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 Second Quarter Financial Results

08/11/08
PDF Version
MannKind Corporation Reports Second Quarter Financial Results

VALENCIA, Calif., Aug. 11 /PRNewswire-FirstCall/ -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the second quarter ended June 30, 2008.

For the second quarter of 2008, total operating expenses were $80.9 million, compared to $75.4 million for the second quarter of 2007. This increase was primarily attributable to increased research and development (R&D) expenses which totaled $67.6 million for this quarter compared to $61.5 million for the same quarter in 2007. The increase in research and development expenses for the three months ended June 30, 2008 as compared to the same period in the prior year was primarily due to increases in manufacturing costs, clinical trial costs, and stock-based compensation expense. General and administrative (G&A) expenses decreased by $0.6 million to $13.3 million for the second quarter of 2008 compared to the second quarter of 2007. The decrease in general and administrative expenses for the three months ended June 30, 2008 as compared to the same period in the prior year was primarily due to lower professional service fees, partially offset by increases in stock-based compensation expense and salary related expenses.

For the first six months of 2008, operating expenses totaled $154.9 million, compared to $152.7 million in the first half of 2007. R&D expenses for the first six months were $126.0 million, compared to $125.3 million in 2007. The increase in R&D expenses for the first six months was primarily due to increases in stock-based compensation expense and manufacturing costs, partially offset by lower clinical trial costs. G&A expenses increased by $1.5 million to $28.9 million for the first half of 2008 as compared to the same period in 2007. The increase in G&A expenses for the first six months was primarily due to increases in salary related expenses and stock-based compensation expense, partially offset by lower professional service fees.

We expect G&A expenses to increase during the remainder of 2008 as a result of increased salary and stock-based compensation related expenses and professional service fees.

The net loss for the second quarter of 2008 was $79.8 million, or $0.79 per share, based on 101.4 million weighted average shares outstanding. This compares to a net loss of $72.0 million, or $0.98 per share, based on 73.4 million weighted average shares outstanding for the second quarter of 2007.

The net loss for the first half of 2008 was $151.2 million, or $1.49 per share based on 101.4 million shares outstanding, compared with a net loss of $145.1 million, or $1.98 per share based on 73.4 million shares outstanding, for the first half of 2007.

Cash and cash equivalents were $180.5 million at June 30, 2008, $269.1 million at March 31, 2008 and $368.3 million at December 31, 2007.

"This is an exciting time for MannKind Corporation," commented Alfred Mann, Chairman and CEO. "We are only about three weeks from completion of our final two pivotal trials for Technosphere Insulin. Importantly, our team was satisfied with the outcome from our July 14 pre-NDA meeting with the FDA. Our science, preclinical and clinical programs have enabled us to target year-end to complete preparation of the NDA, though that is an aggressive target."

Hakan Edstrom, President and COO, added, "Our new Danbury factory is virtually complete and we are looking forward to the dedication on September 17. This factory is being equipped in modular steps to meet our expected demand for Technosphere Insulin. Our other products are also moving forward, and clinical progress for our GLP-1 formulation and two cancer vaccines continues to be very promising. As Al Mann said, this is an exciting time, full of promise for the future."

Conference Call

MannKind management will host a conference call to discuss these results today at 5:00 p.m. Eastern Time. 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 fourteen days. A telephone replay will be accessible for approximately 14 days following completion of the call by dialing (800) 219-6350 or (402) 220-3904 and entering conference number 4423748.

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 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.

Forward-Looking Statements

This press release contains forward-looking statements, including statements related to MannKind's expected G&A expenses, clinical trials, product candidates, regulatory submissions, manufacturing facility and product demand, that involve risks and uncertainties. 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 the Company'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 these risks and uncertainties, which include, without limitation, risks related to the progress, timing and results of clinical trials, difficulties or delays in seeking or obtaining regulatory approval, the manufacture of the Technosphere Insulin System, competition from other pharmaceutical or biotechnology companies, MannKind's ability to enter into any collaborations or strategic partnerships, intellectual property matters 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, 2007 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.

                              (Tables to follow)



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

                                  Three Months Ended     Six Months Ended
                                  June 30,   June 30,   June 30,   June 30,
                                    2008      2007       2008       2007

    Revenue                           $ -       $ -        $20        $10

    Operating expenses:
    Research and development       67,574    61,480    126,019    125,268
    General and administrative     13,290    13,913     28,930     27,463
    Total operating expenses       80,864    75,393    154,949    152,731
    Loss from operations          (80,864)  (75,393)  (154,929)  (152,721)
    Other income (expense)            (60)       44          -         96
    Interest expense on senior
     convertible notes               (124)     (901)      (461)    (2,046)
    Interest income                 1,222     4,261      4,143      9,541
    Loss before provision for
     income taxes                 (79,826)  (71,989)  (151,427)  (145,130)
    Income taxes                        -         -          -          -
    Net loss                     $(79,826) $(71,989) $(151,247) $(145,130)

    Net loss per share -
     basic and diluted            $ (0.79)  $ (0.98)   $ (1.49)   $ (1.98)

    Shares used to compute basic
     and diluted net loss
     per share                    101,427    73,421    101,418     73,405



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

                                                    June 30,      December 31,
    Assets                                            2008            2007

    Current assets:
      Cash and cash equivalents                     $180,454       $368,285
      State research and development tax credit
       exchange receivable - current                       -            831
      Prepaid expenses and other current assets        7,253          9,596

    Total current assets                             187,707        378,712

    Property and equipment - net                     208,742        162,683

    State research and development tax credit
     exchange receivable - net of current portion      2,250          1,500
    Other assets                                         549            548

    Total                                           $399,248       $543,443

    Liabilities and Stockholders' Equity

    Current liabilities                              $61,958        $67,558
    Other liabilities                                      -             24
    Senior convertible notes                         112,004        111,761

    Stockholders' equity                             225,286        364,100

    Total                                           $399,248       $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