To NASDAQ OMX Copenhagen A/S
Announcement no. 20-13 / Copenhagen, August 8, 2013
On August 7, 2013, Spectrum Pharmaceuticals announced that the filing of the New Drug Application (NDA) for belinostat in peripheral T-cell lymphoma (PTCL) has been postponed to Q4 2013. The postponement changes Topotarget’s financial outlook for the year.
In relation to the release of Spectrum Pharmaceuticals’ interim report for Q2 2013, Spectrum Pharmaceuticals announced that the filing of the NDA for belinostat in PTCL in the US has been postponed to Q4 2013. This delay causes a postponement of the first milestone payment from Spectrum Pharmaceuticals and hence changes Topotarget’s financial outlook for the year; Topotarget now expects an estimated pre-tax loss in the range of DKK 46-51 million for the full-year financial result for 2013 (compared to the previous outlook which was a pre-tax profit DKK 49-54 million). The expected net cash and cash equivalents will be around DKK 22-27 million at year-end 2013 (compared to the previously estimated DKK 114-119 million). Topotarget is entitled to receive 1 million shares in Spectrum Pharmaceuticals and a USD 10 million milestone upon acceptance to file by the US Food & Drug Administration (FDA). Topotarget is moreover entitled to receive a milestone cash payment in the form of USD 25 million upon approval of the NDA by the FDA. The first milestone is expected during Q1 2014 and the second during H2 2014.
The reason for this postponement is that a pre-NDA meeting has taken place at which the FDA was specific as to what kind of information and which data format should be included in the belinostat NDA. The pre-NDA meeting was requested as it is essential for Topotarget and Spectrum Pharmaceuticals to submit an NDA of high quality. Our companies have therefore been in continuous dialogue with the FDA in order to align expectations and demands. Topotarget is cooperating with Spectrum Pharmaceuticals in order to facilitate the process as diligently as possible. At this point, the NDA is being fine-tuned in order to ensure a smooth way forward.
Topotarget A/S
For further information, please contact:
Anders Vadsholt, CEO: Direct: +45 39178345 – Cell: +45 28989055
Background information
About Topotarget
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.
