Lannett Enters Into Distribution Agreement For Dantrolene Capsules, Commences Product Launch

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Jun 28, 2019, 06:54 ET

PHILADELPHIA, June 28, 2019 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it has entered into a three-year agreement with Elite Pharmaceuticals to be the exclusive U.S. distributor of a Dantrolene Capsules 25 mg, 50 mg and 100 mg. Total U.S. sales of Dantrolene Capsules 25 mg, 50 mg and 100 mg was approximately $6.4 million for the 12 months ended April 2019, according to IQVIA, although actual generic market values are expected to be lower.

"We have commenced the distribution of Dantrolene, for which the market is currently comprised of a small number of competitors," said Tim Crew, chief executive officer of Lannett. "While the sales potential for this product is modest, adding Dantrolene to our portfolio demonstrates our commitment to our customers and patients, as well as our success in expanding relationships with existing strategic partners. This is our second transaction with Elite."

Under the agreement, Lannett will primarily provide sales, marketing and distribution support for the product, for which it will receive a share of the profits. Other financial terms were not disclosed.

Dantrolene Capsules 25 mg, 50 mg and 100 mg is the therapeutic equivalent to the reference listed drug, Dantrium^® Capsules 25 mg, 50 mg and 100 mg of Par Pharmaceuticals, Inc. (an Endo International Company).

About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company which is developing a pipeline of proprietary pharmacological abuse-deterrent opioid products as well as niche generic products. Elite specializes in oral sustained and controlled release drug products which have high barriers to entry. Elite owns generic products which have been licensed to TAGI Pharma and Glenmark Pharmaceuticals, Inc., USA. Elite currently has twelve approved generic products, three generic products filed with the FDA, two approved generic products pending manufacturing site transfer, and an NDA filed for SequestOx™. Elite's pipeline products include abuse-deterrent opioids which utilize the Company's patented proprietary technology and a once-daily opioid. These products include sustained release oral formulations of opioids for the treatment of chronic pain. These formulations are intended to address two major limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential opioid abuse. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ. Learn more at www.elitepharma.com.

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, successfully commercializing generic Adderall IR^®, 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.