This excerpt taken from the ELN 6-K filed Aug 28, 2009.
Elan Drug Technologies Business Update
Revenue from the EDT business unit decreased slightly to $138.6 million in the first half of 2009 from $139.1 million in the first half of 2008. EDT revenues vary from period to period based on a number of factors including the timing of customer orders, licence fees earned, and contracted in-market sales hurdles for royalties.
Included within the revenue for the first half of 2009 is a licence fee of $7.7 million due from Acorda Therapeutics, Inc (Acorda) as a result of Acorda entering into an agreement with Biogen Idec Inc. (Biogen Idec) to develop and commercialise Fampridine-SR in all territories outside the United States. Acorda paid this license fee to us in July 2009.
Our EDT business continued to make positive progress on the development pipeline with its clients during the first half of 2009. Acorda completed its Phase 3 clinical development programme to assess Fampridine-SRs safety and efficacy in improving the walking ability of people with MS. A New Drug Application (NDA) for Fampridine-SR was submitted to the U.S. Federal Drug Administration (FDA) on 23 April 2009 and subsequently received priority review status with a scheduled Prescription Drug User Fee Act (PDUFA) date of 22 October 2009. The PDUFA date is the target date for the FDA to complete its review of the Fampridine-SR NDA. Fampridine-SR incorporates our proprietary MXDAStm (Matrix Drug Absorption System) technology and is a sustained-release tablet formulation of the investigational drug fampridine (4-aminopyridine or 4-AP) and will be manufactured by EDT if it is approved.
On 3 August 2009, EDT announced the first approval of a long-acting injectable formulation using its proprietary NanoCrystal technology. This follows the announcement by Janssen, a division of Ortho-McNeil-Janssen Pharmaceuticals, of the FDAs approval of Invega® Sustennatm, the first once monthly atypical antipsychotic injection.