SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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|Item 8.01|| |
On June 16, 2021, MannKind Corporation (“MannKind”) and United Therapeutics Corporation (“United Therapeutics”) announced that the U.S. Food and Drug Administration (“FDA”) accepted for priority review the New Drug Application (“NDA”) submitted by United Therapeutics for Tyvaso DPI™ (inhaled treprostinil) for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. The development marks the second compound formulated with MannKind’s Technosphere® technology to be reviewed by the FDA, which is expected to be complete in October 2021. The FDA has also indicated that they have not identified any potential review issues at this time.
A next-generation formulation of treprostinil, Tyvaso DPI incorporates the dry powder formulation technology and Dreamboat® inhalation device technology used in MannKind’s Afrezza® (insulin human) Inhalation Powder, which was approved by the FDA in 2014. MannKind and United Therapeutics are also developing BluHale®, a Bluetooth-connected accessory for the Tyvaso DPI inhaler with a companion mobile application intended to help patients track information about their inhaler use.
MannKind and United Therapeutics entered into a worldwide exclusive licensing and collaboration agreement in September 2018 for the development and commercialization of Tyvaso DPI. In its communications with United Therapeutics, the FDA indicated that approval of the NDA will be subject to an inspection of the Tyvaso DPI manufacturing facility operated by MannKind; the FDA and MannKind have jointly targeted the third quarter of 2021 to complete the inspection.
MannKind is entering an expansion phase as it prepares to transition from producing clinical supply to building pre-launch inventory of Tyvaso DPI, pending FDA approval. MannKind’s manufacturing and R&D facility in Danbury is scaling up by hiring more than 100 positions, as well as readying essential equipment and production lines. A variety of MannKind jobs in commercial manufacturing, engineering, quality control, warehouse operations, maintenance, and more are currently open and planned to be filled this year.
Statements in this report that are not statements of historical fact are forward-looking statements. Words such as “plans,” “expects,” “intend,” “will,” “targeted,” “potential” and similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements regarding: the expected timing for the FDA’s completion of its review of the NDA for Tyvaso DPI; the development of BluHale as an accessory for the Tyvaso DPI inhaler and its intended benefits; the targeted timing for the FDA’s completion of its inspection of MannKind’s Tyvaso DPI manufacturing facility; MannKind’s transition from producing clinical supply to building pre-launch inventory of Tyvaso DPI, pending FDA approval; if MannKind fails as an effective manufacturing organization, MannKind may be unable to support commercialization of Tyvaso DPI; and MannKind’s planned hiring. These forward-looking statements are based upon MannKind’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 various risks and uncertainties, which include, without limitation: risks and uncertainties regarding the regulatory approval process; risks inherent in product development; risks associated with an inspection by a regulatory agency; and challenges that may be encountered during the scale-up of manufacturing operations, including attracting and retaining qualified personnel. These and other risks are detailed in MannKind’s filings with the Securities and Exchange Commission (“SEC”), including under the heading “Risk Factors” in MannKind’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, filed with the SEC on May 12, 2021. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this report. 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 report.
|Item 9.01|| |
Financial Statements and Exhibits.
|104||Cover Page Interactive Data File (embedded within the Inline XBRL document)|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Dated: June 16, 2021||By:|
|David Thomson, Ph.D., J.D.|
|Corporate Vice President, General Counsel and Secretary|