Pharmion plans to resubmit its European application for thalidomide for the treatment of multiple myeloma with data from two ongoing clinical studies.

"What we're really doing with the EMEA is taking a breather," Pharmion CEO Patrick Mahaffy said during a May 20 conference call. "We've been trying to get this drug approved on the current data set for about two years."

The amended thalidomide application is expected to include data from a 400-patient survival study evaluating two doses of thalidomide in relapsed/refractory multiple myeloma; Pharmion expects to complete trial registration by the third quarter.

Pharmion will also submit data from a 436-patient time-to-progression trial evaluating thalidomide plus dexamethasone versus dexamethasone alone in newly diagnosed patients. Enrollment should finish by the first quarter of 2005, the company said.

Pharmion noted that this study could support labeling for first-line therapy. "Our hope would be that our re-submission would include an expanded label," Chief Operating Officer Judith A. Hemberger, PhD, said.

Mahaffy indicated the decision to withdraw the application was not based on any safety concerns at the European Medicines Evaluation Agency.

"While they're very supportive of our continuing named patient sales and they're increasingly supportive of our" planned risk management program, "it felt better for us to take a break and go back with the data set," Mahaffy said.

Pharmion also has an application pending for use of thalidomide to treat cutaneous manifestations of erythema nodosum leprosum, a condition association with leprosy. That application is not affected by the multiple myeloma withdrawal, the company said.

Pharmion in-licensed European and certain Asian thalidomide marketing rights from Celgene in November 2001. It is available in Europe on a compassionate use basis.

Celgene has a supplemental NDA pending at FDA for the treatment of multiple myeloma (under the name Thalomid ).with an estimated user fee date in October 2004, according to F-D-C Reports' The NDA Pipeline. The drug has been approved in the U.S. since 1998 for leprosy.

Pharmion may use data from Celgene's U.S. filing to support its EMEA resubmission. "We are evaluating whether that study will be useful to us," Mahaffy said.

The thalidomide decision was announced on the same day that Pharmion's Vidaza was approved for myelodysplastic syndromes (¹ Also see "Pharmion Vidaza To Be Launched By July 1 For Bone Marrow Disorder" - Pink Sheet, 19 May, 2004.).

- Lee Kalowski

Pharmion European Thalidomide Application For Multiple Myeloma Withdrawn; Resubmission Planned

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