Paris, March 1, 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 financial results for the year ending December 31, 2006. It also announced the start of its third Phase III clinical trial.
1. Accounts for the year 2006
Key figures (IFRS compliant, in thousands of euros)
|Year ending Dec 31 2006
|Year ending Dec 31 2005
|Earnings per share (in euros)||(1.52)||(0.93)|
|Cash at year end||17,573||29,114|
Note: 2005 net sales are stated using the same principles as in 2006. Fiscal year 2005 sales figures published on a quarterly basis related to individual accounts of BioAlliance Pharma SA (non consolidated data).
Group highlights for the year 2006
The company made significant progress in the development of its product portfolio:
- Obtaining Marketing Authorization in France for Loramyc(R) and setting up its sales and marketing team now involved in pre-launch activities
- Starting two pivotal Phase III clinical trials, one for Loramyc(R) in the USA and another for doxorubicin Transdrug(R) for primary liver cancer in Europe with orphan drug status.
- Submission of the Phase III clinical trial protocol for acyclovir Lauriad(R) for oral herpes.
- Continuation of New Chemical entity programs in oncology and HIV in collaboration with French research laboratories. These programs are in the pre-clinical development stage.
These developments will strengthen the company's portfolio of robust, high value-added products.
"2006 has been an important year in the development of our company," said Dominique Constantini, President and CEO of BioAlliance Pharma. "The past year has transformed the company with the setting up of a marketing and sales organization. Loramyc's(R) arrival on the market means that the company expects to make its first revenues from direct or indirect sales in 2007. BioAlliance Pharma is positioning itself as a real 'specialty pharma' company with activities in both development and marketing of niche products to treat patients with severe diseases generally under the supervision of specialists."
Review of the accounts
This is the first time BioAlliance Pharma has reported consolidated results in accordance with IFRS rules. The consolidation includes its operating subsidiary, Laboratoires BioAlliance Pharma (SAS), a 100 per cent subsidiary created in April 2006 to market BioAlliance products.
The company achieved net sales of EUR 460,000. These represent services provided and billed to Eurofins-VirAlliance.
There was an operational loss of EUR 13,638,000. This is explained mainly by the following:
- Purchases and external costs including services and professional fees incurred in the development of preclinical and clinical trials which amounted to EUR 7,939,000. This amount includes in particular expenditure related to the fabrication of compounds.
- Personnel costs of EUR 5,535,000.
Financial income is positive at EUR 473,000, and is principally made up of interest from short term investments of available cash.
No other income or expenditures having been incurred, the result is a net loss of EUR 13,165,000.
Available cash at the end of 2006 amounts to EUR 17,573,000 compared to EUR 29,114,000 in the preceding year.
2. Start of financial year 2007
Start of international Phase III clinical trial for acyclovir Lauriad(R)
BioAlliance Pharma announces to day that it has received authorization from regulatory agencies in Australia, France and the Czech Republic to begin a Phase III clinical trial of acyclovir Lauriad(R) for oral herpes. This trial will involve the recruitment of 634 patients suffering from recurrent oral herpes and will compare acyclovir Lauriad(R) with a placebo with the healing of lesions as principal criterion. It will be carried out in about 40 centers in six countries. Results are expected in approximately 24 months.
"The main advantage of acyclovir Lauriad(R) is that it rapidly reaches high concentrations of the active compound at the site of the infection and maintains this over time," said Dominique Costantini. "The delivery technology used is a mucoadhesive buccal tablet already used with Loramyc(R) and which has already been shown to be well tolerated. This pivotal trial will allow us to verify whether this concept of rapid high concentration makes it possible to treat herpes effectively with a single tablet."
If the results confirm that the treatment is effective, BioAlliance Pharma plans to register the product in 2009, subject to additional demands from the regulatory authorities.
Increase in liquidity
On January 31, 2007, the company increased its shareholder base through a private placement allowing a secondary sale of 970,000 shares at EUR 12 representing 11.2 per cent of the capital. These shares were released by a number of historical investors, including venture capitalists who had supported the company throughout its development. This operation means that the free float now amounts to more than 40 per cent of the capital. This should allow a significant growth in share liquidity.
3. Outlook for 2007
- Continuation and conclusion of the Loramyc(R) Phase III trial in the USA
- Expansion of Phase II/III trial of doxorubicin Transdrug(R)
- Start and expansion of Phase III trial of acyclovir Lauriad(R)
The company plans to sign a partnership agreement in Europe for the sale of Loramyc(R) in this region as soon as Marketing Authorizations are received from national authorities following the European Mutual Recognition Procedure. This procedure has begun and a product launch in Europe is planned for 2008.
The company also plans to conclude a partnership agreement for the same product on the North American market. The launch is planned for 2009 after the conclusion of the Phase III clinical trial in 2007 and registration at the FDA which should take place in 2008.
The company plans to select one candidate from its three New Chemical Entity research programs for a Phase I clinical trial in 2008.
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) 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(R) (miconazole Lauriad(R)) 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(R) is ongoing in the US for the same indication. The company has submitted a Phase III protocol for a second product, acyclovir Lauriad(R), an oral herpes treatment. Approval was granted in Australia, France and the Czech Republic in February 2007. 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|
President and CEO
Tel : +33 1 45 58 76 01
Chief Financial Officer
Tel : +33 1 45 58 71 00
| Agnès GILBERT
Tel : +33 1 53 67 36 33
Tel : +33 1 53 67 35 74
|Andrew Lloyd & Associates|
| Gilles PETITOT
Tel : +33 1 56 54 07 07
| Juliette DOS SANTOS
Tel : +33 1 56 54 07 04
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|ONXEO||Euronext Paris||2.65 (c)||-2.21%||78 345|