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 Fourth Quarter and Full Year 2006 Financial Results

02/02/07
PDF Version
MannKind Corporation Reports Fourth Quarter and Full Year 2006 Financial Results

- Conference Call to Begin Today at 9:00 a.m. ET -

VALENCIA, Calif., Feb. 2 /PRNewswire-FirstCall/ -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the fourth quarter and year ended December 31, 2006.

For the fourth quarter of 2006, total operating expenses were $71.8 million, compared with $35.0 million for the fourth quarter of 2005. Research and development (R&D) expenses increased by $31.2 million to $59.7 million for the fourth quarter of 2006 compared to the fourth quarter of 2005, primarily due to increased costs associated with the Company's expanded clinical development program for Technosphere® Insulin. All of the pivotal Phase 3 trials are now under way in the United States, Latin America and Europe. General and administrative (G&A) expenses increased by $5.6 million to $12.1 million for the fourth quarter of 2006 compared to the fourth quarter of 2005 primarily due to changes in stock-based compensation expense and increased consulting and various other general and administrative expenses. The total number of employees increased from 428 at the end of 2005 to 545 at the end of 2006.

The net loss applicable to common stockholders for the fourth quarter of 2006 was $71.3 million, or $1.30 per share based on 54.7 million weighted average shares outstanding, compared with a net loss applicable to common stockholders of $33.3 million, or $0.66 per share based on 50.3 million weighted average shares outstanding, for the fourth quarter of 2005.

For the year ended December 31, 2006, total operating expenses were $233.8 million, compared with $118.1 million for 2005. R&D expenses were $191.8 million in 2006, up $96.4 million from 2005, primarily related to the expansion of clinical trials of the Technosphere Insulin program. G&A expenses increased by $19.2 million to $42.0 million for 2006 as compared to 2005 primarily related to increased stock compensation expense and increased legal, accounting and consulting fees. The net loss applicable to common stockholders for 2006 was $230.5 million, or $4.52 per share based on 51.0 million weighted average shares outstanding, compared with a net loss applicable to common stockholders of $114.3 million, or $2.87 per share based on 39.9 million weighted averages shares outstanding for 2005. In December 2006, the Company sold 23.0 million shares of common stock and issued $115.0 million of convertible notes, raising gross proceeds of $515.7 million. The resulting aggregate net proceeds from these offerings after expenses was $495.9 million. The number of common shares outstanding at December 31, 2006 was 73,360,154.

Cash, cash equivalents and marketable securities were $436.5 million at December 31, 2006, $50.1 million at September 30, 2006, and $145.6 million at December 31, 2005.

"2006 was another exceptional year for MannKind marked with significant growth and progress. We continue to grow as an organization led by a team of very skilled and experienced managers. We remain committed to our clinical progress and goals, reflecting our confidence in Technosphere Insulin. New data continues to affirm the exciting attributes of Technosphere Insulin. In our completed studies to date, we have seen little, if any, need for meal titration, significant improvement in glycemic control overall and in post- meal profiles, virtually no risk of severe hypoglycemia, no weight gain, and no adverse effect on pulmonary function," said Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. "All of our pivotal trials are under way and the two year pulmonary safety trial, the gating trial for filing, was fully enrolled with 2,051 patients in September 2006. We are continuing the expansion of our manufacturing operations in Danbury, CT, and have completed a successful round of financing this year, and received clearance from the FDA to begin a Phase 1 trial of our first cancer immunotherapy product. In 2007, we will continue on our path to bring Technosphere Insulin to market as quickly as possible."

Conference Call

MannKind management will host a conference call to discuss these results today at 9:00 a.m. Eastern Standard 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 (866) 443-4144 or (203) 369-1112 and entering conference number 2363265.

Presenting from the Company will be:

  • Chairman and Chief Executive Officer Alfred Mann
  • Corporate Vice President and Chief Scientific Officer Peter Richardson
  • 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, 2005 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 Consolidated Statements of Operations (Unaudited) (In thousands, except Three Months Ended Year Ended per share amounts) December 31, December 31, 2006 2005 2006 2005 Revenue $ - $ - $ 100 $ - Operating expenses: Research and development 59,740 28,589 191,796 95,347 General and administrative 12,058 6,457 42,001 22,775 Total operating expenses 71,798 35,046 233,797 118,122 Loss from operations (71,798) (35,046) (233,697) (118,122) Other income 48 85 208 78 Interest expense on note payable to principal stockholder (822) (1,511) Interest expense on convertible debt (222) (222) Interest income 1,526 1,669 4,679 3,707 Loss before provision for income taxes (71,268) (33,292) (230,543) (114,337) Income taxes - - (5) (1) Net loss applicable to common stockholders $(71,268) $(33,292) $(230,548) $ (114,338) Net loss per share applicable to common stockholders - basic and diluted $(1.30) $(0.66) $(4.52) $(2.87) Shares used to compute basic and diluted net loss per share applicable to common stockholders 54,684 50,250 50,970 39,871 MannKind Corporation Condensed Balance Sheet (Unaudited) (in thousands) December 31, December 31, Assets 2006 2005 Current assets: Cash and cash equivalents $319,555 $56,037 Marketable securities 116,924 89,597 State research and development tax credit exchange receivable - current 2,418 1,194 Prepaid expenses and other current assets 10,650 3,044 Total current assets 449,547 149,872 Property and equipment - net 88,328 76,183 State research and development tax credit exchange receivable - net of current portion 1,500 2,031 Other assets 362 285 Total $539,737 $228,371 Liabilities and Stockholders' Equity Current liabilities $44,959 $21,365 Other liabilities 24 29 Senior convertible notes 111,267 Stockholders' equity 383,487 206,977 Total $539,737 $228,371 

SOURCE  MannKind Corporation


      
    CONTACT:   Dick Anderson, Chief Financial Officer, MannKind Corporation,

+1-661-775-5302, danderson@mannkindcorp.com; or Julie Huang, investors, or

Robert Stanislaro, media, both of Financial Dynamics, for MannKind

Corporation, +1-212-850-5600, mnkd@fd.com 

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