It's just gonna be dilutive- ACOR will likely raise some cash to further their pipelines.
Interesting about Fampridine-
Fampridine-SR
Our lead product candidate, Fampridine-SR, is a small molecule drug contained in a sustained release tablet form. Laboratory studies have shown that fampridine, the active ingredient in Fampridine-SR, improves impulse conduction in nerve fibers in which the insulating outer layer, called the myelin sheath, has been damaged. This damage is caused by the body's own immune system in MS. We believe that Fampridine-SR is the first potential therapy in late-stage clinical development for MS that seeks to improve the function of damaged nerve fibers and, if approved, could be complementary to existing drugs used to treat MS. To our knowledge, there are no current therapies indicated to improve walking in people with MS.
On January 30, 2009, we announced the submission of an NDA to the FDA for Fampridine-SR. The Fampridine-SR NDA submission is based on data from a comprehensive development program assessing the safety and efficacy of Fampridine-SR, including two Phase 3 trials that involved 540 people with MS and were conducted under Special Protocol Assessments (SPAs) from the FDA. The safety and efficacy profile of Fampridine-SR was consistent across Phase 2 and Phase 3 trials. Overall, the NDA filing included more than 50 clinical studies of Fampridine-SR. As of June 30, 2009, 177 subjects from our Phase 2 clinical trial had been enrolled in an extension trial and 84, or approximately
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47%, remained active in the trial, with duration of treatment of active patients ranging from 3.4 to 5.3 years. As of the same date, 269 patients from our first Phase 3 clinical trial had been enrolled in a separate extension study and 180 of these, or approximately 66.9%, remained active, with duration of treatment of active patients ranging from 1.1 to 3.6 years. Also, as of this same date, 214 patients from our second Phase 3 clinical trial had been enrolled in a third extension study and 176, or approximately 82%, remained active, with duration of treatment of active patients ranging from 14.3 months to 22.4 months. The total exposure to Fampridine-SR in our MS studies as of June 30, 2009, including both double-blind and open label studies, is approximately 1,750 patient-years.
Following a resubmission of the NDA in April 2009, to correct certain format issues and to provide additional supporting information requested by the FDA following our initial submission, the FDA accepted our NDA for filing in May 2009 and assigned it priority review and a Prescription Drug User Fee Act (PDUFA) date of October 22, 2009. The PDUFA date is the target date for the FDA to complete its review of the NDA for Fampridine-SR. On October 14, 2009, we submitted additional information on our proposed REMS program. The FDA accepted this submission as a solicited major amendment to the Fampridine-SR NDA and, on October 21, 2009, extended the PDUFA date for its review of the NDA for Fampridine-SR to January 22, 2010.
In June 2009, the EMEA determined that Fampridine-SR is eligible to be submitted for a centralized MAA and designated Fampridine-SR an NAS. If approved, compounds designated as NAS receive a 10-year market exclusivity period in European Union member states.
In June 2009, we also entered into an exclusive collaboration and license agreement with Biogen Idec International GmbH (Biogen Idec), a Swiss subsidiary of Biogen Idec Inc., to develop and commercialize Fampridine-SR in markets outside the U.S. (the Collaboration Agreement). Under the Collaboration Agreement, Biogen Idec was granted the exclusive right to commercialize Fampridine-SR and other products containing aminopyridines developed under that agreement in all countries outside of the United States. Biogen Idec will have responsibility for regulatory activities and future clinical development of Fampridine-SR in ex-U.S. markets worldwide. We also entered into a related supply agreement pursuant to which we will supply Biogen Idec with its requirements for the licensed products. On January 12, 2010, Biogen Idec Inc. submitted an MAA to the EMEA and a New Drug Submission (NDS) to Health Canada for Fampridine. Prolonged Release (Fampridine-PR; called Fampridine-SR in the U.S. and Canada) tablets.
Under the Collaboration Agreement, we received an upfront payment of $110 million on July 1, 2009 and will be entitled to receive additional payments of up to $400 million based on the successful achievement of future regulatory and sales milestones. Under the Collaboration Agreement, we will also be entitled to receive double-digit tiered royalties on sales of licensed products by Biogen Idec, its affiliates or certain distributors outside of the United States. As a result of our receipt of the initial payment from Biogen Idec, we paid Elan a royalty of $7.7 million on July 7, 2009. The submissions do not entitle us to any milestone payments under the Collaboration Agreement.
