Lannett To Launch Levorphanol Tablets
-- Signs Exclusive U.S. Distribution Agreement with Novitium Pharma --
PHILADELPHIA, July 27, 2020 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it will soon launch Levorphanol Tablets 2 mg, a partnered product.
Lannett entered into an exclusive U.S. distribution agreement for Levorphanol Tablets with Novitium Pharma, a U.S. based pharmaceutical company. 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.
"We are pleased to establish a new strategic relationship with Novitium Pharma, a private company with a growing portfolio of commercial products," said Tim Crew, chief executive officer of Lannett. "Novitium received FDA approval earlier this month of its Abbreviated New Drug Application (ANDA) for Levorphanol Tablets 2 mg, a product currently with a small number of competitors. Levorphanol Tablets 2 mg is a solid addition to our product offering."
Total U.S. sales for the 12 months ended May 2020 of Levorphanol Tablets 2 mg were approximately $60.9 million, according to IQVIA, although actual generic market values are expected to be lower.
Levorphanol Tablets 2 mg is the therapeutic equivalent to the reference listed drug, Levorphanol Tartrate Tablets 2 mg of Sentynl Therapeutics, Inc.
Levorphanol Tablets are included in the Opioid Analgesic Risk Evaluation and Mitigation Strategies (REMS) program. The FDA has determined that a REMS is necessary for all opioid analgesics intended for outpatient use to ensure that the benefits of these drugs continue to outweigh the risks. The Opioid Analgesic REMS is one strategy among multiple national and state efforts to reduce the risk of abuse, misuse, addiction, overdose and deaths due to prescription opioid analgesics.
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 Levorphanol Tablets 2 mg, 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
SOURCE Lannett Company, Inc.