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 and One Drop to collaborate on delivering better health outcomes for people with diabetes

05/04/17
PDF Version

VALENCIA, Calif. and NEW YORK, May 04, 2017 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) TASE:MNKD) and One Drop today announced that they have signed a memorandum of understanding to enter into a collaborative agreement that would extend One Drop's subscription service and digital health platform — which currently provides unlimited blood glucose testing supplies and 24/7 live in-app support from diabetes experts — by adding Afrezza as a rapid-acting insulin offering. 

The planned collaboration will include three consumer-focused areas:

  1. Access, Cost Savings and Convenience initiatives, intended to simplify the complexity of starting and staying on mealtime insulin.
     
  2. Customized Coaching and Engagement designed to help people on Afrezza achieve the American Diabetes Association (ADA) recommendation of an A1C goal of less than 7%.
     
  3. Design innovation around packaging and exploration of a reusable Afrezza Inhaler with integrated Bluetooth technology.

"Against a backdrop of soaring insulin costs, this proposed collaboration is an essential step in the right direction," said Jeff Dachis, CEO and Founder of One Step. "One Drop began with the goal of bringing affordable, accessible diabetes care to everyone living with diabetes worldwide. Through this partnership with MannKind, we will continue to work tirelessly to empower everyone with diabetes to achieve better health outcomes through the use of modern delivery methods that reduce the burden of diabetes management and increase engagement in self-care."

"The complexity and conflicting incentives of the United States healthcare system are not aligned to help people with diabetes on insulin achieve optimal outcomes, as we see that almost seven out of ten people on mealtime insulin are not at the ADA goal of 7% A1C," said Michael Castagna, Chief Commercial Officer of MannKind Corporation.  "Even though injectable insulins have been available for decades, 20% of users regularly skip injections.  We intend to empower people with diabetes to take charge of their health by trying something different."

"We believe that diabetes care as a fully integrated digital service is the only way that we are going to bend the cost curve for payers and providers, while at the same time delivering evidence-based health outcomes that can scale," continued Dachis. "Working with an innovator like MannKind, with a clinically effective, non-invasive inhaled mealtime insulin product, offers up an exciting opportunity to further our mission of relentlessly improving the lives of everyone with diabetes and a smartphone."

One Drop recently presented findings from a retrospective study demonstrating that One Drop | Mobile app users report a substantial improvement in blood glucose levels, reducing A1c by 1.0 percentage point (8.2% to 7.2%) after only 2 to 12 months of using One Drop | Mobile.[1]

One Drop has also shared preliminary data collected from people with diabetes using One Drop | Mobile and One Drop | Experts for just four consecutive weeks, showing that One Drop users:

•   reduced average blood glucose by 27 mg/dL;

•   reduced average blood glucose from 185 mg/dL (A1c 8.1%) to 158 (A1c 7.1%);

•   reduced average percentage of high blood glucose readings from 19% to 4%;

•   nearly doubled the percentage of in-range blood glucose readings; and

•   consistently tracked food and blood glucose over time.[2]

In the next few months, One Drop will present the complete results of several clinical studies conducted over the past year. Altogether, One Drop | Mobile users have contributed more than 280 million primary health data points, which One Drop analyzes to deliver powerful insights that drive improved health outcomes for people with diabetes, as well as immediate proven cost-savings for both people with diabetes and their care providers.

"Our approach is to advance traditional therapies by delivering better access to scalable care, better education, more convenience, lower costs, and an improved user experience," said Dachis. "Ultimately, we must deliver results. There is too much at stake for business as usual."

ABOUT MANNKIND CORPORATION
MannKind Corporation (NASDAQ:MNKD) (TASE: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.

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1 Osborn, C. Y., et al. (2017, March). One Drop App Users Report Improved Glycemic Control. Poster session presented at the Society of Behavioral Medicine 38th Scientific Sessions, San Diego, CA.

2 Osborn, C. Y., et al. (2017, March). The One Drop | Mobile App and Experts Program is Evidence-based and Improves Blood Glucose. Poster session presented at the Society of Behavioral Medicine 38th Scientific Sessions, San Diego, CA.

3 The American Diabetes Association recognizes this education service as meeting the National Standards for Diabetes Self-Management Education and Support.

About One Drop

One Drop (Informed Data Systems Inc.) is a digital health company harnessing the power of mobile computing and data science to transform the lives of everyone with diabetes.

One Drop's offerings include the first-ever monthly subscription service to provide clinically effective, affordable, accessible diabetes care. For less than the cost of a monthly co-pay, One Drop subscribers receive:

  • One Drop | Chrome with Unlimited Testing Supplies: One Drop | Chrome not only meets the highest standards of clinical accuracy, but also wirelessly transmits blood glucose data directly to the cloud via the One Drop | Mobile app for iOS and Android. Unlimited blood glucose test strips are delivered on-demand directly to the doors of One Drop subscribers — no prescriptions, no insurance, no appointments, and no hassles.
  • One Drop | Experts for Anytime Care: One Drop | Experts moves diabetes education out of the clinic and into the lives of people with diabetes. Each One Drop | Premium subscriber has his/her own "Expert" (Certified Diabetes Educator) available 24/7 for guidance, support, and anytime care. Experts deliver personalized digital therapeutics programs, including ADA-recognized diabetes education[3], to help people with diabetes define and achieve their health management goals. Subscribers can communicate with their Experts anytime via in-app chat; all data recorded in the app is available to Experts in real-time, allowing them to provide relevant behavioral guidance in the moments when subscribers need it most. No appointments necessary.
  • One Drop | Mobile: One Drop | Mobile is an award-winning, cloud-based diabetes management solution delivered entirely via mobile app on iOS and Android. One Drop | Mobile provides real-time and historical blood glucose data and analytics to subscribers and their healthcare providers, allowing both to see relationships between specific health behaviors and health outcomes. One Drop | Mobile also includes a fully-featured Apple WatchOS app for logging and analyzing diabetes data on the go. One Drop | Mobile is the only diabetes management platform that offers comprehensive self-care, peer-support, and expert support all in one place.

One Drop also offers an enterprise solution, One Drop | Professional, for insurers, health care provider networks, and self-insured employers to dramatically lower the cost of caring for people with diabetes.

The One Drop | Mobile solution is available for free worldwide. One Drop | Chrome is sold exclusively by One Drop (iOS, Android, and http://onedrop.today/), Amazon (http://www.amazon.com), and Apple (http://store.apple.com). One Drop's consumer subscription service is available for purchase in-app (iOS and Android) and at http://onedrop.today. For more information, contact just@onedrop.today.

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

One Drop Contact
Rachel M. Sanchez
917-342-2892
rachel@onedrop.today