|Traded as||NASDAQ: MNKD|
|Headquarters||Valencia, CA, USA|
MannKind Corporation, based in Valencia, California, is a biopharmaceutical company focusing on the discovery, development, and commercialization of therapeutic products for diseases such as diabetes and cancer. The company, while technically founded in February 1991, took its present form in 2003 as a merger of three companies owned by Alfred E. Mann, named after its founder. One of the former companies, Pharmaceutical Discovery, was purchased in 2001 from Solomon Steiner; with that purchase MannKind acquired the Technosphere molecule and Medtone Inhaler, upon which was developed its lead product, Afrezza (inhalable insulin), which was under FDA review. Alfred Mann is chairman of the board and chief executive officer. Mann has invested approximately $900 million in his company.
MannKind's corporate headquarters are in Valencia, California. The Afrezza manufacturing facility is in Danbury, Connecticut. In March 2009, MannKind signed a purchase agreement with Pfizer for its insulin manufacturing facility in Frankfurt, Germany; however, the purchase was subject to Sanofi-Aventis' right of refusal within 60 days' notification and approval of Infraserv, the corporate park operator. Infraserv gave its consent; however, Sanofi-Aventis exercised its right to refuse, purchasing the facility. MannKind acquired eight tons of insulin for use in manufacture of a pulmonary product, an option to purchase an undisclosed amount of additional insulin at a specified price, and the license to the manufacturing process. MannKind was relieved of ownership of the manufacturing facility.
Afrezza (as is claimed by MannKind and supported by company-funded research and trials) is an ultra-rapid-acting insulin peaking 12 to 15 minutes following inhalation. More importantly, Afrezza leaves no persistent "tail." After a few hours, it is gone from the system, while injectable insulins typically persist. This leads to the hypothesis that Afrezza may mimic the kinetic synchronization of the hepatic (liver) system, restoring more natural hepatic function by reducing the excess gluconeogenesis. The evidence supporting this hypothesis offered by the company is marked and very significant reduction in post-meal glucose excursions and significant improvements in overall glucose control, as measured by decreases in glycosylated hemoglobin (A1C) levels, without the weight gain typically associated with insulin therapy. However, the investment community, and the pharmaceutical industry, haunted by the failures of Pfizer's Exubera, remain unconvinced that there is any meaningful market for inhalable insulins, including Afrezza, and have ceased research and funding in this area.
MannKind's oncology drug candidates, MKC1106-PP for prostate and MKC1106-MT for advanced stage melanoma (in phase II study), use the body's immune system (immunotherapy) to target specific melanoma antigen (PRAME) and prostate specific membrane antigen (PSMA).
MannKind introduced its next generation inhalation technology, a miniature, breath-powered inhaler used in combination with single-use cartridges containing pre-metered doses. The sleek inhaler fits within the palm of the hand and is ready to use with a quick and intuitive cartridge load mechanism. These attributes result in an easy-to-use, elegant delivery system providing optimal discretion during use. Initial pharmacokinetic studies were followed by studies of safety and efficiency involving technosphere formulations of different therapeutic proteins.
Finances and future of Afrezza
MannKind had approximately $20 million cash, while spending approximately $15 million monthly. It had approximately $188 million of available borrowings under the loan agreement with an entity controlled by Alfred Mann, who more recently agreed to swap debt for equity in 700,000-share increments over several months for $7.15 per share.
No revenue was expected until Afrezza is approved by the FDA and marketed. The FDA approval PDUFA date was January 16, 2010; however, on March 12, 2010 (almost one year after the drug application was submitted) the FDA issued a Complete Response Letter indicating that it required additional information. On June 9, the company met with FDA officials to determine FDA requirements. Based on these discussions, MannKind resubmitted its NDA on June 29, 2010. The PDUFA date for the resubmission was December 29, 2010. On January 19, 2011 MannKind Corporation announced that the FDA rejected Afrezza and asked for two more clinical trials.
In January, 2011, a lawsuit was filed againtst MannKind Corporation, alleging that MannKind's stock price was artificially inflated as a result of untrue or materially misleading statements related to MannKind's communications with the FDA about its new product Afrezza. A settlement of $16 million was reached in 2012.
- Mannkind Corporation, "8K" filing with Securities and Exchange Commission 2009 www.sec.gov (March 16, 2009)
- MannKind Corporation, "8K" filing with Securities and Exchange Commission 2009 www.sec.gov (March 9, 2009)
- MannKind Corporation, 8K filing with Securities and Exchange Commission 2009
- "Lawsuit against MannKing Corp.".
- "MannKind Corporation Investor Files Lawsuit Over Alleged Securities Laws Violations".