BioAlliance Pharma SA a specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and HIV, announced that it has acquired the European commercial rights to ondansetron oral spray (OS) from NovaDel Pharma Inc.
Ondansetron is the leading 5-HT3 antagonist largely used to prevent nausea and vomiting after chemotherapy, radiation, and surgery (tablets or intravenous forms). Upon successful development and approval, ondansetron OS could be the first anti-emetic to be available in Europe in an oral spray formulation. The convenience of drug delivery via an oral spray may be an alternative to improve the quality of life of patients suffering from severe nausea and vomiting. Anti-emetic therapies constitute the largest segment of the supportive care market in the EU and Ondansetron is, by far, the prescription leader in the category.
Under the terms of the Agreement, BioAlliance paid NovaDel a license fee of $3 million upon closing. NovaDel is eligible for additional milestone payments totalling $24 million (an approval milestone of $5 million and sales-related milestone payments of $19 million) as well as a royalty on net sales. BioAlliance and NovaDel anticipate collaborating in the completion of development activities for Europe, with BioAlliance responsible for regulatory and pricing approvals and then commercialization throughout Europe. NovaDel will be responsible for supplying the product. .
"This first in class spray drug delivery system aligns well with BioAlliance' strategy to expand its presence in supportive care for oncology patients and to focus on patient convenience," said Dominique Costantini, President and CEO of BioAlliance. "NovaDel's expertise to design spray formulations will allow us to bring this unique delivery system to market. Strativa, Par Pharmaceutical's branded division, is responsible for the clinical development of this product in the US and BioAlliance will use their US dossier for European registration. "
Steven B. Ratoff, chairman and interim president and chief executive officer of NovaDel said, "I am very pleased to enter into this agreement with BioAlliance. Ondansetron OS is an excellent fit with BioAlliance and is an excellent alternative for patients having difficulties taking tablets and other forms of ondansetron".
Ondansetron OS is NovaDel's proprietary investigational oral spray formulation of ondansetron, the leading 5-HT3 anti-emetic therapy indicated for chemotherapy and radiotherapy induced nausea and vomiting (CINV and RINV), and post-operative nausea and vomiting. NovaDel and Strativa are jointly developing ondansetron OS in the United States under the brand name Zensana. Par/ Strativa recently initiated bioequivalence studies in man. BioAlliance expects to file the European dossier in 2009 - 2010. The partners will jointly develop ondansetron OS, and if BioAlliance has to complement the US dossier for EU registration, it will pay 100% of the costs of the additional studies up to a certain amount, after which the development costs are shared 50:50. Anti-emetic therapies constitute the largest segment of the oncology supportive care market. According to IMS, in 2007:over two million prescriptions for ondansetron were written in the US, and, in Europe, ondansetron unit growth was 19% representing about one million prescriptions in Europe in retail and hospital (800,000 prescriptions in the top five countries).