Neurocrine Biosciences Inc. and Taisho Pharmaceutical Co. Ltd. restructured their two-year-old deal to develop a diabetes product, giving Neurocrine the ability to reacquire and assume all rights to the product outside Japan.
The exclusive deal surrounds Neurocrine's altered peptide ligand (APL), known as NBI-6024, for diabetes mellitus. Signed in January 2000, the original deal, valued at up to $45 million in fees, milestones and development expenses, gave Tokyo-based Taisho European and Asian commercialization rights to NBI-6024. And later that year, the deal was expanded to include North America and countries outside Europe and Asia. The revised agreement was valued at up to $100 million. (See BioWorld Today, Jan. 7, 2000, and Dec. 13, 2000.)
While no one at Neurocrine was available for comment Monday, Gary Lyons, Neurocrine's president and CEO, released a prepared statement saying, "Our agreement with Taisho was amended in April of this year allowing for this potential restructuring. We are interested in securing commercial rights to NBI-6024, especially in the United States, and are now able to move forward with this plan."
NBI-6024 is based on Neurocrine's proprietary APL technology, which was discovered and developed by Neurocrine scientists and its co-founder, Larry Steinman.
The product is the subject of an international Phase IIb trial in 170 adult and adolescent patients with Type I diabetes. Meanwhile, a second U.S. Phase IIb trial including 200 newly diagnosed Type I diabetics is expected to begin late this year or early next year, according to the statement released by Neurocrine.
The company has completed four Phase I trials and has one ongoing Phase I/II safety and dose-escalating clinical trial in approximately 120 diabetic patients overall.
At the American Diabetes Association meeting in June, Neurocrine reported data from the latter trial, saying there were no detectable anti-6024 antibodies following single- and multiple-dose administration, and there was no significant increase in anti-insulin, anti-GAD and anti-ICA 512 levels relative to placebo.
Neurocrine's stock (NASDAQ:NBIX) closed Tuesday at $41.11, up $1.12.