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Regulatory News:
“with Loramyc®, which acts as a frontrunner, acyclovir Lauriad in phase III and the two innovative forms of ondansetron pending registration in 2009, BioAlliance now has a synergistic portfolio in the oncology supportive care field to achieve its European specialty pharma strategy.”
BioAlliance Pharma SA (Paris:BIO), a specialty pharma company focused on the treatment of opportunistic infections in cancer and AIDS, announces a turnover of €1,545k for the third quarter of 2008.
Sales of Loramyc® amounted to €282k, compared with €259k in Q3 2007, the latter generated through initial stocking with wholesalers upon the launch of the product.
In France, sales volume for Q3 was up 23% over the previous quarter. Between the product launch and the end of September, Loramyc® was prescribed for more than 12 000 patients compared with 8 000 at the end of June. This significant progression strengthens the company’s ambition to exceed their target figure of 16 000 patients by the end of 2008.
Throughout the rest of Europe, Loramyc® is now available in the UK, German and Danish markets. The drug has been warmly welcome by oncology and infectious disease specialists, the key hospital prescribers, confirming the interest in innovative products such as Loramyc®. European sales teams from SpeBio (subsidiary in a joint venture with SpePharm) have been mobilised to ensure gradual placement of the product in hospitals prior to market penetration for the product.
“With its first product Loramyc® now available in four European countries, BioAlliance is making its commercial mark. Together with our partner, we are engaged in price negotiations in the other European countries. At the same time, and in close collaboration with our US licensee Par Pharmaceutical/Strativa, we are planning an MA submission for Loramyc® in the United States before the end of the year, subject to further requirements from regulatory agencies”, stated Dominique Costantini, President of the Management Board and CEO, BioAlliance Pharma.
Revenues from Loramyc® licensing agreements amounted €1,242k, compared with €1,417k for Q3 2007. In particular, this figure includes a part of the payments received from Handok (Korea and Southeast Asia) and NovaMed (China). The difference between 2007 and 2008 is due to changes in revenue recognition made in accordance with international accounting standards IAS 18, and already captured in 2008 half year accounts: the sum received in July 2007 upon signature of the agreement with Par Pharmaceutical regarding commercialization of the product in the US is now spread over 30 months, when the duration initially agreed was 24 months.
Finally, the services invoiced to EVI stood at €21k compared with €123k for Q3 07.
Key events in the third quarter of 2008
The company continued to extend its product portfolio through the acquisition from Swiss company APR of a new anti-emetic containing ondansetron developed in the innovative form of a fast dissolving film. This product, complementing the acquisition of ondansetron spray formulation, purchased during the first half of the year from NovaDel, provides BioAlliance with two products close to registration in the field of cancer supportive care.
Dominique Costantini stressed that “with Loramyc®, which acts as a frontrunner, acyclovir Lauriad in phase III and the two innovative forms of ondansetron pending registration in 2009, BioAlliance now has a synergistic portfolio in the oncology supportive care field to achieve its European specialty pharma strategy.”
In keeping with its international growth, BioAlliance Pharma strengthened its management team during the third-quarter with the recruitment of a new Chief Operating Officer, Pierre Morgon, who will specifically oversee commercial operations.
BioAlliance Pharma Chief Financial Officer Nicolas Fellmann added that “the summer also saw the acquisition of over 5% of BioAlliance stock by AGF Private Equity. This investment by a new reference shareholder is a reflection of their mid-term strategy, which marks a crucial step at a time when our company is consolidating its fundamentals and pursuing its growth in Europe.”
Events since the end of the third quarter of 2008
On 14 October 2008, BioAlliance Pharma announced that a civil action was filed in Delaware by Eurofins Pharma US Holding Inc. and one of its affiliates Viralliance Inc. (« Eurofins ») against BioAlliance Pharma. The action concerns mainly the use of intellectual property related to the HIV phenotyping technology called Phenoscript®, which tests resistance to anti-retroviral drugs that BioAlliance developed prior to 2005.
BioAlliance contests the merit of this allegation and moreover considers that only the courts in Paris have jurisdiction over this case.
On October 28, 2008, BioAlliance filed a motion with the US District Court of Delaware contesting the Court's jurisdiction and more generally asking it to dismiss the complaint.
About BioAlliance Pharma
BioAlliance Pharma SA is a specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and HIV. The company develops and commercializes innovative products which address drug resistance issues. BioAlliance Pharma has launched its first portfolio product (Loramyc®) in France and, more recently, in the UK, Germany and Denmark, and has already received European Marketing Authorizations in Belgium and Luxembourg. The product has also completed a pivotal Phase III clinical trial in the United States in oropharyngeal candidiasis. The company is also performing a Phase III trial in labial herpes with acyclovir Lauriad® (which is based on the same Lauriad® muco-adhesive system as Loramyc®, enabling targeted release at the disease site). BioAlliance Pharma is also developing products in the form of nanoparticles (Transdrug®) designed specifically for intracellular targeting, as well as a new therapeutic entities program in oncology and infectious disease. BioAlliance Pharma has established several strategic alliances for commercializing Loramyc®, with agreements in 2007 for Europe (with the SpeBio joint venture) and the United States (with Par Pharmaceutical) and in 2008 for Asia (Korea, Malaysia, Singapore and Taiwan with Handok Pharmaceuticals and then China with Novamed). In May and August 2008, the company expanded its product portfolio by acquiring the Europe commercial rights to, respectively, ondansetron Oral Spray (OS) from NovaDel Pharma Inc. (Amex: NVD) and ondansetron RapidFilmTM from APR/Labtec. For more information, visit BioAlliance Pharma's website at www.bioalliancepharma.com.
Disclaimer
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 April 11 2008 under the number R. 08-021, which is available on the AMF website (http://www.amf-france.org) or on BioAlliance Pharma S.A.'s website (http://www.bioalliancepharma.com).

