Novan Awarded $7.8 Million Contract by BARDA to Develop a Medical Countermeasure for Thermal Burns

Novan Awarded $7.8 Million Contract by BARDA to Develop a Medical Countermeasure for Thermal Burns
Durham, NC (August 26, 2013) – Novan Therapeutics announced today that the U.S. Department of Health and Human Services has entered into a contract with Novan to advance the development of a nitric oxide-based therapy as a topical treatment for thermal burns. The Biomedical Advanced Research and Development Authority (BARDA), an agency within the Office of the Assistant Secretary for Preparedness and Response, awarded this contract. It is widely believed a mass casualty event caused by natural or intentional threats to public health could result in tens of thousands of burn patients which would overwhelm the burn care infrastructure presently available in hospitals across the United States.

Under the terms of the contract, BARDA will provide funding of $7.8 million over two years. The contract will support the pharmaceutical development of the Nitric Oxide Advanced Healing (NOAH) technology including formulation work, nonclinical toxicology, and proof of concept studies in models of deep partial thickness and full thickness thermal injuries. This project is designed to enable the future clinical investigation of the medical countermeasure.

"We are honored that BARDA selected our team to develop a nitric oxide therapy for thermal burns," said Nathan Stasko, president of Novan. Nitric oxide, a molecule produced by the human body, has been demonstrated throughout peer-reviewed literature to speed the migration of epidermal cells, stimulate new blood vessel growth, modulate inflammation, and re-model the wound bed. Dr. Stasko continued, "The link between nitric oxide and the body's ability to heal is well established. The challenge is to create stable nitric oxide drugs that 'perform on command' and deliver a controlled, sustained dose that will supplement the body's ability to regenerate tissue. Our platform technology has allowed us to pursue the development of drugs intended to harness the healing power of nitric oxide with results extending far beyond bioterrorism. We believe the NOAH technology creates a gateway into regenerative medicine and could lead to therapies that can help heal both acute and chronic wounds."

The findings under this contract will complement Novan's existing efforts to develop nitric oxide therapies for combat casualties, multi-drug resistant infections, and chronic wounds outside the scope of this contract. For example, Novan has evaluated the effects of topical nitric oxide therapies in several porcine wound models. Clear enhancements in the rate of wound re-epithelialization have been observed. Dr. Stasko said "These results and the BARDA-funded NOAH program support the company's strategy to create products for the multi-billion dollar advanced wound care market."

About Novan, Inc.
Novan Inc., based in the Research Triangle Park area of North Carolina, is a clinical-stage drug development company focused on topical delivery of nitric oxide. Nitric oxide, one of the most studied molecules in human physiology, has been shown to exhibit anti-microbial activity and to promote vasodilation, regulate inflammation, stimulate tissue repair, and even eradicate cancer cells. The company's proprietary platform technology enables the stable storage and release of nitric oxide in a variety of dosage forms. Novan is currently developing innovative, first-in-class therapies for the field of dermatology and wound care.

For more information, please contact:
Julia Brannan

Pascale Communications

908-464-2470

[email protected]

www.novantherapeutics.com