Profile/strategy

Profile

Onxeo was created through the merger of BioAlliance Pharma, a French innovative company based in Paris specializing in the development of drugs for orphan oncology diseases, and Topotarget, a Danish biopharmaceutical company based in Copenhagen and also a specialist in the development of oncology products.

The company is listed on both Euronext Paris and – since August 1, 2014 – on Nasdaq Copenhagen. The dual listing reflects Onxeo’s shareholder composition and the division of the company’s activities in the two countries.

Onxeo conceives, develops, and registers innovative drugs for the treatment of orphan oncology diseases, an area with significant and unmet medical needs.

Onxeo is a team of about 60 employees situated in Paris and Copenhagen, with a unique expertise in developing and registering drugs. Our key expertise in preclinical and clinical development, regulatory affairs, strategic and medical affairs, business development, quality assurance, intellectual development and intellectual property, is a major asset to Onxeo as we aim to become a leading player in the field of orphan oncology diseases by linking innovation to patients’ needs.

Strategy

The company’s growth strategy is primarily driven by the development of our orphan oncology products, which meet an established and unaddressed therapeutic need for a relatively limited population of patients and which have a very high sales potential, benefiting from more favorable pricing and reimbursement policies.

Onxeo’s orphan oncology products are:

Livatag® (doxorubicin Transdrug™): In Phase III in the treatment of primary liver cancer.

Beleodaq® (belinostat): Based on the positive Phase II trial evaluating Beleodaq® in relapsed or refractory peripheral T-cell lymphoma (PTCL), the product obtained a New Drug Authorization from the US Food and Drug Administration for PTCL in July 2014. A Phase III clinical trial is planned to assess the efficacy of Beleodaq® in combination with CHOP, against CHOP in the 1st line of treatment of PTCL.

AsiDNA™: The first-in-class siDNA (signal-interfering DNA) which has successfully undergone a proof-of-concept Phase I trial in metastatic melanoma.

Validive® (clonidine Lauriad®): Completed Phase II in the treatment and prevention of radio/chemotherapy induced severe oral mucositis in patients suffering from head and neck cancer. The company is seeking for a partner to further co-develop Validive®.

In the medium to long term, the company could directly market these high value-adding products with a strong profitability profile, notably in Europe, in order to benefit from the full profit margin generated.

Onxeo has, moreover, successfully developed and registered two initial drugs in Europe and the US, demonstrating our team’s expertise and know-how.

These products are based on Onxeo’s innovative proprietary technology Lauriad® that makes it possible to improve the efficacy and tolerance profile of an active ingredient for the chosen indication: Loramyc®/Oravig® , indicated for the treatment of oropharyngeal candidiasis, and Sitavig®/Labiriad®, indicated for the treatment of recurrent herpes labialis. With a strong market potential, these products are dedicated to be marketed by international partners, mainly via licensing agreements, contributing towards the funding of development projects.

Onxeo worldwide