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FDA removes hurdle in Endocyte's path to drug approval

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Endocyte Inc. can start enrolling patients again in a clinical trial of its experimental cancer drug, the company announced Monday, clearing away a hurdle to getting the drug approved in Europe.

The change comes after the U.S. Food and Drug Administration OK’d the importation of the cancer drug Doxil from Europe. Supplies of the drug, made by New Jersey-based Johnson & Johnson, have been short since last fall due to equipment failures at one of Johnson’s suppliers.

Endocyte’s Phase 3 clinical trial aims to show that its drug, EC145, when given in combination with Doxil, is a better therapy for certain ovarian cancer patients than Doxil alone. But the West Lafayette-based drug company was forced to halt new patient enrollment last fall because of the worldwide shortage of Doxil.

“This supply is expected to support enrollment through the end of the year and will serve as a bridge to the availability of new supplies of Doxil,” said Endocyte CEO Ron Ellis in a prepared statement released Monday morning. “We also continue to explore alternatives for the resumption of enrollment outside the U.S.”

Endocyte had been planning to submit EC145 for market approval in Europe based on its Phase 2 clinical trial results, rather than the more customary wait for results of the lengthy Phase 3 it is now conducting.

The European Medicines Agency has indicated it is willing to give a conditional, early approval to EC145 because many ovarian cancer patients experience no benefit from traditional platinum-based chemotherapy or from Doxil.

But the European regulators wanted Endocyte to at least be enrolling patients in a Phase 3 trial—so they could later re-evaluate whether the drug should remain on the market.

The Doxil shortage had until now prevented the company from meeting that requirement.

In the United States, the FDA has told Endoycte it wants to see Phase 3 clinical trial results before considering approval of EC145.

The timing of getting a drug to market is important for Endocyte, which currently has no revenue but is operating on $142 million it raised in two public stock offerings last year.

The company has yet to release its year-end financial report, but in the 12 months ended Sept. 30, it burned through $32.8 million.

Some analysts expect EC145 to win European market approval in 2013, but others expect approval to be pushed back until after the completion of the Phase 3 trial, which could mean 2014 or even 2015.

Concerns of a delay spiked in December when Endocyte released additional data from its Phase 2 clinical trial, which showed shorter overall survival than patients taking Doxil alone.

Endocyte officials emphasized that the clinical trial was not designed—nor did it enroll enough patients—to demonstrate overall survival. Instead, it was geared to look at the length of progression-free survival patients experienced on EC145, and showed positive results.

Endocyte’s shares plunged nonetheless, and haven’t recovered since. They closed Friday at $3.49 apiece, although they rose slightly Monday morning after the announcement of the new supplies of Doxil.

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