MOUNTAIN VIEW, Calif., March 24 Based on its recent analysis of the pharmaceuticals and biotechnology market, Frost & Sullivan recognizes MannKind Corporation with the 2010 North America Frost & Sullivan Entrepreneurial Company of the Year Award. The company's growth plan includes the launch of its first marketed product, AFREZZA(TM) (an ultra rapid acting mealtime insulin therapy made using the company's proprietary Technosphere® formulation technology), development of cutting-edge pipeline compounds, and collaboration with other companies on products utilizing the Technosphere technology platform. Technosphere technology can be applied to a wide range of drug delivery challenges and therapeutic areas, thus providing the company with a versatile asset for drug development.
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Significantly, MannKind developed AFREZZA without the involvement of a larger corporate partner. AFREZZA has attractive attributes that make it a potentially important alternative to marketed, rapid-acting insulin. The key advantage of AFREZZA is that it is rapidly absorbed into the bloodstream, reaching peak levels within 12 to 14 minutes in stark contrast to injected rapid-acting insulins, which reach peak levels in 30 to 90 minutes.
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"Additionally, injected rapid-acting insulin can take between four to eight hours to leave the system, sometimes resulting in hypoglycemia, which is listed as a serious concern for diabetics," says Frost & Sullivan Research Analyst Katheryn Symank. "Clinical studies have shown that AFREZZA has reduced the risk for both mild/moderate and severe hypoglycemia when compared to injected insulin comparators because it dissipates within three hours. It also showed less weight gain when compared to other insulins."
The AFREZZA clinical program involved 49 different studies and more than 5,000 patients worldwide. While its first-generation inhaler is an easy-to-use breath-powered, palm-sized device, the second-generation inhaler, currently under development, is even smaller, about the size of a whistle, requires fewer inhalations per dose, and is simpler to use. With these advantages, AFREZZA is expected to gain favor among patients and doctors.
MannKind's Technosphere technology facilitates novel dosing options for compounds that would otherwise be injected. Most biopharmaceuticals on the market are administered through injection or intravenous infusion because they are too complex and delicate for other drug delivery methods. Technosphere technology allows drugs that are normally injected to be formulated into a dry powder form for inhalation. Because the active ingredient passes directly from the lungs into the arterial circulation, drugs formulated using Technosphere technology also avoid first-pass metabolism by the liver.
"As Technosphere technology can be applied to a variety of medications, there is a large potential for its application including the creation of new inhaled therapeutics or the improvement of existing products," notes Symank. "As part of the company's business development strategy, MannKind is actively seeking partners that may have pharmaceuticals products that could benefit from Technosphere reformulation."
In addition to AFREZZA, MannKind is also using its Technosphere formulation technology to develop MKC253, a formulation of GLP-1 (glucagon-like peptide) for the treatment of diabetes. Results from clinical trials have found that patients taking MKC253 do not experience the same adverse side effects (intense nausea) as those taking injected GLP-1 analogs.
MannKind is also developing novel therapies such as the MKC 1106 for the treatment of melanoma and other cancers. This compound is an immunotherapy regimen that is administered directly into the patient's lymph nodes.
Each year, Frost & Sullivan presents this award to the small company that demonstrated superior entrepreneurial ability in its industry during the research period. This award signifies the company's identification of a unique and revolutionary product solution with significant market potential. Additionally, it certifies the company's marketing strategy as sound and poised for success.
Frost & Sullivan Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research in order to identify best practices in the industry.
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 diabetes pipeline includes AFREZZA(TM) and MKC253. MKC253 is currently in phase 1 clinical trials. In March 2009, MannKind submitted an NDA to the FDA requesting approval of AFREZZA for the treatment of adults with type 1 or type 2 diabetes for the control of hyperglycemia. In March 2010, MannKind received a Complete Response to this NDA from the FDA requesting additional information. Currently, AFREZZA remains under regulatory review. Other products in its pipeline include the cancer immunotherapy products MKC1106-PP and MKC1106-MT, which are currently in phase 1 clinical trials. MannKind maintains a website at www.mannkindcorp.com, to which MannKind regularly posts copies of its press releases as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to e-mail alerts that are sent automatically when MannKind issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the website.
About Frost & Sullivan
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Contact: Jake Wengroff 210.247.3806 [email protected]
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