Company Completes Key Step in Process to Submit Product Application

Philadelphia (Press Release) - Lannett Company, Inc. (NYSE MKT: LCI) today announced that it has suc­cess­fully com­pleted a key step in its effort to submit to the U.S. Food and Drug Admin­istra­tion (FDA) an Abbre­vi­ated New Drug Application (ANDA) for Tha­lid­o­mide Capsules. The com­pany believes that it con­tin­ues to be on track to submit its ANDA for Tha­lid­o­mide Capsules by January 2014.

As part of its prod­uct devel­op­ment activities for Tha­lid­o­mide Capsules, Lannett commenced bio-equivalency studies in fasting and fed con­di­tions in healthy volunteers. The com­pany reported that the results of the study in the fasting con­di­tion, the more dif­fi­cult of the two con­di­tions, met bio-equivalency require­ments and, upon successful completion of the study in the fed con­di­tion, it will begin the process of assembling and filing its ANDA for sub­mission and review by the FDA. There can be no assurance if or when the FDA will approve the com­pany’s Tha­lid­o­mide Capsules appli­ca­tion. Using an ex­peri­enced outside consulting firm, Lannett also said it has prepared a Risk Evaluation and Mitigation Strategies (REMS), an FDA require­ment to ensure that the benefits of its Tha­lid­o­mide prod­uct outweigh the risks.

Sales of Tha­lid­o­mide Capsules at Average Wholesale Price (AWP) were approx­i­mately $66 million for the second quarter 2013, according to Celgene’s website. Distribution of Tha­lid­o­mide is controlled by the FDA because of the drug’s toxicity and risk of severe, life threatening human birth defects.

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 com­plet­ing bio-equivalency studies, submitting an ANDA to the FDA by January 2014 and suc­cess­fully com­mer­cial­iz­ing Tha­lid­o­mide 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.

Source: Lannett Company.