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Pfizer Inc.

Drug Names(s): Zerene (EU), Zaleplon

Description: Sonata (zalepon) is a pyrazolopyrimidine derivative hypnotic, whose chemical structure is unrelated to benzodiazepines or other known hypnotics. Sonata interacts with the GABA-BZ receptor complex which is thought to be responsible for the sedative, anxiolytic, muscle relaxant and anticonvulsive properties of the benzidiazepines. Since Sonata is selective for the BZ(1) receptor, it causes minimal effects associated with the BZ(2) receptor, such as interference with memory, cognition and psychomotor function.

Sonata is rapidly absorbed, reaching peak plasma concentrations within 1 hour after oral administration. It has an average elimination half-life of 1 hour, which makes it an ideal drug for problems with sleep onset. The pharmacokinetics of Sonata are not altered in the elderly and do not differ according to gender or renal function.

Deal Structure: Sonata was originally launched by Wyeth in1999. In December 2001, Wyeth and Elan announced a strategic alliance to develop and commercialize novel therapeutics for the treatment of sleep disorders. Under the terms of the alliance, AHP is contributing the U.S. marketing rights to Sonata. This alliance expects to benefit from an expected patent extension from the FDA for Sonata's existing formulation to 2008. As part of the alliance, Elan will contribute its proprietary drug delivery technologies to develop new formulations of Sonata. Elan will also be responsible for the marketing, sales and distribution of Sonata in the U.S. AHP will continue to promote the original formulation of Sonata to psychiatrists in the U.S. and will retain all rights overseas. Financial terms of the agreement were not disclosed.

In January 2003, Elan agreed to sell its primary care franchise (principally its rights toSonata and Skelaxin and related rights to enhanced formulations) to King...See full deal structure in Biomedtracker

Partners: Perrigo Company PLC Mylan Inc.

Sonata News

Pink Sheet Wyeth-Ayerst Sonata

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