Paris , June 7 2007--BioAlliance Pharma SA (Euronext Paris - Code Isin : FR0010095596 - BIO), a specialty pharmaceutical company focused on the development and marketing of innovative therapeutics targeting drug resistance in cancer and HIV, announces today that it has established its new subsidiary, SpeBio, to sell its Loramyc® product in Europe. The move is in line with the agreement signed on March 8 2007 with SpePharm, joint partner in the venture.
The 50:50 joint venture, based in the Netherlands, will distribute Loramyc® in European Union countries except France where BioAlliance has set up its own sales team, and in Switzerland and Norway, both outside the EU.
Loramyc® is a product indicated for oropharyngeal candidiasis in immunodepressed patients. It obtained Marketing Authorization in France in October 2006. BioAlliance is currently awaiting a decision on the reimbursement price.
Under the terms of the contract between BioAlliance Pharma and Spepharm, BioAlliance will receive up to EUR 29.5 million from Spepharm for Loramyc® distribution rights in Europe.
Spepharm has already paid EUR 8 million, made up of:
- EUR 5M in the form of a capital increase approved at BioAlliance Pharma's Annual General Meeting on April 24, 2007.
- EUR 3M as an upfront payment for the licenses granted by BioAlliance and which are worth EUR 24.5M overall. The remaining payments of EUR 21.5M are linked to approvals in two major European countries and to the sales performance achieved by Loramyc® in the territory covered by the Joint Venture.
"The setting up of SpeBio means we will be ready for the launch of Loramyc® once the mutual recognition procedure is completed," said Dominique Costantini, President and CEO at BioAlliance.
About BioAlliance Pharma
BioAlliance Pharma SA (Euronext Paris: BIO) is an emerging specialty pharmaceutical company focused on the development of innovative therapeutics targeting drug resistance in cancer, HIV, and severe and opportunistic infections.
Specialty pharma targets the development and marketing of drugs for specialist markets and selected populations. This business model, unlike that of "big pharma" which targets general medicine, offers faster product development, lower R&D costs, smaller sales teams, and hence higher margins and fast growth.
The Company is developing three broad product ranges based on the Lauriad® mucoadhesive technology which allows an early and prolonged release of therapeutic agents at the site of the disease, the Transdrug® nanoparticle technology designed specifically for intracellular targeting, and a New Chemical Entities program focused on development of new drugs in oncology and HIV.
The Loramyc® (miconazole Lauriad®) 50 mg Mucoadhesive Buccal Tablet has completed two Phase III clinical trials in Europe for treatment of oropharyngeal candidiasis (OPC) in cancer and HIV patients. In October 2006, the company obtained Marketing Authorization for this product in France. A pivotal Phase III trial of Loramyc® is ongoing in the US for the same indication. The company has submitted a Phase III protocol for a second product, acyclovir Lauriad®, an oral herpes treatment. Approval was granted in Australia, France, UK, Germany and the Czech Republic. A Phase II/III trial in primary liver cancer (hepatocellular carcinoma or HCC) utilizing the Company's doxorubicin Transdrug® nanoparticle delivery technology started in Europe in December 2006. This product has been granted orphan drug status by the EMEA and the FDA.
About SpeBio, B.V.
SpeBio is established in the Netherlands as a 50:50 joint venture between BioAlliance Pharma SA and Spepharm Holding BV. The company has been set up to market Loramyc® in Europe apart from France.
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 28 April 2006 under the number R. 06-042, which is available on the AMF website http://www.amf-france.org or BioAlliance Pharma S.A.'s website http://www.bioalliancepharma.com.
|BioAlliance Pharma SA|
Chief Operating Officer
Tel : +33 1 45 58 71 00
Tel : +33 1 53 67 35 74
|Andrew Lloyd & Associates|
|Juliette DOS SANTOS
Tel : +33 1 56 54 07 04
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