[Previous Months][Date Index][Thread Index][Join - Register][Login]
[Message Prev][Message Next][Thread Prev][Thread Next]

[IP] Inhale Announces First Results of Phase IIb Inhaled Insulin

     Contact: Joyce Strand (650) 631-3138
     Inhale Announces First Results of Phase IIb Inhaled Insulin Trials
     Data Show that Pulmonary Insulin Provides Control Comparable to 
     Conventional Injected Therapy for Treatment of Diabetes; Patients 
     Prefer Inhaling to Injecting Insulin
     SAN CARLOS, Calif., June 16, 1998--Inhale Therapeutic Systems 
     (NASDAQ:INHL) today announced the results of three-month clinical 
     trials with 121 outpatients conducted by its collaborator Pfizer
     Inc., which demonstrate the pulmonary delivery of insulin resulted in 
     blood glucose control and dose-to-dose reproducibility comparable to 
     injection for the treatment of diabetes. In these Phase IIb trials,
     patients also significantly favored inhaling over injecting insulin.
     Presentations at the annual American Diabetes Association 58th 
     Scientific Session made today by academic clinical investigators 
     collaborating with Pfizer showed that a treatment regimen using 
     inhaled insulin achieved levels of blood glucose control for patients 
     with both Type 1 (juvenile onset) and Type 2 (adult onset) diabetes 
     that were as good as those obtained with a conventional regimen of 
     injected insulin. 
     Data presented in a poster session from an additional trial of 16 
     patients showed that the dose-to-dose reproducibility of the insulin 
     absorbed into the body by inhalation was as good as that achieved 
     through insulin injection.
     "Inhaled insulin could provide a more convenient, patient-friendly 
     alternative to injections for millions of diabetics," said Robert 
     Chess, president and chief executive officer of Inhale. "Diabetic 
     patients have now used the Inhale pulmonary delivery system in 
     outpatient settings for more than 18 months. We estimate more than 
     100,000 drug doses have been inhaled and well tolerated in human 
     clinical trials. Inhale is very pleased that these results clearly 
     demonstrate the effectiveness of pulmonary delivery and our system for 
     proteins like insulin in an at-home setting over several months of 
     Need for Improved Insulin Delivery
     Inhale believes that pulmonary delivery could increase the use of 
     insulin and expand the $3 billion worldwide market for insulin and its 
     delivery systems. Approximately 3.5 million diabetics in the United 
     States are believed to use injectable insulin currently. Many more of 
     the estimated 16 million diabetics in the United States could benefit 
     from using insulin, but choose not to because of their dislike of 
     injections." Our market research strongly suggests that patients who 
     have never used insulin would be more likely to start if they can 
     inhale rather than inject it, and that those using insulin currently 
     may use it more often," concluded Chess.
     By increasing the use of insulin, pulmonary delivery could help to 
     reduce the complications caused by diabetes and decrease healthcare 
     costs. Poorly treated or left untreated, diabetes can lead to a 
     variety of life-threatening complications, such as blindness, kidney 
     disease, heart disease and stroke. It is one of the most costly health 
     problems in the United States. Total costs, including those related to 
     diabetes treatments as well as lost productivity, are approximately 
     $92 billion per year.
     Studies* show that intensive insulin therapy (giving insulin 3-6 times 
     per day) can delay the onset and slow the progress of the 
     complications of diabetes by as much as 35-60%. Many diabetics have 
     failed to adopt this intensive therapy due to the high number of 
     injections required. A patient-friendly pulmonary system potentially 
     could encourage more frequent insulin use and improve the quality of 
     diabetes care.
     Two Multisite Clinical Studies
     Clinical investigators presented results today from two clinical 
     studies conducted at ten U.S. study sites that indicated that 
     pulmonary insulin provides the same quality of control as injection. 
     In the first study, 70 patients with Type 1 diabetes were randomized 
     to either inhaled treatment or subcutaneous injections for three 
     months. The injection group continued on their prior regimen of two to 
     three injections daily. The inhaled group took one or two inhalations 
     of insulin per meal (depending on their individual dosing need). Both 
     groups also received one injection of a slow-acting insulin at bedtime 
     to control blood sugar levels during the night. The level of glycemic 
     control (Hemoglobin A1c measurement) did not differ statistically 
     between the two groups. The injected group averaged 8.5% at baseline 
     and 7.7% after three months; the inhaled group averaged 8.5% at 
     baseline and 7.8% after three months.
