Study Finds New Antibiotic, Linezolid, Effective for Diabetic Foot Infections

A clinical trial involving 371 patients in eight countries shows that linezolid, a new antibiotic, is at least as effective as two older therapies for treating diabetic foot infections. The drug may be an important new agent for doctors treating infections that are increasingly caused by bacteria resistant to standard antibiotics, and that in severe cases may require amputation. The study, led by a Department of Veterans Affairs (VA) physician and conducted at 30 US and 15 European sites, appeared in the January 1 issue of Clinical Infectious Diseases. Linezolid, sold as Zyvox (Pfizer, Inc.), was approved by the Food and Drug Administration (FDA) in 2000 to treat a variety of infections, including some caused by bacteria resistant to the drug methicillin. Because of the growing problem of MRSA and vancomycin-resistant enterococci (VRE), new agents have been developed. Linezolid is among the first new treatments for MRSA infections since vancomycin was introduced in the 1950s. Based on the results of the new trial, the FDA has now specifically extended the drug’s use to most diabetic foot infections.

RegeneRx Licenses European Rights to Novel Wound Healing Drug

RegeneRx Biopharmaceuticals, Inc. (www.regenerx.com) announced today that it has exclusively licensed certain European rights to its lead product, Thymosin beta 4 (Tb4), a novel drug undergoing human clinical trials for chronic wounds. Under the agreement, Defiante Farmaceutica, Lda, a wholly-owned subsidiary of Sigma-Tau Group, headquartered in Rome (Italy), will develop Tb4 for internal and external wounds in Europe and certain other contiguous and geographically relevant countries.

“This is a significant step toward enhancing our worldwide product development efforts through strategic alliances that complement our U.S. efforts,” explained J.J. Finkelstein, RegeneRx’s President & CEO. “We have come to know Defiante and Sigma-Tau through their equity investments in RegeneRx. They have the technical and financial resources to greatly enhance the speed and quality of Tb4 development, and we are optimistic that together we can effectively commercialize its numerous potential clinical benefits. Both companies should significantly benefit from the sharing of clinical research data generated by each organization.”

“We look forward to developing Tb4 for the European markets as expeditiously as possible,” said Dr. Paolo Carminati, Head of Research and Development at Sigma-Tau. “The preclinical and clinical data are quite interesting and continue to rapidly expand. We intend to engage in a significant effort in order to complete development of Tb4, hoping this will be the beginning of a long and prosperous relationship between our companies, as well as for patients who may benefit from Tb4’s commercialization.”

Doubled Reimbursement Helps Ailing Company

Organogenesis Inc., a once-bankrupt biotech company that manufactures artificial skin, received good news for 2004: Medicare nearly doubled what it will pay for the company’s principal product, Apligraf, from $680 to $1,199 per treatment. Company executives hope the change will boost the privately held corporation that emerged from bankruptcy proceedings last year.

This reimbursement scenario illustrates the effect government price policies can have on the biotechnology and pharmaceutical industries. The payment change was among dozens of pricing moves for individual drugs and treatments that Congress ordered as part of the new senior citizens prescription benefits bill, moves that had no direct bearing on the bill's main purpose. According to the company, Medicare cases comprise about 70 percent of its sales, so the level of government payment is critical. When the reimbursement rate was slashed in 2003, sales plummeted from 500 to 250 artificial skin patches a week. Company executives hope the re-adjusted reimbursement will increase patient access to the product. The company hopes to turn a corner on a tough year. It ended its relationship with a powerful marketing partner, Novartis Pharma AG, and a second marketing partner, PDI Inc., pulled out of its deal withOrganogenesis because artificial skin product sales had not produced expected returns. Now, Organogenesis has its in-house sales force poised for a major new marketing push.

3S Appoints Director of Marketing

3S, the consulting and excutive search firm specializing in the wound and skin care industry, recently announced the appointment of Derek Hill to the position of Director of Marketing, North America. “Derek brings overn 20 years of successful US and international wound and skin care industry experience to the 3S team. This experience, coupled with his unsurpassed industry relationships, further strengthens our ability to provide clients with the strategic solutions necessary to be successful within this dynamic market,” stated the firm’s found and president, Stephen M. Cea. For more information, please visit www.woundcareconsulting.com.

Smith & Nephew is now Offering Gladase™, a Papain-Urea Debriding Ointment

Smith & Nephew’s Wound Management division is expanding their portfolio of wound bed preparation products with the addition of Gladase, a papain-urea debriding ointment for treating chronic wounds and burns. The Gladase brand was previously distributed by Glades Pharmaceuticals, LLC and will now be exclusively available from Smith & Nephew.
Gladase debriding ointment uses papain, a proteolytic enzyme derived from papayas, and urea, a denaturant of proteins. Gladase is indicated for removal of necrotic tissue in wound and is an important initial step in wound bed preparation, providing debridement for burns and chronic wounds. Clinically, wound bed preparation removes barriers to the healing process, including necrotic tissue, to allow the wound repair process to progress normally. Gladase, as an enzymatic debridement agent, can play a key role in a clinical team’s approach to a cost-effective wound management program.

For more information about Gladase and the wound bed preparation platform, please contact your Smith and Nephew Account Manager or Customer Care Representative at (800) 876-1261, or visit www.smith-nephew.com.

TIAX Issued U.S. Patent for Multi-Layered Wound Dressing

TIAX recently announced it has been issued a patent by the United States Patent and Trademark Office for a new, multi-layered wound dressing. The dressing is designed to reduce bandage manufacturing costs since fewer discrete steps are needed to produce the bandage than those products currently on the market.

TIAX is currently seeking a partner in the wound care industry to manufacture the dressing for commercialization in the U.S. market, which is estimated at $2.5 billion.

“We sought to develop a dressing that would not only allow wounds to heal more quickly and effectively, but also would be less cumbersome for patients with hard-to-heal wounds such as pressure ulcers,” said Robert Etheredge, a principal scientist in TIAX’s Biomedical Technologies Group who designed the dressing.

The wound dressing consists of three layers of nonwoven materials, including cotton, rayon-polyester, and polyolefins. Each of the layers within the bandage has a separate function in the healing process. The first layer, or contact layer, protects the afflicted area while allowing oxygen to reach the wound. The second layer effectively wicks and transports wound fluid away from the wound and can act as a depot for topical drug delivery. The third layer allows air to enter, moisture vapor to escape, and is waterproof in use.

Compared to similar products, the TIAX wound dressing is less bulky and removal of the bandage is less traumatic for the skin due to a patterned pressure sensitive adhesive that covers the skin contact layer of the bandage.

For more information, visit the Tiax website (www.tiaxllc.com). •••