Lannett Launches Mexiletine HCl Capsules

Rhea-AI Summary

Lannett Company (NYSE: LCI) announced the launch of Mexiletine Hydrochloride Capsules in three dosages (150 mg, 200 mg, and 250 mg), a generic equivalent to Boehringer Ingelheim's Mexitil^®. The company, in collaboration with Rivopharm SA, expects to be among only three suppliers for the next six months. Total U.S. sales for the product reached approximately $16 million for the 12 months ending May 2020. Lannett will provide sales and marketing support and earn a share of net profits, though specific financial terms were not disclosed.

Positive

• Launch of Mexiletine Hydrochloride Capsules expands product portfolio.
• Collaboration with Rivopharm to enhance market presence.
• Expected to be one of only three suppliers, reducing competition.

Negative

• Market opportunity deemed relatively modest despite recent patient use increases.
• Projected generic market values lower than actual U.S. sales figures.

PHILADELPHIA, July 23, 2020 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it has launched Mexiletine Hydrochloride Capsules 150 mg, 200 mg and 250 mg, a partnered product. Mexiletine Hydrochloride Capsules is the AB-rated generic equivalent to Mexitil^® Capsules of Boehringer Ingelheim. 

"We have expanded our collaboration with Rivopharm SA to now include all three currently available dosage strengths of Mexiletine," said Tim Crew, chief executive officer of Lannett. "For at least the next six months, we believe we will be one of only three suppliers of this medication in the U.S. While the market opportunity for this product is relatively modest, patient use has increased meaningfully over the last few years."

Rivopharm was previously granted by the FDA a Competitive Generic Therapy (CGT) designation for its generic version of Mexitil^® by the FDA. Accordingly, Rivopharm has been granted 180 days of CGT exclusivity, which blocks approval of other pending applications and additional competitors from entering the market.

Total U.S. sales for the 12 months ended May 2020 of Mexiletine Hydrochloride Capsules 150 mg, 200 mg and 250 mg were approximately $16 million, according to IQVIA, although actual generic market values are expected to be lower.

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

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 Mexiletine Hydrochloride Capsules, 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.

Contact:	Robert Jaffe
	Robert Jaffe Co., LLC
	(424) 288-4098

 

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SOURCE Lannett Company, Inc.

FAQ

What is the significance of Lannett's Mexiletine Hydrochloride Capsule launch?

Lannett's launch of Mexiletine Hydrochloride Capsules establishes its position in the market, being one of only a few suppliers.

How does the collaboration with Rivopharm impact LCI's operations?

The collaboration allows Lannett to leverage Rivopharm's Competitive Generic Therapy exclusivity, enhancing its market entry.

What were the U.S. sales figures for Mexiletine Hydrochloride Capsules?

The total U.S. sales for the product were approximately $16 million for the 12 months ending May 2020.

How long will Lannett have exclusivity in the Mexiletine market?

Lannett expects to remain among only three suppliers for at least the next six months.

What are the implications of the modest market opportunity for LCI?

Despite increased patient use, the modest market opportunity may limit significant revenue growth for Lannett.