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...
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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.... Nastech/P&G collaborate on osteoporosis nasal spray: Procter & Gamble payments to Nastech could reach $577 mil. under a collaboration to develop and commercialize parathyroid hormone (PTH1-34) nasal spray for osteoporosis treatment, announced Feb. 1. Nastech will grant P&G worldwide rights in exchange for a $10 mil. upfront fee, plus milestone payments and royalties. The deal calls for joint development with P&G reimbursement. The firms are gearing up for Phase III studies and anticipate submission of a 505(b)(2) NDA. Injectable PTH1-34 is currently approved for postmenopausal osteoporosis.... Eisai gains Prialt rights in Europe: Elan will retain U.S. rights to the intrathecal non-opioid analgesic Prialt (ziconotide) while licensing to Eisai European rights to the chronic pain agent. Announced Feb. 9, the deal will provide Elan with up to $100 mil. in cash, including $50 mil. at closing and $50 mil. based on milestones. The N-type calcium channel blocker gained European approval in February 2005. Prialt achieved $6.3 mil. in sales last year after a first-quarter U.S. debut; the agent received domestic approval in December 2004.... |