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The District Court of Rome in
Evotec AG said partnering discussions
are ongoing for its
lead product, EVT 201, for the treatment of insomnia. Although market
conditions are challenging, there is evidence of continued interest in
this
indication, said Jörn Aldag, the company’s president
and chief executive
officer, in a report on the 2008 first half. This interest is
illustrated by GlaxoSmithKline’s
decision in July to pay £66 million up-front to Actelion AG
of
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GPC Biotech AG is in merger and acquisition talks with a number of public and private oncology-focused companies following the failure of its cancer drug, satraplatin, to win regulatory support in Europe and the US.
“We are indeed in intense discussions on both sides of the Atlantic,” the company’s chief executive, Bernd Seizinger, told analysts in a conference call on 13 August 2008. He said the company has been “quite upfront” with potential partners about the recent regulatory setbacks. Despite this, all of the discussions are continuing.
The conference call was organised to discuss GPC’s first half results and to answer questions about satraplatin, the company’s lead product for the treatment of hormone-refractory prostate cancer.
Satraplatin had been under review at the US Food and Drug Administration and at the European Medicines Agency in London. But GPC withdrew the FDA application in 2007 and the EMEA application in July 2008 after being told the drug was not approvable on the basis of the available data. A key setback was a Phase 3 study which showed that satraplatin did not improve overall survival for patients with prostate cancer whose prior chemotherapy had failed.
On 6 August, 2008 GPC’s development partner, Celgene Corporation, ended its licensing agreement for satraplatin in Europe. GPC still has an agreement withYakult Honsha Co. giving that company exclusive commercialistion rights in Japan. But Dr Seizinger said the future of this deal is under discussion.
“We will meet with our colleagues at Yakult in the next few weeks after which we expect to have more clarity regarding the future of satraplatin. We will update the markets once we have made a final decision,” he commented.