From Empirerelations.com

Healthcare/BioTech

BioAlliance Pharma SA complements its portfolio with a European license for ondansetron RapidFilm(TM)
By MARKET WIRE
Aug 4, 2008 - 12:36:02 AM

PARIS -- (MARKET WIRE) -- 08/04/08 -- BioAlliance Pharma complements its portfolio with aEuropean license for ondansetron RapidFilm(TM)

A new innovative product near registration filing in cancer supportive care

Paris, 4 August, 2008 - BioAlliance Pharma SA. (Euronext Paris ISIN code:FR0010095596-BIO), the specialty pharmaceutical company focused on thetreatment of opportunistic infections in cancer and HIV, and APR AppliedPharma Research SA., together with its joint venture partner Labtec GmbH,today announced that they have entered into an exclusive licensingagreement under which BioAlliance has acquired the commercialization rightsin Europe to the thin film formulation of ondansetron from APR/Labtec,leader in oral thin film technology named RapidFilmTM. Ondansetron thinfilm formulation is a new oral formulation for the prevention ofchemotherapy-induced nausea and vomiting, prevention of nausea and vomitingassociated 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 licenseto BioAlliance may total up to EUR 6.0 million with EUR 1 million atsignature and EUR 1,25 million at approval and sales milestones up to EUR3,75 million; in addition royalties on net sales of the product will alsobe paid.

Anti-emetic therapies constitute one of the largest segments of thesupportive care market in Europe, with annual sales of over EUR 400million in 2007 in the 5 major EU markets (IMS Midas 2007). Ondansetron wasthe prescription leader in the category in 2007, with about 800 000prescriptions (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 filmbased on a water-soluble polymer. The film disintegrates rapidly withinseconds in contact with water or saliva, releases the drug in the mouth andpromotes gastrointestinal absorption. The RapidFilmTM dosage form wasespecially designed for high patient compliance. The application is easy.The patient does not have any swallowing difficulty. The fact that no waterintake after administration is needed is very well accepted by patientswith nausea.

Dominique Costantini, CEO of BioAlliance said, "We are delighted tocollaborate with APR/Labtec and expand our pipeline of supportive careproducts. With two unique, yet complementary delivery systems ofondansetron in our portfolio, ondansetron oral spray from NovaDel and theoral thin film, we are able to offer patients a better opportunity to finda product that meets their individual needs."

Paolo Galfetti, CEO of APR, stated, "BioAlliance is uniquely positioned tomarket and sell our ondansetron thin film product and we are very excitedabout the collaboration. Following approval, ondansetron is expected to bethe first prescription drugs to come to market utilizing thin film drugdelivery technology".

About BioAlliance Pharma

BioAlliance Pharma SA is a specialty pharmaceutical company focused on thetreatment of opportunistic infections in cancer and HIV. The companydevelops and commercializes innovative products which address resistanceissues. 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 thepivotal Phase III clinical development in oropharyngeal candidiasis in theUSA. In addition, two other innovative products are currently in Phase IIIclinical trials: acyclovir Lauriad® in oral herpes (based on the sameLauriad® muco-adhesive technology as Loramyc®, which enables targetedrelease at the disease site) and doxorubicin Transdrug® in primary livercancer (based on the Transdrug® nanoparticle technology, designedspecifically for intracellular targeting of resistant cells - this trial iscurrently suspended on the advice from the Data Safety Monitoring Board andSteering Committee, while waiting for additional clinical functional data).The company is also developing a new therapeutic entities program focusedon the oncology and infectious disease markets.

In 2007, the company has established strategic alliances forcommercializing Loramyc® in Europe (with JV SpeBio) and in the USA withPar Pharmaceutical. In March 2008, BioAlliance Pharma signed a partnershipagreement with Handok Pharmaceuticals for commercializing Loramyc® inKorea, Taiwan, Singapore and Malaysia and with Novamed Pharmaceuticals inJune 2008 for commercialization of Loramyc(TM) in China. In May 2008, thecompany expanded its product portfolio via acquisition of the Europeancommercial rights to ondansetron Oral Spray (OS) from NovaDel Pharma Inc.(Amex: NVD).

For more information, visit BioAlliance Pharma's website atwww.bioalliancepharma.com.

About APR Applied Pharma Research s.a.

APR is a private Research & Development company headquartered inSwitzerland. Core business is the development of its own selected drugcandidates (developed using APR proprietary technologies) as well as on thedevelopment under contract of third party pharmaceutical products andmedical devices. Leveraging on its own technology platforms, R&D know-how,marketing and regulatory expertise, APR is committed to create newsustainable value on its own as well as on third party products andprojects.

The APR products and technologies are licensed to third parties fordistribution and marketing. R&D activities are carried out directly orunder contract.

Disclaimer

This communication expressly or implicitly contains certain forward-lookingstatements concerning BioAlliance Pharma SA and its business. Suchstatements involve certain known and unknown risks, uncertainties and otherfactors, which could cause the actual results, financial condition,performance or achievements of BioAlliance Pharma SA to be materiallydifferent from any future results, performance or achievements expressed orimplied by such forward-looking statements. BioAlliance Pharma SA isproviding this communication as of this date and does not undertake toupdate any forward-looking statements contained herein as a result of newinformation, future events or otherwise. For a discussion of risks anduncertainties which could cause actual results, financial condition,performance or achievements of BioAlliance Pharma SA to differ from thosecontained in the forward-looking statements, please refer to the RiskFactors ("Facteurs de Risque") section of the reference document approvedby the AMF on April 11 2008 under the number R. 08-021, which is availableon the AMF website (http://www.amf-france.org) or on BioAlliance PharmaS.A.'s website (http://www.bioalliancepharma.com).

BioAlliance Pharma SA

Dominique Costantini, President and CEO

Tel.: +33 1 45 58 76 01

dominique.costantini@bioalliancepharma.com

Nicolas Fellmann, CFO

Tel.: +33 1 45 58 71 00

nicolas.fellmann@bioalliancepharma.com

APR

Paolo Galfetti, CEO

APR Applied Pharma Research s.a.

Via Corti 5, CH-6828 Balerna, Switzerland

Tel.:+41 91 69 57 020

www.apr.ch

ALIZE RP

Caroline Carmagnol

Tel.: +33 6 64 18 99 59

caroline@alizerp.com

This information is provided by HUGIN




© Copyright 2005 by Empirerelations.com