Amgen will expand into Alzheimer’s disease treatments, and Novartis will add to its presence in neuroscience drugs, by co-developing and co-commercializing new beta-site APP-cleaving enzyme-1 (BACE) inhibitors designed to fight the memory-robbing illness. The value of the collaboration was not disclosed.

But in announcing a neuroscience collaboration yesterday that will also focus on developing treatments for migraine, the companies did say that Novartis' Phase I/IIa oral BACE inhibitor CNP520 will be the lead molecule to be developed and commercialized.

CNP520 is an oral drug designed to prevent the production of different forms of amyloid, and thus has the potential to prevent, slow, or delay the symptoms associated with Alzheimer’s, according to Novartis.

CNP520 is planned to be included in a prevention study in people with a genetic risk of developing the disease, in collaboration with the Banner Alzheimer's Institute. In the study—part of the Alzheimer's Prevention Initiative—participants will be given CNP520, placebo, or CAD106, a Novartis compound not covered by the company’s collaboration with Amgen. CAD106 is an anti-amyloid active immunotherapy that has completed Phase IIa trials.

Pending regulatory approval, the study with Banner is planned to start in late 2015 or early 2016 in sites in North America and Europe.

More compounds from both companies’ preclinical BACE inhibitor programs may be considered as follow-on molecules, the companies added, with Amgen saying it has “a number” of preclinical candidates targeting BACE inhibition.

Amgen also noted in its announcement that it was the first drug developer to clone the BACE gene, with genetic validation of the BACE target later confirmed by Amgen’s deCODE Genetics subsidiary.

As for the migraine program, the companies said they will work to co-develop new Amgen drugs that include the Phase III compound AMG 334, the Phase I compound AMG 301, and potentially another Amgen compound. Novartis will have global co-development rights and commercial rights to Amgen’s migraine treatments outside the U.S., Canada, and Japan.

AMG 334 is a fully human monoclonal antibody under study for the prevention of migraine. AMG 334 targets the Calcitonin-Gene-Related-Peptide (CGRP) receptor, which according to Amgen is believed to transmit signals that can cause incapacitating pain. AMG 334 is currently under evaluation in several large global, randomized, double-blind, placebo-controlled trials to assess its safety and efficacy in migraine prevention.

AMG 301 is a monoclonal antibody being investigated for the treatment of migraine.

Amgen agreed to pay an upfront payment and payments tied to unspecified milestones—as well as “disproportional” research and development costs for an agreed-upon period, followed by a 50/50 cost and profit share arrangement.

“Our collaboration on BACE inhibition reflects Amgen's strategic focus on genetically validated drug candidates while our collaboration in migraine creates an opportunity to more rapidly advance AMG 334 on a global scale,” Sean E. Harper, M.D., Amgen evp of research and development, said in a statement.

Added David Epstein, head of Novartis Pharmaceuticals: “This Novartis collaboration with Amgen highlights our clear commitment to neuroscience and to bring multiple, new targeted therapies to patients living with Alzheimer's disease and migraine, where the unmet medical need remains high.”

The collaboration comes some two months after Novartis signaled a commitment to expanding its neuro drug pipeline, saying it will acquire Spinifex Pharmaceuticals for $200 million upfront plus undisclosed clinical development and regulatory milestone payments. The deal will expand Novartis’ neuroscience drug portfolio with Spinifex's Phase IIb-ready lead candidate EMA401, a potential first-in-class oral treatment for chronic pain, particularly neuropathic pain, without central nervous system side effects.

On August 21, Novartis said it will acquire all remaining rights to Ofatumumab from GlaxoSmithKline (GSK) for relapsing-remitting multiple sclerosis (RRMS) and certain other autoimmune indications, in a deal that could generate more than $1 billion for GSK. That deal is subject to expiry of any waiting period under the U.S. Hart-Scott-Rodino Act and other customary closing conditions.

Novartis said it is also looking to broaden its Alzheimer’s offerings, which include the Exelon® Patch (rivastigmine transdermal system). The patch is approved for the treatment of mild-to-moderate Alzheimer's dementia in more than 90 countries, including more than 20 countries where it is also approved for Parkinson's disease dementia. Exelon Patch is also indicated for the treatment of patients with severe AD in 14 countries, including the U.S.








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