Pain Therapeutics and King Pharmaceuticals®, Inc. Develop a New Abuse-Resistant Prescription Pain Medication
Pain Therapeutics has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for PTI-721 and expects to announce shortly the initiation of a clinical study with this new investigational drug candidate.
Pain Therapeutics and King Pharmaceuticals now have three investigational drug candidates in various phases of clinical and regulatory development. Each drug is intended to address the problem of prescription drug abuse and misuse:
Drug Name Development Status --------- ------------------ REMOXY NDA Filed with Priority Review PTI-202 Phase I Completed PTI-721 IND Filed
ADVERTISEMENT About REMOXY
REMOXY, an investigational drug, is a unique, abuse-resistant, controlled-release oxycodone for moderate-to-severe chronic pain. REMOXY's high viscosity, liquid formulation in a hard gelatin capsule is designed to resist common methods of misuse and abuse. REMOXY is currently undergoing a priority review by the FDA. The FDA is expected to complete its review of the REMOXY NDA in December 2008. If approved, the Companies believe REMOXY could be the first oxycodone on the market that is designed to reduce the risk of misuse and abuse.
About the Alliance Between Pain Therapeutics, Inc. and King Pharmaceuticals, Inc.
In 2005, Pain Therapeutics and King entered into a strategic alliance to develop and commercialize REMOXY and other abuse-resistant opioid painkillers. Pain Therapeutics is substantially responsible for drug formulation, clinical development and regulatory filings for REMOXY and other abuse-resistant opioid painkillers developed under this alliance. Upon regulatory approval, King will assume sole control of and worldwide responsibility to exclusively commercialize REMOXY and other abuse-resistant opioid painkillers. Pain Therapeutics retains all development and commercial rights in Australia and New Zealand. Drug candidates developed under this alliance are unique formulations of the patented Oradur(tm) technology licensed from Durect Corporation.
About Pain Therapeutics, Inc.
Pain Therapeutics is a biopharmaceutical company that develops novel drugs. In addition to REMOXY, PTI-202 and PTI-721, the Company has two other drug candidates in clinical programs: Oxytrex(tm) and a novel radio-labeled monoclonal antibody to treat metastatic melanoma. Pain Therapeutics is also working on a new treatment for patients with hemophilia. The FDA has not yet evaluated the merits, safety or efficacy of the Company's drug candidates. For more information, please visit http://www.paintrials.com.
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 and acute care. King strives to be a leader and partner of choice in bringing innovative, clinically-differentiated medicines and technologies to market.
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 whether or when the FDA may approve the NDA for REMOXY; the size and scope of the potential market for REMOXY and PTI-721; the timing of inception of clinical trials for PTI-721 and the potential benefits of REMOXY, PTI-721 or the Companies' other drug candidates. 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 development, testing, regulatory approval, production and marketing of the Companies' drug candidates, unexpected delays in the regulatory review of the NDA for REMOXY and unexpected adverse side-effects or inadequate therapeutic efficacy of the Companies' drug candidates and other factors that could slow or prevent product approval or market acceptance (including the risk that current and past results of clinical trials may be found to be insufficient for marketing approval). For further information regarding these and other risks related to the Companies' business, investors should consult the Companies' respective filings with the U.S. Securities and Exchange Commission.
Contact:
Pain Therapeutics, Inc. Christi Waarich, Senior Manager of Investor Relations 650-645-1924
King Pharmaceuticals, Inc. James E. Green, Esq., Executive Vice President, Corporate Affairs 423-989-8125 David R. Robinson, Esq., Senior Director, Corporate Affairs 423-989-7045
Source: Pain Therapeutics, Inc.; King Pharmaceuticals, Inc.