     In the second clinical study, 51 patients with advanced Type 2 
     diabetes were randomized to either inhaled treatment or subcutaneous 
     injection for three months. The same patterns of use and study goals 
     were implemented as in the Type 1 study. The investigators saw 
     improvements in blood glucose in both groups, with the changes in 
     Hemoglobin A1c virtually identical. The injected group averaged 7.8% 
     at baseline and 7.1% after three months; the inhaled group averaged 
     8.7% at baseline and 8.0% after three months.
     In both studies, the incidence of hypoglycemia -- low blood sugar 
     reactions due to over-control -- occurred at about the same rate in 
     both the inhaled and subcutaneous groups. Patients additionally 
     tolerated the inhaled treatment well, and no changes were noted in 
     pulmonary function. Moreover, patient questionnaire results favored 
     inhaled insulin, and 92% of the Type 2 participants who received 
     inhaled insulin during the trial and 80% of the Type 1 participants 
     who received inhaled insulin during the trial opted to continue on 
     inhaled insulin after the three-month study period ended.
     Pharmacological Reproducibility
     In a separate poster presentation of data from an additional 16 Type 2 
     diabetics, investigators showed that the amount of insulin absorbed by 
     the body from each inhaled administration was consistent from 
     dose-to-dose even in inexperienced users of the Inhale device. The 16 
     patients underwent five standardized test-meal sessions, first with no 
     therapy, then in a four-way, randomized-sequence crossover involving 
     two inhalations and two subcutaneous sessions with insulin given ten 
     minutes before mealtime. This dose consistency was comparable to that 
     achieved through insulin injections as measured by several different 
     methods including amount of insulin absorbed and glucose decrease; 
     time of insulin absorption and glucose decrease; and peak glucose 
     decrease. "We are pleased that the data show that pulmonary dosing is 
     as consistent as injection. This is particularly important for drugs 
     with tight dosing regimens such as insulin," said Chess.
     Inhale Pulmonary Delivery System
     Using the Inhale system, a patient takes a slow, deep inhalation of 
     fine-powdered medicine rather than receiving an injection. The Inhale 
     device is designed to efficiently disperse the powders into a small
     standing cloud within a clear chamber. The cloud is then slowly and 
     deeply inhaled by a patient. The system is designed to position the 
     aerosol at the front of the deep inhalation in a small percentage of 
     the total inhaled volume. This helps ensure reproducible delivery of 
     medicine across a wide variety of patient lung capacities.
     The fine-powdered insulin is packaged into individual dosage (blister) 
     packs whose particles are specifically formulated to reach the deep 
     lung, where the drug is quickly and easily absorbed into the blood
     stream. Inhale's patented dry powder technology enables formulations 
     that are stable over a wide range of environmental conditions 
     including room temperature. Most currently marketed peptide and 
     protein drug formulations must either be refrigerated or have other 
     constraining storage and use restrictions. Using Inhale's stability 
     technology, patients could have more freedom to travel and move about 
     without concern for the storage conditions of their drugs.
     Inhale, located in San Carlos, is developing pulmonary delivery 
     systems to enable a range of drugs, including peptides and proteins, 
     to be delivered by the pulmonary route for systemic and local lung
     indications. The company has six drugs in human clinical trials using 
     its delivery system and has feasibility and development partnerships 
     with several pharmaceutical, biotechnology, and medical technology
     companies, including Pfizer, Lilly, Baxter and Centeon. The company is 
     currently scaling-up its system for commercial production.
     This release contains forward-looking statements that reflect 
     management's current views as to the company's collaborative 
     arrangements, clinical trials, product developments, manufacturing 
     scale-up, and other future events and operations. These 
     forward-looking statements involve uncertainties and other risks that 
     are detailed in Inhale's reports and other filings with the SEC, 
     including its Form 10-K for the year ending Dec. 31, 1997. Actual 
     results could differ materially from these forward-looking statements.
     *Editor's note: for more information on the value of increased use of 
     insulin, see The Diabetes Control and Complications Trial (DCCT) 
     Research Group, "The New England Journal of Medicine," Vol. 329,
     No. 14, Sept. 30, 1993.

Insulin-Pumpers website http://www.bizsystems.com/Diabetes/
For subscribe / unsubscribe information,
send the next two lines in a message
to the e-mail address: email @ redacted