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LANNETT ENTERS AGREEMENT TO BE EXCLUSIVE U.S. DISTRIBUTOR OF FLUDARABINE PHOSPATE FOR INJECTION, USP

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Lannett Company (NYSE: LCI) announced its exclusive distribution agreement for Fludarabine Phosphate for injection with Areva Pharmaceuticals. The drug addresses ongoing market shortages and is targeted for release later this year, pending FDA approval. U.S. sales for Fludarabine Phosphate reached approximately $4.9 million in the past year, but the current market value is expected to be higher due to disruptions. The company aims to improve patient access to this oncology medication, solidifying its strategic partnership with Areva.

Positive
  • Exclusive distribution agreement for Fludarabine Phosphate enhances market presence.
  • Targeted release of Fludarabine Phosphate addresses current market shortages.
  • Potential increase in revenue from Fludarabine Phosphate due to existing demand.
Negative
  • Dependence on FDA approval for market launch may cause delays.
  • Unspecified financial terms of the agreement could limit revenue projections.

-- Current Drug Market Shortage Exists for Fludarabine Phosphate, An Injectable Chemotherapeutic Medication; Marketing Anticipated to Commence Later This Calendar Year -- 

PHILADELPHIA, May 12, 2022 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it has entered into an agreement with Areva Pharmaceuticals to be the exclusive U.S. distributor of Fludarabine Phosphate for injection, USP, 50 mg/2mL, single dose vials.

"Fludarabine Phosphate for injection represents a continuation of our push to new dosage forms with attractive market opportunities," said Tim Crew, chief executive officer of Lannett. "Moreover, a drug market shortage has recently existed for Fludarabine Phosphate for injection, so our goal, subject to FDA clearance, is to commence marketing as soon as possible, targeting later this calendar year, to help patients gain access to this important oncology medicine. We are pleased to establish a new strategic relationship with Areva Pharmaceuticals and look forward to launching this product."

While total U.S. sales for the 12 months ended March 2022 of Fludarabine Phosphate for injection, USP, 50 mg/2mL were approximately $4.9 million, according to IQVIA, the current market value is believed to be higher due to the recent market disruptions.

Under the agreement, Lannett will provide sales, marketing and distribution support for Fludarabine Phosphate, for which it will receive a share of the profits. Other financial terms were not disclosed. Fludarabine Phosphate for injection USP is the generic equivalent of Fludara® of Bayer AG.

Fludara® is a registered trademark of Bayer AG.

About Areva Pharmaceuticals
Areva Pharmaceuticals Inc., a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and multi-source pharmaceutical drugs that are easier to use, less labor intensive, and more streamlined in practice. Areva ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they are needed most.

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 Fludarabine Phosphate for injection, USP, 50 mg/2mL, and the potential material impact of COVID-19 on future financial results, 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

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/lannett-enters-agreement-to-be-exclusive-us-distributor-of-fludarabine-phospate-for-injection-usp-301545808.html

SOURCE Lannett Company, Inc.

FAQ

What product is Lannett distributing under the new agreement?

Lannett is distributing Fludarabine Phosphate for injection, USP.

When is Lannett expected to start marketing Fludarabine Phosphate?

Lannett anticipates marketing Fludarabine Phosphate later this calendar year, pending FDA approval.

What were the U.S. sales figures for Fludarabine Phosphate?

The total U.S. sales for Fludarabine Phosphate for the 12 months ended March 2022 were approximately $4.9 million.

Who is Lannett's partner in the distribution of Fludarabine Phosphate?

Lannett's partner is Areva Pharmaceuticals for the distribution of Fludarabine Phosphate.

How does Lannett benefit from the Fludarabine Phosphate agreement?

Lannett will receive a share of the profits from the sales, marketing, and distribution of Fludarabine Phosphate.

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