Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

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...

You may also be interested in...



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)…

Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa

The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.

Partisan Politics Returns To US FDA Congressional Oversight

The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS003334

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel