Onxeo, an innovative company specializing in the development of orphan oncology drugs, founded after the merger of BioAlliance Pharma and Topotarget, announces that it has received from his US partner Spectrum Pharmaceuticals the milestone payment of $25 million related to the approval of Beleodaq by the FDA.

Early July 2014, Beleodaq was granted by the U.S. Food and Drug Administration (FDA) conditional marketing authorization for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) under the FDA’s accelerated approval program. Related to that, Onxeo US partner Spectrum Pharmaceuticals has paid the $25 million milestone as planned by contract. Lymphoma is the most common blood cancer. In US, between 10 and 15% of non-Hodkin Lymphoma (one of the two types of Lymphoma) are PTCL with an incidence of 12 000 cases per year. Nowadays in Europe, no treatment is available for second line therapies, when the disease progress.

Following the New Drug Application approval, Spectrum Pharmaceuticals team has initiated Beleodaq promotion in August to key hematologists and has already generated about $2 million in sales for the 3rd quarter 2014, bringing the first royalty stream for Onxeo.

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“Beleodaq marketing authorization is a tremendous achievement from both teams, who have worked very closely and successfully managed to get this NDA significantly ahead of schedule”, comments Judith Greciet, CEO of Onxeo. “The milestone payment represents of course a large addition to our cash situation but also signs the fruitful collaboration between our two companies, both heading for the same goal, making Beleodaq a recognized product for its clinical value as well as its significant sales potential.”

Spectrum is a leader on the PTCL market thanks to its first product Folotyn, which made a $13M of turnover on the last trimestrial period. Onxeo has been wise to choose Spectrum as partner. They will directly benefit from the existing sales-force of the US company but also from an existing base of customers. Indeed, Folotyn and Beleodaq could be used together for the same patients. A clinical trial is also plan to show potential benefits of the combination. The last clinical results of Beleodaq showed, in 129 participant, that 25,8% of cancers have disappeared completely or partially. For other patients, the treatment has continued until progression of the disease or unbearable side-effects. These results seem to already convinced prescribers in US and could be a good way for Onxeo to assure its future. Indeed, the initial deal with spectrum, including an upfront payment of $30M, plan to give a total milestone amount of $320M plus royalties.

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