PARIS--(BUSINESS WIRE)--Regulatory News:
BioAlliance Pharma SA (Paris:BIO) (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.
About BioAlliance Pharma
Dedicated to cancer treatments with a focus on resistance targeting and orphan products, BioAlliance Pharma conceives and develops innovative products for orphan or rare diseases.
Created in 1997 and introduced to the Euronext Paris market in 2005, BioAlliance Pharma’s ambition is to become a leading player in these fields by coupling innovation to patient needs. The company’s teams have the key competencies required to identify, develop and register drugs in Europe and the USA.
BioAlliance Pharma has developed an advanced product portfolio:
Orphan Oncology products
Livatag® (Doxorubicin Transdrug™) (primary liver cancer): Phase III on going
Validive® (Clonidine Lauriad®) (mucositis): Phase II on going
AMEP® (invasive melanoma): Phase I on going
For more information, visit the BioAlliance Pharma web site at www.bioalliancepharma.com
This communication expressly or implicitly contains certain forward-looking statements concerning BioAlliance Pharma SA and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of BioAlliance Pharma SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. BioAlliance Pharma SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
For a discussion of risks and uncertainties which could cause actual results, financial condition, performance or achievements of BioAlliance Pharma SA to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the 2012 Reference Document filed with the AMF on April 18, 2013, which is available on the AMF website (http://www.amf-france.org) or on BioAlliance Pharma SA's website (http://www.bioalliancepharma.com).