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 to Sponsor Andretti Autosport Type 1 Diabetes Driver, Conor Daly

03/14/19
PDF Version
IndyCar Driver Living with Diabetes Helps Raise Awareness for Diabetes Treatment Options

WESTLAKE VILLAGE, Calif., March 14, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) announced today it is sponsoring Conor Daly as he makes his debut with the Andretti Autosport team at the 103rd Running of the Indianapolis 500 on May 26, 2019. MannKind is an associate sponsor of Andretti Autosport for this race and will partner with Daly on his No. 25 U.S. Air Force Honda. Daly was diagnosed with Type 1 diabetes at the age of 14, and now lends his racing career to raise awareness of diabetes treatment options and innovations.

“Living with diabetes since age 14 has been a challenge, but one that I’ve always faced head on,” said Daly. “Managing my diabetes properly has been a key to being able to live my racing dream.  Diabetes should never stop you from pursuing what you want in life!  Thanks to MannKind I will be able to share my story and live my dream at a higher level than ever."

“MannKind is continually seeking platforms to increase awareness around the challenges, opportunities and successes people living with diabetes encounter on a daily basis,” says Michael Castagna, CEO of MannKind. “Seeing someone like Conor take on a challenging sport such as IndyCar racing, while having to manage his diabetes, is an inspiration to all those living with diabetes. We are excited to be associated with Conor and Andretti Autosport for the Indy 500 and look forward to a partnership where we can help educate people on treatment options for managing their diabetes.”

As an associate sponsor of Daly at the Indy 500, MannKind is planning events and experiences that build awareness of innovation in diabetes treatment.  The events and sponsorship promotion will also allow for Daly to share his story about living with diabetes.

About MannKind Corporation
MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing and research facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

About Andretti Autosport
Led by racing legend Michael Andretti, Andretti Autosport boasts a wide racing portfolio rooted in tradition and designed for success.

Under the banners of Andretti Autosport, Andretti Rallycross and Andretti Formula E, the Indianapolis-based team fields multiple entries across the IndyCar Series, Indy Lights, the FIA Formula E Championship, the GT4 America Series and Americas Rallycross. Additionally, the team competes as Walkinshaw Andretti United in the Australian Supercars category through partnership with Walkinshaw Racing and United Autosports.

The global racing enterprise boasts four IndyCar Series championships, three Indy Lights titles, one Pro Mazda championship and one USF2000 championship, and has captured victory five times at the famed Indianapolis 500-Mile Race. Additionally, the team holds two X Games Gold Medals and four U.S. rallycross championships.

To share in the Andretti story, please visit online at AndrettiAutosport.com and follow along on social media with #AllAndretti.

Company Contact:
Rose Alinaya
SVP, Investor Relations
818-661-5000
ir@mannkindcorp.com

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Source: MannKind