Amgen to Help Develop Novartis AG's Alzheimer's and Migraine Drugs

Amgen to Help Develop Novartis AG's Alzheimer's and Migraine Drugs
September 2, 2015
By Alex Keown, Breaking News Staff

THOUSAND OAKS, Calif. – Amgen and Novartis have struck a collaborative deal to co-develop amyloid plaque treatments for Alzheimer's disease, the companies announced this morning.

The collaboration will accelerate Amgen’s entry into Alzheimer’s treatment using Novartis’s differentiated Alzheimer's disease program that is directed at genetically predisposed individuals at risk of developing the form of dementia. The new agreement will combine each company’s BACE (beta-site APP-cleaving enzyme-1) programs that target amyloid plaque buildup in hopes of preventing Alzheimer's disease. Under the collaboration, Novartis's Phase I/IIa BACE inhibitor (CNP520) will be the lead molecule and each company's pre-clinical BACE inhibitor programs will be potential follow-ons, Amgen said. Novartis's CNP520 is an oral drug designed to prevent the production of different forms of amyloid and has the potential to prevent, slow or delay the symptoms associated with Alzheimer's disease.

In collaboration with the Banner Alzheimer's Institute, CNP520 will be included in a prevention study. Amgen was the first company to clone the BACE gene and subsequent genetic validation of the BACE target has been confirmed by Amgen subsidiary deCODE genetics, Inc..

Merck & Co. has a BACE program in Phase III development, while AstraZeneca PLC and Eli Lilly and Company began a Phase II/III study in December, Reuters said.

Under terms of the agreement, Amgen will make undisclosed upfront and milestone payments, and will be responsible for disproportional research and development costs for an agreed-upon period followed by a 50/50 cost and profit share arrangement, Amgen said.

There are several drugs on the market that help manage Alzheimer’s, including Novartis’s Exelon Patch and Eisai Company, Ltd.’s Aracept, but none treat the primary cause. According to a Bloomberg report, there have been more than 100 failed efforts to develop a treatment for Alzheimer’s disease since 1998, including two from Roche . A 2014 report in Alzheimer’s Research UK showed 244 Alzheimer’s drugs were tested between 2002 and 2012, but only one was approved – Lundbeck A/S’s Ebixa, Bidness Etc.reported.

In addition to collaborating on Alzheimer’s treatments, the two companies will also work on co-developing treatments for migraine headaches. AMG 334 is a fully human monoclonal antibody under investigation for the prevention of migraine. In addition to AMG 334, the migraine portfolio will include the development of AMG 301 and potentially another investigational compound of Amgen. AMG 301 is a monoclonal antibody being investigated in phase I trials for the prevention of migraine.

Alzheimer's disease, a type of dementia, affects 15 million people worldwide, a number that is expected to grow to 75 million by 2030 due, in part, to the lack of effective treatments. In total there are about 50 million people suffering from some form of dementia worldwide. There are currently no drugs that target the cause of Alzheimer’s the most common form of dementia. There is a widespread belief that the buildup of amyloid plaque in the brain is one of the primary causes of the disease. Several biotech companies, including Biogen, Inc., Eli Lilly and Roche, are working on Alzheimer’s treatments that target build-ups of amyloid plaque. The treatments being developed by these three companies are injectables, while the BACE inhibitors are oral treatments.

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