other
statements in this press release,
whether as a result of new information,
future events or otherwise.
For further information, visit www.biomimetics.com
or contact Kearstin Patterson, manager
corporate communications, at 615-236-4419.
|
