BioAlliance Pharma SA (Euronext Paris – BIO), an innovative Company specialized in the development of drugs in orphan oncology diseases, updates on Loramyc®/Oravig® development programs by its Asian partners and on its US partnership.

In the United States, after one year of marketing by American partner Vestiq Pharmaceutical, the sales performance of Oravig® was not meeting the expectations. Consequently, BioAlliance Pharma has decided to regain full U.S. commercialization rights for Oravig® as well as the New Drug Application. The Company is already in advanced discussions with potential partners for the acquisition or for a licensing agreement of the product.

“The commercialization of a product such as Oravig® requires a significant investment from a pharmaceutical company in terms of promotional and commercial resources. Despite a skilled team, Vestiq did not have sufficient means to enable a successful commercialization of the product. We both agreed and decided that, to the benefit of Oravig ®, BioAlliance would regain its rights and entrust the product to another company with the potential to give the product the place it deserves,” commented Judith Greciet, CEO of BioAlliance Pharma.

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.

“We are very satisfied with the Asian clinical development of Loramyc®. Sosei and SciClone have efficiently and professionally implemented all the required operations to gain the product’s registration in Japan and China, respectively. It is very important to us that this product, via our partners, reaches the outcome of its development in the Asian markets, especially on major markets such as Japan and China, to provide patients and prescribers with new therapeutic alternatives,” declared Aude Michel, Head of Corporate Business Development of BioAlliance Pharma.

“These achievements are relevant steps in our licensing strategy expansion of our two specialty drugs. These products are dedicated to provide revenues in the short and middle term with milestones and royalty payments. A the same time, BioAlliance is dynamically progressing on the development of its strategic portfolio with drugs targeting rare cancers, Livatag® and Validive®, both of which represent strong growth drivers for the coming years,” added Judith Greciet.