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 Positive Afrezza® Clinical Data from Three Studies at ADA 79th Scientific Sessions

06/09/19
PDF Version

WESTLAKE VILLAGE, Calif., June 09, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) announced that new data from three different studies of Afrezza® (insulin human) Inhalation Powder were released at the American Diabetes Association’s 79th Scientific Sessions, being held June 7-11, in San Francisco, California.

Poster 1350-P:   Safety and Pharmacokinetics of Technosphere Insulin in Pediatric Patients

MannKind will present a poster with initial information from its ongoing study of Safety and Pharmacokinetics of Technosphere Insulin (Afrezza) in Pediatric Patients ¹ on Monday, June 10.  This study is the first step in preparation for a phase 3 safety and efficacy study.

Poster Highlights:                         

  • In pediatric patients, the rapid rise in insulin concentrations corresponded with early postprandial glucose control within the first hour post-dose. The profile is similar to that previously observed in adults.
  • Consistent with its safety profile in adults, Afrezza was generally well-tolerated in pediatric patients; most treatment emergent adverse events were of mild severity, and no severe hypoglycemia was observed.
  • These data will help guide the finalization of the protocol for a phase 3 safety and efficacy study.

“We are excited to share the progress of the ongoing pediatric study program,” said David Kendall, M.D., Chief Medical Officer of MannKind. “As is well known, type 1 diabetes is often diagnosed in children and adolescents, and these individuals will continue to require insulin therapy throughout their lives. Evaluating as quickly as possible the potential use of Afrezza in children and adolescents as an option for mealtime insulin therapy is a top priority for MannKind.”

Poster 136-LB:   Effective Treatment of T2D Patients Uncontrolled on Multiple Diabetes Medications by Adding Afrezza® Mealtime Ultra-Rapid Insulin

Dr. Philip Levin and colleagues presented data from an independent study supported and funded by MannKind. Dr. Levin presented late-breaking clinical data on interim results of a study² showing how a fixed titration schedule can be implemented to achieve better time in range and reduction of overall A1c.

Late Breaking Poster Highlights:

  • Enrolled adult patients with uncontrolled type 2 diabetes on two or more therapies (orals/ basal/ GLPs) – with the addition of Afrezza at all meals by means of a rapid and ongoing titration protocol
  • Observed a mean decrease in A1c of ~1.6% (all subjects with A1c reduction over 12 weeks of study)
  • 93% (13 of 14 subjects) achieved A1c below 8% (mean baseline A1c 9.1%)
  • Reduced hyperglycemia (>250mg/dL) by 74%
  • Increased time in range more than 75%; daily glucose decreased by ~50 mg/dL as measured by blinded continuous glucose monitoring
  • No significant difference in rates of hypoglycemia with the addition of Afrezza

“We are pleased to share the interim analysis from our independent investigator-initiated trial of Afrezza therapy. These preliminary data significantly advance our understanding of the potential clinical benefits and practical use of Afrezza therapy for those living with type 2 diabetes,” stated Philip Levin, M.D. of Bay West Endocrinology Associates and MODEL Clinical Research in Baltimore, MD. “Data generated to this point are encouraging and support the use of Afrezza as prandial therapy earlier in the treatment of type 2 diabetes.”

Oral Abstract
151-OR: Technosphere Insulin Provides Better Early Postprandial Glucose Control than Subcutaneous Rapid-Acting Analog

MannKind investigators also shared data at an oral presentation³ using mixed meal tolerance testing to assess glucose control, Afrezza dosing and overall safety in a cohort of individuals with type 1 diabetes.

Oral Presentation Highlights:

  • When compared to rapid acting injected insulin, Afrezza provided significantly better glucose control in the first two hours following the meal.
  • Even when adjusting the dose of Afrezza using up to two times the dose of injected insulin aspart, Afrezza treatment was associated with lower rates of overall and level 2 hypoglycemia - an observation that was particularly evident in the late (>2 hour) post-meal period.

Dr. Anne Peters, Clinical Professor of Medicine at the Keck School of Medicine at USC and Director of the USC Westside Center for Diabetes Care noted that “the improved post-meal glucose levels and lower rates of low blood sugars seen in this study of individuals with type 1 diabetes support my growing clinical experience. The presentation of these data provides further evidence that proper dosing of Afrezza has the potential to safely and effectively get more patients into target range at meal times.”

About Afrezza® 

Available by prescription, Afrezza® (insulin human) Inhalation Powder is a 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 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 about Afrezza, please visit www.afrezza.com.

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 orally 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 March 31, 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:
Rose Alinaya
Investor Relations
818-661-5000
ir@mannkindcorp.com 

Appendix – Poster Information

(1) Poster Presentation: Safety and Pharmacokinetics of Technosphere Insulin (TI) in Pediatric Patients
Presenter:          David M. Kendall, M.D.
Poster No.          1350-P
Date/Time:         Monday, June 10; 12:00 PM - 1:00 PM, Hall F (North, Exhibition Level)

(2) Late-Breaking Poster Presentation: Effective Treatment of T2D Patients Uncontrolled on Multiple Diabetes Medications by Adding Afrezza Mealtime Ultra-Rapid Insulin
Presenter:          Philip Levin, M.D.
Poster No:          136-LB (late breaking poster)
Date/Time:         Sunday, June 9; 12:00 PM - 1:00 PM, Hall F (North, Exhibition Level)

(3) Oral Presentation: Technosphere Insulin Provides Better Early Postprandial Glucose Control than Subcutaneous Rapid-Acting Analog
Presenter:          David M. Kendall, M.D.
Poster No:          151-OR
Date/Time:         Sunday, June 9; 9:45 AM

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Source: MannKind