Agreements

* On April 1, 2014, BioAlliance Pharma has updated on Loramyc®/Oravig® development programs by its Asian partners and on its US partnership. In Japan, as usually required by Japanese authorities, a complementary development plan is driven by Sosei to complete the registration file. After a first successful phase I trial, the pivotal phase III trial initiated in March 2013 should be completed by the end of 2014. This study is the final step before filing the registration dossier scheduled several months later. Upon Loramyc® registration, BioAlliance Pharma should receive a significant milestone payment from Sosei. Moreover, Sosei has implemented a commercialization agreement with Fujifilm Pharma for the promotion and distribution of Loramyc® in Japan once its marketing authorization is obtained. Prior to a product’s registration, the Chinese authorities also require a local development plan to be conducted. In 2008, BioAlliance Pharma licensed Loramyc®’s commercialization rights for China to SciClone Pharmaceuticals, also in charge of registering and gaining the marketing approval from the authorities. In 2013, SciClone has started the clinical program with Loramyc® to complete the product’s registration dossier with a pivotal phase III clinical trial.

* On February 4, 2014, BioAlliance Pharma has announced that its Japanese partner, Sosei Co has entered into a distribution agreement with Fujifilm Pharma for commercialization rights in Japan for Loramyc® (miconazole Lauriad®) mucoadhesive tablet. In May 2011, BioAlliance Pharma signed a licensing agreement with Sosei to conduct bridging development program and commercialization rights in Japan for Loramyc® in the treatment of oropharyngeal candidiasis. Following a phase I clinical trial finalized in July 2012, Sosei had started a phase III open-label study in March 2013 which should be the final step before submission, as required by the Japanese authorities. Sosei has signed a distribution agreement with FUJIFILM Pharma for the commercialization of Loramyc® in Japan, once its marketing authorization is obtained.

* On March 12, 2013, BioAlliance Pharma has announced the initiation of Loramyc®/Oravig® Phase III clinical trial for the treatment of oropharyngeal candidiasis by its Japanese partner Sosei. This is the final step before registration of the drug by Japanese authorities. As traditionally required by Japanese authorities, a complementary development plan driven by Sosei has been initiated to complete the registration dossier and meet Japanese regulatory requirements. Following the successful phase I clinical trial finalized in July 2012, Sosei is now starting the final step of development with the phase III open-label, randomised trial versus miconazole gel. This study is anticipated to last 12 to 18 months. 

* On March 8, 2012, Sosei has initiated a Japanese Phase I trial for SO-1105 for the treatment of oropharyngeal candidiasis. SO-1105 was originally developed by a French pharmaceutical company, BioAlliance Pharma, which received its first marketing authorization for SO-1105 in France in October 2006. SO-1105 has since been registered in 26 European countries, in South Korea, and in the United States, under the trade names Loramyc®/Oravig®. The clinical study will be conducted in a single study centre in Japan, and is designed to evaluate the pharmacokinetics and safety of SO-1105 in healthy Japanese adults.