Pfizer Inc and Hoechst Marion Roussel to Co-Develop and Co-Promote Inhaled Insulin 11/04/98 PR Newswire
New Frankfurt Plant Will Produce Insulin for Global Distribution
NEW YORK and FRANKFURT, Germany, Nov. 4 /PRNewswire/ -- Pfizer Inc (NYSE: PFE) and Hoechst Marion Roussel AG announced today that they have entered into worldwide agreements to manufacture insulin, co-develop and co-promote inhaled insulin. This product, completing Phase II development, represents a novel approach to the treatment of Type-1 and Type-2 diabetes. Implementation of the agreements is subject to usual governmental review. No financial details were disclosed.
Under the terms of the agreements, each of the companies will contribute expertise in the development and production of insulin products coupled with their global sales and marketing resources to successfully commercialize inhaled insulin. Pfizer and Hoechst Marion Roussel will construct a jointly owned manufacturing plant -- one of the world's largest insulin producing facilities of its kind -- in Frankfurt, Germany. The plant will employ more than 200 workers. Until its completion, Hoechst Marion Roussel will provide biosynthetic recombinant insulin from its existing facility.
Pfizer brings to the alliance its development of inhaled insulin, in its collaboration with Inhale Therapeutic Systems of San Carlos, California, developers of the inhalation device and formulation processing technology for pulmonary delivery of dry powder insulin. Pfizer also brings experience in successful global development and launches of major products.
"We look forward to working with Hoechst Marion Roussel on this product," said Henry A. McKinnell, Ph.D, executive vice president, Pfizer Inc and president of Pfizer Pharmaceuticals Group. "Inhaled insulin provides a significant commercial opportunity for Pfizer and helps meet unmet medical needs for the diabetic patient. People with diabetes frequently have other medical conditions such as hypertension, dyslipidemia and erectile dysfunction, where several major Pfizer products are used widely."
Hoechst Marion Roussel has a long and successful history in the research, development and manufacture of insulin. Hoechst was instrumental in the production of the first insulin manufactured in Europe in 1923 and has continuously introduced new products and improved formulations for diabetes patients since that time. Hoechst Marion Roussel is a major producer of injectable insulin and oral hypoglycemic agents.
"This dynamic alliance provides an ideal opportunity for Hoechst Marion Roussel to utilize its existing insulin expertise, advanced production technology and global drug promotion capabilities to help make another breakthrough a reality for diabetes patients," said Richard J. Markham, chairman of the board of management and CEO of Hoechst Marion Roussel AG. "Together, Pfizer and Hoechst Marion Roussel can achieve a global presence and distribution for inhaled insulin that no single organization could achieve on its own."
Diabetes is a widespread and chronic condition that results when the body produces either no insulin or inadequate amounts to metabolize sugars normally. Diabetes affects more than 142 million people worldwide. The number of cases is expected to double by the year 2025, according to the World Health Organization. Unless properly treated, diabetes can result in serious medical complications that include kidney failure, blindness, cardiovascular and neurological conditions and impotence. The American Diabetes Association estimates the combined direct and indirect annual cost of the disease is $98 billion in the U.S. alone.
Two landmark studies, the Diabetes Control and Complications Trial and the recently released United Kingdom Perspective Diabetes Study, in people with Type-1 and Type-2 diabetes, respectively, demonstrated that tight control resulting from intensive treatment can prevent debilitating and costly complications of diabetes. The difficulty in treating diabetes is that the disease is progressive and requires more intensive treatment over time. Many patients regardless of the type of diabetes or therapeutic regimen, remain uncontrolled because they choose not to move to a more aggressive treatment which includes insulin injections.
By helping to minimize the need for injections for many people with diabetes, the new, user-friendly option of inhaled insulin has the potential to broaden the usage of insulin in patients with either Type-1 or Type-2 diabetes. To date, phase II studies have demonstrated that inhaled insulin is as effective as regular injectable insulin and that addition of inhaled insulin provides significantly better control for patients not well-controlled on oral agents. "We believe that a breakthrough in the mode of delivery of insulin will help to remove the barriers that currently inhibit many people with diabetes from seeking insulin treatment which could greatly improve their quality of life," said Frank L. Douglas, executive vice president and head of drug innovation and approval for Hoechst Marion Roussel.
"Insulin therapy should play a broader and more important role in diabetic therapy, but effective treatment is often delayed because of the uneasiness caused by insulin shots," said John F. Niblack, Ph.D., executive vice president, Pfizer Inc. "Our partnership with Hoechst Marion Roussel and Inhale should ultimately offer the proven medical benefits of insulin to larger numbers of patients who suffer from this chronic and debilitating disease."
Hoechst Marion Roussel, a world leader in pharmaceutical-based health care, is dedicated to extending and enhancing human life through the discovery, development, manufacture and sale of pharmaceutical products. Its major products are among the world's leading therapies for allergic, metabolic, and central nervous systems disorders and cardiovascular and infectious diseases. Based in Frankfurt, Germany, Hoechst Marion Roussel is the pharmaceutical company of Hoechst AG, an international company that focuses on life sciences.
Pfizer Inc is a research-based global pharmaceutical company that discovers, develops and markets innovative medicines for humans and animals. The company reported sales of about $12.5 billion for 1997 and expects to spend about $2.2 billion on research and development this year.
Statements in this release other than historical information are forward- looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the availability of resources, the timing and effects of regulatory actions, the strength of competition, the outcome of litigation, and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the 1997 Hoechst AG Annual Report on Form 20-F on file with the Securities and Exchange Commission. |