Receipt of $15,000,000 was triggered by acceptance of the REMOXY New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA). Receipt of an additional $5,000,000 was triggered by FDA's acceptance of an Investigational New Drug application for PTI-721.
In 2005, Pain Therapeutics and King entered into a strategic alliance to develop and to commercialize REMOXY and other abuse-resistant pain medications. Pain Therapeutics received an upfront payment of $150,000,000 and, beginning with the first commercial sale of drugs developed under the alliance, will receive a running royalty equal to 20% of net sales, except as to the first $1 billion in cumulative net sales, which royalty is set at 15%.
Pain Therapeutics had $177 million in unrestricted cash, no debt and 41.6 million shares outstanding at June 30, 2008. The Company expects to be cash flow positive in 2008, with no changes to previously announced financial guidance.
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, Pain Therapeutics believes 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.
About Pain Therapeutics, Inc.
Pain Therapeutics is a biopharmaceutical company that develops novel drugs. In addition to REMOXY and PTI-721, the Company has three drug candidates in clinical programs, including PTI-202, 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.
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. disclaims any intent or obligation to update these forward-looking statements, and claims 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 Company's anticipation it will be cash flow positive in 2008; and the potential benefits of REMOXY or the Company's 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 Company's drug candidates, unexpected delays in the regulatory review of the NDA for REMOXY and unexpected adverse side-effects or inadequate therapeutic efficacy of the Company's 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), timing and receipt of payments under the Company's alliance with King and unexpected or increased expenses. For further information regarding these and other risks related to the Company's business, investors should consult the Company's filings with the U.S. Securities and Exchange Commission.
Contact:
Pain Therapeutics, Inc. Christi Waarich, Senior Manager of Investor Relations 650-645-1924 cwaarich@paintrials.com
Source: Pain Therapeutics, Inc.
