Lannett Announces FDA Acceptance, As A Priority Original ANDA, Of The Generic Advair Diskus® Filing
Lannett Company (NYSE: LCI) announced the FDA's acceptance of its ANDA for Fluticasone Propionate and Salmeterol inhalation powder, a generic equivalent to ADVAIR DISKUS. This submission, made on behalf of Respirent Pharmaceuticals, has a GDUFA II goal date of January 31, 2022. U.S. sales of ADVAIR DISKUS were approximately $3 billion for the 12 months ending April 2021. Lannett aims for a potential 2022 launch, leveraging a distribution agreement that extends for 12 years post-approval, with significant future market opportunities also in its pipeline for diabetes and respiratory products.
- FDA acceptance of ANDA for Fluticasone Propionate and Salmeterol inhalation powder, advancing toward commercialization.
- U.S. sales of ADVAIR DISKUS present a substantial market opportunity, valued at approximately $3 billion.
- Exclusive U.S. distribution agreement with Respirent that extends for 12 years post-approval, ensuring profit-sharing.
- Potential delays in the FDA review process given the complexity of the drug/device combination product.
- Risks associated with actual market values potentially being lower than expected sales figures.
PHILADELPHIA, June 1, 2021 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced the U.S. Food and Drug Administration (FDA) has accepted the Abbreviated New Drug Application (ANDA) for Fluticasone Propionate and Salmeterol inhalation powder (100/50 mcg, 250/50 mcg and 500/50 mcg), which was submitted by Lannett on behalf of its strategic alliance partner, Respirent Pharmaceuticals Co. Ltd. The FDA assigned a Generic Drug User Fee Act of 2017 (GDUFA II) goal date for this priority original ANDA of January 31, 2022.
The product is the generic equivalent of ADVAIR DISKUS® of GlaxoSmithKline. Total U.S. sales of the product, according to IQVIA, were approximately
"The FDA's Acceptance of the ANDA submission of generic ADVAIR DISKUS® brings us one step closer to providing asthma patients an affordable option for this critical medication," said Tim Crew, chief executive officer of Lannett. "We anticipate more than one FDA review cycle of this opportunity given the inherent complexity associated with a drug/device combination inhalation product. However, our partners at Respirent have assembled a comprehensive application and have expertise in developing and manufacturing dry powder inhalation products, so we believe we are positioned for a potential U.S. launch of the product in calendar 2022."
Crew added, "We have publicly discussed four meaningful and durable market opportunity assets in our pipeline, including two respiratory products, generic Advair Diskus, which is closest to potential commercialization, and Flovent® Diskus® (Fluticasone Propionate Powder Inhaler); and two products for the treatment of diabetes, biosimilar insulin glargine and biosimilar insulin aspart. The clinical development of biosimilar insulin glargine continues to advance, with a possible launch in 2023. Similarly, the development of generic Flovent and biosimilar insulin aspart continue to progress and both products could potentially launch in 2024."
As previously announced, Lannett entered into an exclusive U.S. distribution agreement for the therapeutically equivalent generic of Advair Diskus of Respirent. Under the agreement, Lannett will commence U.S. distribution of the product after FDA approval and receive a portion of the net profits once it commences distribution of the product. The companies recently extended the term of the agreement to 12 years post commencement of distribution.
ADVAIR DISKUS® and Flovent® Diskus® are registered trademarks of GlaxoSmithKline. Advair Diskus is indicated as a twice-daily treatment of asthma in patients aged four years and older and maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). Flovent Diskus is an inhaled corticosteroid indicated for maintenance treatment of asthma as prophylactic therapy in patients aged four years and older.
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. Respirent recognizes 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. So, Respirent is 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. Respirent's upstream supply partners are also global leaders in their field of expertise which ensures delivery and service to 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 statements, including, but not limited to, advancing the development of Fluticasone propionate and Salmeterol inhalation powder, Fluticasone Propionate Powder Inhaler, biosimilar insulin glargine or biosimilar insulin aspart, as well as FDA approvals and successfully commercializing such products, whether expressed or implied, are 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 difficulty in predicting the timing or outcome of FDA or other regulatory approvals or actions, the ability to successfully manufacture and commercialize products upon approval, including acquired products, and Lannett's estimated or anticipated future financial results, future inventory levels, future competition or pricing, future levels of operating expenses, product development efforts or performance, and other risk factors discussed in the company's Form 10-K and other documents filed with the Securities and Exchange Commission from time to time. 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.
Contact: | Robert Jaffe |
Robert Jaffe Co., LLC | |
(424) 288-4098 |
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