King and Pain Therapeutics Announce REMOXY(R) NDA Update
BRISTOL, Tenn. and SAN MATEO, Calif., July 7 /PRNewswire-FirstCall/ -- King Pharmaceuticals, Inc. (NYSE: KG) and Pain Therapeutics, Inc. (NASDAQ: PTIE) today announced that on July 2, 2009, King met with the US Food and Drug Administration (FDA) to discuss the Complete Response Letter regarding the New Drug Application (NDA) for REMOXY(R). The outcome of this meeting provided King with a clear path forward to resubmit the REMOXY(R) NDA and to address all FDA comments in the Complete Response Letter.
King now anticipates the resubmission of the NDA could occur mid-year 2010. The Company believes the rate-limiting step is the generation of six-month stability data, and no new clinical trials are required. King remains committed to the development and commercialization of REMOXY(R), and looks forward to working closely with the FDA toward approval of the product.
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(R).
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.
About Pain Therapeutics, Inc.
Pain Therapeutics, Inc. is a biopharmaceutical company that develops novel drugs. In addition to REMOXY, the Company has three drug candidates in clinical programs, including a novel radio-labeled monoclonal antibody to treat metastatic melanoma, as well as PTI-202 and PTI-721. Pain Therapeutics is also working on a new treatment for patients with hemophilia. For more information, please visit www.paintrials.com.
Forward Looking Statements
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Pain Therapeutics, Inc. and King Pharmaceuticals, Inc. disclaim 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(R), and the timing and content of any such resubmission; the need to generate stability data or any other information in connection with the resubmission; the Companies' plans to develop and commercialize REMOXY(R); the Companies' plans to work with the FDA in connection with the Complete Response Letter; and the potential approval of the NDA for REMOXY(R). 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(R) and whether or when the NDA for REMOXY(R) 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 each of the Companies' Annual Reports on Form 10-K for the year ended December 31, 2008 and their respective Quarterly Reports 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.