NeuroSearch A/S and Boehringer Ingelheim International GmbH signed a potential $80 million deal to develop and market a drug for the treatment of Alzheimer’s and Parkinson’s diseases.
The deal focuses on a compound called NS2330, a monoamine re-uptake inhibitor that has demonstrated the ability to enhance the function of the neurotransmitters acetylcholine, noradrenaline and dopamine in early studies in Alzheimer’s patients.
“It seems like our drug is very specific to brain regions and does not cause side effects like other drugs on the market that affect the whole body,” Henrik Moltke, NeuroSearch’s director of investor relations, told BioWorld Today, “That is extremely positive for us.”
Based on the research conducted to date by NeuroSearch, of Ballerup, Denmark, it is likely that Alzheimer’s will be the first indication advanced through development.
The companies are prepared to enter Phase IIb studies in Alzheimer’s, while earlier Phase II studies in Parkinson’s patients remain ongoing.
“There are several good reasons why we wanted to work with Boehringer Ingelheim,” said Moltke, who also is one of NeuroSearch’s founders. “One, they have experience in neurology, and they already have a Parkinson’s drug on the market [Mirapex in the U.S., sold by Peapack, N.J.-based Pharmacia Corp.]. They were in the market looking for an Alzheimer’s drug and when they saw the data on our early Phase II studies, they were impressed and interested in a collaboration.”
And since BI is one of the largest pharmaceutical companies in the world, Moltke said NeuroSearch was attracted by the company’s ability to market and develop products.
Finally, Moltke said, the negotiation process with BI was “positive and constructive.”
Upon signing the deal Friday, Boehringer Ingelheim, of Ingelheim, Germany, was responsible for an immediate $20 million up-front payment. A remaining $60 million is scheduled to be paid to NeuroSearch in milestones prior to marketing. When NeuroSearch reaches the first milestone, BI will have the option to acquire 210,000 new NeuroSearch shares at $47.6 per share in lieu of milestones of the same amount ($10 million).
BI also will pay for all future costs in the development of NS2330.
Furthermore, NeuroSearch will receive royalties on drug sales, but will retain rights to market NS2330 in Nordic and Baltic countries.
In a Phase IIa study of 36 U.S.-based Alzheimer’s patients, those taking NS2330 showed an improvement in memory function, including the ability to pay attention, the ability to store and recall information and the speed of access to items held in the memory, NeuroSearch said.
“The primary focus was safety and tolerability, but we also picked up strong efficacy data,” Moltke said. “What was also very encouraging was that we stopped the treatment after one month, and then 14 days after, we had the patients in and we still saw a very positive effect. We haven’t done anything face-to-face with drugs on the market, but by comparing other clinical data and listening to other companies working in this area, it seems like we had very strong data even though it was very early stage. That was also BI’s judgment when they saw the data.”
NeuroSearch plans to begin a Phase IIb study sometime this year.
In Parkinson’s disease, NeuroSearch said it has conducted a number of in-house and external preclinical tests demonstrating that NS2330 shows important advantages over existing treatments. NS2330 now will be studied in a larger Phase II study in Parkinson’s.
“We are right now in a very small Phase II study in the U.S. in Parkinson’s,” Moltke said. “This is a little bit behind Alzheimer’s. We are in discussions right now with leading clinical experts in Parkinson’s in the U.S. about how we should structure our next Phase II study.”
In other business, NeuroSearch has compounds for depression, anxiety and cocaine addition in Phase II studies; compounds for stroke and sickle cell anemia in Phase I; and 11 preclinical programs.