This excerpt taken from the ELN 20-F filed Feb 28, 2007.
Dr. Garo Armen
In relation to Dr. Armens retirement from the board on May 25, 2006, we agreed to vest on his retirement 25,000 options that would otherwise have expired unvested on his retirement date, and extended the exercise term of 50,000 options from ninety days to one year post-retirement.
This excerpt taken from the ELN 20-F filed Mar 30, 2006.
Dr. Garo Armen
In relation to Dr. Garo Armens retirement from the board, we have agreed to vest on his retirement 25,000 options that would otherwise have expired unvested on his retirement date, and have extended the exercise term of 50,000 options from ninety days to one year post-retirement.
In August 2000, we entered into a development and marketing collaboration agreement with Biogen Idec, successor to Biogen, Inc., to collaborate in the development and commercialization of Tysabri. Along with Biogen Idec, we are developing Tysabri for multiple sclerosis (MS) and Crohns disease, with Biogen Idec acting as the lead party for MS and Elan acting as the lead party for Crohns disease.
In November 2004, Tysabri received regulatory approval in the United States for the treatment of relapsing forms of MS. Biogen Idec paid us a $7.0 million approval-based milestone. The approval milestone payment, together with other milestone payments related to the collaboration agreement of $45.0 million, are recognized as revenue based on the percentage-of-completion method, which is based on the percentage of costs incurred to date compared to the total costs expected under the contract.
Biogen Idec manufactures Tysabri. We purchase Tysabri from Biogen Idec for distribution to third parties in the United States. We recorded $11.0 million in product revenue from Tysabri in 2005 (2004: $6.4 million). In general, we share with Biogen Idec most development and commercialization costs. At December 31, 2005, we owed Biogen Idec $21.4 million (2004: $34.4 million) for the reimbursement of costs related to development and commercialization.
In February 2005, Elan and Biogen Idec voluntarily suspended the marketing and dosing in clinical trials of Tysabri. This decision was based on reports of two serious adverse events, one of which was fatal, in patients treated with Tysabri in combination with Avonex® in clinical trials. These events involved two cases of PML, a rare and potentially fatal, demyelinating disease of the central nervous system. Both patients received more than two years of Tysabri therapy in combination with Avonex. In March 2005, the companies announced that their ongoing safety evaluation of Tysabri led to a previously diagnosed case of malignant astrocytoma being reassessed as PML, in a patient in an open label Crohns disease clinical trial. The patient had received eight doses of Tysabri over an 18-month period. The patient died in December 2003.
Subsequent to the voluntary suspension, Elan and Biogen Idec performed a comprehensive safety evaluation of more than 3,000 Tysabri patients in collaboration with leading experts in PML and neurology. The results of the safety evaluation, which was completed in September 2005, identified no new confirmed cases of PML beyond the three previously reported.
In September 2005, Elan and Biogen Idec submitted to the FDA a supplemental Biologics License Application (sBLA) for Tysabri, which the FDA subsequently designated for Priority Review. On March 7-8, 2006, the Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee of the FDA reviewed and voted unanimously to recommend that Tysabri be reintroduced as a treatment for relapsing forms of MS. On March 21, 2006, we and Biogen Idec were informed by the FDA that the agency would extend its regulatory review of Tysabri by up to 90 days in order to complete a full review of the Tysabri risk management plan. Under the revised timeline, we anticipate an action from the FDA about the reintroduction of Tysabri as a treatment for relapsing forms of MS on or before June 28, 2006.
Elan Corporation, plc
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Our business is organized into two business units: Biopharmaceuticals and EDT. Biopharmaceuticals engages in research, development and commercial activities and includes our activities in the areas of autoimmune diseases, neurodegenerative diseases and our specialty business group. EDT focuses on product development, scale-up and manufacturing to address drug optimization challenges of the pharmaceutical industry.