To NASDAQ OMX Copenhagen A/S
Announcement No. 22-11 / Copenhagen, December 7, 2011

Copenhagen, Denmark - December 7, 2011 - Topotarget A/S (NASDAQ-OMX: TOPO.CO) announced today that the company will initiate a reorganization of the company as a step to secure its own financing capabilities until expected significant milestone payments related to the belinostat development in PTCL.


After an extended period of high workload in preparation of the filing of an NDA with the FDA of belinostat for PTCL (peripheral T-cell lymphoma), Topotarget now enters a new phase of development.

Topotarget will take several actions to improve and narrow-in its strategic focus, streamline its organization and enable an adequate, cost-effective operational structure matching future tasks related to the late-stage clinical development and commercialization of belinostat.

The main elements in Topotarget's reorganization include:

  • Directing relevant developmental efforts and investments into the finalization of the PTCL pivotal study for belinostat and the subsequent NDA filing together with Topotarget's partner, Spectrum Pharmaceuticals, Inc.
  • Finalizing the randomized phase II CUP (cancer of unknown primary) study for belinostat
  • Continuing the clinical development of belinostat in solid tumour diseases, e.g. NSCLC (non-small cell lung cancer) and haematological cancer indications. These studies are run by Topotarget in collaboration with the NCI (National Cancer Institute, the US) and other entities
  • Investigating different strategic alternatives for the Totect-related operations in the US
  • Reducing the number of employees in Denmark equivalent to around 40% of current staff

Following the above-mentioned reorganization, the company is operationally and cost-wise fully focused on the further development and capitalization of belinostat for the benefit of Topotarget's shareholders. Topotarget's ongoing partnership with Spectrum Pharmaceuticals will not be influenced by the company's reorganization plans.

Topotarget will restructure its organization by reducing headcount in the areas of clinical development, data management and safety, as well as in administrative functions. However, Topotarget maintains its development capabilities regarding the ongoing further development of belinostat in oncology.

The above-mentioned adjustments are taken as a natural step to improve Topotarget's strategic focus, reduce costs, and ensure the company's continued focus on finalizing the late-stage pivotal clinical development study of belinostat in PTCL, the ongoing clinical study of CUP, as well as possible later relevant belinostat indications in oncology. This will allow for the potential commercialization of belinostat in order to optimize shareholder value. The development of belinostat in PTCL is conducted and finalized by Topotarget's strategic partner, Spectrum Pharmaceuticals.

"The reorganization of Topotarget is a proactive and necessary step in order to secure financing of the company's main activities with a view to meet Topotarget's future challenges and maintaining its strategic focus on developing and bringing belinostat to the market. Hence, these steps are appropriate and in the best interests of shareholders. We nonetheless deeply regret to have to let this number of appreciated employees go", says Francois Martelet, CEO of Topotarget.

Topotarget will immediately enter into relevant negotiations with work labour representatives concerning the coming redundancies of staff.

Financial implications, including revised expectations for 2011

The one-off costs related to the announced reorganization plans are estimated to total of approximately DKK 4.1 million of which DKK 3.6 million are expected to be accounted for in the fourth quarter of 2011 while the majority of the remaining one-off costs are expected to be accounted for in the first half of 2012. Topotarget's expected annual cost reductions as a result of the reorganization are projected to amount to approximately DKK 9 million as from 2012.

As a result of the above, Topotarget now expects an estimated pre-tax loss in the range of DKK 25-45 million for the full year financial result of 2011, compared to the latest announced expectations of DKK 20-40 million.

Topotarget expects to have net cash and cash equivalents of around DKK 110 million at year-end 2011.

Further, subject to a continued successful development of belinostat for PTCL, Topotarget expects to receive significant milestone payments from its partner, Spectrum Pharmaceuticals, related to the expected acceptance of an NDA filing, as well as the expected regulatory approval, respectively, by the FDA of belinostat for PTCL.

Conference call

Topotarget will host a conference call tomorrow, Thursday, December 8, 2011, at 14.00 (CET), at which management will present and highlight the company's reorganization plans in English. A presentation will be available on Topotarget's website, www.topotarget.com, at the start of the conference call. To participate in the conference call please dial:

From Denmark: +45 3272 7625

Outside Denmark: +45 3272 7625 or +44 (0) 1452 555 566 (UK) or +1 1631 510 7498 (US) or +46 0850 336 434 (SE)

Conference id: 34932211


Topotarget A/S
For further information, please contact:

Francois Martelet, CEO: Direct: +45 39 17 83 43; Mobile: +45 51 32 83 41
Anders Vadsholt, CFO: Direct: +45 39 17 83 45; Mobile: +45 28 98 90 55


Background information
About Topotarget

Topotarget (NASDAQ-OMX: TOPO.CO) is an international biopharmaceutical company headquartered in Copenhagen, Denmark, dedicated to clinical development and registration of oncology products. Topotarget focuses, in collaboration with Spectrum Pharmaceuticals, Inc., on the development in pivotal studies of its lead drug candidate, belinostat, which has shown positive results as a monotherapy treating haematological malignancies and positive results in solid tumours. Belinostat may be used in combination with full doses of chemotherapy, and is in a pivotal trial within PTCL (peripheral T-cell lymphoma). The company's first marketed product, Savene®/Totect® , was approved by EMEA in 2006 and the FDA in 2007, and is marketed by Topotarget's own sales force in the US. For more information, please refer to www.topotarget.com.

Topotarget Safe Harbour Statement

This announcement may contain forward-looking statements, including statements about our expectations of the progression of our preclinical and clinical pipeline including the timing for commencement and completion of clinical trials and with respect to cash burn guidance. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Topotarget cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors, including, but not limited to, the following: The risk that any one or more of the drug development programs of Topotarget will not proceed as planned for technical, scientific or commercial reasons or due to patient enrolment issues or based on new information from non-clinical or clinical studies or from other sources; the success of competing products and technologies; technological uncertainty and product development risks; uncertainty of additional funding; Topotarget's history of incurring losses and the uncertainty of achieving profitability; Topotarget's stage of development as a biopharmaceutical company; government regulation; patent infringement claims against Topotarget's products, processes and technologies; the ability to protect Topotarget's patents and proprietary rights; uncertainties relating to commercialization rights; and product liability exposure. We disclaim 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 law.