Specialty pharma BioAlliance expects its Loramyc to go on sale soon in France for the treatment of oropharyngeal candidiasis in immunocompromised patients at a manufacturer's price before taxes (MPBT) of EUR 4 per day, after publication in the Journal Officiel
Paris, June 12 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 France's Economic Committee for French Health Products (CEPS - Comité Economique des Produits de Santé Français) has accepted the price of EUR 4 per day (MPBT) for Loramyc 50 mg for the indication "oropharyngeal candidiasis for immunocompromised patients, in particular for patients with head or neck cancer after radiotherapy treatment and for patients with HIV".
This agreement on pricing follows the favorable opinion of France's health authority (Haute Autorité de Santé) on the reimbursement of Loramyc at 65 percent. Loramyc will be added to the list of drugs that are reimbursed for patients covered by social security and to the list of medicines approved for use by hospitals and various public services.
"The 4 euro price for Loramyc is at the upper end of analyst forecasts and the approval is an important event for BioAlliance Pharma as we get ready to launch the first product resulting from our own research," said Dominique Costantini, President and CEO at BioAlliance.
"The pricing is recognition of the value of the innovative nature of Loramyc, a mucoadhesive buccal tablet, specially designed for oropharyngeal candidiasis in patients weakened by cancer or otherwise immunodepressed," said Florence Dupré, Vice-president Marketing and Sales at BioAlliance Pharma.
Pending publication in the Journal Officiel, the company is carrying out the final preparations for the launch of Loramyc in France, with its dedicated team of scientific representatives.
Marketing of Loramyc in other European countries will be carried out by SpeBio, a 50:50 joint venture recently established by BioAlliance Pharma. The European mutual recognition procedure is under way with France as reference Member State.
About BioAlliance Pharma
BioAlliance Pharma SA (Euronext Paris: BIO) is a specialty pharmaceutical company focused on the development and marketing 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 AMF on 6 April 2007 under the number R. 07-031, 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 Financial 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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