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Pfizer Reports Third-Quarter 2007 Results (October 18, 2007): we made an important decision regarding Exubera, a product for which we initially had high expectations,” said Jeff Kindler, Chairman and Chief Executive Officer. “Despite our best efforts, Exubera has failed to gain the acceptance of patients and physicians. We have therefore concluded that further investment in this product is unwarranted.” “We will work with physicians to transition Exubera patients to other treatment options in the next three months. We remain committed to investing significant resources in the development of new and innovative medicines to manage diabetes, including monitoring inhalation technologies and other innovative delivery systems for insulin and other medicines.”
FDA Approves First Ever Inhaled Insulin Combination Product for Treatment of Diabetes (FDA Press Release, Jan 27, 2006.) At the DiabetesMonitor.
News story at CNN: NEW YORK (CNNMoney.com) - The FDA approved Pfizer's Exubera, the first inhalable form of insulin for diabetics. "Until today, patients with diabetes who need insulin to manage their disease had only one way to treat their condition," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, in a press release. "It is our hope that the availability of inhaled insulin will offer patients more options to better control their blood sugars." The FDA announced the approval Friday afternoon. Before the bell on Friday morning, Pfizer (up $0.94 to $25.99, Research) chief executive officer Henry McKinnell mistakenly said that Exubera had been approved by the FDA, but the company immediately corrected his comments and said the decision is still pending. After the real approval, McKinnell said in a press release: "Exubera is major, first-of-its kind, medical breakthrough that marks another critical step forward in the treatment of diabetes, a disease that has taken an enormous human and economic toll worldwide." But now that Pfizer, and its Exubera partner Nektar Therapeutics (up $0.13 to $20.75, Research), have gotten the green light, they could have a potential blockbusters on their hands. Barbara Ryan, analyst for Deutsche Bank, projected that Exubera sales could peak at $2 billion by 2010. Many other analysts have projected the drug will reach $1 billion a year, though some analysts doubt the drug's effectiveness. Exubera is a dry, powdered form of insulin that is inhaled into the lungs. This is the first new form of delivery since diabetics started injecting insulin in the 1920s. Exubera was also approved by the European Commission, the European equivalent of the Food and Drug Administration, on Thursday.
Press release at Pfizer and the Sanofi-Aventis Group Seek Approval to Market Exubera® in the United States: NEW YORK, March 2, 2005 -- Pfizer Inc and the Sanofi-Aventis Group announced today that the United States Food and Drug Administration (FDA) has accepted for filing a new drug application for Exubera® (inhaled human insulin powder). Exubera, a dry powder form of insulin that is inhaled into the lungs prior to eating, using a specially designed inhalation device, has been studied in more than 3,500 patients, some for over seven years. The companies seek approval to market Exubera for adult patients with type 1 and type 2 diabetes. Exubera is currently also under review by the European Medicines Evaluation Agency … Exubera is being developed for patients with type 1 and type 2 diabetes through a collaboration between Pfizer and Sanofi-Aventis. The two companies have entered into a global agreement to co-develop, co-promote (where permitted by local law) and co-manufacture inhaled insulin. Pfizer is also in collaboration with Nektar Therapeutics, developers of the inhalation device and formulation.
Aventis: Pharma R&D Day delivering results (May 15, 2001) "Exubera (inhaled insulin) is a revolutionary breakthrough approach to delivering insulin in a dry powder formulation to the lungs via inhalation. Aventis Pharma and Pfizer have entered into agreements to co-develop, co-promote and co-manufacture this drug. The development program is now being completed for the treatment of a broad spectrum of type 1 and type 2 diabetes patients. Clinical studies showed that the drug is effective, easy to use and has high patient satisfaction and acceptance. Submission for U.S. and EU regulatory approval is planned for December 2001. Exubera™ is estimated to have peak annual sales of more than 1 billion [Euros]." At Aventis.
Pfizer Press Release (December 11, 2000) "Developed for the treatment of Type 1 and Type 2 diabetes, inhaled insulin is being co-developed with Aventis, with additional support from Inhale Therapeutic Systems, Inc. It uses an innovative delivery system allowing patients to inhale insulin. Dr. Corr said that over 90 percent of patients in clinical trials have chosen to continue using inhaled insulin, enabling extended compliance which is a critical factor in minimizing the long-term effects of diabetes. The agent also exhibits very good efficacy in patients failing oral therapy. The inhaled insulin NDA and MAA will be filed late next year."
Waiting to inhale - news for the diabetes market (September 27, 2000) "Long-awaited changes in drug delivery methods are finally reaching the insulin market. Injection has been the only option available since the first use of insulin as a treatment for diabetes in the 1920s. Within two years, however, this situation is destined to change." At Pharmaceutical Online.
Update on Insulin Inhalers (June 23, 2000) "There are several caveats. First, patients must still test their blood sugar levels to monitor their diabetic control. For many, the task of pricking their fingers is far more painful than giving insulin injections. Second, this is a new treatment and with any new medication there are potential risks. Doses of insulin that are inhaled into the lungs are far greater than those given by injection. Although we have data on small numbers of patients followed for up to two years, it is unknown what the effect of insulin on lung tissue will be after 5 or 10 years of use. Therefore, it will be important to follow patients over time on inhaled insulin to be sure that their lung function remains consistently normal. Third, inhaled insulin is relatively short acting, so an injection or two of longer acting insulin may still need to be given. With these considerations in mind, for some patients, inhaled insulin will provide a welcome relief from the need to give daytime insulin injections." (Editorial Commentary by Dr. Anne Peters) At Mediconsult.com.
Inhale Reports 30-Month Data on Inhaleable Insulin Presented at American Diabetes Association Meeting (June 14, 2000) "These data show that HbA1c levels -- the long-term measurement of blood glucose control -- remained stable in patients for up to 30 months of therapy." At Inhale: "Inhale has developed the first commercially viable solution to a basic problem in biotherapeutics: the non-invasive delivery of a wide range of peptides, proteins, and other macromolecules. Our breakthrough in pulmonary delivery systems are based on innovations in powder processing, protein and small molecule formulations, and aerosol delivery systems... Inhale's most advanced program is inhaleable insulin, sponsored by Pfizer, which is in Phase III human clinical trials."
Pfizer has never been stronger, Steere tells shareholders (April 27, 2000) "Inhaled insulin, a new technology for the treatment of diabetes Pfizer is developing in collaboration with Aventis and Inhale Therapeutic Systems, is well along in clinical development and an NDA filing with FDA is expected next year, Dr. Niblack said. 'Our clinical data show that when used to treat insulin-dependent or Type 1 diabetes, this patient-friendly insulin delivery system is as effective as subcutaneous injections of short-acting insulin'" At Pfizer.
Investigational Drug: Inhaled Insulin -- A new Portable Aerosol Delivery System (From issue No. 248-249 (May/June, 1998) of Medical Sciences Bulletin) "A new device, created by Inhaled Therapeutics Systems, Inc. and being developed for use in diabetes in collaboration with Pfizer, Inc., delivers a dose of short-acting insulin in a dry powder that is inhaled through the mouth. The insulin powder passes directly into the lungs, where it readily enters the blood circulation." At PharmInfoNet.
Research At the DiabetesMonitor
Inhaled Insulin - Will It Really Take Your Breath Away? At the Diabetes Mall