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

05/11/07
PDF Version

VALENCIA, Calif., May 11 /PRNewswire-FirstCall/ -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the first quarter ended March 31, 2007.

For the first quarter of 2007, total operating expenses were $77.3 million, compared with $45.1 million for the first quarter of 2006. A substantial proportion of this increase was attributed to increased research and development (R&D) expenses which were $63.8 million for this quarter compared to $36.0 million for the same quarter in 2006. These increased (R&D) costs were associated with the Company's expanded clinical development program and manufacturing costs for Technosphere(R) Insulin. General and administrative (G&A) expenses increased by $4.4 million to $13.6 million for the first quarter of 2007 compared to the first quarter of 2006. This was due primarily to employee related expenses and professional fees.

The net loss applicable to common stockholders for the first quarter of 2007 was $73.1 million, or $1.00 per share, based on 73.4 million weighted average shares outstanding. This compares to a net loss applicable to common stockholders of $43.6 million, or $0.87 per share, based on 49.8 million weighted average shares outstanding for the first quarter of 2006.

Cash, cash equivalents and marketable securities were $365.6 million at March 31, 2007, $436.5 million at December 31, 2006, and $102.6 million at March 31, 2006.

"Technosphere Insulin continues to demonstrate significant differentiating qualities when compared to other diabetes therapies. Technosphere Insulin produces a rapid elevation in insulin that peaks within 12 to 14 minutes after inhalation. We believe the kinetics for Technosphere Insulin are much faster than any other product in commercial development. The result of these kinetics in safety and efficacy further strengthens our belief that Technosphere Insulin will emerge as the first in a new class of diabetes products," said Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. "We continue to meet our program milestones and remain on track to file our NDA submission with the FDA for Technosphere Insulin in December 2008. All of our key Phase 3 trials for Technosphere Insulin are progressing satisfactorily and I am pleased to announce today the completion of enrollment for the 009 trial and anticipate we will complete enrollment for the 102 and the 103 trials around the end of this month."

MannKind also announced today that it has initiated a clinical trial in healthy individuals for a second Technosphere product, MKC-253. This trial is being conducted in Europe. MKC-253 is a formulation of GLP-1 delivered on Technosphere particles that MannKind is evaluating for safety, tolerability, and pharmacokinetics. GLP-1 is a hormone secreted in the small intestine and colon in response to food intake. GLP-1 in healthy individuals is known to stimulate insulin secretion and slow gastric emptying. Patients with type 2 diabetes often exhibit a lower level of GLP-1 secretion. "The initiation of this trial demonstrates our commitment to expand our proprietary Technosphere formulation for the delivery of other drugs and develop Technosphere as a platform technology," concluded Alfred Mann.

Conference Call

MannKind management will host a conference call to discuss these results today at 9:00 a.m. Eastern Daylight Time. To participate in the call please dial (888) 566-5775 or (210) 839-8503. To listen to the call via the Internet please visit 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 (888) 568-0920 or (203) 369-3791 and entering conference number 2363283.

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

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.

Forward-Looking Statements

This press release contains forward-looking statements, including statements related to MannKind's clinical trials, product candidates and organizational development 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, 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 press release.

                              (Tables to follow)



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

                                                     Three Months Ended
                                                          March 31,
                                                  2007                 2006

    Revenue                                         $10                 $100

    Operating expenses:
    Research and development                     63,788               35,950
    General and administrative                   13,550                9,138
    Total operating expenses                     77,338               45,088
    Loss from operations                        (77,328)             (44,988)
    Other income                                     52                   50
    Interest expense on senior convertible
     notes                                       (1,145)                  --
    Interest income                               5,280                1,380
    Loss before provision for income taxes      (73,141)             (43,558)
    Income taxes                                     --                   (1)

    Net loss                                   $(73,141)            $(43,559)

    Net loss - basic and diluted                 $(1.00)              $(0.87)

    Shares used to compute basic and diluted
     net loss per share                          73,388               49,787



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

                                                      March 31,   December 31,
                                                         2007        2006
    Assets

    Current assets:
      Cash and cash equivalents                        $262,753     $319,555
      Marketable securities                             102,824      116,924
      State research and development tax credit
       exchange receivable - current                      3,918        2,418
      Prepaid expenses and other current assets          13,714       10,650

    Total current assets                                383,209      449,547

    Property and equipment - net                         98,622       88,328

    State research and development tax credit
     exchange receivable - net of current portion           375        1,500
    Other assets                                            361          362

    Total                                              $482,567     $539,737

    Liabilities and Stockholders' Equity

    Current liabilities                                  $55,853     $44,959
    Other liabilities                                         24          24
    Senior convertible notes                             111,406     111,267

    Stockholders' equity                                 315,284     383,487

    Total                                               $482,567    $539,737

SOURCE MannKind Corporation

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