BioAlliance Pharma SA, the specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and HIV, and Applied Pharma Research (APR), together with its joint venture partner Labtec GmbH, announced that they have entered into an exclusive licensing agreement under, which BioAlliance has acquired the commercialization rights in Europe to the thin film formulation of ondansetron from APR/Labtec, leader in oral thin film technology named RapidFilm.
Ondansetron thin film formulation is a new oral formulation for the prevention of chemotherapy-induced nausea and vomiting, prevention of nausea and vomiting associated with radiotherapy, and post-operative, nausea and vomiting.
Based on the results of a recently completed bio-equivalency study, BioAlliance will be preparing registration in Europe. The exclusive license to BioAlliance may total up to € 6.0 million with € 1 million at signature and € 1,25 million at approval and sales milestones up to € 3,75 million; in addition royalties on net sales of the product will also be paid.
Anti-emetic therapies constitute one of the largest segments of the supportive care market in Europe, with annual sales of over € 400 million in 2007 in the 5 major EU markets (IMS Midas 2007).
Ondansetron was the prescription leader in the category in 2007, with about 800 000 prescriptions (as extrapolated from IMS Midas Medical Data 2007).
APR/Labtec´s proprietary RapidFilm technology is a novel, non-mucoadhesive, fast dissolving oral dosage form. It features a thin film based on a water-soluble polymer. The film disintegrates rapidly within seconds in contact with water or saliva, releases the drug in the mouth and promotes gastrointestinal absorption. The Rapid Film dosage form was especially designed for high patient compliance. The application is easy. The patient does not have any swallowing difficulty. The fact that no water intake after administration is needed is very well accepted by patients with nausea.
Dominique Costantini, CEO of BioAlliance said, "We are delighted to collaborate with APR/Labtec and expand our pipeline of supportive care products. With two unique, yet complementary delivery systems of ondansetron in our portfolio, ondansetron oral spray from NovaDel and the oral thin film, we are able to offer patients a better opportunity to find a product that meets their individual needs."
Paolo Galfetti, CEO of APR, stated, "BioAlliance is uniquely positioned to market and sell our ondansetron thin film product and we are very excited about the collaboration.
Following approval, ondansetron is expected to be the first prescription drugs to come to market utilizing thin film drug delivery technology."
BioAlliance Pharma SA is a specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and HIV. The company develops and commercializes innovative products which address resistance issues.
APR is a private Research & Development company headquartered in Switzerland. Core business is the development of its own selected drug candidates (developed using APR proprietary technologies) as well as on the development under contract of third party pharmaceutical products and medical devices.