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 Financial Results

05/05/08
PDF Version
MannKind Corporation Reports First Quarter Financial Results

VALENCIA, Calif., May 5 /PRNewswire-FirstCall/ -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the first quarter ended March 31, 2008.

For the first quarter of 2008, total operating expenses were $74.1 million, compared to $77.3 million for the first quarter of 2007. Research and development (R&D) expenses decreased by $5.3 million to $58.4 million for the first quarter of 2008 compared to the first quarter of 2007, primarily due to lower clinical trial costs and associated packaging costs for clinical materials, partially offset by higher stock compensation expense. General and administrative (G&A) expenses increased by $2.1 million to $15.6 million for the first quarter of 2008 compared to the first quarter of 2007 primarily due to additional patent expenses.

The net loss applicable to common stockholders for the first quarter of 2008 was $71.4 million, or $0.70 per share based on 101.4 million weighted average shares outstanding, compared with a net loss applicable to common stockholders of $73.1 million, or $1.00 per share based on 73.4 million weighted average shares outstanding for the first quarter of 2007.

Cash and cash equivalents were $269.1 million at March 31, 2008 and $368.3 million at December 31, 2007.

Conference Call

MannKind management will host a conference call to discuss these results today at 5:00 p.m. EDT. To participate in the call, please dial (800) 857-0373 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 (866) 457-6651 or (203) 369-1300.



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 diseases such as diabetes and cancer. Its lead product, the Technosphere® Insulin System, is currently in Phase 3 clinical trials in the United States, Europe and Latin America to study its safety and efficacy in the treatment of diabetes. For more information on MannKind Corporation and its technology, visit http://www.mannkindcorp.com.

                              (Tables to follow)



                             MannKind Corporation
                      Condensed Statements of Operations
                                 (Unaudited)
                   (in thousands, except per share amounts)

                                                 Three Months Ended March 31,
                                                   2008                 2007

    Revenue                                         $20                  $10

    Operating expenses:
    Research and development                     58,445               63,788
    General and administrative                   15,640               13,550
    Total operating expenses                     74,085               77,338
    Loss from operations                        (74,065)             (77,328)
    Other income                                     60                   52
    Interest expense on senior convertible
     notes                                         (337)              (1,145)
    Interest income                               2,921                5,280
    Loss before provision for income taxes      (71,421)             (73,141)
    Income taxes                                      -                    -

    Net loss applicable to common
     stockholders                              $(71,421)            $(73,141)

    Net loss per share applicable to common
     stockholders - basic and diluted            $(0.70)              $(1.00)

    Shares used to compute basic and diluted
     net loss per share applicable to common
     stockholders                               101,409               73,388



                             MannKind Corporation
                           Condensed Balance Sheets
                                 (Unaudited)
                                (in thousands)

                                                     March 31,  December 31,
    Assets                                              2008          2007

    Current assets:
      Cash and cash equivalents                       $269,079      $368,285
      State research and development tax credit
       exchange receivable - current                         -           831
      Prepaid expenses and other current assets          8,004         9,596

    Total current assets                               277,083       378,712

    Property and equipment - net                       185,895       162,683

    State research and development tax credit
     exchange receivable - net of current portion        1,875         1,500
    Other assets                                           549           548

    Total                                             $465,402      $543,443

    Liabilities and Stockholders' Equity

    Current liabilities                                $55,447       $67,558
    Other liabilities                                        -            24
    Senior convertible notes                           111,882       111,761

    Stockholders' equity                               298,073       364,100

    Total                                             $465,402      $543,443

SOURCE MannKind Corporation

CONTACT:
Matthew Pfeffer,
Chief Financial Officer
of MannKind Corporation,
+1-661-295-4784,
mpfeffer@mannkindcorp.com

Web site: http://www.mannkindcorp.com