Novan Expands Leadership Team with Vice President of Regulatory Affairs

Company Anticipates Start of Phase 3 Program for Lead Candidate, SB204, by Year-End 2015

DURHAM, N.C.--()--Novan Therapeutics, a clinical stage biotechnology company focused on advancing innovation in dermatology via nitric oxide therapies, today announced that Kevin Barber, Ph.D., has been appointed to the newly created position of Vice President of Regulatory Affairs, effective immediately. Dr. Barber will direct Novan’s regulatory strategy as the primary interface with the FDA and will report directly to Dr. Nathan Stasko, Novan’s President.

“His expertise in dermatology and women’s health will be invaluable to Novan as we progress into late-stage clinical testing with SB204 and expand our number of clinical stage dermatology programs. We look forward to his contributions as a key member of our growing leadership team.”

“Kevin brings to Novan over two decades of experience in therapeutic product development, with a proven track record in leading regulatory affairs for global pharmaceutical franchises and in diverse therapeutic areas,” said Dr. Nathan Stasko, President of Novan. “His expertise in dermatology and women’s health will be invaluable to Novan as we progress into late-stage clinical testing with SB204 and expand our number of clinical stage dermatology programs. We look forward to his contributions as a key member of our growing leadership team.”

Most recently, Dr. Barber served as Vice President, Global Brand Regulatory Affairs at Actavis (formerly Watson Pharmaceuticals). During his tenure, Dr. Barber led the regulatory development of over 20 products in the current Actavis pipeline, as well as regulatory life cycle management of over 70 US NDAs/ANDAs and numerous marketing authorizations in Canada and the EU. Previously, he held positions of increasing responsibility at Durham, NC-based Cato Research Ltd., including Senior Director, Regulatory Affairs and Project Management. Dr. Barber received his B.S. and M.S. degrees in Aerospace Engineering from Virginia Tech, and his Ph.D. degree in Biomedical Engineering from Duke University.

“Novan has demonstrated compelling proof of concept for dermatologic applications of nitric oxide, with a number of pre-clinical and clinical successes. None of which are more important to public health than the ability of the Nitricil™ platform to kill microorganisms without the development of antibiotic resistance,” said Dr. Barber. "I hope to leverage my experience working with new chemical entities to help accelerate Novan’s pipeline and achieve commercialization of nitric-oxide-based treatments that have the potential of becoming the standard of care in the dermatologist’s office.”

The company’s lead product candidate, SB204, a potentially first-in-class non-antibiotic therapy for acne vulgaris, is anticipated to enter Phase 3 clinical testing by the end of 2015. In addition, SB206, a topical anti-viral to treat external genital warts due to human papilloma virus (HPV) infection, is expected to enter Phase 2 studies by mid-2015.

About Novan, Inc.

Novan is a privately-held, clinical stage biotechnology company focused on advancing innovation in dermatology via nitric oxide therapies. 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 eradicate cancer cells. Novan’s core technologies solve the previous delivery issues with nitric oxide by stably storing the gaseous species on macromolecules that result in a diverse pipeline of “timed-release” nitric oxide-releasing new chemical entities. The company's proprietary platform technology enables drugable nitric oxide in a variety of dosage forms.

This press release contains forward-looking statements involving risks and uncertainties, both known and unknown, that may cause actual results to differ materially from those indicated. Actual results may differ materially due to a number of factors, including, but not limited to, risks associated with pharmaceutical development, clinical trials that cost more, are less effective and take longer to complete than expected, raw materials and drug supply, changes in regulatory requirements, competition, and financing.

To learn more about Novan, please visit www.novantherapeutics.com.

Contacts

Burns McClellan, on behalf of Novan Therapeutics
Justin Jackson, 212-213-0006, ext.327
jjackson@burnsmc.com