Therabel to Pay BioAlliance an Initial €6.5M for European Rights to Two Approved Drugs

The Therabel Group is paying BioAlliance Pharma an initial €4.5 million, or about $6 million, over two years for European commercialization rights to the latter’s marketed products, antifungal Loramyc® and antiemetic Setofilm®.

The deal could bring BioAlliance an additional €42 million, or roughly $56.16 million, in sales-related payments as well as additional royalties. Therabel is also considering making two separate €3 million (approximately $4 million) equity investments in BioAlliance over this year and 2011.

BioAlliance says that the deal is in line with its strategy to enter partnerships that enable long-term growth based on its product franchises in its targeted therapeutic fields. “BioAlliance will from now on capitalize on its development and registration expertise, already validated with Loramyc, Setofilm, and acyclovir Lauriad (Phase III positive in orofacial herpes), to build shareholders’ value in the years to come,” states Dominique Costantini, president and CEO.

BioAlliance has a number of products in its clinical pipeline, including candidates based on the mucoadhesive Lauriad technology against oral herpes, oral mucositis, and chronic cancer pain, as well as a doxorubicin transdrug in Phase II trials against liver cancer. In December 2009, final positive results were reported from a Phase III trial evaluating acyclovir Lauriad in immunocompetent patients with recurrent herpes labialis.

Loramyc is an antifungal agent, administered as a mucoadhesive gingival tablet for the treatment of oropharyngeal candidiasis in immunocompromised patients. BioAlliance received its first Loramyc marketing authorization in France in October 2006. BioAllaince reported that sales of Loramyc in France reached €2.1 million (about $2.8 million) in 2009, double its sales in France during 2008.

The drug was cleared in 12 additional European countries at the end of 2007 via the European mutual recognition procedure. Most recently, on March 25, BioAlliance confirmed the approval of Loramyc in 13 more European countries.

At that time the firm said a marketing authorization in the U.S. was also expected during the first half of this year. If the product is approved by the FDA, BioAlliance will receive a $20 million payment from Strativa Pharmaceuticals under the companies’ U.S. commercialization agreement.

In 2009, marketing authorization was obtained in Korea and in Switzerland. During 2008, BioAlliance inked a potentially €12 million (about $16 million) licensing deal with Handok for Loramyc in Korea.

Setofilm is a fast-dissolving film strip-based ondansetron antiemetic for use in the prevention and treatment of nausea and vomiting in adults and children undergoing chemotherapy, radiotherapy, or surgery. Setofilm was granted its first approvals in 16 European countries on March 23.