Valencia-based MannKind Corp. has assumed responsibility for the worldwide development and commercialization of Afrezza (insulin human) Inhalation Powder from Sanofi, effective Tuesday, in a transition that ensures patients will not experience any interruption in their treatment. Under terms of the transfer agreement, Sanofi will continue to distribute Afrezza from its existing inventory until MannKind begins to distribute Afrezza during the third quarter.

“Today’s return of control of Afrezza is a landmark day for MannKind,” said Matthew Pfeffer, Chief Executive Officer of MannKind.

“We are thrilled to begin the process of making Afrezza the successful mealtime treatment for people with diabetes that we always believed it would be. In the coming weeks, we will roll out more information about our commercial team for Afrezza, the resources that we are designing for patients and physicians, and our plans for the future.”

Afrezza (uh-FREZZ-uh), approved in 2014 by the U.S. Food and Drug Administration, is a rapid-acting inhaled insulin therapy indicated to improve glycemic control in adult patients with diabetes. Taken at the start of a meal using a specially designed inhaler, Afrezza dissolves rapidly upon inhalation to the deep lung and delivers insulin quickly to the bloodstream. Peak insulin levels are achieved within 12 to 15 minutes of use and help to control post-meal blood sugar spikes that affect HbA1C levels. Afrezza should not be used by patients who have problems with their lungs (such as asthma or COPD) and is not recommended in patients who smoke or who have recently stopped smoking.

“The continued availability of Afrezza is welcome news for patients and their physicians who seek effective treatment options for type 1 and type 2 diabetes,” said Steven Edelman, M.D., Professor of Medicine, University of California, San Diego and founder and director of Taking Control of Your Diabetes (tcoyd.org). “Afrezza truly addresses an unmet need in diabetes care. Having even a few less injections a week is a benefit for many of my patients.”

Afrezza is not a substitute for long-acting insulin but must be used in combination with long-acting insulin in patients with type 1 diabetes.

MannKind will work with the diabetes community to ensure that Afrezza remains available for the many patients who are passionate about its benefits. “I am thrilled to work with MannKind to ensure current and new patients know about the continued availability of Afrezza,” said Laura Kronen, author of “Too Sweet: The Not-So-Serious Side to Diabetes”, diabetes life coach and an early adopter of Afrezza. “To the diabetes community, Afrezza represents advancement in insulin delivery and a novel way to manage their disease.”

MannKind has established an Afrezza Customer Service Center. Customers with questions or comments about Afrezza can call (877) 323-8505. Certain Afrezza patient support programs (including co-pay assistance cards) will continue and new programs will be introduced in the second quarter, replacing legacy programs.

The company also plans to present four abstracts at the American Diabetes Association (ADA) scientific meeting in June, including the results of two completed post-marketing studies. Two additional late-breaking abstracts have also been submitted to the ADA and, if accepted, will be presented.

About Afrezza

Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 12 units, patients may use a combination of 4 unit, 8 unit and 12-unit cartridges. The disposable inhaler can be used for up to 15 days, should be kept in a clean, dry place with the mouthpiece cover on and may be wiped with a clean, dry cloth if needed.

About MannKind Corporation

MannKind Corporation focuses on the discovery and development of therapeutic products for patients with diseases such as diabetes. MannKind maintains a website at www.mannkindcorp.com to which MannKind regularly posts copies of its press releases as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to e-mail alerts that are sent automatically when MannKind issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the website.