Date: 2014-11-13
Type of information: Milestone
Compound: Beleodaq® (belinostat)
Company: Topotarget (Denmark), now Onxeo (France) Spectrum Pharmaceuticals (USA - CA)
Therapeutic area: Cancer - Oncology
Type agreement: licensing
commercialisation
Action mechanism: Belinostat is a small molecule HDAC (histone deacetylase) inhibitor being investigated for its role in the treatment of a wide range of solid tumors and hematologic malignancies either as a single agent, or in combination with other active anti-cancer agents, including carboplatin, paclitaxel, doxorubicin, idarubicin, cis-retinoic acid, azacytidine, 5-FU, etoposide and bortezomib for injection. HDAC inhibitors represent a new mechanistic class of anti-cancer therapeutics that target HDAC enzymes, and have been shown to: Arrest growth of cancer cells (including drug-resistant subtypes); induce apoptosis, or programmed cell death; promote differentiation; inhibit angiogenesis; and sensitize cancer cells to overcome drug resistance when used in combination with other anti-cancer agents.
Disease: peripheral T-cell lymphoma
Details: * On October 7, 2013, Topotarget and Spectrum Pharmaceuticals announce an amendment to the companies\' existing License Agreement. Pursuant to the amendment, Spectrum Pharmaceuticals will carry the responsibility for the commercial manufacture of belinostat for a 5-year period with the possibility of renewal. In collaboration, Topotarget and Spectrum have made an amendment to the License Agreement dated February 2, 2010. The amendment entails a shift from Topotarget to Spectrum in the area of world-wide clinical, commercial, and Named Patient product supply. Henceforward, Spectrum carries the responsibility for the future manufacture of belinostat for all territories. The agreement has a term of 5 years with possibility for prolongation; alternatively Topotarget may, at its own choice, take over the responsibility of manufacturing belinostat in Topotarget\'s commercial territory. Spectrum\'s organizational and financial strengths and qualities (including company size, number of projects, area-specific experience, and in-house competencies) will benefit belinostat\'s supply chain and truly underline Topotarget\'s and Spectrum\'s confidence in belinostat\'s potential as a near-term anti-cancer treatment for patients with PTCL (peripheral T-cell lymphoma). This company announcement does not affect the filing of an NDA for belinostat in PTCL, which is still expected to take place in Q4 2013.
* On February 2, 2010, Spectrum Pharmaceuticals and Topotarget have entered into a co-development and commercialization agreement for belinostat. Under terms of the agreement, Spectrum licensed the rights to belinostat for North America and India, and an option for China, in exchange for an upfront cash payment of $30 million, potential milestone payments of up to $320 million, and one million shares of Spectrum common stock based upon the successful achievement of certain development, regulatory and commercial milestones, as well as double-digit royalties on net sales of Belinostat.
Financial terms:
Latest news: * On November 13, 2014, Onxeo, an innovative company specializing in the development of orphan oncology drugs, announced 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 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. 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. * On March 26, 2014, Topotarget has announced the receipt of the milestone payment of $ 10 million and 1 million shares from Spectrum Pharmaceuticals, related to the FDA recent acceptance to file Beleodaq® (belinostat) for peripheral T-cell lymphoma. The Spectrum Pharmaceuticals shares are expected to be sold within a non-disclosed time period. An additional milestone cash payment of $25 million from Spectrum Pharmaceuticals is triggered upon an NDA approval. Upon an approval, Topotarget will moreover be eligible to receive potential royalty payments and sales milestones.
