MannKind Corporation

MannKind Corporation
Public company
Traded as NASDAQ: MNKD
Industry Biotechnology
Founded 1991
Headquarters Valencia, CA, United States
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, who has invested approximately $900 million in the firm. 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).[1]

Leadership

Mann was chief executive officer until January 12, 2015 when Hakan Edstrom became CEO and Mann transitioned to executive chairman.[2]

In November 2015, Hakan Edstrom stepped down as CEO and president and will remain until July, 2017 to provide other services for the company. Company founder Alfred Mann stepped in as interim CEO.[3] 8-K file on November 19, 2015. In January 2016, MannKind Corporation announced that Duane M. DeSisto would become president and chief executive officer effective January 5, 2016.

Facilities

MannKind's corporate headquarters are in Valencia, California. The Afrezza manufacturing facility is in Danbury, Connecticut.[4]

Products and product candidates

Afrezza is an ultra-rapid-acting insulin peaking 12 to 15 minutes following inhalation. 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.[5]

On August 11, 2014 MannKind entered into an exclusive global licensing agreement with Sanofi for Afrezza sales.[6] Under the agreement, MannKind received $150 million cash from Sanofi, in exchange for sharing profits and losses of sales of Afrezza, with 65% for Sanofi and 35% for MannKind. On January 5, 2016, MannKind Corporation announced the termination of the license and collaboration agreement with Sanofi.[6][7]

The firm'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).[8]

The firm has stated that it 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.[9][10]

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".[11] A settlement of $16 million was reached in 2012.[12] It should be noted that company stock performance during this period was strongly influenced by Martin Shrkeli, who shorted the company stock while contacting the FDA with concerns that would cost the company two years in delays and hundreds of millions of dollars Link to Washington Post

References

  1. ↑ Mannkind Corporation, "8K" filing with Securities and Exchange Commission 2009 www.sec.gov (March 16, 2009)
  2. ↑ Calia, Michael (January 12, 2015). "MannKind Appoints Edstrom CEO as Mann Steps Aside". Wall Street Journal. Retrieved January 13, 2015.
  3. ↑ "Mannkind CEO steps down". NewsTimes.com. 23 November 2015.
  4. ↑ "Mannkind regains marketing rights to inhaled insulin | Westfair Communications". westfaironline.com. Retrieved 2016-04-26.
  5. ↑ "MannKind Corporation Announces FDA Approval of AFREZZA®; A Novel, Rapid-Acting Inhaled Insulin for the Treatment of Diabetes". MannKind Corporation. Retrieved December 25, 2014.
  6. 1 2 "Sanofi and MannKind Announce Global Licensing Agreement for Afrezza® (insulin human) Rapid-Acting Inhaled Insulin". MannKind Corporation. Retrieved December 25, 2014.
  7. ↑ http://investors.mannkindcorp.com/releasedetail.cfm?ReleaseID=948810
  8. ↑ StockMatusow (2012-01-31). "The Curious Case Of MannKind Corporation". Seeking Alpha. Retrieved 2016-04-26.
  9. ↑ MannKind Corporation, 8K filing with Securities and Exchange Commission 2009
  10. ↑ Brashier, Dick B. S.; Khadka, Anjan; Anantharamu, Tejus; Sharma, Ashok Kumar; Gupta, A. K.; Sharma, Sushil; Dahiya, N. (2015-01-01). "Inhaled insulin: A "puff" than a "shot" before meals". Journal of Pharmacology & Pharmacotherapeutics. 6 (3): 126–129. doi:10.4103/0976-500X.162013. ISSN 0976-500X. PMC 4544132Freely accessible. PMID 26311994.
  11. ↑ "Lawsuit against MannKing Corp.".
  12. ↑ "MannKind Corporation Investor Files Lawsuit Over Alleged Securities Laws Violations".
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