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LANNETT expands respiratory pipeline, signs exclusive distribution agreement for generic SPIRIVA® handihaler®

PHILADELPHIA, July 29, 2021 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it has entered into an exclusive U.S. commercialization agreement for a therapeutically equivalent generic of Spiriva® Handihaler® (Tiotropium Bromide inhalation powder) with Respirent Pharmaceuticals Co. Ltd. The 10-year term of the agreement commences upon distribution of the product. U.S. sales of Spiriva Handihaler were $1.5 billion for the 12 months ending May, 2021 according to IQVIA, although actual generic market values are expected to be lower.

"We continue to add drug and device combination respiratory medications to our pipeline. We believe such products provide durable sales opportunities with relatively fewer competitors, due to the technical expertise, specialized manufacturing and financial commitment required to develop these products," said Tim Crew, chief executive officer of Lannett. "With generic Spiriva Handihaler, our strategic relationship with Respirent now includes three inhaler products, each of which has the potential to be a meaningful contributor to our company's financial performance. The generic Spiriva Handihaler product is currently in development and tracking to Abbreviated New Drug Application (ANDA) submission in 2023." 

As previously disclosed, Lannett and Respirent are collaborating on two other inhaler products. For generic of ADVAIR DISKUS® (Fluticasone Propionate – Salmeterol Xinafoate Powder Inhaler), Lannett announced in June 2021 that the U.S. Food and Drug Administration (FDA) had accepted the ANDA, with priority review. For generic Flovent® Diskus® (Fluticasone Propionate Powder Inhaler), the company said development is underway and an ANDA submission is expected in 2022.

Spiriva® Handihaler® is a registered trademark of Boehringer Ingelheim. ADVAIR DISKUS® and Flovent® Diskus® are registered trademarks of GlaxoSmithKline.

About Respirent Pharmaceuticals Co. Ltd.:

Respirent's commitment is to provide Affordable Respiratory Medicines. Asthma and chronic obstructive pulmonary disease (COPD) are chronic diseases that require daily medications. We recognize the cost burden to patients and health authorities around the world, especially as prevalence and incidence have been increasing world-wide - particularly in underprivileged populations. At Respirent, we are dedicated to addressing a significant unmet need to tackle this growing global public health problem and to create value for healthcare providers and patients. Respirent's generic products are developed and manufactured in new state-of-the-art facilities that meet the most stringent regulatory and quality standards of the United States and Europe. Our upstream supply partners are also global leaders in their field of expertise which ensures our delivery and service to our commercial partners and patients is world-class.

About Lannett Company, Inc.:

Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications. For more information, visit the company's website at www.lannett.com.

This news release contains certain statements of a forward-looking nature relating to future events or future business performance. Any such statement, including, but not limited to, advancing the development of Tiotropium Bromide inhalation powder, Fluticasone propionate and Salmeterol inhalation powder, and Fluticasone Propionate Powder Inhaler, as well as FDA approvals and successfully commercializing such products, whether expressed or implied, is subject to market and other conditions, and subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated due to a number of factors which include, but are not limited to, the risk factors discussed in the Company's Form 10-K and other documents filed with the SEC from time to time, including the prospectus supplement related to the proposed offering to be filed with the SEC. These forward-looking statements represent the Company's judgment as of the date of this news release. The Company disclaims any intent or obligation to update these forward-looking statements.

Robert Jaffe
Robert Jaffe Co., LLC
(424) 288-4098

SOURCE Lannett Company, Inc.

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