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Focalin XR

Novartis AG

Drug Names(s): dexmethylphenidate, d-isomer of methylphenidate, Focalin LA

Description: Focalin XR is an extended release version of Focalin. Focalin XR uses the proprietary SODAS (Spheroidal Oral Drug Absorption System) technology developed by Elan Corporation, where 50% of the dose is released immediately and the remaining 50% is released after approximately four hours, resulting in a maximum peak at about 1.5 hours and a second peak at about 6.5 hours.

Focalin (dexmethlyphenidate hydrochloride) contains only the effective d-isomer, and is a refined form of Ritalin (d,l-thero-methlyphenidate hydrochloride), which provides similar efficacy and a favorable side effect profile at half the Ritalin milligram dosage. It exerts its effects by blocking the reuptake of dopamine and norepinephrine.

Deal Structure: Celgene entered into an agreement with Novartis in April 2000 in which the company granted to Novartis an exclusive license (excluding Canada) for the development and marketing of Focalin. Celgene received a $10 million upfront payment in July 2000, a $5 million milestone payment in December 2000 and a $12.5 million milestone payment in November 2001. Celgene is currently selling Focalin to Novartis as well as receiving royalties on all of Novartis' Ritalin family of ADD- and ADHD-related products.

Focalin XR is manufactured for the US market by Elan.

Elan and Alkermes
In May 2011, Alkermes and Elan announced the execution of a definitive agreement under which Alkermes will merge with Elan Drug Technologies (EDT), the drug formulation and manufacturing business unit of Elan, in a cash and stock transaction currently valued at approximately $960 million. Alkermes and EDT will be combined under a new holding company incorporated in Ireland. This newly created...See full deal structure in Biomedtracker

Partners: Celgene Corporation Alkermes plc

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