BioWorld International Correspondent

BRUSSELS, Belgium - EuroGen Pharmaceuticals Ltd. dropped its European application for marketing authorization for Orathecin (rubitecan) in pancreatic cancer. It formally notified the European medicines agency of its decision Jan. 19, and the agency announced the withdrawal on Jan. 23.

The move follows the Jan. 5 withdrawal of a parallel U.S. application for Orathecin by SuperGen Inc., EuroGen's parent. The FDA had indicated that the supporting data for the application were insufficient. Orathecin is a topoisomerase I inhibitor extracted from the bark and leaves of China's Camptotheca acuminata tree.

EuroGen submitted its European marketing authorization application for treatment of patients with advanced or metastatic pancreatic cancer July 1, 2004, and the product had been under review by the agency's committee for medicinal products for human use. But after reviewing the data submitted, the committee recently signalled to EuroGen that it did not consider the data presented sufficient to demonstrate a clinical benefit for Orathecin.

Back in June 2003, EuroGen was granted orphan designation for the product, entitling it to concessionary rates for pre-approval scientific advice and for evaluation fees - and to a 10-year market exclusivity if approved. The European committee for orphan medicinal products found that the product could be of significant benefit to those affected by pancreatic cancer.

When it submitted the European application, EuroGen estimated the incidence of pancreatic cancer in the EU at about 0.7 per 10,000 persons - an incidence almost identical to that of the U.S. This, EuroGen calculated, would give an estimated advanced pancreatic market of 31,500 newly diagnosed patients per year among the EU population of 450 million.

When SuperGen announced the withdrawal of the U.S. application, it said it planned to keep trying for European approval of Orathecin. James Manuso, president and CEO of SuperGen, said at the time he expected European regulators to take a clinical rather than statistical approach to the data, and he hoped they would favorably assess what he termed "the limited but very real clinical benefit inherent in this drug."

The company's European decision was announced by the European medicines agency rather than by the company itself. It is the first publication of a withdrawal under the revised European Union pharmaceutical legislation, which came into force this year, and aims to bring a new degree of transparency into what companies and authorities are doing on high-technology medicines.

A European medicines agency statement on Jan. 23 - just as the agency's committee for medicinal products for human use convened for its monthly meeting in London - pointed out that "withdrawal of an application does not prejudice the possibility of a company to make a new application at a later stage." The agency also said that it would publish a "question-and-answer" document, together with the company's letter of withdrawal, after the committee meeting ends Jan. 26.

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