ETHICON, INC. Announces Revised Label For REGRANEX(R) (becaplermin) Gel 0.01%

SOMERVILLE, N.J., June 6 /PRNewswire/ -- ETHICON, INC. today announces
revised labeling for REGRANEX Gel, a topical formulation of recombinant human
platelet-derived growth factor indicated as an adjunct to the treatment of
lower extremity diabetic neuropathic ulcers.
The WARNINGS section of the label has been updated to include a BOXED
WARNING and a description of the epidemiologic data that is the basis for it.
These data come from a retrospective study that compared cancer incidence and
cancer mortality among 1,622 patients exposed to REGRANEX Gel to 2,809 matched
comparators. The results were consistent with no overall increase in cancer
incidence among patients exposed to REGRANEX Gel, however, there was a five-
fold increased risk of cancer mortality in the group exposed to three or more
tubes of REGRANEX Gel, based on four cases. The types of cancers varied and
were remote from the treatment site.
The BOXED WARNING states "An increased rate of mortality secondary to
malignancy was observed in patients treated with three or more tubes of
REGRANEX Gel in a post-marketing retrospective cohort study. REGRANEX Gel
should only be used when the benefits can be expected to outweigh the risks.
REGRANEX Gel should be used with caution in patients with known malignancy."
The Company has worked closely with the FDA to ensure that the REGRANEX
Gel label provides physicians and patients with the information they need to
make the most appropriate and informed treatment decisions. ETHICON, INC. is
committed to broadly disseminating this new prescribing information about the
safety of REGRANEX Gel through a "Dear Healthcare Professional" letter and its
field-based employees.
"We remain confident in the safety and efficacy of REGRANEX Gel when used
according to its label," said James C. Hart, MD, Vice President, Global
Medical Affairs, ETHICON. "The benefits of REGRANEX Gel have been established
in well-controlled studies and confirmed in clinical practice."
REGRANEX Gel, manufactured by OMJ Pharmaceuticals, Inc. for its
distributor Ortho-McNeil, is commercialized in the United States by Johnson &
Johnson Wound Management, a division of ETHICON, INC.
About REGRANEX Gel
REGRANEX Gel is the only FDA-approved prescription medicine that contains
platelet-derived growth factor (PDGF), a substance that helps the body heal.
It is applied directly to the ulcer. REGRANEX Gel, in conjunction with good
wound care, has been proven to help heal diabetic ulcers more effectively than
standard wound care. The product has been on the market for ten years and
has been used to treat more than 750,000 patients.
Important Safety Information
REGRANEX Gel is contraindicated in patients with neoplasms at the site of
application. An increased risk of mortality secondary to malignancy remote
from the site of treatment has been observed in patients treated with 3 or
more tubes of REGRANEX Gel in a post-marketing retrospective cohort study.
(See Boxed WARNING). However, in a separate analysis of cancer incidence,
these results were consistent with no overall increase in cancer incidence
(See WARNINGS). REGRANEX Gel should be used with caution in patients with
known malignancy. REGRANEX Gel is contraindicated in patients with known
hypersensitivity to any component of this product (eg, parabens). Erythematous
rashes occurred in 2% of patients treated with REGRANEX Gel or placebo gel.
REGRANEX Gel should not be used in wounds that close by primary intention.
Please visit www.Regranex.com for the full Prescribing Information.
(C) ETHICON, INC. 2008 REGRANEX Gel is a registered trademark of
Ortho-McNeil TM, Division of Ortho-McNeil Janssen Pharmaceuticals, Inc.
SOURCE ETHICON, INC.

Jackie Jankewicz of ETHICON, INC., +1-908-218-2764