Washington Editor

Memory Pharmaceuticals Corp. and F. Hoffmann-La Roche Ltd. are yet again tweaking their relationship.

The companies amended one of their two alliances to expand the resources dedicated to the discovery and development of nicotinic alpha-7 agonists. Montvale, N.J.-based Memory granted Roche an exclusive worldwide license to its intellectual property on that class of drugs. Notably excluded from the license is MEM 3454, a later-stage nicotinic alpha-7 receptor compound that will remain under the terms of the original option agreement.

"I think over the last four years, the partnership has really developed," said Jzaneen Lalani, Memory’s vice president of legal affairs. Noting that nicotinic alpha-7 is "a target that both companies are very, very interested in," she told BioWorld Today that this revamped deal removes the clinical-stage option for Roche to get into that development and instead puts the partners on more equal collaborative footing at this earlier stage.

The products are in early preclinical research as treatments for Alzheimer’s disease and other central nervous system disorders, and under the new agreement, both partners will collaborate actively on the discovery and clinical development of nicotinic alpha-7 agonists.

"Now both companies will join forces," Lalani said.

Memory will conduct Phase I trials for compounds that emerge from the collaboration, and Roche will assume responsibility for later-stage development and commercialization. Memory has the potential to receive about $2.3 million in research funding next year upon the achievement of defined preclinical milestones, and will receive milestone payments upon the achievement of development, regulatory and sales events for drug candidates that progress under the collaboration. Such clinical milestone payments and royalties have been adjusted to reflect the respective contributions of the two parties.

In contrast to the other compounds to be developed under the new collaboration, MEM 3454 will continue to advance under Memory’s sole direction through Phase IIa trials, at which point Roche can opt into a license for further development and commercialization. Its indications include schizophrenia and Alzheimer’s disease.

Recently released preliminary cognitive data from a multiple-ascending dose study of MEM 3454 demonstrated that a 15 mg dose, given once daily over 13 days, showed a statistically significant effect of the Quality of Episodic Secondary Memory, one of the Phase I trial’s primary efficacy variables. Lalani said the company would begin Phase IIa testing next quarter, although she said the coming study’s design and indication are yet to be determined.

In the companies’ other collaboration, Memory has concluded its work under the discovery portion of the phosphodiesterase-4 inhibitor deal, research that has yielded a number of compounds now in preclinical development. Memory and Roche agreed to direct the remaining funding under the PDE4 inhibitor collaboration toward the amended nicotinic alpha-7 collaboration.

Last summer, the companies rewrote an original agreement on that drug class, and Memory regained rights to the two lead compounds from the PDE4 inhibitor program, MEM 1414 and MEM 1917. "Otherwise, the collaboration continues," Lalani said. (See BioWorld Today, Aug. 22, 2005.)

Roche, of Basel, Switzerland, now has expanded Memory’s co-promotion rights to the two relatively advanced products to include Europe. Roche maintains its exclusive, worldwide license to develop and commercialize candidates from the PDE4 inhibitor program.

In mid-April, Roche halted its work on MEM 1414 for Alzheimer’s disease and MEM 1917 as its backup in that indication, as well as depression. That deal dates back almost four years. (See BioWorld Today, July 31, 2002.)

On Tuesday, Memory’s stock (NASDAQ:MEMY) lost 1 cent, to close at $2.41.

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