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 CEO Alfred Mann to Transition to Executive Chairman; COO and President Hakan Edstrom Appointed to CEO

01/12/15
PDF Version

VALENCIA, Calif., Jan. 12, 2015 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD), a biopharmaceutical-based technology company, today announced that Alfred Mann, the company's founder, retired from his role as Chief Executive Officer effective January 9, 2015 and will transition to Executive Chairman. Mr. Mann intends to remain engaged with the company in business matters, including those relating to development and financing of MannKind's future therapies. On January 9, 2015, MannKind's Board of Directors appointed Hakan Edstrom, current President of MannKind, as the new Chief Executive Officer of the company. Mr. Edstrom will retain his title as President. 

"I am honored to succeed Al, an industry icon I have long admired. I want to personally thank him for his tireless work in bringing his vision to the market and guidance over the years. Bringing to the world an effective inhalable insulin with unique pharmacokinetic properties is another standout accomplishment in a long list of Al's remarkable achievements," noted Mr. Edstrom. "I am truly excited to lead MannKind at this critical juncture as the company anticipates the launch of its first therapy and looks to move ahead with other blockbuster therapies enabled by its powerful Technosphere platform. The company is well positioned to deliver for its stakeholders worldwide."

Mr. Edstrom has served as MannKind's President and as a member of the Board of Directors since 2001.  From 2001 until his appointment as Chief Executive Officer, he also served as the Chief Operating Officer of MannKind. Prior to joining the company, Mr. Edstrom was with Bausch & Lomb, Inc. and prior to that with Pharmacia Corporation. Mr. Edstrom was recruited to Bausch & Lomb upon its acquisition of Chiron Ophthalmics and Storz Surgical Instrument Company. His responsibility was to merge the two companies' global operations and integrate them into Bausch & Lomb's global structure. Following the success of this combination, Mr. Edstrom was given responsibility for all of the Bausch & Lomb businesses in the North America region. At Pharmacia, Mr. Edstrom was part of the commercialization of Healon®, a viscoelastic agent for cataract surgery, on an international basis with management responsibilities in Canada and as President of Pharmacia Ophthalmics Inc.

Under Mr. Mann's leadership, MannKind has developed Afrezza, a rapid-acting inhalable insulin indicated to improve glycemic control in adults with diabetes. Following approval from the U.S. Food and Drug Administration in June 2014, MannKind entered into a worldwide exclusive collaboration and licensing agreement with Sanofi for commercialization of the therapy. Afrezza is expected to be launched in the United States in the first quarter of 2015.

Afrezza utilizes MannKind's proprietary Technosphere® formulation technology, which is based on a class of organic molecules that are designed to self-assemble into small particles onto which drug molecules can be loaded.

"I am extremely proud of all that has come to fruition at MannKind. Together with my colleagues, we have built a truly unique biopharmaceutical company with an incredibly bright future," said Mr. Mann. "With the commercialization of Afrezza well underway and the future potential of the Technosphere platform being actively explored for additional products, the timing is right for me to step back from CEO. I have the upmost confidence in Hakan and the entire executive team who have already made great strides in achieving key milestones in bringing Afrezza through development and into commercialization. Hakan's ability to manage and grow actively marketed products while guiding the development of potential blockbuster therapies make him an ideal fit for MannKind's next chapter of success."

Alfred Mann has founded and largely funded 14 companies in his career. Nine of these companies were acquired at an overall total of almost $8 billion, and three companies became publicly traded, MannKind being one of them. For nearly six decades, Alfred Mann has been a revolutionary voice and thinker in aerospace, medical technology and biopharmaceuticals and has led development of many products to fill unmet and poorly met medical needs. 

About MannKind Corporation

MannKind Corporation (Nasdaq:MNKD) focuses on the discovery, development and commercialization 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 as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include, without limitations, statements relating to plans, objectives, intentions and expectations with respect to the future activities and roles of management, commercial plans and operations (including the launch of Afrezza), product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expect," "anticipate," "believe," "intend," "estimate," "plan" and similar words and expressions, although not all forward-looking statements contain such identifying words. Although MannKind's management team believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of MannKind, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include, among other things, those discussed or identified in MannKind's public filings with the Securities and Exchange Commission, including those listed under "Risk Factors," "Forward-Looking Statements" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in MannKind's annual report on Form 10-K for the year ended December 31, 2013 and subsequent quarterly reports on Form 10-Q, and listed or described in subsequent reports filed by MannKind with the Securities and Exchange Commission. Other than as required by applicable law, MannKind undertakes no obligation to update or revise any forward-looking information or statements.

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         MCS Healthcare Public Relations

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