BioAlliance Pharma SA (Euronext Paris – BIO), an innovation Company dedicated to the development of orphan oncology products and specialty products, has announced today the completion of phase I clinical study with Loramyc® in Japan by its partner Sosei Co., Ltd, in accordance with the development plan established to register the product in this country.
In May 2011, BioAlliance Pharma licensed its product Loramyc® to Sosei Co. Ltd. (a fully owned subsidiary of Sosei Group Corporation) for a global amount of $18.5 million before royalties, as well as handing over the management for the product development and its registration in Japan. Loramyc®, miconazole Lauriad™ muco-adhesive buccal tablet, is indicated in Europe and in the United States for the treatment of oropharyngeal candidiasis in immunocompromised patients. The phase I clinical trial, first step of the development in Japan, was designed to evaluate the pharmacokinetics and safety of Loramyc® in healthy Japanese adults. In addition to confirming the good tolerance of Loramyc®, the collected data have also shown an expected consistency with the patients’ profile from previous studies.
This phase I trial completed within the planned timelines, thus confirms that the European and US clinical trial results can be used for the following steps of the development and the registration of Loramyc® in Japan, which should now be discussed with the Japanese drug agency.
« Almost a year after the signature of our partnership agreement with Sosei for the commercialization of Loramyc® in Japan, the development program of the product is progressing as planned. Our partner has already successfully reached a key step towards the registration of an innovative product on his territory, which will represent an important innovation compared to the available treatments for oropharyngeal candidiasis, by enhancing patients’ compliance and improving their quality of life”, declares Judith Greciet, CEO of BioAlliance Pharma. “After Europe and the United States, BioAlliance Pharma is pursuing the international development of Loramyc® in Japan, as planned in its objectives”.
Sosei is an international biopharmaceutical company anchored in Japan with a global reach. It practises a reduced risk business model by acquiring compounds from, and bringing compounds into, Japan through exploitation of its unique position within global markets.
For further information about Sosei, please visit www.sosei.com