Apr 21 2008
BioAlliance Pharma SA today announced the preliminary positive results for its US pivotal Phase III clinical trial with Loramyc (miconazole Lauriad), Mucoadhesive Buccal Tablets (MBT) developed for the treatment of OroPharyngeal Candidiasis in immunocompromised population. This trial was conducted to support an NDA filing to market the product in the US.
Loramyc achieved its pre-specified two co-primary endpoints both in Intent To Treat (ITT) and Per Protocol (PP) populations. The primary end point was a complete resolution of signs and symptoms (complete clinical cure). In this pivotal phase III trial carried out according to a randomized, double-blind, double-dummy design in 577 HIV - positive patients, 290 patients received Loramyc applied once a day and 287 patients were administered clotrimazole troches 5 times a day, as defined during the pre-IND meeting with the FDA. As usual in this indication, the pivotal phase III trial was designed to demonstrate the non-inferiority versus a reference drug. All secondary endpoints were also met and the product confirmed its already established good safety profile.
“Based on this study and the results from the European phase III trials, BioAlliance is confident that Loramyc strongly confirms its properties in terms of efficacy and safety. We are very proud to achieve this important milestone we can fully credit our team for, as well as our external partners,” said Dominique Costantini, BioAlliance Pharma's President and CEO. “We also had the strong support of our highly experienced scientific committee and investigators involved in this trial, including the professors L. Patton, M. A. Ghannoum and J. Epstein. We will now be working on our filing application, and depending on favourable review of the full study results and ongoing discussions with the FDA, an NDA could be filed in the 2nd half of 2008,” Mrs. Costantini continued.
Loramyc is designed to enable concentrated and localised once daily dosing of the active ingredient at the site of infection. The product is approved in Europe by Mutual Recognition Procedure and already marketed in France. According to the July 2007 exclusive licensing agreement signed with Par Pharmaceutical, Inc., Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical, Inc., will be responsible for marketing Loramyc in the U.S.
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 resistance issues. The company has launched its first portfolio product (Loramyc) in France and already received European Marketing Authorizations in UK, Germany, Belgium, Denmark and Luxemburg. The compound has completed the pivotal Phase III clinical development in oropharyngeal candidiasis in the USA. In addition, two other innovative products are currently in Phase III clinical trials: acyclovir Lauriad in oral herpes (based on the same Lauriad muco-adhesive technology as Loramyc, which enables targeted release at the disease site) and doxorubicin Transdrug in primary liver cancer (based on the Transdrug nanoparticle technology, designed specifically for intracellular targeting of resistant cells). The company is also developing a new therapeutic entities program focused on the oncology and infectious disease markets.
In 2007, the company has established strategic alliances for commercializing Loramyc in Europe (with JV SpeBio) and the USA with Par Pharmaceutical. In March 2008, BioAlliance Pharma signed a partnership agreement with Handok Pharmaceuticals for commercializing Loramyc in Korea, Taiwan, Singapore and Malaysia.
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