MNKD Investors

Technosphere®

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.

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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.”

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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 Presents Novel Scientific Data at 13th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2020)

02/20/20
PDF Version

WESTLAKE VILLAGE, Calif., Feb. 20, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ: MNKD) today announced the presentation of results from multiple clinical studies of Afrezza® (insulin human) Inhalation Powder and MannKind’s BluHale® technology system. These data are being presented in both oral and poster presentations during the 13th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2020) in Madrid Spain, February 20-22, 2020. 

“We are very pleased to have the opportunity to highlight these positive results during this year’s ATTD,” stated Dr. David Kendall, Chief Medical Officer of MannKind. “These presentations highlight original studies of Afrezza in individuals with both type 1 and type 2 diabetes, and include initial studies of Afrezza in pediatric patients. In addition to the results of clinical studies, we are pleased to disclose novel data on the use of BluHale, our Bluetooth-enabled technology for real-time profiling of inhalation effort and other parameters associated with the use of our inhaler. Collectively, these data further expand our understanding of the unique clinical profile of Afrezza, and highlight the potential use of Afrezza in children and adolescents, as well as advancing the opportunity to create connected technology for our drug delivery system.” 

Highlights of the original scientific disclosures:

  • Preliminary data from an independent, investigator initiated study of Afrezza on the background of closed loop pump insulin delivery by means of an “artificial pancreas” system showed that pulmonary dosing allows for titration to higher unit doses in individuals with type 1 diabetes (presented by Alfonso Galderisi MD, PhD from Yale University).
  • Clinical use of Afrezza in adults with uncontrolled type 2 diabetes on two or more glucose lowering therapies resulted in a significant (1.6%) drop in A1c levels and a significant increase in time in range (presented by Dr. Philip Levin MD, Endocrinology, MODEL Clinical Research).
  • Pharmacokinetics (and pharmacodynamics) of Technosphere insulin in children and adolescents ages 8-17 with type 1 diabetes showed that the ultra rapid rise in insulin concentrations corresponded with early post-prandial glucose control within the first hour post-dose, similar to what has been observed in adult patients.
  • Two poster presentations highlighting the use of MannKind’s unique Bluetooth enabled technology for enhanced instruction on use of the Afrezza inhaler and as a tool to provide connected dose information on top of continuous glucose monitoring data. 

Dr. Phillip Levin, Principal Investigator from MODEL Clinical Research in Baltimore, MD and lead author on the study of uncontrolled type 2 diabetes patients, noted that “the addition and rapid titration of Afrezza in patients with type 2 diabetes not currently at goal using two or more glucose lowering therapies, resulted in a 1.6% reduction in A1C and significantly increased time in range as measured by CGM. Our study provides additional clarity on both dose requirements and the clinical impact of adding ultra rapid-acting Afrezza therapy in uncontrolled type 2 diabetes.”

In addition to the original scientific disclosure presented at this year’s ATTD meeting, Dr. Kendall will participate as faculty in the “Ultra-rapid Insulin Analogues” session on Saturday, February 22, during which he will provide a current perspective on the clinical use of Afrezza, including evidence that ultra rapid-acting Afrezza can be safely and effectively titrated in fixed dose increments and that speed of insulin action may supersede dose precision for achieving post-prandial glucose control.

The full title of each of the presentations, presenting author, and the date and time of each disclosure are provided below.

ORAL PRESENTATION HIGHLIGHTS
   
Title:  Technosphere® Insulin Provides Better Early Postprandial Glucose Control Than Subcutaneous Rapid-Acting Analogue
(ATTD 2020 - Saturday February 22, 2020; 8:50 – 9:00 a.m. – Berlin Room)
   
Presenter: David Kendall, MD, MannKind Corporation
   
ELECTRONIC POSTER PRESENTATION HIGHLIGHTS
   
Title: Patient Trainer Experience with BluHale® V1.0 for Proper Technosphere® Insulin Administration
(ATTD 2020 – Thursday, February 20, 2020; 8 a.m.)
   
Presenter: Nadia Zaveri, PharmD, MannKind Corporation
   
   
Title: Safety and Pharmacokinetics of Technosphere® Insulin in Pediatric Patients
(ATTD 2020 – Thursday, February 20, 2020; 8 a.m.)
   
Presenter: David Kendall, MD, MannKind Corporation
   
   
Title: Insights to Improve Use of Technosphere® Insulin Provided By BluHale®, a Digital Diabetes Tool
(ATTD 2020 – Thursday, February 20, 2020; 8 a.m.)
   
Presenter: Benoit Adamo, MannKind Corporation
   
   
Title: Effective Treatment of Patients with Uncontrolled Type 2 Diabetes On Multiple Diabetes Medications By Adding Mealtime Ultra-rapid Technosphere® Insulin
(ATTD 2020 – Thursday, February 20, 2020; 8 a.m.)
   
Presenter: Philip Levin, MD, Endocrinology, MODEL Clinical Research
   
   
Title: Afrezza® Pre-meal Bolus Reduces Early Glycemic Excursion During Hybrid Closed Loop Treatment
(ATTD 2020 – Saturday, February 22, 2020; 8:30 a.m.)
   
Presenter: Alfonso Galderisi, MD, PhD, Yale University

About ATTD Annual Meeting
The ATTD is a scientific program that brings leading international experts together to discuss breakthroughs in diabetes treatments, technological innovations and showcase the latest developments in new insulin analogues, delivery systems, pumps, glucose sensors, closed-loop systems and much more.

About Afrezza®
Available by prescription, Afrezza® (insulin human) Inhalation Powder is an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within about 12 minutes of administration. Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 12 units, patients may use a combination of existing cartridge strengths. For more information on Afrezza, please visit www.afrezza.com.

About MannKind
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 ultra 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 facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

Forward-Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind's filings with the SEC. For a discussion of these and other factors, please refer to MannKind’s quarterly report on Form 10-Q for the quarter ended September 30, 2019 as well as MannKind’s other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

MannKind Contact:
818-661-5000
ir@mannkindcorp.com

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Source: MannKind