BioWorld International Correspondent

TopoTarget A/S is gearing up to launch Totect (dexrazoxane) in the U.S. before year-end, following FDA approval of the product for the prevention of tissue damage resulting from extravasation or accidental leakage of anthracyclines during intravenous chemotherapy procedures.

Approval had been delayed by two successive approvable letters, prompted by questions concerning its manufacture. Those have been dealt with, and a 10-person sales force, in place since July 1, will be responsible for promoting the product in cancer treatment centers in the U.S.

Oncology nurses will be an important part of the target audience. "In the U.S., especially, the administration of the chemotherapy, the anthracyclines, is in the hands of nurses - more than in Europe," TopoTarget CEO Peter Buhl Jensen told BioWorld International.

The U.S. label contains one "subtle difference" from its European Union counterpart, he said. It allows for treatment of lesions that result from the use of catheters for the delivery of anthracyclines, reflecting the higher frequency of use of that delivery method in the U.S.

The product was launched as Savene in Europe in October 2006, and Copenhagen, Denmark-based TopoTarget recently reported sales of DKK8.3 million (US$1.5 million) for the first half of 2007. The company estimates the total addressable market in the U.S. and Europe is worth between €40 million (US$55.3 million) and €50 million, Jensen said.

It will take around three years to attain peak sales, he said, although in some markets the ramp-up may be slower. "It's clear we're paying more than we're earning in 2007 - there's no doubt about that," Jensen said.

The product has been launched successfully in Germany, the Benelux region and in Scandinavia, Jensen said. Reimbursement discussions are under way in France, and the company is promoting the product among the clinical community in the UK, although it has been sold into individual cancer centers there. In the U.S., the product will cost $15,000 per kit. Current treatment of the problem can require surgical removal of damaged tissue, followed by plastic surgery and rehabilitation, TopoTarget said.

TopoTarget aims eventually to in-license additional niche cancer products for promotion via its sales infrastructure, which, Jensen said, will be an asset during partnering negotiations.

It also hopes to gain co-commercialization rights for part of its proprietary pipeline, including the histone deacetylase (HDAC) inhibitor belinostat, which is in multiple Phase II clinical trials in hemotologic and solid tumors. However, any such moves are still some time off.

"We definitely need to get this on the shelf first," Jensen said.

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