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 Partner to Launch the A-ONE Clinical Trial

08/07/17
PDF Version

VALENCIA, Calif., Aug. 07, 2017 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) and One Drop today announced the first step of their collaboration with the launch of the A-ONE study, a randomized controlled trial investigating the use of Afrezza® inhaled insulin and One Drop's integrated digital diabetes care platform.

In May 2017, MannKind and One Drop announced a memorandum of understanding to explore collaborations related to One Drop | Premium (i.e., One Drop | Mobile app, One Drop | Chrome meter and test strips, One Drop | Experts coaching service) and Afrezza®, MannKind's inhaled rapid-acting mealtime insulin. One goal of the collaboration is to identify ways of simplifying the complexity of starting and staying on mealtime insulin along with Customized Coaching to help people achieve their A1C goals.

Appropriate people with type 2 diabetes who meet inclusion criteria will be randomized to one of two treatment arms:  Afrezza® with One Drop | Premium — or — One Drop | Premium alone. Changes in hemoglobin A1C, quality of life, self-care, treatment satisfaction, and other metrics will be assessed.  People with type 2 diabetes interested in learning more should email Aone@onedrop.today.

Dr. Raymond Urbanski, Chief Medical Officer of MannKind Corporation, said, "This study is intended to evaluate whether combining a solutions-oriented digital disease management platform like One Drop with an innovative drug like Afrezza® will provide patients with an improved ability to manage their diabetes."

"One Drop is a unique, fully integrated solution with the prospects of a huge health benefit," says Dr. Chandra Osborn, VP of Health and Behavioral Informatics at One Drop. "We know each piece of the puzzle works, and now we want to see how well they work together. With 9 peer-reviewed outcomes shared at medical meetings and a paper in press at JMIR Diabetes, One Drop is committed to delivering the most effective diabetes management solution in the market. The combination of One Drop with inhaled insulin could offer consumers, health care providers, and payers a potentially powerful solution with unprecedented benefits."

"Diabetes technology is evolving in a very exciting way," said Jeff Dachis, CEO and Founder of One Drop. "But not surprisingly for the vast majority of people with diabetes worldwide, expensive sensors, automated insulin delivery solutions, or call center approaches to care can create barriers and challenges to effective disease management. However, we are excited to evaluate whether a completely integrated digital diabetes therapeutics platform — encompassing evidence-based interventions, ADA-recognized diabetes education and coaching, wireless blood glucose tracking, user-centered design, robust data science, and an innovative pharmaceutical product like MannKind's Afrezza — can deliver improved health outcomes at a fraction of the cost of current standards of care."

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. For more information about Afrezza, please visit www.afrezza.com.

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 worldwide.

The One Drop platform is evidence-based and clinically effective. It brings affordable, accessible diabetes care to everyone with diabetes and a smartphone, as well as their insurers and health care providers. One Drop's current offerings include:

  • One Drop | Chrome: One Drop's FDA-approved, CE-certified Bluetooth wireless blood glucose monitoring system, which meets the highest standards of clinical accuracy and wirelessly transmits blood glucose data to the cloud via the One Drop | Mobile app for iOS and Android.
  • One Drop | Plus: One Drop's newest subscription offerings, providing 50 to 100 blood glucose test strips per month for One Drop | Chrome and unlimited coaching via One Drop | Experts, starting at $13 per month.
  • One Drop | Premium: One Drop's unlimited subscription, providing unlimited blood glucose test strips for One Drop | Chrome and unlimited coaching via One Drop | Experts, starting at $33 per month.
  • One Drop | Experts: One Drop's 24/7, on-demand, digital diabetes education and coaching service, available as a standalone subscription, starting at $11 per month.* Each One Drop | Experts 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, 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 personalized behavioral guidance when subscribers need it most — no appointments necessary.
  • One Drop | Mobile: One Drop's free, 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 people with diabetes and their healthcare providers, allowing both to see relationships between specific health behaviors and health outcomes. One Drop | Mobile 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 | Professional: One Drop's HIPPA-compliant enterprise solution for insurers, healthcare provider networks, self-insured employers, and drug/device manufacturers seeking to dramatically improve health outcomes and lower the cost of caring for people with diabetes. One Drop | Professional delivers real-time data, real-time messaging, custom branding, custom content delivery, custom educational support, EMR/EHR integration, and the most affordable, effective, turnkey diabetes solution in market.

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 services are available for purchase in-app (iOS and Android) and at http://onedrop.today. The One Drop | Mobile solution is available for free download worldwide (iOS and Android). For more information, contact just@onedrop.today.

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

MannKind Contact:
Rose Alinaya SVP, Investor Relations
661-775-5300
IR@mannkindcorp.com

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