Profile: Pain Therapeutics Inc (PTIE.O)

Pain Therapeutics, Inc., incorporated in May 1998, is a biopharmaceutical company that develops drugs. As of December 31, 2008, the Company had four drug candidates in clinical programs, including Remoxy, PTI-202, PTI-721 and a radio-labeled monoclonal antibody to treat metastatic melanoma. The Company is also working on a new treatment for patients with hemophilia. PTI-202 and PTI-721 are abuse-deterrent forms of opioid drugs. The Company and King Pharmaceuticals, Inc. (King) are engaged in a strategic alliance to develop and commercialize Remoxy, PTI-202, PTI-721 and other abuse-resistant opioid painkillers.

Pursuant to the collaboration agreement in the strategic alliance, Pain Therapeutics, Inc. retains sole control of drug development activities in the United States through Phase II clinical trials. The Company and King will jointly manage Phase III clinical trials and new drug application (NDA) submissions in the United States. King has responsibility for these development activities outside the United States. Upon regulatory approval, King will assume sole control and worldwide responsibility to exclusively commercialize Remoxy and other abuse-resistant opioid drugs developed pursuant to the strategic alliance. The Company retains all development and commercial rights in Australia and New Zealand.

Remoxy

Remoxy is a controlled-release oral capsule form of oxycodone in a viscous liquid formulation matrix that includes excipients. It is formulated to help address issues of abuse and misuse of time-release oxycodone tablets. The Remoxy formulation is designed to resist common methods of chemical or physical manipulation. Remoxy’s capsule dosage form provides therapeutic drug levels of oxycodone on a twice-daily dosing schedule, while resisting the increases in plasma levels of oxycodone associated with common methods of abuse and misuse. Its formulation also resists delivery by unapproved routes of administration, such as injection, snorting or inhalation.

PTI-202

PTI-202 has completed Phase I clinical trial. The active ingredients in PTI-202 are opioids. These Phase I clinical trials were designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamic profile of a single, oral dose of the drug candidates in healthy volunteers.

PTI-721

PTI-202 has completed Phase I clinical trial. The active ingredients in PTI-202 are opioids. These Phase I clinical trials were designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamic profile of a single, oral dose of the drug candidates in healthy volunteers. King made payments to the Company in 2008, in connection with the acceptance by the The United States Food and Drug Administration (FDA) of the investigational new drug application (IND) for PTI-721.

Metastatic Melanoma

Pain Therapeutics, Inc.’s monoclonal antibody program, developed at Albert Einstein College of Medicine, is aimed at treating patients with metastatic melanoma. These monoclonal antibodies deliver lethal radiation to melanoma tumors. The technology may also have therapeutic uses outside of oncology, such as infectious diseases. The Company licensed worldwide commercial rights to this technology from Albert Einstein College of Medicine. This antibody technology will enable clinicians to provide medical treatment for metastatic melanoma, a deadly form of skin cancer. In June 2008, it announced the completion of the first clinical study using the radio-labeled monoclonal antibody technology. The objectives of this study were to assess safety, pharmacokinetics and dosimetry. Results of this clinical study indicate this antibody binds to melanoma tumor sites. The Company is conducting pre-clinical studies using this technology in certain infectious diseases.