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Novavax/Esprit Androsorb deal

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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...

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Licensing In Brief

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)…

Novartis Blocks Sun’s Nilotinib Plans In India

Novartis thwarts Sun’s efforts to commercialize nilotinib in India, though the Indian firm indicates that its actions are covered under a local Bolar-type provision and that it has no plans to market the anticancer while the originator's patent stands valid.

QUOTED. 29 September 2020. Phil Brown.

ABHI’s Phil Brown believes the future of UK device regulation will be innovation-friendly and patient-responsive system – but doesn’t expect easy alignment with the EU. See what he had to say.





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