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Functional Pharmaceuticals, Inc. Announces Exclusive License Agreement With Massachusetts General Hospital For Alzheimer's Drugs


10/19/2005 5:09:11 PM

Lowell and Boston MA, August 29, 2005 Functional Pharmaceuticals, Inc., (FPI) a new drug development company based in Lowell, MA, announced today that it has signed an exclusive license agreement with Massachusetts General Hospital (MGH) to develop a new class of drugs for the diagnosis and treatment of Alzheimer's Disease (AD).

The drugs, invented in the laboratory of Dr. Xudong Huang of the MGH Department of Psychiatry, have shown tremendous potential to decrease the amount of neuro-filamentory tangles that are the hallmark of the disease. Previous research at MGH by Dr. Huang's lab at the MassGeneral Institute for Neurodegenerative Disease demonstrated the complex role played by metals in the formation of peptide plaques. The drugs are designed to bind to both metals and peptides and act to short-circuit the biochemical events leading to AD. The first candidate in this technology platform, FP-1, has shown efficacy in mouse models and in cell culture, specifically reducing the amount of the amyloid peptide in a dose-response manner. Preliminary data have been published (Exper. Gerontol., 39, 1641 (2004)) and patents on this invention have been filed in the US and at the World Patent Office.

The molecules also show promise in the diagnosis of AD through Magnetic Resonance Imaging (MRI). Currently, there is no approved method to diagnose AD. By attaching an MRI-active metal to the drug, it is possible to detect amyloid plaques in the brain. Preliminary experiments have demonstrated that the imager will enter the brain, and that the resulting MRI signals are dependent upon the amount of amyloid peptide.

The agreement gives FPI the exclusive rights to develop the new technology. Under the terms of the agreement, MGH will receive royalties on future sales, reimbursement of its patent costs and milestone payments as the drugs proceed through the regulatory process. In addition, MGH has acquired a minority equity stake in the new company.

"We have a candidate drug that has done everything that was asked of it in our preliminary screens" said Dr. Jonathan N. Kremsky, CEO of FPI. "The next step is to begin pre-clinical studies for both the diagnostic and the therapeutic. We're very happy to be working so closely with MGH, one of the premier centers for medical research in the world and we are especially proud and excited that MGH has chosen to hold an equity position in FPI."

About Alzheimer's Disease

Almost everyone has some personal experience with AD, through a family member or friend. It is a form of progressive senile dementia that slowly destroys brain nerve cells. The disease is characterized by the deposition of plaques composed of a peptide called amyloid. These plaques cause metals to accumulate and these metals are responsible for oxygen-induced damage.

There are currently 4.5 million AD patients in the US and this number is expected to grow to 14 million by 2050 as the population ages. The worldwide market for AD therapeutics was ~$2 billion in 2003 and at a growth rate of >20% per year will reach $4.5 billion by 2008. The current drugs are quite limited: they merely ease some symptoms of the disease and some have unacceptable side-effects. There is no approved method for diagnosis: the only definitive diagnosis of AD is through the examination of brain tissue after death.

About Massachusetts General Hospital

Massachusetts General Hospital, established in 1811, is the original and largest teaching hospital of Harvard Medical School. The Massachusetts General Hospital conducts the largest hospital-based research program in the United States, with an annual research budget of more than $450 million and major research centers in AIDS, cardiovascular research, cancer, cutaneous biology, medical imaging, neurodegenerative disorders, transplantation biology and photomedicine. In 1994, Massachusetts General Hospital and Brigham and Women's Hospital joined to form Partners HealthCare System, an integrated health care delivery system comprising the two academic medical centers, specialty and community hospitals, a network of physician groups, and nonacute and home health services.

About Functional Pharmaceuticals

FPI was founded in 2004 as a drug discovery company to develop and commercialize new technologies for the treatment and diagnosis of AD and other neurodegenerative diseases.

Contacts:

Perry L. Catchings, Sr. President Functional Pharmaceuticals, Inc. 450 Chelmsford St. Lowell, MA 01851 pcatchings@functionalpharma.com (978) 970-1074 (978) 934-0731 fax

Susan R. McGreevey Manager, Science and Research Communications Massachusetts General Hospital (617) 724-2764 smcgreevey@partners.org



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