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PTIE Signs $400 Million Deal

 

   
   
 
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REMOXY™

Remoxy is a novel, abuse-deterrent form of twice-daily oxycodone. In December 2007, we announced that Remoxy met the primary endpoint (p<0.01) of a pivotal Phase III study in over 400 patients with osteoarthritis; as a result, we plan to file an NDA for Remoxy in Q2 2008.

Remoxy is intended to meet the needs of physicians who appropriately prescribe opioid painkillers and who seek to minimize risks of drug diversion, abuse or accidental patient misuse. Remoxy resists injection or snorting. Published data also show that freezing, crushing or submerging Remoxy in high-proof alcohol for hours at a time releases just a fraction of oxycodone at time points when abusers presumably expect to get high. These properties of Remoxy may deter recreational abuse or accidental patient misuse of long acting oxycodone.

In November 2005, we entered into a $400M strategic alliance with King Pharmaceuticals, Inc. (NYSE: KG) to develop and commercialize Remoxy and three other abuse-deterrent opioid painkillers. Terms included an upfront payment fee of $150M cash, $150M in clinical and regulatory milestones and $100M in research and development expenses. Additionally, King will record net sales of all products and pay Pain Therapeutics a 20% royalty, except for the first $1 billion in cumulative net sales, which royalty is set at 15%.