BioMimetic Therapeutics, Inc.
(NASDAQ: BMTI) today announced it initiated enrollment in a Phase
II clinical trial to assess the safety and efficacy of Augment™
Chronic Tendinopathy (ACT) as a treatment for lateral
epicondylitis, commonly known as tennis elbow. The randomized,
controlled trial is expected to enroll up to 100 patients at seven
clinical sites in the U.S. and will evaluate the safety and
therapeutic potential of escalating doses of a one-time injection
of pure recombinant human platelet-derived growth factor
(rhPDGF-BB) homodimer solution into the extensor carpi radialis
brevis (ECRB), the tendon in the elbow that is generally the source
of pain in tennis elbow. The product candidate is aimed at the
large tendinosis market for which there is significant unmet
clinical need with limited effective long-term treatments currently
available.
“We have seen promising pre-clinical data with ACT and believe
the initiation of this Phase II dose finding clinical trial is the
logical next step in the development of our sports medicine
program,” said Dr. Samuel Lynch, BioMimetic president and CEO. “ACT
has the potential to help millions of patients suffering from
painful inflammation of the tendon at the outer border of the elbow
resulting from overuse of lower arm muscles or trauma.”
Study Design
The Phase II trial is designed as a randomized, ascending dose,
double-blinded, placebo controlled, multi-center study. The trial
is expected to enroll up to 100 patients ranging from 21 – 80 years
of age, who will receive a single injection into the ECRB. The
injection will consist of either a placebo or one of four different
doses of rhPDGF-BB.
The primary efficacy endpoints will be derived from a
combination of pain and disability assessments as measured by the
Visual Analog Scale (VAS), Disabilities of the Arm, Shoulder and
Hand (DASH) Score and the Patient Rated Tennis Elbow Evaluation
(PRTEE), along with sincerity of effort measured by grip strength
testing. These clinical outcome measures will be used to detect
changes in pain and function up to 24 weeks from baseline. Adverse
event reporting, including incidence, relationship with treatment
and severity will be recorded throughout the study to evaluate
safety of the drug. The product candidate will be reviewed by the
U.S. Food and Drug Administration’s (FDA) Center for Drug
Evaluation and Research (CDER), which regulates over-the-counter
and prescription drugs, including biological therapeutics and
generic drugs.
The study is currently open for enrollment, and more information
can be found at www.clinicaltrials.gov. The Company anticipates
completing enrollment around year end 2013.
Lateral Epicondylitis
Augment Chronic Tendinopathy (ACT) is being developed to treat
chronic tendon injuries, or tendinosis. The target indication for
this clinical trial is lateral epicondylitis, commonly referred to
as tennis elbow. Lateral Epicondylitis is an inflammation of the
tendons that join the forearm muscles on the outside of the elbow.
The forearm muscles and tendons become damaged from overuse, or in
some cases trauma, leading to pain and tenderness on the outside of
the elbow. It is estimated that lateral epicondylitis currently
affects one to three percent of the total U.S. population (or
approximately three to nine million people), and there is no
decisive effective standard of care. Various conservative treatment
options are available and include topical and oral non-steroidal
anti-inflammatory drugs (NSAIDs), corticosteroid injections, and
autologous blood injection (PRP). These conservative treatment
options may be effective in short term pain relief and return to
function, but studies have shown that a significant portion of
patients treated with conservative therapies continue to have
recurrent symptoms. Additionally, none of the currently available
therapies address the fundamental need to enhance healing at the
tendon-to-bone interface and improve long-term outcomes. Thus,
lateral epicondylitis is an indication that not only represents a
large market opportunity, but it is also one with a significant
unmet clinical need. The Company believes there is an opportunity
for rhPDGF-BB to fulfill this unmet clinical need and is currently
testing this hypothesis in the clinic.
About BioMimetic Therapeutics
BioMimetic Therapeutics (NASDAQ: BMTI) is a biotechnology
company specializing in the development and commercialization of
clinically proven products to promote the healing of
musculoskeletal injuries and diseases, including therapies for
orthopedics, sports medicine and spine applications. All Augment®
branded products are based upon recombinant human platelet-derived
growth factor (rhPDGF-BB), which is a bio-engineered form of PDGF,
one of the body's principal agents to stimulate and direct healing
and regeneration. Through the commercialization of this patented
technology, BioMimetic seeks to become the leading company in the
field of regenerative medicine by providing new treatment options
for the repair of bone, cartilage, tendons and ligaments.
