Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

SmithKline Beecham

This article was originally published in The Tan Sheet

Executive Summary

Obtains exclusive U.S. and Canadian OTC marketing rights for Avanir Pharmaceuticals' 10% docosanol cream for herpes cold sores. In the first 12 months of the agreement, SmithKline will pay Avanir up to $25 mil., comprising an upfront licensing fee and milestone payments tied to product launch and sales performance. Avanir also will receive royalties on product sales. Avanir, which expects FDA action on its NDA by June 3, does not believe the agency's recent draft guidance disfavoring use of OTC antiviral treatments for herpes labialis will hinder agency approval because docosanol uses a different mechanism than the drugs FDA cited (1"The Tan Sheet" March 13, p. 3). The San Diego-based firm plans to initiate the OTC approval process in Canada this summer
Advertisement

Related Content

Topics

Advertisement
UsernamePublicRestriction

Register

PS091078

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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