Licensing In Brief
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Merck drops Pargluva partnership: Additional trials needed to support approval of Bristol-Myers Squibb's Pargluva (muraglitazar) type 2 diabetes treatment prompt Merck to drop out of its co-development partnership with BMS. Bristol remains in discussions with FDA about what clinical studies would be required to settle questions about the cardiovascular safety of the dual peroxisome proliferator-activated receptor agonist. Merck and Bristol announced FDA's "approvable" action, based on cardiovascular safety concerns, on Oct. 18. The firms subsequently determined that approval and commercial success would require additional trials that could take up to five years. Pargluva is not the first PPAR agent to succumb to safety issues: Novo Nordisk/Dr. Reddy's ragaglitazar and Merck/Kyorin's MK-0767 were discontinued in 2003 in Phase III due to animal carcinogenicity findings, and AstraZeneca pushed back a planned Galida (tesaglitazar) NDA to 2007 to gather longer-term safety data (1Pharmaceutical Approvals Monthly July 2005, p. 24)…
You may also be interested in...
Novavax/Esprit Androsorb deal
Esprit gains exclusive marketing rights to Novavax' female hypoactive sexual desire treatment Androsorb (topical testosterone emulsion) deal announced May 19. The pact marks the second license agreement for the companies. "The anticipated milestone and royalty payments from this new agreement will be similar in scope to our license agreement with Esprit" for the topical estradiol Estrasorb, Novavax says. The terms of the earlier agreement, announced in October 2005, called for Esprit to pay Novavax $12.5 mil., plus royalties and milestone payments (1Pharmaceutical Approvals Monthly October 2005, p. 11). Androsorb, which has completed Phase I, employs Novavax' micellar nanoparticle (MNP) delivery technology, which the firm says includes benefits such as stability at room temperature, long shelf life, preservative-free formulation and high drug payload...
AstraZeneca Discontinues PPAR Candidate Galida, Readies New Crestor Claim
AstraZeneca will discontinue development of its Phase III dual peroxisome proliferator-activator receptor agonist Galida due to safety concerns associated with the class, according to the company
PTI’s Oxytrex “Worth One More Shot” After Phase III Study Spoiled By Vioxx
Inappropriate enrollment of former Vioxx patients in Pain Therapeutics’ Phase III trial of Oxytrex for severe osteoarthritic pain undermined the study’s statistical power and necessitates a new trial, according to PTI.