MNKD MannKind Corporation

MannKind Corporation (NASDAQ:MNKD) (TASE:MNKD) will host an analyst call for the investment community to learn about the company’s general commercialization strategy in the US for Afrezza® (insulin human) Inhalation Powder. MannKind has recently assumed responsibility for the worldwide development and commercialization of Afrezza from Sanofi and will begin to distribute Afrezza in the third quarter. Until that time, Sanofi will continue to distribute Afrezza from its existing inventory of product.

To participate in the live call by telephone, please dial (888) 224-7957 or (303) 223-4394 and use the participant passcode: 21809665. Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at http://www.mannkindcorp.com.

A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (800) 633-8284 or (402) 977-9140 and use the participant passcode: 21809665.   A replay will also be available on MannKind's website for 14 days.

MannKind’s Chief Executive Officer, Matthew J. Pfeffer, and Chief Commercial Officer, Michael E. Castagna, will discuss the strategic commercial approach for Afrezza in the U.S. The discussion will include plans for sales and marketing of Afrezza, including reimbursement and access programs for patients, marketing programs and expansion plans.  Timelines for relaunch activities will also be discussed.

MannKind plans to report quarterly earnings on May 9, 2016 and will discuss financial results of the first quarter of 2016 and future financial projections for the remainder of 2016 and beyond at that time.

INDICATION 

Prescription Afrezza® (insulin human) Inhalation Powder is a rapid-acting inhaled insulin used to treat adults with diabetes for the control of high blood sugar.

LIMITATIONS OF USE

Do not use Afrezza as a substitute for long-acting insulin; Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes.

Do not use Afrezza to treat diabetic ketoacidosis.

Afrezza is not recommended in patients who smoke or who have recently stopped smoking.

IMPORTANT SAFETY INFORMATION FOR AFREZZA

WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE

• Acute bronchospasm has been observed in patients with asthma and COPD using Afrezza.
• Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD.
• Before initiating Afrezza, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients.

Do not use Afrezza if you have problems with your lungs, such as asthma or COPD. Do not use Afrezza during a low blood sugar reaction (hypoglycemia). If you are allergic to any of the ingredients in Afrezza, do not use Afrezza as this may cause a significant and severe allergic reaction.

Before using Afrezza, your doctor will take a medical history, and do a physical exam and a breathing test (called spirometry) to determine if you have lung problems. Patients with lung problems should not use Afrezza. If your doctor finds you have lung problems, use of Afrezza may cause a severe asthma-like breathing problem. Afrezza can reduce lung function, so your doctor will also want to test your breathing 6 months after starting Afrezza, and then each year after that, with more frequent testing done if you have symptoms such as wheezing or coughing. Tell your doctor if you currently have lung cancer or have had it in the past, or if you have an increased risk of developing lung cancer.

You must test your blood sugar levels while using insulin, such as Afrezza. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made carefully and only under your doctor's care.

The most common side effect of insulin, including Afrezza® (insulin human) Inhalation Powder, is low blood sugar (hypoglycemia), which can be serious and life-threatening. Some people may experience symptoms such as shaking, sweating, fast heartbeat, and blurred vision. It may cause harm to your heart or brain. It is important for you to understand how to manage the use of Afrezza, and to understand how to lessen the risk of hypoglycemia events.

Tell your doctor about other medicines you take, especially ones commonly called TZDs (thiazolidinediones) and supplements, because they can change the way insulin works. If you have heart failure or other heart problems, it may get worse while you take TZDs with Afrezza. Before starting Afrezza, it is important to tell your doctor about all your medical conditions including if you have a history of lung problems, if you are pregnant or plan to become pregnant, or if you are breast-feeding or planning to breast-feed.

In addition to low blood sugar (hypoglycemia), other possible side effects associated with Afrezza include cough, throat pain or irritation, headache, diarrhea, tiredness, and nausea.

Please see full Prescribing Information for Afrezza, including Boxed WARNING and www.afrezza.com.   

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 (Nasdaq:MNKD) (TASE:MNKD) 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.

Forward-Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties, including statements regarding MannKind’s ability to directly commercialize Afrezza and the commercial potential of Afrezza.  Words such as “believes”, “anticipates”, “plans”, “expects”, “intend”, “will”, “goal", “potential” and similar expressions are intended to identify forward-looking statements.  These forward-looking statements are based upon the MannKind’s current expectations.  Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the ability to generate significant product sales for MannKind, difficulties or delays in obtaining regulatory feedback or completing and analyzing the results of clinical studies, MannKind’s ability to manage its existing cash resources or raise additional cash resources, stock price volatility and other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the year ended December 31, 2015 and subsequent periodic reports on Form 10-Q and current reports on Form 8-K.  You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release.  All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

Company Contact:
Rose Alinaya
SVP, Finance
661-775-5300
ralinaya@mannkindcorp.com