Procter & Gamble Announces Strategic Alliance With Gmp Companies For Novel Treatment Of Diabetes Mellitus

Published: 18 April 2002

Naturally Occurring Peptide Stimulates the Growth of Insulin-Producing Cells

The Procter & Gamble Company (P&G) announced today that they have entered into a global, multi-year strategic alliance with GMP Companies, Inc. (GMP) to develop and commercialize a novel way to treat diabetes mellitus, which could benefit patients currently requiring insulin injections.

This new therapeutic approach is based on the breakthrough discoveries of Dr. Aaron I. Vinik of the Strelitz Diabetes Institutes and Eastern Virginia Medical School (EVMS) and Dr. Lawrence Rosenberg of McGill University and the McGill University Health Center in Montreal, Canada. Since licensing the discoveries from EVMS and McGill University in 2000, GMP has completed the pre-clinical development and initiated an early-phase human clinical trial of its first drug candidate, INGAP Peptide, a substance that has promise to encourage the formation of new pancreatic islets of Langerhans, which naturally regulate insulin and blood glucose levels.

Under the terms of the agreement, GMP will receive a $5 million upfront payment. As the development program of INGAP Peptide progresses toward approval and through launch, GMP can receive additional milestone payments tied to the drug's clinical and commercial performance. GMP will also receive tiered royalty payments based on future sales. In an additional agreement, P&G is making a $24 million investment in GMP Companies. The two companies said they will be looking for other opportunities to bring novel technologies to health professionals and consumers.

P&G and GMP Companies will collaborate on research in the field of regeneration of islets of Langerhans in diabetic patients and on the resulting development and commercialization of potential drug candidates. INGAP Peptide is currently in a Phase I clinical trial in insulin-requiring type 1 and type 2 diabetic patients at three sites in the United States.

"We believe that INGAP Peptide has the potential to be an important approach in the treatment of patients with diabetes mellitus," said Bart Chernow, M.D., President and CEO of GMP Companies, Inc. "We are pleased to enter into a strategic alliance of this importance with P&G. They have developed what we believe to be an outstanding reputation in the endocrine community, and they are well positioned to help in the research and development of this potentially important drug candidate."

"We are delighted to be selected by GMP to bring our clinical development and commercialization expertise to such a promising new diabetes therapy," said Mark A. Collar, President of P&G's global pharmaceutical business. "The INGAP Peptide, if successfully developed, has the potential to dramatically improve the treatment of diabetes."

Collar added that P&G also brings expertise in endocrinology, gained through years of experience in working in bone metabolism, hormone replacement therapy, and obesity. He said P&G will also provide consumer marketing expertise. "We have top talent who can't wait to work on this project."

Dr. Emil Skamene, scientific director of the MUHC research institute, said that this discovery is an example of the important link between the health mission of the MUHC and the innovative science conducted at the Research Institute of the MUHC. "Dr. Rosenberg's research is an excellent demonstration of a science that produces knowledge, upon which evidence-based medicine depends, and that directly benefits our community through its translation, application and technology transfer."

Dr. Abraham Fuks, dean of the McGill faculty of Medicine, is very proud of Drs. Rosenberg and Vinik, and the late pathologist-in-chief at Montreal General Hospital and professor of pathology at McGill, William Duguid, M.D., who collaborated with Dr. Rosenberg beginning in 1981. Dr. Fuks is also thankful to the following granting agencies: the Canadian Institutes for Health Research; the National Institutes of Health; the Strelitz Diabetes Research Institute at EVMS, which is supported by Cosmopolitan

International, Cosmopolitan Foundation of Canada, and the Canadian Diabetes Association. "Without the funding of these agencies, the discovery made 21years ago may not have been pursued to the point where a drug has entered clinical trials."

About INGAP Technology

Drs. Vinik and Rosenberg identified and isolated a previously unknown, naturally occurring gene and its protein product that is associated with the generation of islets of Langerhans during normal development of the pancreas in mammals. Islets of Langerhans are areas within the pancreas that contain the cells that produce the hormones insulin and glucagon, which are largely responsible for keeping the blood glucose concentration within the normal range.

Drs. Vinik and Rosenberg termed their protein discovery INGAP, which stands for Islet NeoGenesis Associated Protein. They found that administration of this protein in diabetic animals regenerated new islets of Langerhans that naturally regulated insulin and blood glucose levels. They later identified the smaller, active portion of this protein, a section of which was isolated and termed INGAP Peptide, which is the drug currently in clinical trials.

About Diabetes Mellitus

Diabetes mellitus is a chronic, life-threatening disease for which there is currently no cure. Diabetes is a common disease that affects more than 16 million people in the United States and more than 130 million people worldwide. According to the American Diabetes Association (ADA), nearly 800,000 new cases of diabetes will be diagnosed this year in the U.S. In both human and economic terms, diabetes is one of the most costly diseases in the world. The ADA estimates that the total direct expenses associated with diabetes care each year in the U.S. is $44 billion.

In patients with diabetes, the body does not produce enough or respond adequately to insulin, which is a hormone produced by the islet cells in the pancreas. As a result, glucose is not fully metabolized in patients with diabetes. In severe cases, high glucose levels can lead to coma and death. Chronically elevated blood glucose levels result in significant, long-term complications, including heart attacks, strokes, blindness, kidney disease, nerve disease, vascular disease and amputations. Insulin replacement treatments and other oral medications have only limited success in controlling the consequences of diabetes.

There are two types of diabetes. All type 1 and nearly half of type 2 diabetic patients are insulin dependent. Type 1 diabetes, sometimes referred to as juvenile onset diabetes, is characterized by destruction of the pancreatic islet cells and loss of the insulin producing cells. Type 1 patients require life-long therapy, including repeated monitoring of blood glucose and replacement of insulin one or more times daily in order to maintain blood glucose levels in near normal range.

Type 2 diabetes, or adult onset diabetes, is characterized by the body becoming increasingly resistant to the effects of insulin, requiring the islet cells to produce larger and larger amounts of insulin to control blood sugar levels. Eventually, the body is unable to produce as much insulin as is required. Medications, eventually including exogenous insulin supplements, are required to help control the blood sugar. Gradually, the islet cells start dying off as part of the disease process.

About P&G

P&G (NYSE:PG) makes and sells 250 brands in more than 140 countries. The company's fast-growing prescription drugs unit, called P&G Pharmaceuticals, is focusing in the areas of endocrinology, cardiovascular and musculoskeletal diseases as well as anti-infective therapies. P&G's leading prescription drugs include Actonel® (Risedronate sodium), Didronel® (etidronate disodium), Asacol® (mesalamine) and Macrobid® (nitrofurantoin monohydrate macrocrystals). To learn more about P&G, please visit our website at :

Caution Concerning Forward-Looking Statements

All statements, other than statements of historical fact included in this news release, are forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. In addition to the risks and uncertainties noted in this news release, there are certain factors that could cause results to differ materially from those anticipated by some of the statements made. These factors include the successful development and commercialization of pharmaceutical products internally and with companies such as GMP, including any regulatory clearances required therefore, as well as factors listed in Management's Discussion and Analysis of Financial Condition and Results of Operations in the company's most recently filed Forms 10-K and 8-Ks.

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