BioWorld International Correspondent

Shares in TopoTarget A/S broke through the DKK30 barrier for the first time last week as investors welcomed news that the FDA had assigned priority-review status to the company's lead product, Totect, which is in development for extravasation following anthracycline chemotherapy.

With a review time of six months, the dossier, which was filed Jan. 31, could gain approval during the third quarter.

"If we don't have any clock-stop, it could be July 31 or Aug. 1. We expect some questions, of course," TopoTarget CEO Peter Buhl Jensen told BioWorld International.

The Copenhagen, Denmark-based company has not disclosed an anticipated launch date for the product, a topoisomerase II inhibitor, but it is in the process of preparing both U.S. and European sales plans.

"We expect to go and sell it ourselves in the U.S.," Jensen said. However, the company still is open to partnering discussions at this point, he added. It plans to hire a 15-person sales force to cover Europe, where the drug will be marketed as Savene. Analyst estimates put the combined value of the U.S. and European markets at $50 million annually, Jensen said.

TopoTarget's share price closed at DKK30.20 (US$4.97) April 12, up from the previous day's close at DKK29.50. The stock climbed higher Tuesday, when the Copenhagen Stock Exchange reopened following the Easter break, peaking at DKK32 during early morning trading, a 42 percent gain on the company's initial public offering price of DKK22.50 in June.

The company grossed around DKK259 million in that transaction and has no immediate plans to seek further investment. It held DKK298.3 million in cash and securities as of Dec. 31.

"We've got two years of runway now, including costs for launching the product," Jensen said.

It has an additional seven programs in the clinic, four of which are in Phase II trials. PXD101, a small-molecule histone deacetylase inhibitor (HDAC), which is the subject of an alliance with Branford, Conn.-based CuraGen, is undergoing five clinical trials in various cancer indications at present. It also will be the subject of an additional nine combination studies, under a clinical trials agreement between CuraGen and the National Cancer Institute.

TopoTarget also recently reported positive Phase II data on Avugane, a topical treatment for acne based on valproic acid, which is used as an epilepsy treatment. The company aims to partner that program, Jensen said, as it is outside its core cancer focus.

TopoTarget's stock (CSE:TOPO) closed Tuesday at DKK31.80, up 5.3 percent.