BioAlliance Pharma Files For European Marketing Authorization For Ondansetron RapidFilm™ In Supportive Care In Cancer

February 18, 2009 at 2:00 pm Leave a comment


BioAlliance Pharma SA (Paris:BIO), the specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and AIDS, today announced the initiation of its European marketing application for ondansetron RapidFilm™, the fast-dissolving oral film strip formulation of ondansetron (which until now has been used in tablet form). This innovation is designed to prevent and treat nausea and vomiting induced by chemotherapy and radiotherapy. Ondansetron RapidFilm™ facilitates administration of the drug and improves efficacy and patient compliance.




The ondansetron film uses the RapidFilm™ drug delivery technology developed in joint venture by APR Applied Pharma Research s.a. (“APR”) of Switzerland and Labtec GmbH of Germany and enables novel oral dosing via a fast-dissolving film strip. The formulation is particularly suitable for patients with nausea or who have trouble swallowing.




In Europe, antiemetic drugs represent the main component of cancer supportive care and accounted for annual sales totaling over €400 million in the five largest markets in 20071. Ondansetron was the leading drug in its class in 2007, with around 800,000 prescriptions2.




BioAlliance Pharma estimates that the decentralized registration procedure (covering 16 European countries) should take between 9 and 12 months.




Dominique Costantini, BioAlliance Pharma’s President and CEO, stated that “filing for marketing authorization in Europe via a decentralized procedure is a key milestone for our company on the road to commercialization of this new product. Our pharmaceutical, clinical and regulatory teams are fully committed to driving this application forward”.




“RapidFilm™ technology aims to provide the quickest, easiest and most patient friendly way for the oral intake of drugs,” said Paolo Galfetti CEO of APR. “Ondansetron was an ideally candidate to maximize both the patient and the market value of such feature and we believe BioAlliance is the best partner to bring this opportunity to a successful outcome in the market”.



About BioAlliance Pharma




As a preferred partner for hospital-based specialists, BioAlliance Pharma is a specialty biopharmaceutical company which develops and markets innovative products, especially in the fields of opportunistic infections and chemotherapy complications. In areas where medical needs are insufficiently met, our targeted approaches help overcome drug resistance and improve patient health & quality of life. BioAlliance Pharma’s ambition is to become a leading European player in these fields by coupling innovation to patient needs.




For more information, visit the BioAlliance Pharma web site at http://www.bioalliancepharma.com



About Applied Pharma Research s.a. (APR)




APR is an international drug research & development company headquartered in Switzerland. Its core business is the development of its own prescription drugs. APR also provides contract pharmaceutical product and medical device development services. By leveraging its technology platforms, R&D know-how and marketing & regulatory expertise, APR is committed to adding value to its own products and those of its partners.



Disclaimer




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 (http://www.amf-france.org) or on BioAlliance Pharma S.A.’s website (http://www.bioalliancepharma.com).




1 IMS Midas 2007


2 estimate based on IMS Midas 2007 data



http://www.bioalliancepharma.com

[Via http://www.medicalnewstoday.com]

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