MannKind Annouces FDA Approval of Tyvaso DPI

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MannKind’s Technosphere® Inhalation Platform Utilized in FDA-Approved Tyvaso DPI™

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Tyvaso DPI represents the second FDA-approved product utilizing MannKind’s Technosphere® inhalation technology
First approval of a dry powder inhaled treatment for PAH and PH-ILD

Manufacturing of Tyvaso DPI for United Therapeutics underway at MannKind’s Connecticut facility with product availability expected in June 2022

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 24, 2022 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative therapeutic products for patients with endocrine and orphan lung diseases, celebrated today that the U.S. Food and Drug Administration (FDA) has approved United Therapeutics’ Tyvaso DPI™ (treprostinil) inhalation powder for the treatment of patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). Tyvaso DPI represents the second FDA-approved product utilizing MannKind’s innovative Technosphere® inhalation technology and is the first and only approved dry powder inhaled treatment for these indications.

“We are elated that Tyvaso DPI has received approval from the FDA, which paves the way for patients to receive treprostinil in a new and convenient way,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “This approval exemplifies MannKind’s commitment to developing products that give people control of their health and the freedom to live life. With Tyvaso DPI, patients can potentially fit in the palm of their hand a full day of dosing treprostinil from a Dreamboat® inhaler.”

“This approval is a result of the hard work of the research, development, regulatory, and operations teams at MannKind and United Therapeutics,” said Patrick Poisson, Executive Vice President of Technical Operations at United Therapeutics. “We are thrilled to provide a dry powder inhaled alternative to liquid nebulization of Tyvaso.”

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 August 2021, the two companies established a commercial supply agreement that has an initial term through 2031. 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. Tyvaso DPI is produced at MannKind’s manufacturing facility in Connecticut.

PAH is a life-threatening high blood pressure in the arteries of the lungs, affecting the ability of the heart and lungs to work properly in afflicted patients. PAH affects an estimated 45,000 patients in the United States. ILD is a group of lung diseases in which marked scarring occurs within the lungs. It is often complicated by pulmonary hypertension (PH), which furthers symptoms and decreases survival. PH is estimated to affect at least 15% of patients with early-stage ILD (approximately 30,000 PH-ILD patients in the United States) and may affect up to 86% of patients with more severe ILD. Tyvaso® and Tyvaso DPI are the only therapies approved by the FDA to treat PH-ILD.

investors.mannkindcorp.com/news-releases/news-release-details/mannkinds-technospherer-inhalation-platform-utilized-fda

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New Form 8-k

investors.mannkindcorp.com/static-files/316a8eb6-7831-4b9e-80be-a149be514027

Item 8.01 Other Events.
On May 24, 2022, MannKind Corporation (the “Company”) issued a press release, a copy of which is filed herewith as Exhibit 99.1 and is incorporated herein by reference, except the website addresses and hyperlinks contained in such press release are inactive textual references only and no information accessible through any such website address or hyperlink is incorporated by reference herein.

Forward-Looking Statements
Statements in Exhibit 99.1 to this report that are not statements of historical fact are forward-looking statements, including statements regarding the expected timing for Tyvaso DPI product availability. 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 various risks and uncertainties, which include risks and uncertainties regarding manufacturing pharmaceutical products. These and other risks are detailed in the Company’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, 2022, filed with the SEC on May 5, 2022. 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 the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this report.

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quote, "Manufacturing of Tyvaso DPI for United Therapeutics underway at MannKind’s Connecticut facility with product availability expected in June 2022"

The samples order.