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 Third Quarter Financial Results

11/07/07
PDF Version

VALENCIA, Calif., Nov. 7 /PRNewswire-FirstCall/ -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the third quarter ended September 30, 2007.

For the third quarter of 2007, total operating expenses were $75.6 million, compared to $61.1 million for the third quarter of 2006. A substantial portion of this increase was attributed to increased research and development (R&D) expenses which totaled $64.8 million for this quarter compared to $50.8 million for the same quarter in 2006. These increased R&D costs were associated with the Company's expanded clinical development program and the associated manufacturing costs (including clinical supplies) for Technosphere Insulin. General and administrative (G&A) expenses increased by $0.4 million to $10.7 million for the third quarter of 2007 compared to the third quarter of 2006. This increase was due primarily to the increased number of employees.

For the first nine months of 2007, operating expenses totaled $228.3 million, compared to $162.0 million in the first nine months of 2006. R&D expenses were $190 million, up $58.0 million as compared to the first nine months of 2006, again primarily related to the Company's expanded clinical development program and the associated manufacturing costs (including clinical supplies) for Technosphere Insulin. G&A expenses increased by $8.3 million to $38.2 million for the first nine months of 2007 compared to the first nine months of 2006 primarily related to the increased number of employees and increased professional fees.

The net loss for the third quarter of 2007 was $73.0 million, or $0.99 per share, based on 73.5 million weighted average shares outstanding. This compares to a net loss of $61.0 million, or $1.23 per share, based on 49.7 million weighted average shares outstanding for the third quarter of 2006.

The net loss for the first nine months of 2007 was $218.2 million, or $2.97 per share based on 73.4 million weighted average shares outstanding, compared with a net loss of $159.3 million, or $3.20 per share based on 49.7 million weighted average shares outstanding, for the first nine months of 2006.

Cash, cash equivalents and marketable securities were $204.2 million at September 30, 2007, $284.0 million at June 30, 2007, and $436.5 million at December 31, 2006. On October 5, 2007 the company received $250 million in gross proceeds from its self managed registered direct offering of approximately 27 million shares of common stock.

"While Exubera stumbled in the marketplace and then was ultimately withdrawn, our Technosphere Insulin is very different and continues to be well received by patients and physicians in our clinical trials," stated Alfred Mann, Chairman and Chief Executive Officer. "Our Phase 3 program is on track and our readiness for commercial operations is proceeding according to schedule. As data becomes available in 2008, we will be able to share more of this progress with our investors. In the meantime, the recently announced positive Phase 1 data for our Technosphere/GLP-1 product were encouraging. More than ever, there is a need for improved and innovative diabetes therapies. We at MannKind remain committed to bringing such therapies to the enormous number of diabetes patients who suffer from this disease."

Conference Call

MannKind management will host a conference call to discuss these results today at 8:00 a.m. Eastern Time. To participate in the call please dial (888) 566-5775 or (210) 234-0001. 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) 262-4859 or (203) 369-3220.

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 Dick Anderson
  •  
    • 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 the anticipated availability of clinical trial data in 2008, MannKind's commitment to develop diabetes therapies, the status of MannKind's Phase 3 program, and MannKind's readiness for commercial operations. 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 progress, timing and results of clinical trials, difficulties or delays in seeking or obtaining regulatory approval, MannKind's ability to enter into any collaborations or strategic partnerships, MannKind's ability to raise additional financing 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, 2006 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 news release.

                              (Tables to follow)



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

                                 Three Months Ended     Nine Months Ended
                                Sept. 30,   Sept. 30,  Sept. 30,  Sept. 30,
                                  2007        2006       2007        2006

    Revenue                          $-           $-         $10        $100

    Operating expenses:
    Research and development     64,825       50,785     190,093     132,056
    General and administrative   10,744       10,349      38,207      29,943
    Total operating expenses     75,569       61,134     228,300     161,999
    Loss from operations        (75,569)     (61,134)   (228,290)   (161,899)
    Other income                     62           51         158         160
    Interest expense on
     senior convertible notes      (778)           -      (2,824)          -
    Interest expense on note
     payable to principal
     stockholder                      -         (689)          -        (689)
    Interest income               3,238          802      12,779       3,153
    Loss before provision
    for income taxes            (73,047)     (60,970)   (218,177)   (159,275)
    Income taxes                      -            -           -          (5)
    Net loss                   $(73,047)    $(60,970)  $(218,177)  $(159,280)

    Net loss - basic and
     diluted                     $(0.99)      $(1.23)     $(2.97)     $(3.20)

    Shares used to compute
     basic and diluted net
     loss per share              73,520       49,731      73,444      49,718



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

                                                   September 30, December 31,
    Assets                                             2007          2006

    Current assets:
      Cash and cash equivalents                       $152,298     $319,555
      Marketable securities                             51,875      116,924
      State research and development tax credit
       exchange receivable - current                     3,171        2,418
      Prepaid expenses and other current assets         11,876       10,650

    Total current assets                               219,220      449,547

    Property and equipment - net                       143,244       88,328

    State research and development tax credit
     exchange receivable - net of current portion        1,125        1,500
    Other assets                                           547          362

    Total                                             $364,136     $539,737

    Liabilities and Stockholders' Equity

    Current liabilities                                $72,847      $44,959
    Other liabilities                                       24           24
    Senior convertible notes                           111,641      111,267


    Stockholders' equity                               179,624      383,487

    Total                                             $364,136     $539,737

SOURCE MannKind Corporation

CONTACT:
Dick Anderson,
Chief Financial Officer,
+1-661-775-5302,
danderson@mannkindcorp.com,
of MannKind Corporation;
or
investors, Robert Stanislaro,
+1-212-850-5600,
mnkd@fd.com,
for MannKind Corporation

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