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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly) -- Ignore unavailable to you. Want to Upgrade?

To: Barron Von Hymen who wrote (331)	6/16/1998 2:53:00 PM
From: Anthony Wong	Respond to of 1722

Inhale Therapeutic's New Insulin Therapy Found Safe, Effective [Barron & all, Pfizer co-developed this drug] Bloomberg News June 16, 1998, 9:01 a.m. PT Inhale Therapeutic's New Insulin Therapy Found Safe, Effective Chicago, June 16 (Bloomberg) -- Inhale Therapeutic Systems' new inhaled-powder form of insulin is safe and effective in treating diabetes, according to new research that suggests it could be a breakthrough treatment for millions of diabetics who take multiple daily injections. Studies of 121 diabetics found the experimental drug had almost an identical effect as injected insulin. Patients in one group took either one or two inhalations of the powdered insulin before meals in addition to one injection of slow-acting insulin before going to bed. Those in a control group followed their regular regime of two to three insulin shots a day. The inhaled product is designed to reduce the need for painful insulin shots that sometimes keep diabetics from following the strict dosing regime designed to prevent complications of the disease, including blindness, kidney disease, amputations and death. ''The new delivery system may dramatically change diabetes, particularly in patients who have been hesitant to use appropriate insulin therapy because of the discomfort and inconvenience of injections,'' said Jay Skyler, a University of Miami professor who helped conduct the trials. Pfizer Inc. is co-developing the product with San Carlos, California-based Inhale Therapeutic, which invented the system. Should it win regulatory approval for sale in the U.S., it will compete in an insulin market dominated by Indianapolis-based Eli Lilly & Co. and Novo Nordisk A/S of Denmark. Aerosol Cloud Inhale Therapeutic Systems' product is delivered using a hand-held device the size of a flashlight that produces an aerosol cloud that patients inhale. The drug is then transmitted through the lungs to the bloodstream. Researchers reviewed the trials of the new drug at the annual meeting of the American Diabetes Association in Chicago, where physicians and researchers gathered to discuss advances in treatments for diabetes, the sixth-leading cause of death by disease in the U.S. The data was from the second of three stages of clinical trials needed to gain regulatory approval for the product. There is no cure for diabetes. Patients with the disorder can't properly produce or utilize insulin, a hormone that regulates absorption of glucose by cells. That can cause cells to literally starve to death. ''The main issue is patient compliance. If patients don't have the burden of the ceremony of insulin injections, they are going to go along with it very well,'' said Gerald Bernstein, president of the American Diabetes Association. That should save lives, reduce the incidence of complications from diabetes and ultimately cut down on medical costs, Bernstein said. Glucose Levels A landmark 1993 National Institute of Health study known as the Diabetes Control and Complications Trial found that carefully controlling glucose levels throughout one's life greatly reduces the results of severe diabetic complications. ''The typical diabetic takes insulin 1.9 times a day, but should be taking it 3.6 times a day,'' said Inhale Therapeutic Systems Chief Executive Robert Chess. ''They don't because they don't want to turn themselves into pin cushions.'' To date, diabetics have had to receive insulin through injection because the hormone is rendered useless when digested by chemicals in the stomach. Inhaled Therapeutic Systems and New York-based Pfizer aren't the only companies trying to develop inhaled insulin systems. Novo Nordisk A/S and Hayward, California-based Aradigm Corp. earlier this month signed an agreement to develop a system that they plan to start testing for effectiveness and safety in the second half of this year. The trials presented today surveyed 70 patients with Type 1 diabetes -- a disorder in which the body destroys insulin- producing beta cells in the pancreas -- and 51 with Type 2 diabetes -- a condition most common in overweight people above the age of 45 in which the body fails to use insulin properly. The studies compared the effectiveness of the two treatments by looking at HBa1C, a long-term measure of blood glucose. In the study of Type 1 diabetics, researchers found the inhaled-insulin group began the trial with an average HBa1C level of 8.5 percent, which fell to 7.8 percent after three months. The group treated with injections saw that average fall from 8.5 percent to 7.7 percent. The study of Type 2 diabetics found that the average HBa1C level fell 0.7 percentage point in both groups, from a base of 7.8 percent in the injection group and 8.7 percent in the inhaled group. The incidence of low-blood sugar reactions known as hypoglycemia occurred at the same rate in all groups that were studied. Testing revealed no changes in pulmonary function or any other significant side effects from inhaling the powder, the researchers said. The trials discussed today will be followed up with ones starting in November that will study more than 1,000 patients. Diabetics interested in participating in future trials of inhaled insulin can call 1-800-438-1985 for further information. --Jim Finkle in the San Francisco newsroom (415) 912-2996/dd