Transition Therapeutics Announces Modification of the Collaboration Agreement for ELND005
TORONTO - Transition Therapeutics Inc. announced that 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 3 milestone payment, Transition will receive from Elan a
payment of US$9 million at the time of signing and will be eligible to
receive a US$11 million payment upon the commencement of the next
ELND005 clinical trial. Transition also will be eligible to receive up
to an aggregate of US$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.
About ELND005 (Scyllo-inositol)
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. The safety and pharmacokinetics of ELND005 were evaluated in a total of 9 Phase 1 studies in 161 healthy volunteers, including healthy elderly subjects. ELND005 has also been evaluated in a completed Phase 2 study in mild to moderate Alzheimer's patients and an open-label extension of this Phase 2 study is currently ongoing.
ELND005 received fast track designation from the U.S. Food and Drug Administration in 2007 for treatment of Alzheimer's disease. 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.