Vion planning commercialization strategy for Cloretazine in acute myelogenous leukemia

By Jennifer Lanning Drey

Eugene, Ore., May 31 - Vion Pharmaceuticals, Inc. has developed a launch plan that includes initial targeting, pricing and competitive positioning for Cloretazine (VNP40101M) in acute myelogenous leukemia, said Meghan Fitzgerald, chief business officer for Vion, in a company conference call held Wednesday.

"Vion, by focusing on the market opportunity for Cloretazine and addressing it early in the pre-launch phase, is taking care of its primary asset in the best possible way. This should be reflected down the road in value to our shareholders," Fitzgerald said during the call.

Cloretazine, the company's lead anticancer agent, is being evaluated in two pivotal trials for acute myelogenous leukemia, but the company does not expect to have a commercial product before 2008.

"We are now continually analyzing our various commercialization options and also taking the important early steps necessary to ensure the best product launch in the United States if Cloretazine is approved," Alan Kessman, president and chief executive officer of Vion, during the call.

The company also announced on Wednesday that it is planning to meet with the European Medicines Agency this year to discuss requirements for registering Cloretazine in the European Union.

"We believe this could be an important step in the establishment of a commercialization partnership in the European Union," Fitzgerald said.

The company will hold an advisory board meeting with leading European leukemia physicians at the Annual Congress of the European Hematology Association meeting in Amsterdam in June.

New Haven, Conn.-based Vion is also actively pursuing partners in other parts of the world and expects the process to accelerate after it establishes and meets the requirements for foreign registration, Fitzgerald said.

"Whether we commercialize Cloretazine in the United States or chose a partner, we are doing the necessary work to ensure a successful product launch," Fitzgerald said during the call.

The company believes that, if approved, Cloretazine is likely to become a widely used drug for treating acute myelogenous leukemia.

"The standard care for AML has changed little over the last 30 years, and the life expectancy of patients who are diagnosed with this disease has changed very little as well over this time period. Furthermore, there are some patients with AML that have very few commercially available treatment options," said Kessman during the call.

Vion began a phase 2 clinical trial of Cloretazine in elderly patients with previously untreated de novo acute myelogenous leukemia last week.

The trial is expected to be conducted in more than 20 North American and European sites. Accrual of 85 patients is expected to take about one year.

Cloretazine is also being evaluated in a pivotal phase 3 trial in combination with cytarabine (Ara-C) for the treatment of patients of any age with relapsed acute myelogenous leukemia.

There are more than 140 patients enrolled in the study, which is now open in 65 sites in North America and Europe, according to a company news release.

An interim analysis is planned when 210 patients have been evaluated for response, which is expected to be in the second half of 2006. The trial is designed to accrue 420 patients in total, which Vion expects to be completed in 2007, according to the release.

Cloretazine in other indications

Vion is also conducting phase 2 trials of Cloretazine in small cell lung cancer and a phase 1 trial of the drug in combination with temozolomide in advanced hematologic toxicity.

The company expects to have preliminary data from the small cell lung cancer trial by the end of the year.

The company discontinued trials of the drug in chronic lymphocytic leukemia, which will help it to conserve cash and personnel resources, while focusing on other ongoing trials, Kessman said.

As of March 31, Vion had cash of $46.6 million, which the company expects to be sufficient until halfway through 2007, he said.

Second clinical anticancer compound

Triapine, Vion's second clinical anticancer compound, is also being evaluated in several clinical trials sponsored by the National Cancer Institute.

Since the program began, 13 studies have been conducted and five are ongoing. In addition, up to five studies are currently planned to begin in coming months, including an oral formulation and Triapine as a radio-sensitizer, according to a company press release.

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