USPTO issues Notice of Allowance for Transcept Pharmaceuticals' Intermezzo

Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for claims under U.S. patent application no. 11/833,323, which covers the use of Intermezzo® (zolpidem tartrate sublingual tablet), the lead Transcept product candidate. Once issued, this patent will expire in February 2025.

"This Notice of Allowance represents a significant accomplishment for Transcept and is an important event in our Intermezzo® product development program," commented Glenn A. Oclassen, President and Chief Executive Officer. "Once issued, this patent is expected to provide an important layer of intellectual property protection covering our proprietary low-dose sublingual Intermezzo® formulation. This patent allowance is a testament to the scientific talent of its inventor, Nikhilesh Singh, Ph.D., Transcept Co-Founder and Chief Scientific Officer."

Mr. Oclassen continued, "In addition to this formulation patent, there are other key elements to our program to protect Intermezzo®. These include the three years of Hatch-Waxman regulatory exclusivity which we have requested that the U.S. Food and Drug Administration (FDA) grant to Intermezzo®, and additional patent applications under review by the USPTO that include a second formulation patent application and another family of patent applications for methods of treating middle of the night awakenings."

Under the terms of the exclusive license and collaboration agreement between Transcept and Purdue Pharmaceutical Products L.P. to commercialize Intermezzo® in the United States, Transcept is eligible to receive a $10 million milestone payment from Purdue after the listing of the issued patent subject to the Notice of Allowance in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book. The obligation of Purdue to make this milestone payment is subject to an FDA approval of Intermezzo® and Purdue electing to continue with the alliance after its review of the terms of such FDA approval, if such approval is received.