Cambridge NeuroScience Inc. intends to collaborate with BoehringerIngelheim GmbH on the development of its drug Cerestat for strokeand traumatic brain injury. Cambridge NeuroScience will receive upto $43 million in the deal.

Elkan Gamzu, president and CEO of Cambridge NeuroScience, saidThursday some details remain to be worked out. But he expects thedeal to be signed this quarter.

Upon closing, Cambridge NeuroScience will receive $15 million incash and equity. Gamzu said Germany-based Boehringer Ingelheimwill own about 10 percent of the Cambridge, Mass., company,meaning the $15 million would be roughly split as $8 million inequity (one million shares at $8 apiece) and $7 million in cash.

Cambridge NeuroScience stock (NASDAQ:CNSI) was up 88 cents,or 21 percent, Thursday, closing at $5.13 per share.

Cerestat is an N-Methyl-D-Aspartate (NMDA) ion-channel blockerthat acts to prevent nerve cell death and brain damage after stroke orhead injury by preventing excessive entry of calcium into nervecells. The drug is in Phase II trials in both stroke and traumatic braininjury.

Gamzu told BioWorld that discussions were being held with anumber of potential collaborators. But Boehringer Ingelheim waschosen because of the strategic fit, he said, in terms of thepharmaceutical company's experience in stroke, its marketingpotential in the area (including possible development of tPA for thatindication), and its sales force in Japan.

The dose-escalating study of Cerestat in head injury will involve 32patients who will receive the drug intravenously as soon as possibleafter injury. Previous studies involved infusion of the drug for fourhours, while this trial is designed to involve infusions up to 72 hours.Gamzu said "a number of patients already have received 12-hourinfusions without any problems."

The primary purposes of the trial are to make sure Cerestat is welltolerated, and to look a the surrogate endpoints of intracranialpressure and cerebral perfusion pressure. Gamzu said enrollmentshould be completed in the first half of the year, and the companywould expect to go directly into a Phase III study after completion ofthe study.

Last month Cambridge NeuroScience initiated a Phase II dose-response study of Cerestat in stroke patients. The randomized,double-blind, placebo-controlled study will involve 120 patients at30 centers in North America and Europe.

Preliminary efficacy in the stroke trial will be assessed using changein baseline on a stroke scale at one month. Functional outcome scaleswill be used three months after treatment. Gamzu said enrollment forthat trial may be completed by the end of the year.

"In every single animal test, where the drug is given after a variety ofexperimental strokes, the drug invariably reduces the amount of celldeath in the brain," Gamzu said. "As many as a dozen independentlyconducted studies showed, in every case, there's been protection. Atthe clinical level we've shown we can get up to doses that produceplasma levels that are neuroprotective in animal models."

In addition to the $15 million Cambridge NeuroScience will getupon closing of the deal, the company can get another $28 million in"event-driven" milestones, paid in equity and cash, Gamzu said.Boehringer Ingelheim will fund 75 percent of the development costsfor the product in the U.S. and Europe, and all costs in Japan. Thecompanies will jointly develop and co-promote the product in theU.S., while Boehringer Ingelheim will market the product elsewhereand pay a royalty on sales. Cambridge NeuroScience retainsworldwide manufacturing rights.

When the deal is signed, Cambridge NeuroScience will have enoughmoney, Gamzu said, "to get us through and beyond 1995. Plus thiswill reduce our anticipated clinical burn rate."

Boehringer Ingelheim officials did not return telephone calls fromBioWorld. n

-- Jim Shrine

(c) 1997 American Health Consultants. All rights reserved.

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