Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, today reported that based on a meeting held last week with the U.S. Food and Drug Administration (FDA), the Company plans to begin its Phase 3 program in December 2012 in support of a New Drug Application (NDA) for DSC127 for treatment of diabetic foot ulcers. The FDA has expressed concurrence with the Company’s Chemistry, Manufacturing and Controls (CMC) program. “We had a productive meeting with the FDA and are working to finalize components of the development program discussed with the Agency during the meeting. The Agency provided helpful guidance, which our development team is now incorporating into our studies. We maintain our goal of beginning our Phase 3 program before the end of the year,” said Edward J. Quilty, president and chief executive officer of Derma Sciences. “Importantly, our drug manufacturing can proceed, and is in the final testing stage with the first doses expected to be available next month. We were very pleased with our discussion with the FDA and with the Agency’s recognition that the healing of diabetic foot ulcers represents a significant unmet medical need.” About Diabetes and Diabetic Foot Ulcers According to the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, diabetes affects 25.8 million people of all ages, or 8.3% of the U.S. population and nearly 2 million new cases are diagnosed yearly in people age 20 or older. More than 60% of non-traumatic lower-limb amputations occur in people with diabetes and in 2006, about 65,700 non-traumatic lower-limb amputations were performed in people with diabetes. About 80% of amputations were preceded by a foot ulcer. In 2007, the total cost, both direct and indirect attributed to diabetes was $174 billion in the U.S. alone and was the seventh leading cause of death. The International Diabetes Foundation estimates that 366 million people worldwide had diabetes in 2011 and that by 2030 this will have risen to 552 million.
About DSC127DSC127, a novel investigational angiotensin analog, has been shown to improve epithelialization, and granulation and vascularization, accelerating wound healing in a variety of normal and diabetic animal models. These findings suggest that DSC127 produces different actions at the wound site during various stages of healing. Derma Sciences has advanced the DSC127 development program through Phase 1 and Phase 2 clinical studies, where no significant safety concerns were identified. 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 a Phase 2 clinical trial in diabetic foot ulcer healing with DSC127, an investigational pharmaceutical drug under development for the healing of diabetic foot ulcers, 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 www.dermasciences.com. 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," “plans,” "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, 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.