H. Lundbeck and Otsuka Pharmaceutical said today they will expand their two-year-old CNS drug collaboration to include joint development of a third Alzheimer’s disease candidate, the preclinical vaccine Lu AF20513.
Otsuka agreed to pay Lundbeck €4 million ($5.5 million) upfront on signing their deal, with Lundbeck agreeing in return to fund Lu AF20513 through Phase I clinical development. Additional financial terms were not disclosed.
Lu AF20513 is an anti-beta amyloid (Aβ) active vaccine candidate expected to enter Phase I in 2014. After they complete the Phase I study, Lundbeck and Otsuka have an option to enter into a co-commercialization and co-development agreement under terms to be agreed upon. The companies say Lu AF20513 can fight Alzheimer’s better than monoclonal antibody treatment strategies by providing an enhanced and heterogeneous immunogenic response towards Aβ peptides.
Lundbeck and Otsuka launched their collaboration in November 2011, and are now pursuing development of two other potential Alzheimer’s disease treatments now in Phase III trials — Lu AE58054, a 5HT6 receptor antagonist for cognitive impairment associated with Alzheimer’s; and brexpiprazole, an investigational agent with high affinity to multiple serotonin, dopamine and norepinephrine receptors for the treatment of agitation in patients with Alzheimer’s.
In October, the companies launched their first of four planned Phase III trials of Lu AE58054, a three-year, 930-patient study in the U.S., Canada and 15 other countries mainly in Europe. About 3,000 patients will be studied in all four Phase III trials for Lu AE58054, during which several doses of Lu AE58054 ranging from 10-60 mg will be used in combination with donepezil in mild-to-moderate Alzheimer’s disease as adjunctive therapy to acetylcholinesterase inhibitors (AChEls). Key endpoints for the four trials are Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-cog), Activities of Daily Living (ADL), and the Clinical Global Impression of Change Scale (CGIC).
The candidate advanced into pivotal trials following promising Phase II results presented in July at the Alzheimer’s Association International Conference. Results showed adjunctive therapy with Lu AE58054 (plus 10 mg/day donepezil resulted in statistically significant improvement in cognitive performance, as measured by ADAS-cog over 24 weeks of treatment vs. placebo plus 10mg/day donepezil.
Back in March, Otsuka agreed to pay Lundbeck $150 million upfront upon signing, as well as $675 million tied to regulatory and sales milestones associated with bringing Lu AE58054 to market. The companies also agreed to share sales, development, and commercialization costs.
In November 2011, Lundbeck and Otsuka launched their “multi-billion DKK” collaboration to develop new CNS treatments for conditions that include schizophrenia, depression, Alzheimer’s disease and alcohol dependency.
The companies already market the intramuscular once-monthly injection drug Abilify® (arpiprazole) for maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole. Last month, Ablify won marketing authorization approval from the European Commission.
Lundbeck and Otsaku are also working to develop and commercialize nalmefene (sold under the brand name Selincro in Europe) in Japan. Earlier this year, nalmefene was approved by the European Medicines Agency as the first treatment for the reduction of alcohol consumption.