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Published on: April 10, 2016
by Aliyah Kaleem for Bidness:
AstraZeneca Plc ADR and Eli Lilly may finally be headed towards a long sought success in Alzheimer’s treatment. The drugmakers’ experimental regimen is the first ever BACE inhibitor (AZD3293) meant to treat Alzheimer’s, that has achieved safety parameters.
AZD3293 belongs to an emerging class of drugs known as BACE inhibitors, which work by blocking the accumulation of amyloid proteins inside the brain. These are known to be responsible for degenerative neurological disease, Alzheimer’s.
Alzheimer’s is a type of dementia marked by problems with memory, and thinking. Currently, there is no foolproof treatment in the market, and the standard treatments only reduce the intensity of symptoms. The neurological disease affects almost 5.3 million people in the US, and the market for these treatments is expected to expand in coming years. Data by research firm GlobalData suggests the market, which stood at $4.9 billion in 2013, has potential to grow to a hefty $13.3 billion by 2023.
If AstraZeneca and Eli Lilly and Co succeed in tapping this unaddressed facet, the companies would have yielded a strong and successful partnership. According to the terms of the deal struck in 2014, Lilly adopted a lead role in carrying out research and development on the drug, which was initially being developed by AstraZeneca alone.
The two drug makers became equally responsible for development expenses, and would split revenues if the drug was successful. Lilly was to pay amounts following certain development milestones, to AstraZeneca. It will therefore pay AstraZeneca almost $100 million, since the drug is proceeding to a trial.
Enrolment of participants in the phase 3 clinical trial of AZD3293, named Daybreak, is expected to begin by the third quarter of this year, the two companies revealed yesterday. The study will involve a total of approximately 2,200 subjects, in 14 countries, and the total duration of the study is expected to be around two years.
In the press release by Eli Lilly on Friday, its VP and global development leader for the Alzheimer’s segment, Phyllis Ferrell, said: “This is an important and meaningful step forward on the path to better understand the Alzheimer’s puzzle. We’d like to thank the AMARANTH participants and the trial investigators for taking part in this important study, and thank our colleagues at AstraZeneca for their partnership.”
AstraZeneca was also pleased with the development. Its EVP of the IMED Biotech Unit, Menelas Pangalos said: “Alzheimer’s disease remains one of the biggest challenges facing medical science today. BACE inhibitors have the potential to target one of the key drivers of disease progression and we are delighted that our combined efforts have resulted in the development of AZD3293 moving into the next phase of study. Disease-modifying approaches, such as this, have the potential to transform the treatment of Alzheimer’s disease and help patients in this area of large unmet medical need.”
Why is this a huge win for Lilly?
Lilly’s previous attempts in the BACE inhibitors segment had failed. In 2012, Lilly scrapped the late study for solanezumab, after it was criticized for its harmful side effects. After this, another one of its drugs, semagacestat, a gamma-secretase treatment, was found to be harmful to patients. In 2013, its BACE inhibitor LY2886721, was revealed to be damaging to the liver.
In the last ten years, most clinical trials aimed at testing a regimen for Alzheimer’s have failed, and the failure rate currently stands at a staggering 99%. Other research carried out by trade group Pharmaceutical Research & Manufacturers of America in 2012, showed that almost 101 drugs had failed in clinical trials in the last 13 years.
Other Drugmakers working on Alzheimer’s
Three leading pharmaceutical companies are currently developing Alzheimer’s drugs using the same mechanism. Merck has a clinical program for MK-8931 in the late stages of clinical trials. Novartis is evaluating its BACE inhibitor meant for presymptomatic patients. Biogen has signed an agreement with Eisai to acquire the development rights to its BACE inhibitor, E2609.
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