Lannett Submits ANDA For Generic ADVAIR DISKUS®
Lannett Company (NYSE: LCI) has submitted an Abbreviated New Drug Application (ANDA) for Fluticasone propionate and Salmeterol inhalation powder to the FDA, marking a step towards offering a generic version of ADVAIR DISKUS® from GlaxoSmithKline. This submission covers three dosage strengths and could tap into a $3 billion U.S. market. The company has entered a 12-year U.S. distribution agreement with Respirent Pharmaceuticals, which will allow Lannett to share in the net profits post-approval. The ANDA process is expected to be complex, possibly extending beyond one review cycle.
- Submission of ANDA for generic ADVAIR DISKUS® could capture a share of the $3 billion market.
- 12-year exclusive U.S. distribution agreement with Respirent may provide long-term revenue opportunities.
- Strategic move towards expanding respiratory product portfolio, signaling growth potential.
- Complexity of ANDA review may lead to delays in FDA approval.
- Potential for lower actual market values compared to estimated $3 billion in U.S. sales.
PHILADELPHIA, April 1, 2021 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced the submission of an Abbreviated New Drug Application (ANDA) for Fluticasone propionate and Salmeterol inhalation powder (100/50 mcg, 250/50 mcg and 500/50 mcg) to the U.S. Food and Drug Administration (FDA), by its strategic alliance partner, Respirent Pharmaceuticals Co. Ltd. The product is the generic equivalent of ADVAIR DISKUS® of GlaxoSmithKline. Total U.S. sales of the product, according to IQVIA market, were approximately
"The ANDA submission of generic ADVAIR DISKUS® marks a significant advancement toward our goal of adding larger and more durable products to our portfolio," said Tim Crew, chief executive officer of Lannett. "We anticipate a rigorous FDA review, extending beyond one review cycle, for the ANDA, given this is a complex combination drug/device product, involves two active pharmaceutical ingredients (APIs) and includes multiple dosage strengths.
"Currently, our agreements with Respirent include generic Advair Diskus, as well as second powder inhaler product, generic Flovent® Diskus® (Fluticasone Propionate Powder Inhaler). A key element of our growth strategy is to further build a franchise of respiratory drug/device products, and we are currently evaluating and in negotiation for additional product opportunities. We believe we have gained valuable experience during the development of the product and will learn important insights on the regulatory front, which we can bring to bear on these potential future opportunities."
Commenting on Respirent, Crew added, "We continue to build an effective, close working relationship with our colleagues at Respirent – a team that has expertise and a deep working knowledge in developing, filing and manufacturing inhalation products and is committed to bringing affordable respiratory products to market."
As previously announced, Lannett entered into an exclusive U.S. distribution agreement for the therapeutically equivalent generic of ADVAIR DISKUS® (Fluticasone Propionate – Salmeterol Xinafoate Powder Inhaler) 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, which begins upon commencement of distribution. Other terms were not disclosed.
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 or other inhalation/respiratory drug/device products, 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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SOURCE Lannett Company, Inc.
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