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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-SR’s 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 FDA’s approval of
Invega®
Sustennatm,
the first once monthly atypical antipsychotic injection.
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