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 Corporation Reports First Quarter of 2009 Financial Results

05/04/09
PDF Version
MannKind Corporation Reports First Quarter of 2009 Financial Results

VALENCIA, Calif.--(BUSINESS WIRE)--May. 4, 2009-- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the first quarter ended March 31, 2009.

For the first quarter of 2009, total operating expenses were $57.8 million, compared to $74.1 million for the first quarter of 2008. Research and development (R&D) expenses decreased by $15.6 million to $42.9 million for the first quarter of 2009 compared to the first quarter of 2008. This decrease in R&D expenses as compared to the same period in the prior year was primarily due to decreased costs associated with the clinical development of AFRESA® as well as decreased manufacturing costs associated with raw material purchases. General and administrative (G&A) expenses decreased by $0.7 million to $14.9 million for the first quarter of 2009 compared to the first quarter of 2008.

The net loss applicable to common stockholders for the first quarter of 2009 was $59.4 million, or $0.58 per share, based on 102.0 million weighted average shares outstanding, compared with a net loss applicable to common stockholders of $71.4 million, or $0.70 per share, based on 101.4 million weighted average shares outstanding, for the first quarter of 2008.

Cash, cash equivalents and marketable securities were $30.2 million at March 31, 2009 compared to $46.5 million at December 31, 2008, and $269.1 million at March 31, 2008. Currently, the Company has $260.0 million of available borrowings under the loan agreement with an entity controlled by the Company’s principal stockholder.

"This past quarter was extremely busy for MannKind," said Alfred Mann, Chairman and Chief Executive Officer, "culminating in our submission to the FDA of a New Drug Application for AFRESA. With this milestone accomplished, we are now turning our attention to commercial readiness activities."

Conference Call

MannKind management will host a conference call to discuss these results today at 4:00 PM EDT. To participate in the call, please dial (888) 677-5721 or (210) 839-8507. To listen to the call via the internet, please visit http://www.mannkindcorp.com. The web site replay will be available for 14 days. A telephone replay will be accessible for approximately 14 days following completion of the call by dialing (888) 566-0513 or (203) 369-3063.

Presenting from the Company will be:

  • Chairman and Chief Executive Officer Alfred Mann
  • President and Chief Operating Officer Hakan Edstrom
  • Corporate Vice President and Chief Financial Officer Matthew Pfeffer
  • Corporate Vice President and Chief Scientific Officer Peter Richardson

About MannKind Corporation

MannKind Corporation (Nasdaq: MNKD) focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes and cancer. Its diabetes pipeline includes AFRESA, an ultra rapid-acting insulin and MKC253, an inhaled formulation of human GLP-1. MannKind also has two cancer immunotherapeutic products in clinical development. MannKind maintains a website at http://www.mannkindcorp.com to which the company regularly posts copies of its press releases as well as additional information. 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.

Forward-Looking Statements

This press release contains forward-looking statements, including statements related to MannKind’s commercial readiness activities. Words such as "believes," "anticipates," "plans," "expects," "intend," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations and involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the difficulties or delays in seeking or obtaining regulatory approval, and other risks detailed in MannKind's filings with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the year ended December 31, 2008 and periodic reports on Form 10-Q and Form 8-K. 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 Corporation and Subsidiaries

(A Development Stage Company)

Condensed Consolidated Statements of Operations

(Unaudited)

(In thousands, except per share amounts)

 

 

 

 

 

 

Three months ended
March 31,

Cumulative

period from

February 14,

1991 (date of

inception) to

March 31,

2009       2008 2009
 
Revenue

$

—

 

$

20

  $

2,988

 
Operating expenses:
Research and development 42,889 58,445 1,040,371
General and administrative 14,917 15,640 260,759
In-process research and development costs — — 19,726
Goodwill impairment   —     —     151,428  

Total operating expenses

  57,806     74,085     1,472,284  
Loss from operations (57,806 ) (74,065 ) (1,469,296 )
Other income (expense) 71 60 (1,872 )
Interest expense on note payable to related party (593 ) — (2,116 )
Interest expense on senior convertible notes (1,115 ) (337 ) (7,072 )
Interest income   31     2,921     36,892  
Loss before provision for income taxes (59,412 ) (71,421 ) (1,443,464 )
Income taxes   —     —     (26 )
Net loss (59,412 ) (71,421 ) (1,443,490 )
Deemed dividend related to beneficial conversion feature of convertible preferred stock — — (22,260 )
Accretion on redeemable preferred stock   —     —     (952 )
Net loss applicable to common stockholders

$

(59,412

)

$

(71,421

) $

(1,466,702

)

Net loss per share applicable to common stockholders — basic and diluted

$

(0.58

)

$

(0.70

)
Shares used to compute basic and diluted net loss per share applicable to common stockholders   102,030     101,409  
 
 
               

MannKind Corporation and Subsidiaries

(A Development Stage Company)

Condensed Consolidated Balance Sheet

(Unaudited)

(in thousands)

 

 

March 31, 2009

December 31, 2008

 
Assets
Current assets:
Cash and cash equivalents

$

27,114

$ 27,648
Marketable securities 3,115 18,844
State research and development credit exchange receivable — current — 1,500
Prepaid expenses and other current assets   4,907   5,983
Total current assets 35,136 53,975
Property and equipment — net 228,352 226,436
State research and development credit exchange receivable — net of current portion 1,675 1,500
Other assets   10,548   548
Total

$

275,711

$ 282,459
 

Liabilities and Stockholders’ Equity

Current liabilities

$

40,159

$ 53,472
Senior convertible notes 112,378 112,253
Note payable to related party 90,000 30,000
Other liabilities — —
Stockholders’ equity   33,174   86,734
Total

$

275,711

$ 282,459

Source: MannKind Corporation

MannKind Corporation
Matthew J. Pfeffer
Corporate Vice President and
Chief Financial Officer
661-775-5300
mpfeffer@mannkindcorp.com