Aclerastide

November 13, 2015 By Alex Keown , BioSpace.com Breaking News Staff PRNCETON, N.J. – The failure of Derma Sciences Phase III aclerastide, which was being studied for the treatment of diabetic foot ulcers, has the company mulling several options forward, including a possible sale Reuters reported this morning. Derma Sciences plunged nearly 30 percent after the company announced Thursday it was ceasing its Phase III clinical trials for aclerastide, which was being studied for the treatment of diabetic foot ulcers. A third-party assessment by Data Monitoring Committee of aclerastide found the drug did not meet its end goals of healing diabetic foot ulcers, the company said in a statement. Derma Sciences said it was halting the clinical trial and is terminating the aclerastide program. There were no safety concerns related to the treatment, the company said. In addition to halting the trial of aclerastide for foot ulcer treatment, Derma Science said it would also stop developing aclerastide as a treatment to reduce scars and treat radiation dermatitis. If untreated diabetic foot ulcers can be a factor in amputations in diabetic patients. Some patients who experience foot ulcers may not know they are there because of nerve or blood vessel damage. Treatments for diabetic foot ulcers can include hemorheologic agents and antiplatelet agents. Smith & Nephew Inc. ’s Regranex , a topical gel, for the treatment of diabetic foot ulcers, has been on the market since 1997. Aclerastide was the company’s only clinical program, although it does have some wound-care products on the market, including Medihoney, Xtrasorb and Bioguard. Derma Sciences ’ three divisions, advanced wound care, pharmaceutical wound care and traditional wound care, generated a combined $22 million in revenue for the third quarter of 2015. Company stock dropped from $5.60 per share to $4.04 per share after the company announced its decision. Thursday’s sell off of the stock saw 1.4 million shares sold. On average, 140,000 shares of the stock move monthly, The Street reported . The Street rated the stock a “sell,” saying the “company’s weaknesses can be seen in multiple areas, such as its feeble growth in its earnings per share, disappointing return on equity, weak operating cash flow, deteriorating net income and generally disappointing historical performance in the stock itself.” The day before the stock plummeted, Zacks rated the stock a “buy.” “We are very disappointed with the findings of the analyses of the DMC, but are grateful for the support and commitment from the participating patients and the study investigators,” Edward J. Quilty , chairman and chief executive officer of Derma Sciences , said in a statement. “We have stopped further enrollment and initiated an orderly termination of the aclerastide trials and program, which we believe will be substantially complete by year end. We are also halting all development work with DSC127 in scar reduction and radiation dermatitis.” The termination of the drug trial will cost the company approximately $2 million and overall save about $5 million per quarter, the company said. As of Sept. 30, Derma Sciences had $49.4 million of cash and cash equivalents and $12 million of long-term investments, the company said. Before the stock drop, Derma Sciences had a market value of $145 million, Reuters said.

PRINCETON, N.J.--(BUSINESS WIRE)-- Derma Sciences, Inc. (DSCI), a medical device and pharmaceutical company focused on advanced wound care, announces receipt of the CE Mark for the Company’s patented MEDIHONEY® HCS (hydrogel colloidal sheet) dressings. With this determination the entire current line of MEDIHONEY products has CE marking. "We will launch commercial sales of MEDIHONEY HCS dressings in Europe in January 2013,” said Edward J. Quilty, chief executive officer of Derma Sciences. “This will be a significant launch as it will help bring our products more deeply into the acute care segment and, for the first time, into the burn care segment. Currently approximately 20% of MEDIHONEY product sales are from Europe and we look forward to further penetration of that market with our advanced wound care products.” Derma Sciences’ HCS dressings (XTRASORB® and now MEDIHONEY) are differentiated in the market in that they utilize super-absorbing hydrogels not only to provide moisture to dry wounds, but also to absorb moderate to even heavy amounts of wound fluid. This creates extremely versatile dressings that can be used on multiple wound indications and conditions, are easy to use and can be left on wounds for extended periods of time, helping to reduce the overall cost of care. Notably, these novel super-absorbent hydrogels have been shown to lock damaging wound proteases into the dressings, which helps to maintain a more optimal wound environment for healing. MEDIHONEY is a unique line of patented wound care dressings containing Active Leptospermum Honey from New Zealand, which possess unique qualities that make them ideal for the management of chronic and acute wounds and burns. With a strong and growing base of peer-reviewed evidence including several large-scale randomized controlled studies, MEDIHONEY dressings have shown to be effective for debridement and helping to advance hard-to-heal stalled wounds through the healing process. About Derma Sciences, Inc. Derma Sciences is a medical technology company focused on three segments of the wound care marketplace: pharmaceutical wound care products, advanced wound care dressings and traditional dressings. Derma Sciences has successfully completed the Phase 2 clinical trial in diabetic foot ulcer healing with DSC127, an investigational pharmaceutical drug under development for accelerated wound healing and scar reduction, and is preparing to begin Phase 3 clinical trials. Its MEDIHONEY® product is the leading brand of honey-based dressings for the management of wounds and burns. The product has been shown to be effective in a variety of indications, and was the focus of a positive large-scale, randomized controlled trial involving 108 subjects with leg ulcers. Other novel products introduced into the $14 billion global wound care market include XTRASORB® for better management of wound exudate, BIOGUARD® for infection prevention and TCC-EZ™, a gold-standard treatment for diabetic foot ulcers. For more information please visit Forward-Looking Statements Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "expect," "believe," "anticipate," "intend," "could," "estimate" or "continue" are intended to identify forward-looking statements. Readers are cautioned that certain important factors may affect the Company's actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release or that are otherwise made by or on behalf of the Company. Factors that may affect the Company's results include, but are not limited to, product demand, market acceptance, impact of competitive products and prices, product development, including clinical trial results, completion of an acquisition, commercialization or technological difficulties, the success or failure of negotiations and trade, legal, social and economic risks. Additional factors that could cause or contribute to differences between the Company's actual results and forward-looking statements include but are not limited to, those discussed in the Company's filings with the U.S. Securities and Exchange Commission. Contact: Derma Sciences, Inc. Barry Wolfenson, 609-514-4744 Executive Vice President, Global Marketing & Business Development bwolfenson@dermasciences.com or LHA Investors : Kim Sutton Golodetz, 212-838-3777 kgolodetz@lhai.com or Bruce Voss, 310-691-7100 bvoss@lhai.com @LHA_IR_PR or Media : Mackenzie Mills, 212-838-3777 mmills@lhai.com