Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50

Lilly, AstraZeneca Alzheimer’s Trial Advancing To Phase 3

By Mike Botta | April 8, 2016

Indianapolis, IN – Eli Lilly and AstraZeneca will continue to Phase 3 their Amaranth study of AZD3293 oral beta secretase cleaving enzyme (BACE) inhibitor as a potential treatment for early Alzheimer’s disease.

Amaranth is a Phase 2/3 study that is investigating the safety and efficacy of AZD3293 and testing the hypothesis that it is a disease-modifying treatment. The study, which has a two-year treatment period, aims to enroll approximately 2,200 patients in 14 countries.

An independent data monitoring committee recommended that the study continue without modification after conducting an interim safety analysis, which was not designed to review efficacy.

The Phase 3 trial, named Daybreak, will study the safety and efficacy of AZD3293 in people with mild Alzheimer’s dementia. The trial will begin enrolling participants in this year’s third quarter, according to the companies.

Under the terms of the alliance agreement reached in 2014, Lilly will pay AstraZeneca up to $500 million in development and regulatory milestone payments.

Now that AZD3293 has moved into Phase 3 testing, AstraZeneca will receive a milestone payment from Lilly resulting in a second-quarter charge of $100 million (pre-tax) to Lilly’s Generally Accepted Accounting Principles (GAAP) and non-GAAP research and development expense.

Lilly leads clinical development in conjunction with AstraZeneca researchers, while AstraZeneca will be responsible for manufacturing. The companies will take joint responsibility for commercialization of the molecule and will share all future costs equally for development and commercialization, as well as net global revenues post-launch.

In Phase 1 studies AZD3293 reduced levels of amyloid beta in the cerebro-spinal fluid of people with Alzheimer’s and healthy volunteers, according to the drug companies. Alzheimer’s progression is characterized by the accumulation of amyloid plaque in the brain.

Inhibiting BACE, an enzyme associated with the development of amyloid beta, is expected to prevent the formation of amyloid plaque and eventually slow the progression of the disease.

Of the 5.4 million Americans suffering from the disease in 2016, the Alzheimer’s Association reports that an estimated 5.2 million people are age 65 and older, and approximately 200,000 are under age 65. Those numbers are expected to escalate rapidly in coming years as the baby boom generation ages, potentially reaching an estimated 13.8 million people by 2050 barring the development of medical breakthroughs to prevent or cure the disease.

Worldwide, the U.K.-based Alzheimer’s Disease International estimates that 46 million people currently are living with dementia, a number that is expected to grow to more than 74 million in 2030 and 131 million in 2050. The total estimated worldwide cost of dementia in 2015 was $818 billion. By 2018, dementia will become a trillion dollar disease, rising to $2 trillion by 2030.

In the U.S., the Alzheimer’s Association estimates total payments for healthcare, long-term care and hospice in connection with Alzheimer’s and other forms of dementia will total $236 billion in 2016, rising to more than $1 trillion (in 2016 dollars) by 2050.

Follow us on Twitter and Facebook for updates on the latest pharmaceutical and biopharmaceutical manufacturing news!


Filed Under: Drug Discovery

 

Related Articles Read More >

Takeda Pharmaceutical in the Drug Discovery & Development Pharma 50
Takeda’s Takhzyro fares well in pediatric hereditary angioedema study
Novartis in the Pharma 50
Novartis to cut up to 8,000 positions
Gilead Sciences in the Drug Discovery & Development Pharma 50
Gilead resubmits application to FDA for twice-yearly HIV drug lenacapavir
George Floyd mural
How the pandemic and George Floyd made clinical trial diversity a priority

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Drug Discovery news in a minute?

We Deliver!
Drug Discovery & Development Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Drug Discovery and Development
  • MASSDEVICE
  • DEVICETALKS
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • MEDTECH 100
  • Medical Design Sourcing
  • Subscribe to our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50