In its largest deal since 1995, Albany Molecular Research Inc. exclusively licensed a portfolio of biogenic amine reuptake inhibitors to Bristol-Myers Squibb Co. for the development of drugs to treat depression and other central nervous system disorders.
AMRI has been working for several years on the compounds, which range from discovery to the advanced preclinical stage, said David Albert, director of communications for the Albany, N.Y.-based company, which has a "strong research and development engine," but does not have capabilities for late-stage development or commercialization.
"We realized that, at some point, we would have to hand it off to an experienced company," he said, "and Bristol-Myers Squibb was the ideal company to work with on this because it has experience in progressing CNS drugs through the clinic."
Terms call for AMRI to receive an up-front payment of $8 million, in addition to $10 million in research funding over the next three years. That research funding will cover the company's ongoing medicinal chemistry work on the compounds. It will be up to BMS to select compounds for further development work, and AMRI would receive up to $66 million in development and regulatory milestones for each of the first two compounds. If two products reach the market, the deal would be worth about $150 million in overall funding to Albany Molecular, and it would receive additional total milestone payments of $22 million per compound after that.
AMRI also stands to receive royalties on sales of any products resulting from the deal.
The company's shares (NASDAQ:AMRI) closed at $13.46 Monday, up 64 cents.
Albert called the collaboration with BMS the "most significant announcement resulting from AMRI's internal R&D efforts since the Allegra agreement," referring to the 1995 deal with Aventis Pharmaceuticals (now part of Sanofi-Aventis Group, of Paris). AMRI, which licensed fexofenadine HCl, the active ingredient in the allergy medication, brought in $16 million in royalties from Allegra sales during the second quarter.
"We think this deal [with BMS] certainly has Allegra-type potential," Albert told BioWorld Today.
The agreement also calls for AMRI to conduct manufacturing if outsourced by BMS.
AMRI's series of compounds includes various combinations of amine-transporter inhibition profiles designed to regulate the reuptake of the brain's neurotransmitters to increase the levels of serotonin, norepinephrine or dopamine.
"This particular portfolio includes dual- and triple-action reuptake inhibitors," Albert said, "which act on two or three of those neurotransmitters at the same time."
Triple inhibitors represent a new class of drugs, though other companies are in development with their own versions. DOV Pharmaceuticals Inc., of Hackensack, N.J., recently released positive Phase II results of its DOV216,303, a triple reuptake inhibitor to treat depression. DOV sublicensed the product from Whitehouse Station, N.J.-based Merck & Co. Inc. And London-based GlaxoSmithKline plc has partnered with NeuroSearch A/S, of Ballerup, Denmark, to develop GSK372475, also for depression. That drug is in Phase II.
In addition to CNS, AMRI also has late-discovery-stage programs in oncology and immunology, and early stage programs in inflammation/asthma and irritable bowel disease.
Meanwhile the company continues "to initiate programs drawing on the strengths of our chemistry and natural product collections," Albert said.
AMRI offers its chemistry services platform to pharma and biotech companies, on a fee-for-services basis. It also has screening libraries composed of natural product extracts. The company entered a two-year collaboration in July with the National Institute of Neurological Disorders and Stroke to provide its chemistry services in the lead optimization of target compounds for treatment spinal muscular atrophy, and, earlier this year, signed a drug discovery research agreement for its medicinal chemistry services with Indianapolis-based Eli Lilly and Co.
Its third-quarter results have not yet been reported, but AMRI ended the second quarter with a net income of $7.3 million, or 23 cents per share. As of June 30, the company had cash, cash equivalents and investments totaling $143.3 million.