Healthcare Industry News: U.S. Food and Drug Administration
News Release - September 25, 2017
Lannett's Board Of Directors Initiates CEO SearchCEO Arthur Bedrosian to Step Down Upon Naming of a Successor
Company Submits 505(b)(2) New Drug Application for Its Proprietary Anesthetic Product, Cocaine Hydrochloride (HCl) Topical Solution
PHILADELPHIA, Sept. 25, 2017 -- (Healthcare Sales & Marketing Network) -- Lannett Company, Inc. (NYSE: LCI) today announced that its board of directors has begun a search for a new chief executive officer (CEO). As part of the unanimously approved search process, the board has retained a leading executive search firm to identify potential candidates to assume the role of CEO, succeeding Arthur Bedrosian, who has agreed to step down once a new CEO is appointed. During the search process, Bedrosian will remain a member of the board of directors. Following the appointment of a successor, it is expected that Bedrosian will remain with the company in a strategic advisory role, ensuring a seamless transition of leadership responsibilities.
The company also announced that it has filed a 505(b)(2) New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Cocaine Hydrochloride (HCl) Topical Solution, the company's proprietary local anesthetic product. The filing is the company's first 505(b)(2) NDA submission to include full clinical trial studies in its history. Cocaine HCl Topical Solution is a liquid formulation of cocaine hydrochloride, with a proposed indication for the introduction of local (topical) anesthesia for diagnostic procedures and surgeries on or through the accessible mucous membranes of the nasal cavities. The 505(b)(2) NDA submission is supported by two Phase III, randomized, double-blind, placebo-controlled, multicenter studies in several hundred patients, as well as a Phase I pharmacokinetic study.
"Today's announcement regarding the filing of the NDA for C-TopicalŪ is among the highlights of my tenure at Lannett," said Bedrosian. "I believe the company is strong financially and operationally, and has excellent prospects for continued success. We have built a solid core business, exemplary R&D leadership and a regulatory department that has worked tirelessly to assemble the NDA for C-TopicalŪ. In addition to the ANDAs on file with FDA, we have put in place multiple initiatives to further grow the company for years to come."
Jeffrey Farber, Lannett's chairman, said, "The Board extends its deep appreciation to Arthur for his outstanding leadership over the past 11 years as CEO, his 15 years as an officer and 13 years as a director. During his tenure, Arthur significantly increased the size of the company through organic growth and acquisitions, with revenues climbing to $637 million for fiscal 2017 from $25 million for fiscal 2002. As CEO and president, he formed key strategic alliances, established and advanced our pain management business, forged a robust product development program and oversaw an extraordinary record of regulatory compliance, as well as the company's evolution into an industry leader. We look forward to benefiting from Arthur's continued leadership and insights during the transition and beyond. The board's search for Arthur's successor is in the early stages."
Bedrosian has served as Lannett's CEO since 2006. He was named president of the company in 2002, after a short stint as its vice president of business development. Bedrosian has been a member of the Lannett Board of Directors since 2006; he also served as a director from 2000 to 2002.
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 timing and success of product launches; the difficulty of predicting the timing or outcome of product development efforts and regulatory agency approvals or actions, if any, and market acceptance of and continued demand for Lannett's products, 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
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