Cardiome preparing to resubmit application for RSD1235 in early Q4

By Jennifer Lanning Drey

Eugene, Ore., Sept. 12 - Cardiome Pharma Corp. is finalizing its resubmission application to the Food and Drug Administration for RSD1235 (iv) and plans to re-file the documents early in the fourth quarter, said Doug Janzen, Cardiome's president and chief business officer, Tuesday at the Bear Stearns health care conference.

Cardiome received a "refusal to file" letter from the FDA in May in response to its original application for RSD1235. The company said previously the RTF reflected errors in the execution of the application, not the underlying data.

Prior to resubmitting its application, Cardiome's co-development partner, Astrellas Pharma US Inc., and a third party will each perform audits of the resubmission documents.

"Certainly after our surprise on the original RTF, we think it's prudent to take a three-levels-of-redundancy type of approach to re-filing this application," Janzen said Tuesday.

The intravenous form of RSD1235 is estimated to have a $300 million to $500 million market in North America, he said.

"We think 1235 will be approved and in the market in the back half of next year and generating revenues for Cardiome as we go through '07 and '08," Janzen said.

Focus on oral RSD1235

With RSD1235 nearly ready for resubmission in the intravenous form, Cardiome will shift its focus toward advancing RSD1235 in an oral form as a prophylactic treatment for patients with a high propensity for atrial fibrillation, Janzen said.

The company is preparing to receive final data from a 180-patient phase 2a clinical trial of the oral drug, which consisted of 300 mg and 600 mg cohorts. Interim data from the study found that 61% of patients in the 300 mg cohort demonstrated normal heart rhythm through the end of the study, versus 37% of placebo patients, he said.

The study also found the drug to be well-tolerated.

"The data was strong at the interim look," Janzen said.

Following a review of the full trial data, Cardiome plans to begin a phase 2b study. Although plans for the study have not yet been finalized, Janzen said the company hopes the study will begin late this year or in early 2007.

Cardiome is a cardiovascular drug development company based in Vancouver, B.C.

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