MannKind Corporation Issues Statement on Lawsuit
VALENCIA, Calif.--(BUSINESS WIRE)--Nov 5, 2010 - MannKind Corporation (Nasdaq: MNKD) reported in its recent 10Q filing that a former employee in the regulatory affairs department, Mr. John Arditi, filed a lawsuit for wrongful termination claiming he was retaliated against for raising concerns about the company's clinical trials. The Company today stated that Mr. Arditi's employment was terminated by MannKind's Vice President - Worldwide Regulatory Affairs for legitimate reasons unrelated to his claim of retaliation.
Mr. Arditi's claims were thoroughly investigated by the company in an internal investigation as well as by an independent regulatory expert. The independent investigator was provided with unfettered access to the data related to the company's FDA submission for Afrezza® including the studies conducted in Bulgaria and Russia. Mr. Arditi provided information to the company and the independent investigator.
The independent investigator concluded that MannKind is, and was, taking prudent measures under Good Clinical Practice regulations to meet the requirements of Good Clinical Practices, and that there was no evidence of any deception or intent on the part of MannKind to deceive the FDA.
MannKind's Chief Financial Officer Matthew Pfeffer stated that, "We believe that Mr. Arditi's claims have no merit, and the company will vigorously defend the lawsuit in the normal course of business."
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(R) 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 letter to this NDA from the FDA, requesting additional information. In July 2010, the FDA accepted MannKind's reply to the Complete Response letter and set a PDUFA action date of December 29, 2010. Other products in MannKind's pipeline include the cancer immunotherapy products MKC1106-PP and MKC1106-MT, which have completed 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.
This press release contains forward-looking statements, including statements related to the defense of the lawsuit filed by Mr. Arditi, future interactions with the FDA, and the regulatory status of MannKind's product candidates, 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, the risks and uncertainties inherent in litigation, difficulties or delays in seeking or obtaining regulatory approval, MannKind's ability to manage its existing cash resources or raise additional cash resources, stock price volatility 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, 2009 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.
Contact: MannKind Corporation
Matthew J. Pfeffer
Chief Financial Officer
Posted: November 2010