What exactly is the Technosphere® Platform?

One of the largest organs in your body are the lungs. Picture the size of a full tennis court and that is roughly the surface area of both lungs in a typical adult. Running through those lungs are airways whose total length measures 1,500 miles – that’s the distance between Chicago and Las Vegas, New York to Albuquerque, and Los Angeles to Nashville.

Simply put, the lungs create a wonderful platform for effective drug delivery. MannKind’s Technosphere technology recognizes this and provides the distinct advantage of rapid, deep lung drug delivery. The effect is similar to intravenous delivery (I.V.; within a vein) and has the added benefit of bypassing the liver which can be especially helpful in reducing systemic side effects.

Examining it closer, it helps to look at inhalation, air flow travel, and the exhale. When you breathe in, air is drawn into the lung and flows down curving, narrowing airways that end in the air sacs or alveoli. When air is exhaled, the flow is reversed. Between the end of an inhalation and the start of exhalation, the air in the lung is stationary. To reach the deep lung, inhaled particles must be carried by the air stream and have enough momentum to continue through the stationary air to collide with the lung surface.

Particles that can reach the lung have aerodynamic diameters between 0.5 µm and 5-6 µm (1 µm is 1 micro-meter or about 0.00004 inches). Particles that are larger than 6 µm will leave the air stream and hit the back of your mouth and throat; smaller than 0.5 µm wouldn’t have the ability to reach the lungs and would simply get exhaled.

“The average Technosphere particle is about 2-2.5 µm which is in the middle of the respirable range,” explains Marshall Grant, PhD, MSc, Executive Director, Clinical Pharmacology & Research for MannKind Corporation. “The particle size distribution is a major reason Technosphere powders are highly efficient in delivering drug to the lungs than other dry powder inhalers (DPIs).”

The Technosphere particles in FDA-approved Afrezza® (insulin human) Inhalation Powder and Tyvaso DPI™ (treprostinil) Inhalation Powder are manufactured by different processes and possess different characteristics. But both are made up of small crystals of FDKP (fumaryl diketopiperazine), MannKind’s proprietary molecule. FDKP provides high solubility and fast dissolution at physiologic pH – and more importantly – can crystallize and form particles in the range appropriate for optimum delivery to the lungs.

When Technosphere powder reaches the lung surface, the FDKP and drug dissolve. The FDKP is then rapidly cleared from the lung into systemic circulation. The FDKP is not metabolized, but rather excreted primarily in the urine. Another value of Technosphere powders has been their versatility – they are compatible with a wide range of doses with different types of drugs.

MannKind’s Technosphere powders are delivered into the lung’s airstream via an inhalation device or DPI (dry powder inhaler). The breath-powered inhalers (Dreamboat® being the most common version) provide excellent delivery efficiency and are proven to deliver up to 70% of the dry-powder dose deep into the lungs. Our DPI are designed to be simple, easy to use and discreet. For patients, imagine having a drug in the convenient form of an inhaler that fits in the palm of your hand. This approach allows patients to not only take control of their health but do it while going about their day and enjoying life more humann.

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NTM Lung Disease on the Rise

“I cough every morning upon waking, so I don’t feel rested.” “Imagine not being able to breathe.” “Anxiety ruins everything about you – it’s not a normal life.” “You just exist from day to day and week to week.” These are a sampling of comments about the most bothersome symptoms from living with Nontuberculous Mycobacteria (NTM) shared in a study from NTM Info & Research, Inc. The statements are unfortunately typical and those with NTM often have unpredictable day-to-day health functioning and reduced quality of life.

NTM lung disease is a serious infection that is caused by bacteria that are common in the environment and can cause lung damage. The reality is that we are all exposed to these bacteria in our day-to-day lives – more than 120 species of mycobacteria have been identified. These common bacteria exist in water and soil particles that are in the air, wet places like hot tubs, steamy bathrooms, dishwashers, and even the dewy ground we walk on at the park. But not everyone is at risk of getting NTM lung disease just because they are exposed.

