By Brady Huggett
Memantine, the Merz and Co. drug attached to a tridimensional group of partners, will begin a pivotal trial in the United States in patients with painful diabetic neuropathy, bringing it up to speed with its progress in the rest of the world.
Neurobiological Technologies Inc., of Richmond, Calif., conducted Memantine¿s first pivotal trial in the United States, a trial for neuropathic pain involving 400 patients. The results were positive, but from that point on, the development and subsequent marketing of the product falls to Forest Laboratories Inc., of New York.
¿Our deal was to finish a Phase IIb trial,¿ said Paul Freiman, CEO and president of NTI. ¿And [Forest¿s] responsibility is to continue from here on out. The expenses are all Forest¿s and the work is all Forest¿s. Our only involvement is [that] our medical director works with Forest¿s people.¿
Forest Laboratories officials could not be reached for comment.
The compound has several partners. Originally a discovery of Merz and Co., of Germany, Memantine is linked to NTI, Forest Laboratories and Lundbeck A/S, of Copenhagen, Denmark. It has finished, is currently in, or is nearing pivotal trials in three indications around the globe.
Memantine, an orally active N-methyl-D-aspartate (NMDA) antagonist, is not approved anywhere, although it is being used to treat dementia in Germany. But it¿s knocking on the regulatory door.
In the United States, the product has been through an Alzheimer¿s Phase III trial, which NTI conducted; Phase II trials for AIDS-related dementia, a trial conducted by the AIDS Clinical Trial Group; and will begin the pivotal diabetic neuropathy trial.
¿There are going to be meetings between Merz, our company and Forest to decide what the next step is,¿ Freiman said, referring to the AIDS-related dementia program. ¿We need a Phase III, but we don¿t know when it will be done.¿
Outside the States, Lundbeck has the rights to the product for all three indications, and the development is ¿running parallel¿ with the U.S., Freiman said. Merz and Lundbeck have filed jointly for European approval in the Alzheimer¿s indication and should hear back this month, if all goes well.
Memantine¿s marketing is handled by Suntory Ltd., of Tokyo, in the remaining major market, Japan, but only for Alzheimer¿s. AIDS dementia is a minor issue there, Freiman said, and no one has the rights to neuropathic pain.
Even though the development and marketing of Memantine will be directed by Forest Labs in the United States now, that doesn¿t mean NTI won¿t see money. It is slated to get royalties on all three indications.
¿Are you familiar with baseball?¿ Freiman asked BioWorld Today. ¿Royalties are paid from Tinkers to Evers to Chance.¿ Only in this case it goes Forest to Merz to NTI. And the same is true for Lundbeck.¿
Neurobiological Technologies¿ stock (NASDAQ:NTII) fell 17 cents Thursday to close at $3.26.