BioMimetic has received regulatory approvals to market Augment®
Bone Graft in Canada, Australia and New Zealand for use in hindfoot
and ankle fusion indications. Augment is pending regulatory
decisions in the U.S. and European Union for similar indications.
The Company also markets a bone graft substitute line of products
for orthopedic indications called AugmatrixTM Biocomposite Bone
Graft.
On November 19, 2012, BioMimetic and Wright Medical Group, Inc.
entered into a definitive agreement for a business combination of
the two companies. The transaction will combine BioMimetic’s
breakthrough biologics platform and pipeline with Wright’s
established sales force and product portfolio to further accelerate
growth opportunities in Wright’s Extremities business. The merger
is subject to a vote by BioMimetic shareholders, and, if approved,
is expected to close in the first quarter of 2013.
For further information contact Kearstin Patterson, senior
director of corporate communications, at 615-236-4419.
Important Additional Information Regarding the
Transaction
In connection with the proposed transaction, Wright filed a
registration statement on Form S-4 (the “Form S-4”) with the
Securities and Exchange Commission (“SEC”) on December 20,
2012, but such registration statement has not been declared
effective by the SEC. BioMimetic will be mailing a proxy
statement/prospectus for its stockholders and each will be filing
other documents regarding the proposed transaction with the SEC.
BEFORE MAKING ANY VOTING OR INVESTMENT DECISION, BIOMIMETIC
STOCKHOLDERS AND INVESTORS ARE URGED TO READ THE PROXY STATEMENT
AND OTHER RELEVANT MATERIALS CAREFULLY IN THEIR ENTIRETY WHEN THEY
BECOME AVAILABLE BECAUSE THE DOCUMENTS WILL CONTAIN IMPORTANT
INFORMATION ABOUT THE PROPOSED TRANSACTION AND BIOMIMETIC.
Investors and stockholders may obtain copies of the proxy statement
and other relevant documents filed with the SEC by BioMimetic free
of charge at the SEC’s web site at www.sec.gov. In addition,
investors and stockholders may obtain copies of the proxy statement
and other relevant documents filed with the SEC by BioMimetic (when
they are available) by going to BioMimetic’s Investor Relations
page on its corporate website at www.biomimetics.com.
BioMimetic, Wright and their respective directors and executive
officers and other persons may be deemed to be participants in the
solicitation of proxies in respect of the proposed transaction.
Information regarding BioMimetic’s executive officers and
directors, and their beneficial ownership of BioMimetic’s common
stock as of April 12, 2012 is available in BioMimetic’s proxy
statement for its 2012 annual meeting of stockholders, which was
filed with the SEC on April 27, 2012. Information regarding
Wright’s executive officers and directors is available in Wright’s
proxy statement for its 2012 annual meeting of stockholders and its
current reports on Form 8-K, which were filed with the SEC on
March 27, 2012, August 3, 2012 and November 6,
2012, respectively. Other information regarding the interests of
such potential participants in the proxy solicitation are included
in the Form S-4 and will be contained in the proxy statement and
other relevant materials to be filed with the SEC when they become
available.
Forward-looking Statements
This press release contains forward-looking statements about our
future results of operations and financial position, product
development programs, business strategy, plans and objectives of
management for future operations that are not historical facts. The
words “may,” “continue,” “estimate,” “intend,” “plan,” “will,”
“believe,” “project,” “expect,” “anticipate,” “optimistic” and
similar expressions may identify forward-looking statements, but
the absence of these words does not necessarily mean that a
statement is not forward-looking. There are many important factors
that could cause actual results to differ materially from those
indicated in the forward-looking statements, including that: (i)
the Food and Drug Administration may not approve Augment Chronic
Tendinopathy and (ii) despite the Company’s future marketing and
commercialization efforts, Augment Chronic Tendinopathy may not
achieve broad market acceptance. Further, 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 detailed in BioMimetic’s recent annual
and quarterly reports filed with the Securities and Exchange
Commission (SEC), including those factors discussed under the
caption "Risk Factors" in the Company’s Annual Report on Form 10-K
filed with the SEC on March 13, 2012, which are incorporated in
this press release by this reference. 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, and has no policy of doing so.
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