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BioAlliance acquired European rights for Ondansetron oral spray to complement its franchise in cancer supportive care from NovaDel Pharma Inc.
BioAlliance Pharma SA (Euronext Paris - BIO) a specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and HIV, today announced that it has acquired the European commercial rights to ondansetron Oral Spray (OS) from NovaDel Pharma Inc. (Amex: NVD).
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".
About Ondansetron OS
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).
About BioAlliance Pharma
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. The company has launched its first portfolio product (Loramyc®) in France and already received European Marketing Authorizations in UK, Germany, Belgium, Denmark and Luxemburg. The compound has completed the pivotal Phase III clinical development in oropharyngeal candidiasis in the USA. In addition, two other innovative products are currently in Phase III clinical trials: acyclovir Lauriad® in oral herpes (based on the same Lauriad® muco-adhesive technology as Loramyc®, which enables targeted release at the disease site) and doxorubicin Transdrug® in primary liver cancer (based on the Transdrug® nanoparticle technology, designed specifically for intracellular targeting of resistant cells). The company is also developing a new therapeutic entities program focused on the oncology and infectious disease markets.
In 2007, the company has established strategic alliances for commercializing Loramyc® in Europe (with JV SpeBio) and in the USA with Par Pharmaceutical. In March 2008, BioAlliance Pharma signed a partnership agreement with Handok Pharmaceuticals for commercializing Loramyc® in Korea, Taiwan, Singapore and Malaysia.
For more information, visit BioAlliance Pharma's website at www.bioalliancepharma.com.
About NovaDel Pharma
NovaDel Pharma Inc. is a specialty pharmaceutical company developing oral spray formulations for a broad range of marketed drugs. The Company's proprietary technology offers, in comparison to conventional oral dosage forms, the potential for faster absorption of drugs into the bloodstream leading to quicker onset of therapeutic effects and possibly reduced first pass liver metabolism, which may result in lower doses. Oral sprays eliminate the requirement for water or the need to swallow, potentially improving patient convenience and adherence.
NovaDel's oral spray technology is focused on addressing unmet medical needs for a broad array of existing and future pharmaceutical products. The Company's most advanced oral spray candidates target angina, nausea, insomnia, migraine headaches and disorders of the central nervous system. NovaDel plans to develop these and other products independently and through collaborative arrangements with pharmaceutical and biotechnology companies. To find out more about NovaDel Pharma Inc. (AMX: NVD), visit our website at www.novadel.com.
This communication expressly or implicitly contains certain forward-looking statements concerning BioAlliance Pharma SA and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of BioAlliance Pharma SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. BioAlliance Pharma SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For a discussion of risks and uncertainties which could cause actual results, financial condition, performance or achievements of BioAlliance Pharma SA to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the reference document approved by the AMF on April 11 2008 under the number R. 08-021, which is available on the AMF website (www.amf-france.org) or on BioAlliance Pharma S.A.'s website (www.bioalliancepharma.com).
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BioAlliance Pharma SA
President and CEO
Tel.: +33 1 45 58 76 01
Nicolas Fellmann, CFO
Tel.: +33 1 45 58 71 00
Tel.: +33 6 64 18 99 59
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