Dec 15 2009
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. 11/060,641, which covers the composition and use of Intermezzo® (zolpidem tartrate sublingual tablet), the lead Transcept product candidate. Once issued, this patent will expire no earlier than February 2025.
"This is the second USPTO Notice of Allowance issued to Transcept to cover our proprietary low-dose sublingual Intermezzo® formulation. We are pleased with the continued progress of our patent prosecution efforts," commented Glenn A. Oclassen, President and Chief Executive Officer.
"Other key elements in our program to protect Intermezzo® include a request to the U.S. Food and Drug Administration (FDA) to grant three years of Hatch-Waxman regulatory exclusivity to Intermezzo®, and multiple applications on file with the USPTO related to an additional family of patents to cover 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 one $10 million milestone payment from Purdue after either of the two formulation patents, once issued, is listed 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 to Purdue electing to continue with the alliance after its review of the terms of such FDA approval. This single $10 million milestone payment is part of the previously announced $90 million of potential milestones which Transcept is eligible to receive upon the achievement of certain intellectual property and U.S. net sales targets.
SOURCE Transcept Pharmaceuticals, Inc.