Novan Therapeutics to Build New Manufacturing Site for its Experimental Acne Treatments

Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact

Lukas Roth

October 28, 2015
By Alex Keown, BioSpace.com Breaking News Staff

DURHAM, N.C. – Novan Therapeutics will develop a new facility in North Carolina to manufacture nitric-oxide pharmaceutical ingredients to use in the company’s treatments for acne and other skin ailments, the Triangle Business Journal reported this morning.

The new 51,000 square-foot facility will be called the Nitric-Oxide Center of Excellence and is expected to be completed by the summer of 2016, the Journal said. Despite the size of the facility, its name and use, information about projected investment costs or if the new facility will require new hires were not available. BioSpace reached out to Novan’s media representatives this morning, but has yet to hear back.

Novan is developing dermatological treatments for acne and other skin conditions using nitric oxide therapies. Nitric oxide is produced by the body and has been shown to be effective in killing the bacteria associated with acne. The benefits have been somewhat short-lived, but Novan believes its researchers have found a method to increase the benefits.

Novan believes it has solved delivery issues for nitric oxide-based treatments 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 said on its website.

In March, Novan received $50 million in funding from several investors, including Malin Corporation PLC, which has been slated to advance SB204, the company’s experimental treatment for acne vulgaris, through Phase III trials. The company said it expects to begin Phase III trials in the first quarter of 2016. The topical acne treatment successfully completed Phase IIb, which “demonstrated statistically significant reductions in the percent change of non-inflammatory (white heads and black heads) and inflammatory (larger red bumps and pustules) lesions at Week 12 with all doses of SB204,” the company said in a statement.

Portions of the funding are also expected to be used to finance the clinical development of SB206, a topical anti-viral that the company believes could lead to a treatment for human papillomavirus (HPV) infections. The drug is currently in Phase II testing for the treatment of genital warts.

As the company moves closer to bringing a product through regulatory approval, it tapped two new members for its executive leadership team. Earlier this month the company hired Chief Financial Officer Richard Peterson, who served as CFO of Medicis Pharmaceutical Corporation until its acquisition by Canada-based Valeant Pharmaceuticals . Brian Johnson was tapped to lead Novan’s sales and marketing efforts. Before coming to Novan, Johnson held sales leadership positions at Ortho Pharmaceuticals, a division of Johnson & Johnson and Galderma Laboratories, LLC where he served as Vice President of Prescription Marketing and Chief Digital Officer.

On Novan’s website, the company has several job listings posted, including a contract position for clinical research associate, and full-time positions such as program manager, clinical study manager and regulatory affairs manager of medical devices.

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