Those predisposed often have underlying conditions such as asthma, COPD, and bronchiectasis, which makes them prone to NTM infection. NTM is not considered to be contagious. Women over the age of 65 make up the majority of those impacted, with a predominance in those of Caucasian and Asian descent.

A rare disease, NTM can often be difficult to diagnose. Many will experience coughing, fatigue, weight loss and shortness of breath – all of which are common with other lung disease symptoms and other conditions like tuberculosis. With NTM, symptoms often worsen, and that is a marker not to be ignored.

It is estimated that some 86,000 individuals are living with NTM lung diseases, and it is on the rise growing 8% each year. Coastal regions including Gulf States have higher rates of infection accounting for 70% of annual NTM cases.

While no cure is available, treatments to manage NTM are available. Treatment for NTM involves antibiotic and multidrug regimens with duration lasting from months to years with tolerability and adverse reactions to treatment which often leads to a lack of adherence to therapy.

There is a valuable need to develop medicines that are well tolerated and effective that lends to consistent patient use and alleviates symptoms of NTM lung disease. MannKind continues to progress MNKD-101 (Clofazimine) for the treatment of NTM.

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Release Details

MannKind Expands Commercial Capabilities With Two New Hires

04/19/16
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VALENCIA, Calif., April 19, 2016 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) (TASE:MNKD) today announced two senior appointments to its commercial organization.  Joining the Company are Joseph Saldanha as Vice President of Marketing and Agustin (Tino) Quintero as Vice President of Market Value, Access and Trade.  Both will report to Michael Castagna, MannKind's Chief Commercial Officer.

"I am excited to have Joe and Tino join my team to help us transition into a commercial organization with dedicated capabilities," said Michael Castagna.  "Each brings a wealth of experience in commercialization, diabetes and pharmaceutical product launches, and their skills will be critical as MannKind moves forward with our commercial plans."

Matthew Pfeffer, Chief Executive Officer of MannKind added, "The expansion of Mike's organization with these two key roles supports MannKind's business objectives for 2016 and beyond.  Under Joe and Tino's leadership, MannKind can develop strong relationships with payors that benefit patients, and produce innovative and focused marketing and sales programs that establish MannKind's market presence with Technosphere®-based products."

Mr. Saldanha has worked in the diabetes space for over 13 years, in both U.S. and global roles.  He has experience marketing oral anti-diabetic medications, insulins (both injectable and inhaled), and medical devices.  Mr. Saldanha commercialized Sanofi's Lantus® in the Intercontinental Region.  After returning to the U.S., he was part of the team that commercialized the Lantus SoloSTAR® pen.  In addition to heading up Sanofi's strategy and medical education teams, he was responsible for all hospital business.  Mr. Saldanha launched an initiative with Certified Diabetes Educators® to train patients in diabetes and the appropriate use of insulin.  Prior to that, Mr. Saldanha served as Director of Business Development for the insulin delivery device business at Johnson and Johnson Diabetes (LifeScan®/Animas®). More recently, he worked in the biosimilars business with Pfizer in New York.  Mr. Saldanha holds a Bachelor of Science from Drexel University and a Master of Science from the University of Pennsylvania.

Mr. Quintero has 18 years of experience in bio-pharmaceutical market access as well as a proven record of achieving commercial excellence.  He joins MannKind from AbbVie, a global biopharmaceutical company, where he served as National Managed Care Executive.  In this role, Mr. Quintero was responsible for negotiating AbbVie's portfolio of products (including Humira®) while developing contracting and pricing strategies for hepatitis C, multiple sclerosis and oncology product launches.  Prior to that, he held integral leadership roles in sales and account management at Vertex Pharmaceuticals, including oversight of the commercial launch of Incivek®, their first commercial product. Earlier, he was part of Gilead Sciences and Sandoz's leadership teams, responsible for sales, product launches and market access for both commercial and government payers.   Mr. Quintero holds a Bachelor of Science in economics from Florida International University.

Members of the investment community are reminded of the upcoming conference call to discuss the company's general commercialization strategy in the US, being held later today (April 19, 2016) at 5:00 pm (Eastern Time). 

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.

The trademarks mentioned in this release are the property of their respective owners.

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 pharmaceutical products.  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