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GAP and IMI to Sign MOU to Accelerate Alzheimer's Drug Development

WASHINGTON and NICE, FRANCE, March 19, 2015 (GLOBE NEWSWIRE) -- The Global Alzheimer's Platform (GAP) and the Innovative Medicines Initiative (IMI) announced today that they will sign a Memorandum of Understanding (MOU) to accelerate Alzheimer's drug development by building a global, standing, trial-ready platform for Alzheimer's drug development. The collaboration represents a significant commitment to work together to recruit patients for clinical trials, to create a high-performing clinical trial system, and to develop a standing adaptive protocol to test new molecules quickly, and move those with promise into later stage development.

"This agreement represents an important commitment from major initiatives in Europe and the United States to expand and improve our capacity to conduct trials in Alzheimer's in order to bring innovative medicines to patients faster," said George Vradenburg, convener of the Global CEO Initiative on Alzheimer's Disease, co-founder of USAgainstAlzheimer's, and a member of the World Dementia Council. "Through our collaborative efforts here in the U.S., organized through GAP, and with these consortia in Europe, we believe we can begin to design a truly global clinical trial system of speed, power, and efficiency. No one company or one government can do this alone. We must have a global commitment and it must come from government, industry, and academia and be driven by the passion and urgency of the patient community."

Currently, there is no global pool of persons with or at risk of Alzheimer's who are standing ready, able, and willing to participate in clinical trials of promising innovative Alzheimer's medicines. The challenge of recruiting into the range of trials underway today and in the future stands as one of the single greatest barriers to increasing the pace of drug development in Alzheimer's. This problem is further compounded by the fact that each new Alzheimer's trial must start the process of participant recruitment and trial site preparation anew, with the consequence that lessons are lost, participant experience is wasted, and investments are repeated, costing individuals and industry precious time.

The Global Alzheimer's Platform, initiated by the Global CEO Initiative (CEOi) on Alzheimer's Disease and the New York Academy of Sciences, is in advanced development with leadership and initial funding from Janssen Pharmaceuticals, the drug development division of Johnson and Johnson, Eli Lilly and Company, Lundbeck, Takeda, and The Ray and Dagmar Dolby Family Fund. GAP's objectives are to establish a global standing, trial-ready platform, projected to reduce clinical testing cycle times by two years or more, to achieve greater efficiency and uniformity in trial populations through large, well-characterized trial-ready cohorts and certified clinical trial sites, and to more rapidly test the effectiveness of drugs through an adaptive proof of concept trial mechanism. This platform will enable the delivery of efficient and effective proof of concept and confirmatory trials and ultimately the more rapid delivery of effective therapies to patients or those at risk.

The Innovative Medicines Initiative is a private-public partnership between the European Union (represented by the European Commission) and the European pharmaceutical industry (represented by EFPIA, the European Federation of Pharmaceutical Industries and Associations) that aims to improve clinical trials success rate and deliver clinical proof of concept, biomarkers, and new medicines.

"Alzheimer's disease is a global challenge that requires a global solution, and it is in this spirit that the IMI and GAP will collaborate and align their research. The Memorandum of Understanding is the evidence for our genuine interest in working together to create an international clinical trials platform," said Irene Norstedt, IMI Acting Executive Director. "Everyone working on Alzheimer's disease needs to pull together if we want to deliver results that will help us to end the suffering caused by this terrible disease."

"This collaboration has the potential to be a game changer for Alzheimer's drug development," said Dr. Janet Woodcock, Director of the Center for Drug Evaluation at the U.S. Food and Drug Administration. "A global trial-ready platform will increase our prospects of finding important biomarkers, or discovering effective treatments for Alzheimer's. If we don't do this, we may be facing decades of uncoordinated, one-off efforts that fail to enhance our ability to accelerate learning and human testing and really move the field forward."

