Lannett has entered into separate agreements with three strategic alliance partners. Under two of the agreements, Lannett will serve as the exclusive U.S. distributor for certain off-patent products manufactured by the partners. Initially, the agreements cover one product from each partner, Diclofenac ER and Fluvastatin ER. Under the third agreement, Lannett will provide five of its currently marketed products to Pharmaceutical Associates, Inc. (PAI) for repackaging into unit dose cups and distribution into the managed care and hospital markets. For all the above transactions, Lannett will receive a percentage of the net profits. Other financial terms were not disclosed.
"We have commenced shipping products to PAI and expect to launch Diclofenac ER within the next few months," said Tim Crew, chief executive officer of Lannett. "Fluvastatin ER is pending approval at the FDA and we are optimistic about launching the product in the second half of the current calendar year. The goal of these deals, as well as others that are in process, is to grow our topline and bottomline, diversify our product mix and further strengthen our cash position."
For the 12 months ended January 2018, total U.S. generic sales of Diclofenac ER were approximately $8.7 million, and total U.S. sales of Fluvastatin ER were approximately $15.5 million, according to IMS. Currently, Diclofenac ER has one generic competitor and Fluvastatin ER has three. Diclofenac ER is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild-to-moderate pain and helps to relieve symptoms of arthritis and Fluvastatin ER is a cholesterol-lowering drug.
The company also said that it returned the rights to a pending Abbreviated New Drug Application to its development partner for other consideration plus royalties on sales once the product is commercialized.