BioAlliance Pharma SA, an innovative company dedicated to the development of orphan oncology products, has executed a licensing agreement with Innocutis Holding LLC to commercialize Sitavig (acyclovir Lauriad) for the treatment of recurrent labial herpes in North America. In Europe, the company received a positive opinion from the Health Authorities in France and Germany for the Market Authorization of the drug.

Innocutis, based in Charleston (South Carolina), is a pharmaceutical company dedicated to dermatology, with “best-in-class” branded prescription products in skin related therapies. Innocutis deploys a direct sales force to promote its products to the fastest-adopting, highest-prescribing dermatologists in the United States, providing clinicians with improved solutions for managing the challenges presented in their daily practice.

Innocutis will promote Sitavig to dermatologists and top tier general practitioners alone, or with a sublicensee, allowing coverage of the largest panel of patients in the US product launch in the US is expected as early as early third quarter 2014.

Under this agreement, BioAlliance Pharma is eligible to receive a total of $5 million in upfront and milestones payments. The agreement also includes double-digit royalties which should represent significant downstream revenues. In addition, Innocutis shall fund a major portion of the paediatric clinical study required by the FDA, as well as US regulatory taxes. Locust Walk Partners, LLC served as transaction advisor to BioAlliance Pharma.

“Sitavig represents a unique opportunity for Innocutis corporately and will change the way clinicians will treat herpes labialis. In order maximize Sitavig opportunity, Innocutis will pursue sublicensing opportunities in multiple specialty fields while the Innocutis sales force focuses on dermatology. As an organization, Innocutis couldn’t be more pleased with the partnership that has been develop with BioAlliance Pharma and we look forward to a successful launch of Sitavig in North America”, commented Joe Pecora, CEO of Innocutis Holdings LLC.

Regarding Europe, Sitavig had already been registered in 8 countries through a decentralized procedure successfully achieved in December 2012. As its registration strategy, the company had filed in these countries first to ensure optimized registration timelines, and then filed a mutual recognition procedure in France and Germany, which are two major European countries with the greatest commercial potential in the European herpes labialis market.

This second procedure is now finalized and both Health Authorities have issued a positive opinion for the registration of Sitavig.

“Obtaining the opinion from these two countries was key, as they together represent more than 60 per cent of the total European market, estimated to €90 million. Indeed, these will significantly accelerate the discussions with potential European partners, which are our priority now that Sitavig is licensed in the US”, declared Aude Michel, head of corporate development of BioAlliance Pharma.

“These 2 steps are key advancements in our licensing strategy for Sitavig. We are delighted with this agreement with Innocutis, a strategic US partner with a highly skilled management team and a dedicated sales force, and we trust this collaboration will ensure the rapid and successful commercialization of Sitavig in the US, the largest sales potential market, estimated up to $500M”, commented Judith Greciet, CEO of BioAlliance Pharma. In Europe, regulatory procedure has been finalized with success and Sitavig is now approved in all key countries. Indeed, we are confident that it will significantly help licensing discussions with potential European partners, already fairly well advanced”.

Created in 1997 and listed on the Euronext stock market in Paris in 2005, BioAlliance Pharma designs, develops and brings to market innovative drugs for the treat¬ment of cancer and its associated pathologies, more specifically for severe and rare orphan-status diseases.