Pain Therapeutics, Inc. has entered into a strategic alliance with King Pharmaceuticals, Inc. to develop and commercialise Remoxy and other abuse-resistant opioid painkillers. Remoxy (long-acting oral oxycodone) is an investigational drug in late-stage clinical development by Pain Therapeutics for the treatment of moderate-to-severe chronic pain.
Brian Markison, president and chief executive officer of King Pharmaceuticals, stated, "This alliance is the culmination of an extensive screening process for late-stage development opportunities in the pain market. We have strong capabilities in the neuroscience space and have focused our licensing efforts toward the unmet medical needs in today's evolving pain market. The technologies at Pain Therapeutics rose to the top of our list of the most attractive opportunities in this market."
Markison emphasised, "Today's announcement underscores King's commitment to form strategic alliances with companies at the forefront of drug development. We are confident our alliance with Pain Therapeutics adds considerable strength to King's pipeline and positions both companies for solid long-term growth."
"We see this alliance as a winning combination of commercial expertise and unique technology. King has enjoyed considerable success in commercialising neuroscience drugs, while our track record is in drug development. By pooling expertise, we aim to position abuse-resistant opioid painkillers, such as Remoxy, as a new class of drugs in the biopharmaceutical industry. We are confident the capabilities and incentives of King and Pain Therapeutics are aligned to achieve this goal," said Remi Barbier, president and chief executive officer of Pain Therapeutics.
According to a company release, the value of this alliance could exceed $400 million, plus royalties. Under the terms of the agreement, King will make an upfront payment of $150 million in cash to Pain Therapeutics. Pain Therapeutics could also receive additional milestone payments of up to $150 million in cash based on the successful clinical and regulatory development of Remoxy and other abuse-resistant opioid products. This amount includes a $15 million cash payment upon acceptance of a regulatory filing for Remoxy and an additional $15 million upon its approval. King is responsible for all R&D expenses related to this alliance, which could total $100 million.
Brian Markison added, "Our primary research indicates that safe and appropriate use of opioid painkillers is a major concern among physicians, patients, managed care and regulatory agencies. Remoxy addresses this concern, while at the same time its technical foundation serves as a platform to develop a pipeline of other abuse-resistant opioid painkillers. Our vision is to create a large market opportunity around this platform to complement our existing neuroscience portfolio."
Pain Therapeutics is currently designing a pivotal Phase III study with Remoxy in patients with severe chronic pain. This randomised, placebo-controlled Phase III clinical trial will enrol 400 patients with moderate-to-severe chronic pain in multiple US clinical sites. This trial is expected to begin in January 2006 and to be completed by December 2006. If this Phase III clinical trial is successful, a new drug application for Remoxy could be filed with the FDA in 2007.
Remoxy is being developed as an abuse-resistant version of long-acting oxycodone. It is intended to meet the needs of physicians who appropriately prescribe opioid painkillers and who seek to minimise risks of drug diversion, abuse or accidental patient misuse. Remoxy has a sticky, high-viscosity mass that resists injection or snorting.