Healthcare Industry News: Head and Neck Cancer
News Release - October 13, 2006
BioAlliance Pharma Receives Marketing Authorisation for Its First Product, Loramyc(R)PARIS--(HSMN NewsFeed)--BioAlliance Pharma SA (Paris: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 that the Company has received marketing authorization for Loramyc® (miconazole Lauriad) from France's regulatory body, AFSSAPS (Agence Francaise de Securite Sanitaire des Produits de Sante).
AFSSAPS has approved the product for the treatment of Oropharyngeal Candidiasis in immunodepressed patients, particularly those with Head and Neck Cancers who have undergone radiotherapy, and those infected by HIV.
"This approval represents another major milestone for BioAlliance and demonstrates the success of our specialty pharma model based on close partnerships between cancer and infection specialists," said Dominique Costantini, MD, President and CEO of BioAlliance. "We now move on to establishing the price and reimbursement for the product, and preparing Loramyc®'s market launch in France, planned for 2007."
The market for Oropharyngeal Candidiasis is estimated at EUR 350 million according to IMS Health (research carried out in the five major European countries, the US and Japan.). According to this research, Loramyc® is expected to obtain peak sales equivalent to a 30 per cent market share.
Loramyc® is an innovative drug specifically developed for Oropharyngeal Candidiasis in immunodepressed patients, who frequently suffer an associated mucositis. This first marketing authorisation will be the basis for European Mutual Recognition with France as rapporteur. In the US, Loramyc® is currently undergoing a pivotal Phase III clinical trial with the objective of registering the drug in the US.
Loramyc® offers an optimized anti-fungal treatment with the same order of efficacy as systemic therapies, with the advantage that it specifically targets the mouth and the oropharynx.
The new therapeutic approach uses an innovative delivery system based on a mucoadhesive buccal tablet. This ensures an early and extended release of the active component at the site of the infection, with only one dose per day. The targeted approach reduces the risk of drug interactions and systemic effects, key issues for patients undergoing a multiplicity of treatments. The therapy is also designed to solve epidemiological and ecological problems caused by the emergence of resistant fungal infections.
In preparation for the Loramyc® launch, BioAlliance has already assembled a scientific marketing team whose first mission will be to meet oncologists and hospital infection specialists.
"This first marketing authorisation also demonstrates how right we have been in our selection of strategic alliances in the field of innovation. These include various universities, the CNRS, Inserm, the Ecole Normale Superieure and the Institut Gustave Roussy," said Gilles Avenard, COO at BioAlliance.
About Oropharyngeal Candidiasis
Fungal infections of the oral mucosa are most frequently caused by Candida species, with C. albicans being the most common species associated with such infections. Oropharyngeal candidiasis is commonly found in immunocompromised patients, including HIV and cancer patients, and in other chronic disease states such as diabetes. For instance, oropharyngeal candidiasis is the most frequently occurring infection in Head and Neck Cancer patients undergoing radiation therapy. The clinical presentation of oropharyngeal candidiasis is variable with symptoms including soreness, burning, and/or altered taste. The signs of clinical candidiasis usually include white pseudomembraneous plaques and patches (thrush), erythematous lesions or occasionally angular cheilitis. Left untreated, the condition may progress to involve the esophagus or to more serious systemic complications.
About Loramyc® (Miconazole Lauriad®)
Miconazole is an antifungal agent with broad-spectrum activity against various Candida species, limited potential for drug-drug interactions, greatly diminished likelihood of development of azole resistant forms of fungi, and little to no systemic absorption. Miconazole Lauriad® is an oral bioadhesive buccal tablet containing miconazole developed to optimize local antifungal activity in the oropharyngeal cavity by ensuring an early and extended release of a dosage resulting in miconazole saliva concentrations greater than 1 (mu)g/mL which is the required minimum inhibitory concentration (MIC) level to treat oropharyngeal candidiasis. Miconazole Lauriad® is designed to be administered once daily, applied to the upper gum, while providing adequate local miconazole concentrations in the saliva and negligible plasma concentrations. This compares to other topical treatments, such as gels, rinses, or lozenges, which require multiple applications or intakes per day. Systemic treatments enter into the general bloodstream and cause drug interactions as well as disturbance of the fungal ecology.
About BioAlliance Pharma
BioAlliance Pharma SA (Euronext Paris: FR0010095596 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® 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® (miconazole Lauriad®) 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® is ongoing in the US in 2006 for the same indication. A second product, acyclovir Lauriad®, for the treatment of oral herpes, has completed a Phase I clinical trial in Europe. A Phase I/II trial in primary liver cancer (hepatocellular carcinoma or HCC) utilizing the Company's doxorubicin Transdrug® nanoparticle delivery technology has been completed in Europe, and has been granted orphan drug status by the EMEA and the FDA. These last two programs should be able to enter Phase III towards the end of 2006.
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.
Source: BioAlliance Pharma SA
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