BioMimetic Therapeutics Addresses FDA Communication on Regranex Safety Review

FRANKLIN, Tenn.--(Business Wire)--
BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today addressed a
communication the U.S. Food and Drug Administration ("FDA") released
on its website this afternoon regarding the agency's ongoing safety
review of Regranex(R), a Johnson & Johnson product. Regranex is
composed of recombinant human Platelet-Derived Growth Factor
(rhPDGF-BB) (becaplermin) in a non-sterile ointment, which has been
approved since 1997 for the chronic treatment of non-healing diabetic
foot ulcers. The FDA communication specifically addresses Regranex use
and does not address other rhPDGF-BB containing products. BioMimetic
has not received any communications from the FDA related to today's
web posting regarding Regranex.

The FDA communication provided information regarding a study that
was performed to investigate the possibility of an increased risk of
cancer in patients with diabetes who applied the product Regranex (a
topical medicine) daily, directly to their dermal ulcers for up to 140
consecutive days. According to the communication, "posting this
information does not mean that FDA has concluded a causal relationship
between the drug product and the emerging safety issue. Nor does it
mean that FDA is advising healthcare professionals to discontinue
prescribing this product."

In the study referenced in the FDA communication and highlighted
below, there appeared to be inconsistent data. One analysis indicated
no elevation in risk of cancer while another analysis suggested that
among those who were prescribed Regranex three or more times, there
was an increase in the number of patients who died as a result of
cancer.

BioMimetic has obtained a copy of a published abstract that
provides data that is discussed in the FDA communication. The abstract
titled "A Cohort Study of the Risk of Cancer in Regranex (Becaplermin)
Users and Matched Comparators" can be found in the journal
Pharmacoepidemiology and Drug Safety, 2007, Volume 16, Issue S2, pages
S167-168. A full copy of the abstract can be purchased at the
publisher's website,
(http://www3.interscience.wiley.com/journal/114293165/issue). The
study results reported in the abstract were obtained from data
contained within the Ingenix Research Data Mart, a health insurance
claims database. The reported results stated that there were 47 (2.9%)
confirmed cancers among 1,622 becaplermin initiators and 86 (3.1%)
confirmed cancers among 2,809 comparators (non-becaplermin treated).
The abstract further indicated that there was no elevation in risk of
cancer for subjects with one becaplermin dispensing compared to those
with none or for subjects with three or more becaplermin dispensings
compared to those with none.

In a separate mortality analysis based on 16 cancer deaths, the
authors stated that there was an elevated risk for the four deaths
among subjects with three or more becaplermin dispensings compared to
those with none. The authors concluded, however, that the incidence of
increased mortality "is based on a small number of cases and may
reflect chance or residual confounding in the mortality models, which
had too few deaths to address the confounders in the incidence."
Moreover, a conclusion provided in the abstract stated that "this
study suggests no relationship between becaplermin exposure and cancer
incidence."

Based on these published study results, which BioMimetic has
reviewed but did not take part in, BioMimetic does not believe that an
increased risk for cancer or cancer deaths has been demonstrated for
the chronic administration of becaplermin up to multiple months, much
less for a single application of becaplermin as is done with the
product candidates from BioMimetic Therapeutics.

BioMimetic obtained one FDA approved product, GEM 21S(R), and has
two product candidates in clinical development, GEM OS1 and GEM OS2.
The product and product candidates contain the same drug product
(becaplermin) as Regranex. For GEM 21S, over 50,000 units have been
sold with no reported serious adverse events associated with the
product. The use of GEM 21S for approved periodontal applications, and
the ongoing clinical studies with GEM OS1 and GEM OS2 for orthopedic
applications, use a single application of the product at the time of
surgery, rather than multiple daily applications for up to 140 days,
as is currently approved for Regranex.

As stated above, BioMimetic has not received any communications
from the FDA related to today's web posting regarding Regranex. The
Company will provide updates as new information becomes available.

About BioMimetic Therapeutics

BioMimetic Therapeutics, Inc. is developing and commercializing
bio-active recombinant protein-device combination products for the
healing of musculoskeletal injuries and disease, including orthopedic,
spine and sports injury applications. BioMimetic received marketing
approval from the FDA in 2005 for its first product, GEM 21S, for
regeneration of bone and periodontal tissue loss resulting from
periodontal disease. Currently, the Company has clinical trials
ongoing with its product candidates GEM OS1 and GEM OS2 in multiple
orthopedic bone healing indications including the treatment of foot
and ankle fusions and the stimulation of healing of fractures of the
wrist. The Company's product and lead product candidates all combine
recombinant human platelet derived growth factors (rhPDGF-BB) with
tissue specific scaffolds to actively stimulate tissue healing and
regeneration.

GEM 21S(R) is a registered trademark of Luitpold Pharmaceuticals,
Inc., who owns and markets that product through its Osteohealth
Company division for use in periodontal and cranio-maxillofacial
applications.

For further information, visit www.biomimetics.com or contact
Kearstin Patterson, associate director of corporate communications, at
615-236-4419.

BioMimetic Therapeutics, Inc.
Corporate Communications
Kearstin Patterson, 615-236-4419
Mobile: 615-517-6112
kpatterson@biomimetics.com

Copyright Business Wire 2008