King Provides Additional Information On The REMOXY® NDA Resubmission Plan

Main Category: Pain / Anesthetics
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 01 Aug 2009 - 1:00 PDT

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King Pharmaceuticals, Inc. (NYSE: KG) announced additional information regarding the resubmission plan for the REMOXY® New Drug Application (NDA). The Company is not required by the Food and Drug Administration (FDA) to conduct clinical trials in order to provide additional safety or efficacy data in patients with moderate to severe chronic pain. However, as part of the resubmission plan, and in order to strengthen the NDA, King plans to conduct a likeability study and a pharmacokinetic trial in volunteers. The Company continues to anticipate the resubmission could occur mid-year 2010.

About REMOXY®

REMOXY, an investigational drug, is a unique, long-acting oxycodone formulation for moderate-to-severe chronic pain designed to reduce potential risks of unintended use. In mid-2008, an NDA for REMOXY was accepted by the FDA and was granted Priority Review. In December 2008, Pain Therapeutics received a Complete Response Letter from the FDA. Subsequent to the receipt of the Complete Response Letter, King assumed full control of all activities related to the development of REMOXY®.

About King Pharmaceuticals, Inc.

King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products that complement the Company's focus in specialty-driven markets, particularly neuroscience, hospital care. King's wholly-owned subsidiary, Alpharma, Inc., is also a leader in the development, registration, manufacturing and marketing of pharmaceutical products for food producing animals.

Forward Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). King Pharmaceuticals, Inc. disclaims any intent or obligation to update these forward-looking statements, and claim the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, any statements relating to the resubmission of the NDA for REMOXY® and the timing and content of any such resubmission; the need to generate any information or conduct any study or trial in connection with the resubmission and the timing of any such study or trial. Such statements are based on management's current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in preparation and resubmission of the NDA for REMOXY® and whether or when the NDA for REMOXY®,; the outcomes of any study or trial conducted in connection with the resubmission; and whether or when the NDA is approved by the FDA. Other important factors that may cause actual results to differ materially from the forward-looking statements are discussed in the "Risk Factors" section and other sections of King's Annual Report on Form 10-K for the year ended December 31, 2008 and it's Quarterly Report on Form 10-Q for the quarter ended March 31, 2009, each of which is on file with the U.S. Securities and Exchange Commission.

Source: King Pharmaceuticals, Inc