MannKind Corporation
 | |
| Public company | |
| Traded as | NASDAQ: MNKD |
| Industry | Biotechnology |
| Founded | 1991 |
| Headquarters | Valencia, CA, USA |
| Website | www.mannkindcorp.com |
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 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. Mann has invested approximately $900 million in his company. 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 review by the U.S. Food and Drug Administration (FDA).[1] Previously led by Mann in his position as chief executive officer, Mannkind's board announced the appointment of Hakan Edstrom as CEO on January 12, 2015 as Mann has transitioned to the role of executive chairman.[2]
Facilities
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.[3] 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.
Product candidates
According to MannKind and company-funded research and trials, Afrezza 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. The company asserts that Afrezza may mimic the kinetic synchronization of the hepatic (liver) system, restoring more natural hepatic function by reducing the excess gluconeogenesis.
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 is developing a next generation inhalation technology, a miniature, breath-powered inhaler used in combination with single-use cartridges containing pre-metered doses. Initial pharmacokinetic studies were followed by studies of safety and efficiency involving technosphere formulations of different therapeutic proteins.[4]
Lawsuits
In January 2011, a lawsuit was filed against 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, resulting in the Mannkind Co. stock being deemed "toxic".[5] A settlement of $16 million was reached in 2012.[6]
Approval of Afrezza
The FDA approved Afrezza on June 27, 2014 with a 13-1 vote for type 1 diabetes and 14-0 vote for type 2 diabetes.[7]
On August 11, 2014 MannKind entered into an exclusive global licensing agreement with Sanofi for global Afrezza sales.[8] Under the licensing agreement, MannKind received $150 million cash from Sanofil, in exchange for sharing profits and losses of sales of Afrezza, with 65% for Sanofil and 35% for MannKind. [9]
References
- ↑ Mannkind Corporation, "8K" filing with Securities and Exchange Commission 2009 www.sec.gov (March 16, 2009)
- ↑ Calia, Michael (January 12, 2015). "MannKind Appoints Edstrom CEO as Mann Steps Aside". Wall Street Journal. Retrieved January 13, 2015.
- ↑ 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".
- ↑ "MannKind Corporation Announces FDA Approval of AFREZZA®; A Novel, Rapid-Acting Inhaled Insulin for the Treatment of Diabetes". MannKind Corporation. Retrieved December 25, 2014.
- ↑ "Sanofi and MannKind Announce Global Licensing Agreement for Afrezza® (insulin human) Rapid-Acting Inhaled Insulin". MannKind Corporation. Retrieved December 25, 2014.
- ↑ "Sanofi and MannKind Announce Global Licensing Agreement for Afrezza® (insulin human) Rapid-Acting Inhaled Insulin". MannKind Corpation. Retrieved December 25, 2014.