10/2005 Press Release
BioAlliance Pharma Announces European Marketing Authorization Application (MAA) Submission for Miconazole Lauriad®
PARIS - October 3, 2005 - BioAlliance Pharma, a biopharmaceutical company focused on the development of innovative therapeutics in the field of drug resistance, announced today that it has filed a marketing authorization application (MAA) with the French Health Products Safety Agency (AFSSAPS) to initiate the approval process within the European Union (EU) for miconazole Lauriad®, the Company’s investigative anti-fungal agent for the treatment of oropharyngeal candidiasis (OPC), an oral fungus and opportunistic infection commonly known as "thrush". Utilizing the Mutual Recognition Procedure with France acting as the Reference Member State, BioAlliance intends to pursue marketing authorization applications in various countries of the EU.
Miconazole Lauriad® is a once-daily 50 mg extended-release Bioadhesive Buccal Tablet for use as a first-line local treatment of OPC. Oral candidiasis infections are frequent within immunocompromised populations, such as those represented by HIV-infection, ICU and transplant patients, and in chronic diseases such as cancer. A pivotal Phase III trial in HIV-positive patients with OPC is expected to initiate in the US in 2006, under an IND recently allowed by the US Food and Drug Administration (FDA).
"The submission of this marketing authorization application is a key milestone in the advancement and commercialization strategy for miconazole Lauriad®," said Dominique Costantini, M.D., president and CEO of BioAlliance Pharma. "We plan to work cooperatively with the regulatory authorities in order to facilitate the review process and make this new treatment option available as quickly as possible to European physicians and their patients suffering from OPC."
The focus, in the EU registration, is on the specialized hospital market and the selected patient population represented by immunocompromised patients contracting oropharyngeal candidiasis in oncology, HIV and other chronic diseases. The product is designed for the supportive care hospital setting, where these diseases are now more frequently being treated as chronic conditions, allowing for growing use of products such as miconazole Lauriad®.
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 immuno-compromised 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 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 mg/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.
About BioAlliance Pharma
BioAlliance Pharma is a privately held late stage biopharmaceutical company focused on drug resistance through development and commercialization of innovative therapeutics targeting markets in cancer, HIV, severe infections and supportive care. The company has two broad proprietary drug delivery systems represented by the Lauriad® adhesive technology and the Transdrug® nanoparticle technology that provide multiple product opportunities. Together with a New Chemical Entities program focused on development of new drugs in oncology and HIV, the company is able to address worldwide markets in the EU, US, and Asia.
The company’s lead product within its adhesive technology program, the miconazole Lauriad® 50 mg Bioadhesive Buccal Tablet, has been investigated in two completed Phase III trials in Europe for treatment of oropharyngeal candidiasis in cancer and HIV patients. EU registration is on track for filing
before the end of Q3 2005 and a pivotal Phase III trial in the same indication is planned to start in the U.S. later this year. A near term follow-on product, acyclovir Lauriad® for treatment of oral herpes, using the same delivery system, has recently completed Phase I clinical studies in the EU. A Phase I/II trial in hepatocellular carcinoma utilizing the company’s doxorubicin Transdrug® nanoparticle delivery technology is ongoing in Europe, and has been granted orphan drug status by the EMEA and the US FDA.
For additional company background, click here.
Company Contact
Richard Keatinge
Vice President, Business Development
BioAlliance Pharma SA
Tel : +33 (0) 1 45 58 76 00
richard.keatinge@bioalliancepharma.com
Media Contact
Andrew Lloyd & Associates
Andrew Lloyd
Tel : +44 1 273 675100
Gilles Petitot
Tel : +33 1 56 54 07 00
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