PHILADELPHIA, Aug. 17, 2020 /PRNewswire/ — Lannett Company, Inc. (NYSE: LCI) today announced that it has entered into an exclusive U.S. distribution agreement for the therapeutically equivalent generic of Flovent® Diskus® (Fluticasone Propionate Powder Inhaler) of Respirent Pharmaceuticals Co. Ltd. According to the Orange Book, all patents covering Flovent Diskus have expired. U.S. sales of Flovent Diskus, which have been increasing in recent years, were $94 million for the 12 months ending June, 2020 according to IQVIA, although actual generic market values are expected to be lower.
The company also said its previously announced exclusive U.S. distribution agreement with Respirent for the therapeutically equivalent generic of ADVAIR DISKUS® (Fluticasone Propionate – Salmeterol Xinafoate Powder Inhaler) has been extended from 10 years to 12 years. The term of the agreement commences upon distribution of the product. The company further noted that the earlier trademark lawsuit between Respirent and the innovator company was recently dismissed, thereby clearing a potential impediment to commercialization.
«Expanding our relationship with Respirent for a second powder inhaler product for asthma speaks to the mutual respect we have for each other’s expertise. Generic Flovent Diskus is a large market opportunity product that complements our increasingly important portfolio of inhalation medications,» said Tim Crew, chief executive officer of Lannett. «Extending the distribution period for generic ADVAIR DISKUS reflects our growing optimism for the product. We remain on track to submit late this calendar year an Abbreviated New Drug Application (ANDA) for this product.»
Crew added that early development is underway for the generic Flovent Diskus product and the company will provide updates as clinical milestones are achieved.
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, the company successfully commercializing Fluticasone Propionate – Salmeterol Xinafoate Powder Inhaler or Fluticasone Propionate Powder Inhaler, 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 Co., LLC
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SOURCE Lannett Company, Inc.