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Healthpoint Acquires Regranex® Gel


6/2/2011 10:01:46 AM

Healthpoint Biotherapeutics Acquires Regranex® Gel

Represents Strategic Fit for Commercial Portfolio

PR Newswire

FORT WORTH, Texas, June 2, 2011 /PRNewswire/ -- Healthpoint Biotherapeutics today announced that it has acquired Regranex® Gel, along with the corresponding intellectual property (including patents), from Systagenix. Terms of the deal were not disclosed.

"This acquisition is aligned with our strategic focus on building a portfolio of novel biopharmaceuticals for wound healing and tissue regeneration," said Travis E. Baugh, President and Chief Operating Officer of Healthpoint Biotherapeutics. "Moreover, Regranex® Gel is a good fit for our commercial organization, which has a well established record of successfully marketing biologics for wound care."

Regranex® Gel (0.01% Becaplermin) is a recombinant human platelet-derived growth factor (rhPDGF) and was the first biotechnology product approved for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond, and have adequate blood supply.

About Regranex® Gel

Regranex® Gel (0.01% Becaplermin) is a recombinant human platelet-derived growth factor (rhPDGF) and was the first biotechnology product approved for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond, and have 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. In clinical trials, Regranex® Gel in conjunction with good ulcer care demonstrated a statistically significant increase in the incidence of complete healing (defined as complete ulcer closure) versus placebo gel. It is not known if Regranex® Gelis effective for the treatment of pressure ulcers or ulcers that are due to poor blood flow (circulation). It is not known if Regranex® Gelis safe and effective in children under 16 years of age.

Important Safety Information

Regranex® Gel should not be used in patients with skin tumors at the site of application.

People who use 3 or more tubes of Regranex® Gel may have an increased risk of death from cancer.

You should talk with your doctor about the possible benefits and risks to you if you use more than 3 tubes of Regranex® Gel.

If you already have cancer, you and your doctor should carefully consider whether you will use Regranex® Gel.

If you decide to use Regranex® Gel, your healthcare provider will tell you how to use Regranex® Gel.

Common side effects of Regranex® Gel include: Red skin rash, burning at the application site. Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Regranex® Gel gel. For more information, ask your doctor or pharmacist.

Regranex® Gel should not be used by patients sensitive to any components of this product. Please see the Full Prescribing Information for Regranex® Gel (http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=13535).

About Growth Factors

Growth factors play major roles in normal wound healing and have been shown to be dysregulated in difficult to heal and chronic wounds. Regranex® Gel has biological activity similar to that of endogenous platelet-derived growth factor, which includes promoting the chemotactic recruitment and proliferation of cells involved in wound repair and enhancing the formation of granulation tissue.

About Diabetic Foot Ulcers

Most wounds proceed toward healing in a timely, organized manner; however, for many wounds the healing process is slowed, less well organized and may even come to a halt altogether, leading to a chronic wound (one that appears stuck in a prolonged, non-healing, inflammatory state). Chronic wounds are often derivative of another illness or condition such as diabetes, obesity, peripheral vascular disease and immobility.

Diabetic foot ulcers are those that occur in individuals with diagnosed diabetes mellitus with peripheral neuropathy. These wounds are considered inherently difficult-to-heal and at risk of becoming chronic due to the underlying disease state interfering with the normal healing process. The longer it takes for a wound to heal, the greater the likelihood of complications.

It is estimated that 7% or 20.8 million people have diabetes in the Unites States alone, and the incidence is expected to increase some 14% annually. Of those diagnosed with diabetes, up to 15% will develop a diabetic foot ulcer in their lifetime, and up to 59% will have recurrence of their foot ulcers, leading to over 82,000 amputations annually. The total annual direct cost of non-infected diabetic ulcer treatment has been estimated at over $6 billion.

"Non-healing diabetic foot ulcers are the number one cause of non-traumatic amputations in the United States," said Bert Slade, MD, Chief Medical Officer of Healthpoint Biotherapeutics. "Regranex® Gel continues to be an important option in the therapeutic armamentarium for patients with these wounds."

About Healthpoint Biotherapeutics

Healthpoint Biotherapeutics is a biopharmaceutical company focused on the development and commercialization of novel, cost-effective solutions for tissue repair and healing. The company's diversified research and development strategy is presently centered around therapeutic enzymes, biologics and next-generation cell- and cell-matrix based therapies for the prevention and treatment of acute, chronic and burn-related wounds. Currently marketed products include Collagenase SANTYL® Ointment, OASIS® Wound Matrix, OASIS® Ultra Tri-Layer Matrix and Regranex® Gel. Healthpoint Biotherapeutics is also committed to advancing the care and treatment of wounds through support of industry leading continuing education from The Wound Institute®. To learn more about this comprehensive and award winning educational resource, please visit TheWoundInstitute.com®. Healthpoint Biotherapeutics is a DFB Pharmaceuticals, Inc., affiliate company, and is based in Fort Worth, Texas. For more information, visit the company website at www.Healthpoint.com.

HEALTHPOINT, SANTYL, THE WOUND INSTITUTE, THEWOUNDINSTITUTE.COM and REGRANEX are registered trademarks of Healthpoint, Ltd.

OASIS is a registered trademark of Cook Biotech, Inc.

SOURCE Healthpoint Biotherapeutics


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