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

Licensing In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Impax to promote Shire's Carbatrol: Impax will kick-start its brand pharmaceutical business by promoting Shire's epilepsy treatment Carbatrol (carbamazepine extended-release) in the U.S., beginning in July, under a Jan. 19 agreement. Announced in conjunction with settlement of the firms' Adderall XR patent suit, the Carbatrol pact calls for Impax to detail the latter agent in the U.S. for three years. The "general framework of the [Carbatrol] agreement calls for Impax to receive approximately $40 mil." plus performance-based incentives based on prescription growth, Impax says. Impax expects Carbatrol to help the firm achieve promotion synergies in the central nervous system field as it awaits FDA approval sometime this year for its Vadova (carbidopa/levodopa) Parkinson's treatment. The Adderall XR (amphetamine salts) settlement allows Impax to bring a generic of the Shire attention-deficit hyperactivity disorder drug to market by at least 2010 - almost a decade before expiration of exclusivity. Shire remains in litigation with Barr, which also has filed an ANDA for generic Adderall XR. No trial date has yet been set for Shire's suit against Barr. Teva and Colony also have filed ANDAs for generic Adderall XR, but Shire has not announced plans to sue...

You may also be interested in...



FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011

September 2010 Approvals

Product

Provenge Paradox Sparks New Thinking About Immunotherapy Trials, Clinical Care

The paradoxical finding that Dendreon's cancer immunotherapeutic Provenge (sipuleucel-T) improved overall survival in men with metastatic castration-resistant prostate cancer but did not appear to slow the progression of the disease is raising questions about the future of clinical development for the burgeoning class

Topics

UsernamePublicRestriction

Register

LL1132098

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