Alkermes Inc. is seeking a court ruling to prohibit CortexPharmaceuticals Inc. from testing, developing and marketingcalpain inhibitors for the treatment of cerebral vasospasm.
In a lawsuit filed Monday in the U.S. Federal District Court inMassachusetts, Alkermes (NASDAQ:ALKS) charged Cortex withbreach of contract in their development and license agreementfor calpain inhibitors.
At the time the two-year agreement was signed, in January1992, Cortex said it covered development of calpain inhibitorsto treat "stroke and other acute degenerative disorders of thebrain." Calpain is an enzyme in neurons that is thought to playa role in the destruction of nerve cells.
Alkermes' lawsuit stated that the agreement prohibits Cortexfrom developing calpain inhibitors " 'for the prevention ortreatment of acute neurodegenerative CNS disorders,' and acerebral vasospasm is an acute neurodegenerative CNS disorderas defined in Section 1.1 of the agreement."
By way of illustration, the suit continued, "Section 1.1references stroke as an acute neurodegenerative CNS disorder.The World Health Organization definition of stroke is 'rapidlydeveloping clinical signs of focal (or global) disturbance ofcerebral function, with symptoms lasting 24 hours or longer orleading to death, with no apparent cause other than of vascularorigin."
However, Cortex maintains that "cerebral vasospasm is adisorder of the vascular system, not the nervous system," andtherefore calpain inhibitors for this indication are not coveredunder the agreement.
Cortex (NASDAQ:CORX) plans to file an investigational new drug(IND) application for a product to treat cerebral vasospasm inthe second quarter of 1994. To date, the product has beentested in rabbits.
Alkermes of Cambridge, Mass., has paid Cortex $3.1 million tofund basic research, $500,000 for license rights and $1.5million in an equity investment. In return, Alkermes received aworldwide, exclusive license to manufacture and market anyproducts resulting from the collaboration.
Alkermes also is seeking remuneration for damages, which itsaid are in excess of $50,000, plus interest and costs. Damagesinclude "the loss in value of the sole and exclusive licensegranted Alkermes, and the potential loss of sales of anyproduct resulting from the research that Alkermes maysucceed in marketing," the lawsuit stated.
Alkermes' stock was down 50 cents a share on Monday, closingat $9.25 a share; Cortex's stock was down 31 cents a share,closing at $2.31
-- Brenda Sandburg News Editor
(c) 1997 American Health Consultants. All rights reserved.