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[IP] Novel Treatment of Diabetes Mellitus

Read this interesting item today:

Linda V

Naturally Occurring Peptide Stimulates the Growth of Insulin-Producing Cells

CINCINNATI, April 18, 2002 - 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 will 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 magnitude 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 technology," said Mark A. Collar, President of P&G's 
global pharmaceutical business. "The INGAP Peptide, if successfully 
developed, could dramatically advance the treatment of diabetes." Collar 
added that P&G also brings expertise in endocrinology, gained through years 
of experience working on 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." 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 whi
ch 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). 
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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