Today's GAP-IMI announcement was made at the 12th International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders taking place in Nice, France. The meeting comes on the heels of the first-ever World Health Organization Ministerial Conference on Global Action Against Dementia, which took place in Geneva, Switzerland earlier this week.

"Lilly is pleased to see this level of global collaboration that aims to accelerate clinical trials and ultimately help speed drugs to patients," noted Phyllis Ferrell, global brand development leader, Alzheimer's disease at Eli Lilly and Company. "We look forward to our continued work with GAP and IMI to assure the promise of this collaboration is realized."

Background on Alzheimer's

Alzheimer's disease is an incurable, progressive brain disease that slowly destroys memory and thinking skills and eventually is fatal. Recent research indicates that Alzheimer's disease and dementia claims more than 500,000 lives in America annually, and more than 44 million worldwide. The cost to care for Alzheimer's patients in the United States will exceed $1 trillion by 2050, according to USAgainstAlzheimer's, the organizer of CEOi. Without a means of prevention or cure, the number of persons with Alzheimer's and dementia is projected to triple in size by 2050 and threaten the solvency of national health care systems the world over. However, the scientific understanding of the disease continues to advance. And there are several promising drug candidates now in development that potentially could benefit patients worldwide.

Since the G8 Dementia Summit was held in London in December 2013, the global momentum in the response to Alzheimer's and dementia has grown tremendously. This work includes the formation of the World Dementia Council; the convening of G8/G7 legacy meetings by Prime Minister Cameron of the United Kingdom, Health Minister Ambrose of Canada, and Prime Minister Abe of Japan; and the recognition by an increasing number of international organizations (United Nations, WHO, and the Organization for Economic Cooperation and Development) of the commitments needed to address the global challenge of Alzheimer's.

The Global CEO Initiative on Alzheimer's Disease (CEOi) is an organization of private-sector leaders providing business leadership in the fight against Alzheimer's. The CEO Initiative seeks to partner with political leaders to transform the disease from a social, health, and economic crisis into an opportunity for healthy aging and innovation in research and care. The CEO Initiative believes that, during this era of aging populations, it will take visionary, united, goal-oriented leadership of public and private leaders working together to solve our greatest challenges. Learn more at: www.ceoalzheimersinitiative.org.

The Innovative Medicines Initiative (IMI) is working to improve health by speeding up the development of, and patient access to, innovative medicines, particularly in areas where there is an unmet medical or social need. It does this by facilitating collaboration between the key players involved in healthcare research, including universities, the pharmaceutical and other industries, small and medium-sized enterprises (SMEs), patient organisations, and medicines regulators. IMI is a partnership between the European Union and the European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA). Through the IMI 2 programme, IMI has a budget of €3.3 billion for the period 2014-2024. Half of this comes from the EU's research and innovation programme, Horizon 2020. The other half comes from large companies, mostly from the pharmaceutical sector; these do not receive any EU funding, but contribute to the projects 'in kind', for example by donating their researchers' time or providing access to research facilities or resources.

New York Academy of Sciences (NYAS), founded in 1817, is one of the oldest scientific institutions in the U.S. with more than 20,000 members in 100 countries. The Academy fosters new international collaborations among experts in academia, industry, and government to drive advances in science, medicine, technology, and sustainability, and is viewed as a global neutral convener, having formed international public private partnerships and aligning with the WHO to address the global challenges of under- and over-nutrition. In 2011, the Academy expanded its portfolio of interdisciplinary scientific programs to launch the Alzheimer's Disease and Dementia Initiative (ADDI) that seeks to accelerate the transfer of basic research into the development of new methods to address Alzheimer's disease and dementia. ADDI is committed to ensuring that there is coordinated action to develop improved diagnostics, preventive measures, and disease-modifying therapies for Alzheimer's disease and dementia. Please visit www.nyas.org/ADDI to learn more.

CONTACT: Ranit Schmelzer, 202-538-1065, rschmelzer@usgainstalzheimers.org

Source: The Global CEO Initiative on Alzheimer's Disease