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A new innovative product near registration filing in cancer supportive care
BioAlliance Pharma SA. (Paris:BIO), the specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and HIV, and APR Applied Pharma Research SA., together with its joint venture partner Labtec GmbH, today 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 RapidFilmTM. 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 RapidFilmTM 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 RapidFilmTM 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".
About BioAlliance Pharma SA.
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 - this trial is currently suspended on the advice from the Data Safety Monitoring Board and Steering Committee, while waiting for additional clinical functional data). 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 and with Novamed Pharmaceuticals in June 2008 for commercialization of Loramyc™ in China. In May 2008, the company expanded its product portfolio via acquisition of the European commercial rights to ondansetron Oral Spray (OS) from NovaDel Pharma Inc. (Amex: NVD).
For more information, visit BioAlliance Pharma's website at www.bioalliancepharma.com.
About APR Applied Pharma Research s.a.
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. Leveraging on its own technology platforms, R&D know-how, marketing and regulatory expertise, APR is committed to create new sustainable value on its own as well as on third party products and projects.
The APR products and technologies are licensed to third parties for distribution and marketing. R&D activities are carried out directly or under contract.
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
+33 1 45 58 76 01
President and CEO
+33 1 45 58 71 00
APR Applied Pharma Research s.a.
+41 91 69 57 020
Via Corti 5, CH-6828 Balerna, Switzerland
+33 6 64 18 99 59
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