To NASDAQ OMX Copenhagen A/S
Announcement no. 23-13 / Copenhagen, 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 Pharmaceuticals (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).
“We are very happy to share this positive news with our shareholders. Spectrum has great experience and in-depth knowledge in this field and will be the first of our two companies to launch belinostat commercially. Hence, we only find it natural for them to take on this responsibility. Both belinostat and Topotarget will benefit from this and we are pleased that we will be able to positively utilize our partner’s strengths in this respect while maintaining the possibility of in time making belinostat available in our own territory”, says Anders Vadsholt, CEO of Topotarget A/S.
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.
For further information, please contact:
Anders Vadsholt, CEO – direct: +45 39178345
Topotarget (NASDAQ OMX: TOPO) is a Scandinavian-based biopharmaceutical company headquartered in Copenhagen, Denmark, dedicated to the clinical development and registration of oncology products. In collaboration with Spectrum Pharmaceuticals, Inc., Topotarget focuses on the development of its lead drug candidate, belinostat, which has shown positive results in the treatment of hematological malignancies and solid tumors, obtained by both mono- and combination therapy. For more information, please refer to www.topotarget.com.
Topotarget Safe Harbor Statement
This announcement may contain forward-looking statements, including statements about Topotarget A/S’ expectations to the progression of Topotarget A/S’ clinical pipeline and with respect to cash burn guidance. Such statements are subject to risks and uncertainties of which many are outside the control of Topotarget A/S, and which could cause actual results to differ materially from those described. Topotarget A/S disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by Danish law.