Elan Pays Transition Therapeutics $9 Million in Amended Deal for Phase II Candidate
Transition Therapeutics Inc. recently announced the company and Elan Corporation, plc have mutually agreed to modify their collaboration agreement for the development and commercialization of ELND005. Under the terms of the modification, in lieu of a contractually required Phase III milestone payment, Transition will receive from Elan a payment of $9 million at the time of signing and will be eligible to receive an $11 million payment upon the commencement of the next ELND005 clinical trial. Transition also will be eligible to receive up to an aggregate of $93 million in additional regulatory and commercial launch-related milestone payments plus tiered royalties ranging from 8% to 15% based on net sales of ELND005 should the drug receive the necessary regulatory approvals for commercialization.
As the agreement is now a royalty arrangement, Transition will no longer fund the development or commercialization of ELND005 and will relinquish its 30% ownership of ELND005 to Elan.
Based on studies in preclinical models of Alzheimer’s disease, ELND005 is believed to inhibit the aggregation (clumping) of amyloid-beta proteins in the brain, thereby neutralizing the toxic effects of these aggregates on nerve cell membranes (synapses). The toxic effects of amyloid-beta proteins include inhibition of nerve cell function and eventually death of nerve cells (neurons), resulting in memory loss and ultimately the dementia that is characteristic of Alzheimer’s disease (AD). The safety and pharmacokinetics of ELND005 were evaluated in a total of 9 Phase I studies in 161 healthy volunteers, including healthy elderly subjects. ELND005 has also been evaluated in a completed Phase II study in mild-to-moderate Alzheimer’s patients and an open-label extension of this Phase II study is currently ongoing.
ELND005 received fast-track designation from the US FDA in 2007 for treatment of AD. Fast-track designation can facilitate development and may expedite regulatory review of drugs that the FDA recognizes as potentially addressing an unmet medical need for serious or life-threatening conditions.
Transition is a biopharmaceutical company developing novel therapeutics for disease indications with large markets. Transition’s lead product is ELND005 (AZD-103) for the treatment of AD, and Transition also has an emerging pipeline of innovative preclinical and clinical drug candidates. The other drugs in the pipeline address anti-inflammatory and metabolic indications.
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