BioAlliance Pharma SA: Q3 2009: Strong Sales Growth and Significant Progress in Clinical Development.PARIS Paris, in Greek mythology Paris or Alexander, in Greek mythology, son of Priam and Hecuba and brother of Hector. Because it was prophesied that he would cause the destruction of Troy, Paris was abandoned on Mt. -- Regulatory News: BioAlliance Pharma SA (Paris:BIO), a company dedicated to the treatment and supportive care of cancer and AIDS patients, today announced a consolidated turnover of [euro]1.6 million for the third quarter of 2009. Turnover and cash reserves Quarterly sales of Loramyc([R]) in France remained strong over the summer, totaling [euro]0.5 million - more than twice the figure for the equivalent period in 2008. A total of more than 42,000 patients have now been treated since the product's launch at the end of 2007. "The clear commercial success of our first product has been made possible by a cutting-edge sales and marketing organization" commented Dominique Costantini, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , BioAlliance Pharma. "Our specialist sales force is a true asset that has already been acknowledged by a major pharmaceutical company - Lundbeck, which signed a co-promotion agreement with us in July for in-hospital prescription of its star antidepressant, Seroplex([R]). These two products confirm our strong brand image as a pharmaceutical company with skills ranging from R&D expertise to direct hospital sales". The Q3 2009 turnover from licensing agreements amounted to [euro]1 million, compared with [euro]1.2 million in the same period in 2008. This variation is due to the payment schedule for one-off fees. "The dynamism of our international licensing activities has been accentuated by the progress of our registration procedure for Loramyc([R] )in the United States, where the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. accepted our new drug application in August" added Nicolas Fellmann, CFO See Chief Financial Officer. . "We expect to receive marketing authorization in the first half of 2010. That would be a significant milestone for our company and would trigger the payment of $20 million by our US licensee Par Pharmaceutical. We also expect to receive $1.5 million in 2010 from Handok (our licensee for south-east Asia) when Loramyc([R]) is launched on the Korean market. As of September 30, 2009, our consolidated cash reserves stood at [euro]18.4 million". Very significant advances in clinical development programs Along with acceptance of its new drug application in the United States, Loramyc([R]) made other notable progress during Q3 2009: European approval of Loramyc([R]) tablet embossing embossing, process of producing upon various materials designs or patterns in relief by mechanical means. The material is pressed between a pair of dies especially adapted to its hardness and the depth of the design needed. and extension of its shelf life to 36 months, plus marketing authorization in Switzerland. BioAlliance Pharma has also announced significant clinical progress in its other muco-adhesive tablet programs: * Strongly positive interim results in the acyclovir acyclovir /acy·clo·vir/ (a-si´klo-ver) a synthetic purine nucleoside with selective activity against herpes simplex virus; used as the base or the sodium salt in the treatment of genital and mucocutaneous herpesvirus infections. Lauriad([R]) Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the , which will constitute a solid basis for discussions with the regulatory agencies on the drug's subsequent development. This is the second product to use the company's patented Lauriad([R])technology. * Approval in France of a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I application for fentanyl fentanyl /fen·ta·nyl/ (fen´tah-nil) an opioid analgesic; the citrate salt is used as an adjunct to anesthesia, in the induction and maintenance of anesthesia, in combination with droperidol (or similar agent) as a neuroleptanalgesic, and Lauriad([R]) in the treatment of chronic pain in cancer patients. The effective initiation of this study was announced on October 12, 2009. * The filing (on October 12, 2009) of a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II application in France for clonidine clonidine /clo·ni·dine/ (klo´ni-den) a centrally acting antihypertensive agent, used as the hydrochloride salt; also used in the prophylaxis of migraine and the treatment of dysmenorrhea, menopausal symptoms, opioid withdrawal, and Lauriad([R]) - a promising product in the treatment of oral mucositis (inflammation of the oral mucosa) which is very frequent in cancer patients but currently lacks an effective treatment. About BioAlliance Pharma As a preferred partner for hospital-based specialists, BioAlliance Pharma is a company which develops and markets innovative products in France, especially in the fields of opportunistic infections and chemotherapy complications. In areas where medical needs are insufficiently met, our targeted approaches help overcome drug resistance and improve patient health & quality of life. BioAlliance Pharma's ambition is to become a leading player in these fields by coupling innovation to patient needs. For more information, visit the BioAlliance Pharma web site at http://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 ris·qué adj. Suggestive of or bordering on indelicacy or impropriety. [French, from past participle of risquer, to risk, from risque, risk; see risk.] Adj. ") section of the 2008 Reference Document filed with the AMF AMF ACE (Allied Command, Europe) Mobile Force AMF Autorité des Marchés Financiers (French) AMF Action Message Format AMF Arab Monetary Fund AMF Asian Monetary Fund AMF Autocrine Motility Factor on April 7, 2009, which is available on the AMF website (http://www.amf-france.org) or on BioAlliance Pharma S.A.'s website (http://www.bioalliancepharma.com). |
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion