STOCKHOLM, Sweden, Sept. 8, 2003 (PRIMEZONE) -- Amgen Inc. (Nasdaq:AMGN) and Biovitrum AB today announced that they have signed a multifaceted agreement under which Amgen receives exclusive rights to develop and commercialize Biovitrum's small molecule 11b-HSD1 enzyme inhibitors for the treatment of metabolic diseases and certain other medical disorders.
The most advanced compound included in the agreement is BVT.3498, currently in Phase IIa clinical trials for type 2 diabetes. Type 2 diabetes, a disease in which insulin resistance leads to elevated blood sugar levels, currently afflicts over 160 million people worldwide. Approximately 20 million Americans currently suffer from type 2 diabetes. Early intervention using innovative therapies has the potential to delay the onset of life-threatening metabolic disorders.
Amgen will make an upfront payment of $86.5 million and will fund and conduct all further development and commercialization activities in the licensed territory, which includes North and South America, the European Union, Australia and New Zealand. Amgen will also make significant periodic milestone payments related to development progress, regulatory submissions and approvals for metabolic diseases and certain other indications. Once a product has been approved, Biovitrum will also receive tiered royalties on future sales of all products arising from the agreement. In addition, Amgen will fund a three-year research program conducted by Biovitrum to develop additional 11b-HSD1 enzyme inhibitor compounds.
Amgen has also granted co-promotion rights in the European Union for Amgen's Kineret(R) (anakinra), a rheumatoid arthritis treatment. Biovitrum will also have co-promotion rights in the Nordic region for all products developed under the agreement as well as for Amgen's cinacalcet hydrochloride (HCI), a treatment for some hyperparathyroid conditions, and palifermin, a therapy for treating chemotherapy-related inflammations of the mouth. Cinacalcet and palifermin are investigational products in clinical development. In addition, Biovitrum will perform biopharmaceutical process development work funded and directed by Amgen over the next three years.
The agreement is subject to review by applicable governmental antitrust and competition authorities.
"This agreement represents a significant commitment by Amgen to pursue innovative treatments for metabolic diseases including insulin resistance" said Roger M. Perlmutter, Executive Vice President -- Research and Development for Amgen. "Through this agreement we are gaining access to important research that we hope will develop into an effective treatment for type 2 diabetes and related metabolic diseases. At the same time, we are establishing a strong working relationship with an organization whose work complements our own."
"Amgen has a history of pioneering work, excellent research and development capabilities, and extensive marketing and distribution expertise," said Mats Pettersson, CEO of Biovitrum. "We are confident that in Amgen we have a strong and committed partner for completing development of this innovative approach for helping those suffering from type 2 diabetes and related disorders."
Paul de Potocki, Head of Commercial Operations at Biovitrum said, "We are also pleased to have reached an agreement that will assist Biovitrum in developing a marketing and sales presence in Europe."
Amgen enquiries: Sabrina Johnson, +1 805 447-4587 (media) Cary Rosansky, +1 805 447-1060 (investors) Biovitrum enquiries: Mikael Widell, SVP Communications Biovitrum AB Phone +46 8 697 20 85 Mobile +46 70 311 99 60 mikael.widell@biovitrum.com Douglas Pretsell, Ph.D. Noonan Russo EURO RSCG Life Phone +44 20 7726 4452 d.pretsell@eurorscg.com
Notes to editors:
About Amgen
Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology.
About Biovitrum
Biovitrum is a privately-held biotech company active in the discovery and development of drugs to treat metabolic diseases, such as type 2 diabetes and obesity, and in the contract process development and manufacturing of protein therapeutics. The company has a strong intellectual property and technology platform, with a number of compounds in pre-clinical and clinical development. Biovitrum is one of the largest biotech companies in Europe with more than 575 employees. Annual revenues, including royalties and contract service fees, finance the major part of the annual research budget. For more information, please visit Biovitrum's website at www.biovitrum.com.
11b-HSD
Excess glucocorticoids such as cortisol produce visceral obesity and diabetes. 11beta-hydroxysteroid dehydrogenases (11b-HSDs) are enzymes that play an important role in the interconversion of glucocorticoids between the active and inactive forms. Two enzymes have been identified, 11b-HSD1, and 11b-HSD2. These 11b-HSDs play a major role in the modulation of local cortisol levels and the access of active steroid to its receptors in the target tissues. Thereby, the 11b-HSDs are also believed to have important roles in a number of common diseases, including obesity, type 2 diabetes and hypertension.
11b-HSD2 is found primarily in tissues such as kidney, sweat glands and salivary glands. 11b-HSD2 converts active glucocorticoids into inactive steroids and appears to act as an effective barrier to excess cortisol across a wide range of cortisol concentrations. However, in studies where the 11b-HSD2 enzyme activity has been inhibited with liquorice this results in an excess of steroids that cause hypokalemia and hypertension.
11b-HSD1 is present in tissues of importance for metabolism and insulin sensitivity such as the liver and the adipose tissue. Its activity can be altered by factors such as glucocorticoids, stress, sex steroids, growth hormone, cytokines and PPAR agonists. Under normal conditions, 11b-HSD1 is believed to amplify local glucocorticoid concentrations in target tissues, in particular when the circulating plasma cortisol levels are low. However, in obese subjects the levels of 11b-HSD1 are usually markedly increased, at least in adipose tissue. This observation is of importance in the light of a rodent study recently published in Science, demonstrating that animals with an increased 11b-HSD1 activity (i.e. transgenic animals) have an excess of visceral fat and are insulin resistant, diabetic and dyslipidemic. Furthermore, in humans, pharmacological inhibition of 11b-HSD1 with non-selective compounds has previously been shown to result in enhanced insulin sensitivity. This finding indicates that 11b-HSD1 appears to play an important role in type 2 diabetes and the metabolic syndrome also in man, and that selective inhibitors of 11b-HSD1 could become a very useful tool in the treatment of this disorder.
Type 2 Diabetes (also known as non-insulin dependent, adult onset or type 2 diabetes mellitus) Type 2 diabetes is a lifestyle disease with a strong hereditary component. Estimates of diabetes prevalence around the world have more than tripled since 1985. The current global prevalence is approximately 160 million people and has been estimated to increase to 300 million people in 2025. Presently, approximately 6% of the population in the United States is diabetic. Of these patients, 90-95% are afflicted with different forms of type 2 diabetes, a condition that is expected to become increasingly widespread, due to the increasing number of elderly, a more sedentary lifestyle and rapidly growing incidence of obesity. The worldwide annual average mortality in diabetics (5.4%) is twice as high as in non-diabetics. Each year in the United States alone type 2 diabetes results in about 200,000 deaths, 400,000 heart attacks, 130,000 strokes, 60,000 amputations, 10,000 new cases of kidney failure requiring dialysis or transplantation and 6,000 new cases of blindness. Type 2 diabetes also leads to other disabilities, especially nerve damage, that could result in erectile dysfunction, numbness, intractable nausea, and diarrhea. Diabetes is currently the sixth leading cause of death by disease in the United States and is estimated to cost the US health care system 100 billion USD per year. It is estimated that by the year 2010, diabetes will exceed both heart disease and cancer as the leading cause of death through complications.
Type 2 diabetes is a progressive disease caused by a combination of decreased tissue sensitivity to insulin (insulin resistance) and an insufficient insulin secretion. The blood glucose control in type 2 diabetes usually deteriorates over time and, despite lifestyle intervention efforts, additional pharmacological treatment in many cases ultimately becomes necessary. Type 2 diabetes is frequently associated with obesity, dyslipidemia, hypertension, atherosclerosis, thrombosis and cardiovascular disease. In the treatment of diabetes it is important to address all these aspects of the disease. The unmet need for new, safe and effective treatment tools to prevent the progression of the type 2 diabetes, its serious complications and the associated over-mortality in this disease remains enormous.
Oral mucositis
A painful condition caused by toxic effects of chemo/radiotherapy on rapidly dividing cells of the oral mucosa. Therapies with the highest incidence of mucosal toxicity (70%-90% rate of severe mucositis) include myeloablative-conditioning regimens associated with bone marrow and stem cell transplantation and for hematological tumors and chemo/radiotherapy for treatment of solid tumors (Head and Neck Cancer, Non Small Cell Lung Cancer and Esophageal Cancer).
Secondary hyperparathyreoidism is characterized by hyperplasia of the parathyroid glands and elevated concentrations of circulating parathyroid hormone (PTH). PTH acts on the bone and kidney to increase serum calcium levels, increase urinary phosphorus excretion, and stimulate renal production of vitamin D3 (calcitriol). PTH levels are regulated by a negative feedback loop in which increased levels of serum calcium act directly on parathyroid cells to inhibit PTH secretion. Secondary HPT is most commonly seen as a consequence of chronic renal failure.
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If you have any questions please do not hesitate to contact Noonan Russo on +44 20 7726 4452