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Alzheimer’s Disease Therapeutics Pipeline to Witness Remarkable Growth due to Adoption of Advanced Regulatory Approaches by Drug Developers

According to a new research report “Alzheimer’s Disease Therapeutics – Pipeline Analysis 2019, Clinical Trials and Results, Patents, Designations, Collaborations, and Other Developments” published by Pharma Proff, Alzheimer’s disease therapeutics currently exhibits a proliferating pipeline with 50+ therapeutic candidates.

Alzheimer’s Disease Pipeline Insights

Alzheimer’s disease is an irreversible brain disorder caused due to degradation of cells and tissues in the brain. The progressive disorder slowly destroys memory, thinking, social, and behavioral skills. It is the most common cause of dementia and accounts for 50–75% of dementia cases. The progression of disease leads to severe impairment of cognitive ability and losing the ability to carry out day-to-day tasks. The disease has three major stages: mild, moderate, and severe.

In the mild or early stage of the disease, patient may experience minute memory lapses but is still able to perform daily tasks independently. The moderate stage is the longest with more pronounced dementia symptoms. In the severe or final stage of the disease, the symptoms of dementia become severe and result in worsened memory and cognitive skills. The symptoms of disease include vision loss and cognitive impairment.

The disease can be caused due to genetic mutation or age. One of the risk factors associated with the disease includes presence of apolipoprotein E (APOE) gene. However, it is not necessary that a person carrying the gene is affected by Alzheimer’s disease. The disease can be diagnosed through test of behavioral change in patient, and conducting memory or analytical test, blood test, magnetic resonance imaging (MRI) scan, and computed tomography (CT) scan. Nutritious diet, physical activities, mentally stimulating activities, and social engagement can help in reducing possibility of the disease. In addition, there is no particular medication available to cure Alzheimer’s disease, but drugs, including Aricept (Eisai Co. Ltd.), Razadyne (Janssen Pharmaceuticals Inc.), and Exelon (Novartis AG), have been approved by the U.S. Food and Drug Administration (USFDA) to reduce the symptoms of the disease.

Insights into Pipeline Segments

According to the research, most of the drug candidates are being developed for oral administration. It is observed that this route of administration is easy to use, cost-effective, non-invasive, and most convenient method of treatment, and ensures high level of patient satisfaction.

Positive Clinical Trial Results are Expected to Drive Alzheimer’s Disease Therapeutics Pipeline

There are several companies that are involved in developing therapeutics for Alzheimer’s disease have shown positive clinical results in various phases of drug development. For instance, a Chinese pharmaceutical company, Green Valley Pharmaceutical Co. Ltd. announced positive topline results from the phase III trial of GV-971. As per the results of the trial, GV-971 resulted in statistically significant improvement in patients, based on their Alzheimer’s disease assessment scale-cognitive 12 scores.

Strategic Advancements Play a Pivotal Role in the Alzheimer’s Disease Therapeutics Development

In the wake of strategic development, various companies are collaborated with other companies to enhance their footprint in the global market. For instance, in March 2014, Eisai Co. Ltd. and Biogen Inc. entered into a collaboration to develop and commercialize two of Eisai Co. Ltd.’s clinical candidates (E2609 and BAN2401 [aducanumab]) for Alzheimer’s disease. Later in October 2017, both the companies expanded their existing collaboration to jointly develop and commercialize investigational drugs. Under the terms of the expanded agreement, Eisai Co. Ltd. exercised its option to co-develop and co-promote Biogen Inc.’s aducanumab for patients with Alzheimer’s disease.

Designation Grants by Regulatory Bodies to Accelerate the Development Process of Alzheimer’s disease Therapeutics

Since there are marketed products to reduce the symptoms and not to treat Alzheimer’s disease, companies are actively seeking designation grants to accelerate the process of development of drugs for the disease. For instance, in November 2016, Eisai Inc. was granted Fast-Track Designation for the development of E2609, currently being evaluated in the phase III clinical trials for early Alzheimer’s disease. Similarly, in August 2016, AstraZeneca PLC and Eli Lilly and Company jointly received Fast-Track Designation by the USFDA for AZD3293 for the treatment of Alzheimer’s disease.

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Some of the key players involved in the development of drugs, therapies, and devices for Alzheimer’s disease include Novartis AG, TauRx, Acelot Inc., Eli Lilly and Company, Genentech Inc., Biogen Inc., MorphoSys AG, Green Valley Pharmaceutical Co. Ltd., AstraZeneca PLC, Boehringer Ingelheim International GmbH, AbbVie Inc., Grifols S.A., Alzheon Inc., and Eisai Co. Ltd.

Alzheimer’s Disease Therapeutics Pipeline Analysis

  • By Phase
  • By Molecule Type
  • By Route of Administration
  • By Company

The report comprises detailed pipeline analysis of therapeutics being developed for the treatment of Alzheimer’s disease. Comprehensive insights on the pipeline products have been provided, with special focus on strategic developments of key players, information on drug licensing, designations, financing, and grants, technological advancements, patents, and upcoming conferences. In addition, the report highlights the winning strategies of companies involved in the Alzheimer’s disease therapeutics development. Detailed regulatory approval procedures in the U.S., Europe, and Japan are also provided in the report. Furthermore, the report contains competitive analysis and extensive information on monotherapies, combination therapies, targets and mechanisms of action, and drug origin with respect to Alzheimer’s disease.