MARION MERRELL DOW TO FILE DILTIAZEM/ENALAPRIL COMBO NDA BY MID-1994
Executive Summary
MARION MERRELL DOW TO FILE DILTIAZEM/ENALAPRIL COMBO NDA BY MID-1994 after licensing the calcium channel blocker/angiotensin- converting enzyme (ACE) inhibitor combination from Merck June 23, MMD said. The once-a-day tablet, developed by Merck under license from Alza, combines diltiazem malate, a variation of the active ingredient of Marion Merrell Dow's Cardizem (diltiazem HCl), and enalapril maleate, the active ingredient in Merck's Vasotec. The combo is in Phase III for second-line treatment of hypertension. "Physicians prescribe ACE inhibitors and calcium channel blockers together for the treatment of hypertension in an estimated 10%-15% of the patients using either class of drugs," Marion Merrell Dow said. The Alza delivery system used for the product is patented through 2006, MMD said, and Merck's enalapril patent runs until 2000. There is no product patent for diltiazem malate. MMD also has licensed Merck's once-a-day single-agent diltiazem malate product. Like the combo, single-agent diltiazem malate was developed under license from Alza and is in Phase III clinical trials with an NDA filing slated for mid-1994. MMD already markets a once-a-day diltiazem, Cardizem CD. The company said it plans to market the Merck/Alza drug as well, citing a longer patent life. Marketing exclusivity for Cardizem CD expires at the end of 1994. Immediate-release diltiazem HCl lost its exclusivity in November 1992. "Merck licensed the products to Marion Merrell Dow so that it can concentrate its development efforts on numerous other products it currently has in the late stages of development," Merck said. Marion Merrell Dow said the agreement is "in line with" its efforts to "refocus its search and licensing efforts toward products in later stages of development." Terms of the deal were not disclosed. "Pending completion of clinical trials and regulatory approvals, Marion Merrell Dow plans to market the products in the U.S. and selected other markets," MMD said.