Paris, February 5, 2007 -- BioAlliance Pharma SA (Euronext Paris - Code Isin : FR0010095596 - BIO), an emerging specialty pharmaceutical company focused on the development of innovative therapeutics targeting drug resistance in cancer, HIV, and severe and opportunistic infections, announced today its revenues for Q4 2006.
(1) Until the end of 2005, BioAlliance Pharma's financial statements were presented according to French accounting rules.
The EUR 160,000 revenues for Q4 derive from services supplied to Eurofins-VIRalliance (EVI, Inc.) as in past quarters over 2006.
- On October 13, the Company announced it had received its first Marketing Authorization. This was granted in France for Loramyc®, the first bioadhesive antifungal treatment for oropharyngeal candidiasis for immuno-depressed patients.
- The team of scientific staff set up by the Company has been pre-launching the product since October through meetings with hospital clinicians specializing in oncology and infectious diseases. So far, these specialists have shown a great interest for this innovative product.
- The Marketing Authorization for Loramyc® in France is the first step in the European mutual recognition procedure that will start in the coming months under the leadership of the French regulatory agency AFSSAPS, France being the lead country.
- In parallel, the Company is progressing at the international level while conducting its Phase III trial in view of registering Loramyc® in the USA.
2. Acyclovir Lauriad
- On December 14, the Company submitted to the regulatory authorities the Phase III protocol for labial herpes treatment acyclovir Lauriad®, and expects to start the pivotal trial in Europe in Q1 2007.
3. Doxorubicin Transdrug
- On December 14, the Company announced that it has received approval from France's medical agency, AFSSAPS, to begin Phase II/III clinical trials for its primary liver cancer treatment doxorubicin Transdrug®. This randomized Phase II/III trial will measure the efficacy of doxorubicin Transdrug® delivered by repeated intra-arterial hepatic injection. The efficacy will be measured over the short term in Phase II by the number of patients out of 50 in whom there is no disease progression over a three-month period. The second, Phase III, part of the trial will be extended to 200 patients, and a 12-month evaluation will focus on length of time where disease progression is absent.
If the results confirm the efficacy of this treatment, BioAlliance Pharma expects to register the product in Europe using its orphan drug status already obtained in Europe. The company expects a first submission in Europe during the second half of 2009 provided there are no additional requirements imposed by the regulatory authorities.
With Loramyc®, acyclovir Lauriad® and doxorubicin Transdrug®, BioAlliance Pharma will carry out three Phase III clinical trials in 2007 which shows the internal dynamic as well as the progress made by the company since its IPO in December 2005.
From a commercial perspective, the Company has strengthened its teams in view of the planned launch of Loramyc in France. In addition, the Company is actively working in order to build an optimized organization able to prepare the commercial deployment of Loramyc® out of France especially in Europe in 2008 and the USA in 2009.
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(R) adhesive 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(R) (miconazole Lauriad(R)) 50 mg Bioadhesive Buccal Tablet has completed two Phase III clinical trials in Europe for treatment of oropharyngeal candidiasis (OPC) in cancer and HIV patients. A pivotal Phase III trial of Loramyc(R) is ongoing in the US in 2006 for the same indication. The company has submitted a Phase III protocol for a second product, acyclovir Lauriad(R), an oral herpes treatment. 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..
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|
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