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's Chairman and CEO Recognized as One of PharmaVOICE's "100 Most Inspiring People in the Life Sciences"

08/03/10
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MannKind's Chairman and CEO Recognized as One of PharmaVOICE's "100 Most Inspiring People in the Life Sciences"

VALENCIA, Calif., Aug 03, 2010 (BUSINESS WIRE) --

MannKind Corporation (Nasdaq: MNKD) today announced that the company's chairman and CEO Alfred E. Mann has been named to PharmaVOICE's list of the "100 Most Inspiring People in the Life Sciences." Mr. Mann was recognized for his extraordinary leadership and passion in his lifelong roles as a scientist, inventor, entrepreneur and philanthropist, for which he has received more than 70 honors from the public and private sectors, including life achievement and humanitarian awards. He was nominated to the list by peers, colleagues and friends who have worked with him throughout his career and who describe him as "boundlessly visionary and persistent." Throughout Mr. Mann's nearly 60 years in the life sciences industry, the octogenarian billionaire has founded 17 companies, devoting his professional life to developing innovative medical products and technologies to satisfy the unmet needs of patients with health issues ranging from diabetes and heart disease to hearing impairment and chronic pain.

"It is our extreme pleasure to once again be able to pay tribute to the men and women who are driving change, providing guidance, and fostering relationships to position the industry in the best way possible to serve the ultimate stakeholders: patients," said Taren Grom, editor-in-chief and cofounder of PharmaVOICE.

Mr. Mann has made it his personal mission to identify a solution for the current global diabetes epidemic, which affects 246 million people worldwide. Following this vision, in 2001 Mr. Mann formed MannKind Corporation, which, under his guidance, developed the ultra rapid-acting mealtime insulin therapy, AFREZZA™ (insulin human [rDNA origin]) Inhalation Powder. Mr. Mann is passionate about the promise that this investigational therapy holds for the diabetes community. A New Drug Application (NDA) requesting approval of AFREZZA for the treatment of adults with Type 1 or Type 2 diabetes for the control of hyperglycemia is currently under review by the U.S. Food and Drug Administration (FDA).

"I am truly honored to have been included in this year's PharmaVOICE 100 list, and would like to express my appreciation to all those who nominated me," said Mr. Mann. "While I have many experiences to be thankful for and successes to be proud of, my hope is that my biggest career highlight is yet to come."

Born in Portland, Oregon, Mr. Mann holds B.A. and M.S. degrees in physics from the University of California, Los Angeles, and his first industry job was as a research physicist at Technicolor Corporation in 1951. Mr. Mann went on to receive honorary doctorate degrees from the University of Southern California, Johns Hopkins University, Western University and the Technion-Israel Institute of Technology. Together with his wife, Claude, he enjoys classical music and has made numerous philanthropic contributions to the arts. He has seven children and 10 grandchildren.

"Al has been the guiding force behind the development of AFREZZA," said Hakan S. Edstrom, President and Chief Operating Officer, MannKind Corporation. "He is a constant source of vision and leadership, and an inspiration to everyone at MannKind, and for these and other qualities he certainly deserves this recognition."

Mann's charitable contributions are as impressive as his professional ones. He founded and endowed the Alfred Mann Foundation, which develops medical products to fill poorly-met medical needs, and also founded medical research institutes at the University of Southern California, Purdue University and the Technion-Israel Institute.

Mr. Mann is featured in the sixth annual PharmaVOICE 100 issue, which is the July/August 2010 issue of the publication.

About the PharmaVOICE 100

Established six years ago by PharmaVOICE magazine, the PharmaVOICE 100 is an annual list of individuals recognized for their positive contributions to the life sciences industry. The distinguished honorees are nominated by thousands of PharmaVOICE readers. The PharmaVOICE 100 represent a broad cross section of industry sectors, including pharmaceutical, biopharmaceutical, biotechnology, contract research, clinical trial, research and development, patient education, patient recruitment, advertising, regulatory, technology, and many others. Furthermore, the leaders chosen as this year's most inspiring representatives within the industry have accomplishments that are diverse; this group of thought leaders contribute to the growth and well-being of not only their companies, but to their communities as well as varied industry associations.

About AFREZZA

AFREZZA™ is a novel, ultra rapid-acting mealtime insulin therapy being developed by MannKind Corporation for the treatment of adult patients with Type 1 and Type 2 diabetes for the control of hyperglycemia. It is a drug-device combination product, consisting of AFREZZA Inhalation Powder pre-metered into single use dose cartridges and the light, discreet and easy-to-use AFREZZA Inhaler. Administered at the start of a meal, AFREZZA dissolves immediately upon inhalation and delivers insulin quickly to the blood stream. Peak insulin levels are achieved within 12 to 14 minutes of administration, mimicking the release of meal-time insulin observed in healthy individuals. To date, the AFREZZA clinical program has involved more than 50 different studies and over 5,000 adult patients.

About MannKind Corporation

MannKind Corporation (NASDAQ: MNKD) focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes and cancer. Its diabetes pipeline includes AFREZZA™ and MKC253. MKC253 is currently in phase 1 clinical trials. In March 2009, MannKind submitted a NDA to the FDA requesting approval of AFREZZA for the treatment of adults with type 1 or type 2 diabetes for the control of hyperglycemia. In March 2010, MannKind received a Complete Response letter to this NDA from the FDA, requesting additional information. In July 2010, the FDA accepted MannKind's reply to the Complete Response letter and set a PDUFA action date of December 29, 2010. Other products in MannKind's pipeline include the cancer immunotherapy products MKC1106-PP and MKC1106-MT, which are currently in phase 1 clinical trials. MannKind maintains a website at http://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.

SOURCE: MannKind Corporation 

MCS Healthcare Public Relations
Alanna Jamieson, 908-234-9900
alannaj@mcspr.com