CDSCO Approves Afrezza® (insulin human) Inhalation Powder in India

MNKD 12.11.2024

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DANBURY, Conn.andWESTLAKE VILLAGE, Calif.,Dec. 11, 2024(GLOBE NEWSWIRE) --MannKind Corporation(Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, and Cipla Ltd. announced today that theCentral Drugs Standard Control Organisation(CDSCO) inIndiahas approved Afrezza (insulin human) Inhalation Powder in adults. The CDSCO decision follows existing approvals inthe United StatesandBrazil.

“Achieving approval for Afrezza inIndia, a country with the second highest burden of diabetes worldwide, is an exciting milestone forMannKindand our partner Cipla,” saidMichael Castagna, PharmD, Chief Executive Officer forMannKind Corporation. “We are excited for Cipla to market the first inhaled insulin treatment option for adults living with diabetes inIndiaand expect to prepare product for export by the end of 2025.”

MannKindentered into an exclusive marketing and distribution agreement for Afrezza inIndiawith Cipla Ltd., a global pharmaceutical company, inMay 2018. Under the terms of the agreement, Cipla was responsible for obtaining regulatory approvals to distribute Afrezza inIndiaas well as marketing and sales activities.MannKindis responsible for supplying Afrezza to Cipla.

“The availability of Afrezza has the potential to help so many people inIndialiving with diabetes in improving glycemic control via a non-injectable and convenient delivery of inhaled insulin,” said Dr.Satish Garg, MBBS, DM, Professor of Medicine and Pediatrics at theAdult Clinicof theBarbara Davis Center for Diabetesof the University ofColorado School of MedicineinDenver.

TheInternational Diabetes Federation(IDF) reported in 2021 that diabetes mellitus affects 537 million adults (20-79 years of age) worldwide, including more than 74 million people inIndia. IDF estimations are that the total number of people living with diabetes is projected to rise to 643 million by 2030 and 783 million by 2045.

About AfrezzaAfrezza (insulin human) Inhalation Powder is a rapid-acting inhaled human insulin indicated to improve glycemic control in adults with diabetes mellitus.

Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis or in patients that smoke or have recently stopped smoking.

Important Safety Information

WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE

  • Acute bronchospasm has been observed in Afrezza-treated patients with asthma and COPD.
  • Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD.
  • Before initiating Afrezza, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients.

Most common adverse reactions are hypoglycemia, cough, and throat pain or irritation.

Please see additional Important Safety Information, Full Prescribing Information, including BOXED WARNING, available onAfrezza.com/safety.

AboutMannKindMannKind Corporation(Nasdaq: MNKD) focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases.

We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.

With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life.

Please visitmannkindcorp.comto learn more, and follow us onLinkedIn,Facebook,XorInstagram.

Forward-Looking StatementsThis press release contains forward-looking statements about the estimated shipment of product that involves risks and uncertainties. Words such as “believes”, “anticipates”, “plans”, “expects”, “intends”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements. 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, manufacturing risks that may adversely affect our ability to manufacture our products as well as other risks detailed in MannKind’s filings with theSecurities and Exchange Commission, including its Annual Report on Form 10-K for the year endedDecember 31, 2023, and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Youare 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, andMannKindundertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

CIPLA is a registered trademark of Cipla, Ltd.

AFREZZA andMANNKINDare registered trademarks ofMannKind Corporation.

For MannKind:Media RelationsChristie Iacangelo(818) 292-3500Email: media@mnkd.comInvestor RelationsAna Kapor(818) 661-5000Email: ir@mnkd.com

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Source: MannKind

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