OSLO, Norway--(BUSINESS WIRE)-- Regulatory News: DiaGenic ASA (OSE:DIAG.ol - News) and Pfizer Inc [NYSE: PFE] today signed an agreement for explorative R&D collaboration to identify biomarkers in early stages of Alzheimer’s disease (AD) using DiaGenic’s patented gene expression technology and its blood samples from ongoing clinical studies.
The companies will perform a joint modular study where they will compare longitudinal changes in blood based gene expression patterns in subjects with stable mild cognitive impairment (MCI), progressive MCI (prodromal AD), and Alzheimer’s disease. The objective is to identify gene expression patterns in blood from patients who progress from MCI to Alzheimer’s disease and with different stages of Alzheimer’s disease.
The study expects to start in December and the agreement gives Pfizer a non-exclusive, world-wide license to use DiaGenic’s MCI test and AD tests in their research and drug development programs.
“MCI progression biomarkers will be very useful in drug discovery, in clinical trials as surrogate markers of treatment efficacy as well as being very valuable as diagnostic tests in clinical practice”, said DiaGenic CEO Dr. Erik Christensen, MD PhD. “This collaboration is the first result of DiaGenic’s refocused strategy on teaming up with large pharmaceutical companies to deliver new diagnostic tools. It also demonstrates that DiaGenic is an attractive partner for identifying progression biomarkers as we bring along a unique experience in blood based gene expression testing as well as an extensive bio bank of well characterized MCI and AD patients.”
“Teaming up with Pfizer for an explorative R&D collaboration is a significant recognition of the work DiaGenic has performed for the last 12 years. DiaGenic’s strong IP portfolio linked to measuring gene expression in blood makes us unique as a partner in the CNS field,” said DiaGenic’s R&D Director and co-founder, Dr. Anders Lönneborg. “In drug development, DiaGenic’s biomarker program will enable an early and accurate diagnosis of Alzheimer’s disease and therefore improve success rates in clinical trials.”
The commercial terms of the agreement remains undisclosed.
About MCI and prodromal AD
Mild cognitive impairment (MCI) is a transitional stage between normal aging and dementia. It involves problems with memory, language, thinking and judgment that are greater than typical age-related changes. Mild cognitive impairment increases your risk of later developing dementia, including Alzheimer’s disease and studies show that 50% of patients with amnestic MCI will convert to Alzheimer’s patients. There is no proven treatment or therapy for MCI. Prodromal AD is an early disease stage of Alzheimer’s disease before any dementia symptoms have developed.
About Alzheimer’s disease
Alzheimer’s disease (AD), the most common form of dementia, is a fatal, degenerative brain disorder that gradually destroys a person’s memory and ability to learn, reason, make judgments, communicate and carry out daily activities, such as personal hygiene and eating. As AD progresses, individuals may also experience changes in personality and behaviour, such as anxiety, suspiciousness or agitation, delusions or hallucinations.
According to the Alzheimer’s Association the worldwide prevalence of dementia including AD is 35.6 million people. This number is projected to triple to 115.4 million people in 2050 with 1 in 85 persons living with the disease. In the United States alone, recent estimates indicate as many as 5.3 million Americans have AD.
AD is among the most costly diseases worldwide. The annual cost of dementia, including AD, has been estimated at $604 billion. In the United States, the indirect and direct costs of caring for people with AD are estimated to be $100 billion a year. An aging global population will result in an increased burden on AD caregivers and public health systems worldwide.
About DiaGenic ASA
DiaGenic is an innovative Norwegian biotechnology company that seeks to create value for patients, partners, and investors by developing new and more patient friendly methods for early detection of diseases. DiaGenic is currently a world leader in analyzing gene expression signatures related to disease in easily available clinical samples such as peripheral blood. This unique method is based on the principle that even when a disease is localized at a specific part of the body, secondary responses, which are also characteristic of the disease, can be measured in other parts of the body. DiaGenic has developed and CE marked two blood based diagnostic tests, BCtect® for early breast cancer detection and ADtect® for early detection of Alzheimer’s Disease. The company protects its technology through an extensive patent portfolio. DiaGenic promotes its products towards leading pharmaceutical and imaging companies, and towards clinicians. DiaGenic is listed on the Oslo Stock Exchange. For more information visit www.diagenic.com
