EURO-PARTNER TO FUND CHEMGENEX FLYING SOLO IN THE US
April 19th 2009 07:23
Friday April 17, 2009
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CHEMGENEX
Chemgenex chief executive officer Dr Greg Collier says the company will market omacetaxine for drug-resistant leukemia in the US, while licencing it out in Europe.
In a telephone conference, Dr Collier told Biotech Daily that he wanted to “hold onto as much value as we can”.
“We want to book our own sales … find the patients ourselves and sell the drugs ourselves in the US,” Dr Collier said.
He said omacetaxine was initially targeted at the $US336 million market of chronic myeloid leukemia patients with the T315I mutation who are resistant to Gleevec.
Dr Collier and the company’s chief medical officer Dr Adam Craig said the phase II/III was fully-enrolled with submissions to the US Food and Drug Administration and the European Medicines Agency expected in the middle of 2009 for approval early in 2010.
Dr Collier said new data from the trial would be presented in May and June this year and he expected an “increased news flow” during the course of the year.
Dr Collier said omacetaxine had a novel mechanism of action allowing it to be used with existing drugs, but it was important that omacetaxine had shown that it could kill chronic myeloid leukemia stem cells.
“We want to get the drug on the market as soon as possible for patients with the T315I mutation which will generate significant revenues in the near term,” Dr Collier said.
Dr Craig said Chemgenex had a successful pre-new drug application meeting with the FDA in March 2009 and several parts of the application had already been filed.
He said the company would meet with the European Medicines Agency by the end of June 2009. Dr Craig said the FDA required “durable responses and our responses are durable”.
He said the mean duration of complete haematological response was 11.5 months and one patient was in the third year of treatment.
Dr Craig said omacetaxine could be taken by patients at home and did not have adverse events associated with many cancer treatments.
He said omacetaxine did not result in hair loss or nausea and vomiting.
Dr Collier said omacetaxine was also in trials for myelodysplastic syndrome and acute myeloid leukemia.
Chemgenex fell one cent or 2.17 percent to 45 cents.
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