Healthcare Industry News:  Ortho-McNeil 

Biopharmaceuticals Wound Care

 News Release - January 23, 2006

Recent Study Confirms REGRANEX Gel to be Effective Treatment of Diabetic Neuropathic Foot Ulcers

SOMERVILLE, N.J., Jan. 23 (HSMN NewsFeed) -- Johnson & Johnson Wound Management, a division of ETHICON, INC., today announced the publication of results in a study designed to estimate the effectiveness of recombinant human platelet-derived growth factor (rhPDGF) in actual clinical practice. The study, published in the November-December 2005 edition of Wound Repair and Regeneration, showed that diabetic neuropathic foot ulcers treated with rhPDGF were 32% more likely to heal within 20 weeks than those not treated with rhPDGF (802/2394 vs 5806/22504). RhPDGF is marketed as REGRANEX* (becaplermin) Gel 0.01%.

The retrospective patient cohort study utilized a claims database to evaluate more than 24,000 patients with neuropathic diabetic foot ulcers who were treated at specialty wound clinics between 1998 and 2004. Patients who had received rhPDGF were more likely to have healed at 20 weeks versus those treated with other methods of ulcer care. These results were similar to the results of previous randomized controlled trials of REGRANEX Gel.

"Clinical studies show how something works in an ideal setting," stated David J. Margolis, MD, PhD, Departments of Dermatology and Biostatistics and Epidemiology, University of Pennsylvania School of Medicine and lead researcher. "Our study looked at how rhPDGF performs in clinical practice and demonstrated that it achieves similar results in the real world as in the ideal setting."

REGRANEX Gel is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. When used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control, REGRANEX Gel increases the incidence of complete healing of diabetic ulcers.

The efficacy of REGRANEX Gel has not been established for treatment of pressure ulcers and venous stasis ulcers (see Clinical Studies), and has not been evaluated for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue (Stage I or II, IAET staging classification) or ischemic diabetic ulcers.

IMPORTANT SAFETY INFORMATION

REGRANEX Gel is contraindicated in patients with known neoplasms at the site of application or with known hypersensitivity to any component of this product (e.g. 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.

For Full Prescribing Information or more information about REGRANEX Gel, visit http://www.regranex.com.

About Johnson & Johnson Wound Management:

Johnson & Johnson Wound Management, a division of ETHICON, INC., a Johnson & Johnson company, continues the company's 100-year commitment to wound care today with inventive products for chronic and acute wound management and hemostasis. For more information about Johnson & Johnson Wound Management or other ETHICON divisions, visit http://www.ethicon.com.

* Trademark

REGRANEX Gel is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.


Source: ETHICON

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