BioAlliance Pharma SA, an emerging specialty pharmaceutical company focused on the development of innovative therapeutics targeting drug resistance in cancer, HIV, and severe and opportunistic infections, has received marketing authorization for Loramyc from France's regulatory body, AFSSAPS (Agence Française de Sécurité Sanitaire des Produits de Santé).
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 optimised 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 Supérieure and the Institut Gustave Roussy," said Gilles Avenard, COO at BioAlliance.
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 immuno-compromised patients, including HIV and cancer patients, and in other chronic disease states such as diabetes.
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, erythematous lesions or occasionally angular cheilitis. Left untreated, the condition may progress to involve the esophagus or to more serious systemic complications.
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 optimise 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 µg/mL. Which is the required minimum inhibitory concentration (MIC) level to treat oropharyngeal candidiasis.