| February
21, 2007
BioMimetic Therapeutics Receives
Orphan Drug Designation for rhPDGF-BB
Treatment of Osteonecrosis of the
Jaw
Franklin, Tenn – February 21,
2007 - BioMimetic Therapeutics, Inc.
(NASDAQ: BMTI) today announced that
it has received orphan drug designation
from the Food and Drug Administration
(FDA) for its protein therapeutic,
recombinant human platelet derived
growth factor (rhPDGF-BB) for the
treatment of Osteonecrosis of the
Jaw (ONJ). ONJ is a growing problem
in the United States in patients receiving
high doses of bisphosphonates for
the treatment of severe osteoporosis
and other diseases. Orphan drug status,
designated to drugs that have the
potential to treat rare diseases,
provides an accelerated path to FDA
approval and seven years of market
exclusivity.
“ONJ lesions are often severely
painful and debilitating open sores
in the mouth for which there are currently
no proven therapeutic treatments,”
said Dr. Samuel Lynch, president and
CEO of BioMimetic Therapeutics. “Based
on the ability of rhPDGF-BB to stimulate
bone and tissue healing, we believe
that rhPDGF-BB has the potential to
help these patients. Thus, ONJ represents
another potential to leverage our
platform rhPDGF technology and be
assured of market exclusivity in this
indication.”
Orphan drug designation was designed
by the FDA to encourage the development
of therapeutic products for clinical
indications that affect fewer than
200,000 individuals within the United
States. Drugs that receive orphan
drug designation obtain seven years
of marketing exclusivity from the
date of drug approval as well as tax
credits for clinical investigation
costs, marketing application filing
fee waivers and assistance from the
FDA in the drug development process.
Orphan drug designation does require
a clinical trial to gain market approval
authorization through the New Drug
Application (NDA) process.
Osteonecrosis of the Jaw
Osteonecrosis of the Jaw (ONJ) is
also known by several other names,
such as avascular or aseptic necrosis
of the mandible/maxilla, bisphosphonate-
associated osteonecrosis of the jaw
(BON), Jaw Rot, Dead Jaw disease or
Bisphossy Jaw. The typical clinical
presentation of ONJ includes pain,
soft-tissue swelling and infection,
loosening of teeth, drainage, and
exposed bone. These symptoms may occur
spontaneously, or more commonly, at
the site of previous trauma, including
tooth extraction. Patients may also
present with feelings of numbness,
heaviness and/or tingling of the jaw.
The latter cases may be diagnosed
after finding exposed bone in the
jaw which doesn’t heal following
use of current therapies.
Biology of rhPDGF
BioMimetic's product and product candidates
use rhPDGF-BB (recombinant human Platelet-Derived
Growth Factor), one of the principal
wound healing stimulators in the body.
The Company believes that rhPDGF-BB
is well suited for various therapeutic
applications due to its stimulation
of a broad spectrum of cellular events
critical for the initiation and progression
of healing of musculoskeletal tissues
including bones, tendons, ligaments
and cartilage. rhPDGF-BB acts like
a magnet to attract cells necessary
for tissue healing through a process
known as chemotaxis, while also stimulating
an increase in the number of healing
cells through a process known as mitogenesis,
thereby expanding the number of cells
available for the repair process.
In addition, published in vivo and
in vitro studies demonstrate that
rhPDGF-BB may enhance processes important
in new blood vessel formation at the
wound site, a process called angiogenesis
which is critical for wound healing.
About BioMimetic Therapeutics
BioMimetic Therapeutics, Inc. is developing
and commercializing bio-active drug-device
combination products for the healing
of musculoskeletal injuries and disease,
including periodontal, orthopedic,
spine and sports injury applications.
BioMimetic received marketing approval
from the FDA for its first product,
GEM 21S®, as a grafting material
for bone and periodontal regeneration
following completion of human clinical
trials, which demonstrated the safety
and efficacy of its platform technology
in this indication. Additionally,
the Company has clinical trials ongoing
with its product candidate GEM OS1
in multiple orthopedic bone healing
indications including the treatment
of foot and ankle fusions and the
stimulation of healing of fractures
of the arm. The Company's product
and product candidates all combine
recombinant protein therapeutics with
tissue specific scaffolds to actively
stimulate tissue healing and regeneration.
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. These statements are
not guarantees of future performance
and involve risks and uncertainties
that are difficult to predict. There
are many important factors that could
cause actual results to differ materially
from those indicated in the forward-looking
statements. 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 the marketing
of BioMimetic’s product and
product candidates, unproven preclinical
and clinical development activities,
regulatory oversight, and other risks
detailed in the company's filings
with the Securities and Exchange Commission.
Except as required by law, BioMimetic
undertakes no responsibility for updating
the information contained in this
press release beyond the published
date, whether as a result of new information,
future events or otherwise, or for
changes made to this document by wire
services or Internet services.
For further information, visit www.biomimetics.com
or contact Kearstin Patterson, manager
corporate communications, at 615-236-4419.
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