POINT RICHMOND, Calif., Aug. 21, 2012 /PRNewswire/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) today announced that the U.S. Food and Drug Administration has listed U.S. Patent No. 8,242,131 (the '131 patent) in its Approved Drug Products with Therapeutic Equivalence Evaluations, or "Orange Book." This patent, which was issued by the United States Patent and Trademark Office (USPTO) on August 14, 2012, includes claims directed to methods of treating middle-of-the-night insomnia with low doses of zolpidem. The '131 patent will expire no sooner than 2029.
As part of the collaboration agreement between Purdue Pharmaceutical Products L.P. (Purdue) and Transcept, Transcept is eligible to receive a $10 million milestone payment from Purdue in connection with the '131 patent being listed in the Orange Book. Pursuant to this agreement, Transcept is also eligible to receive up to an additional $70 million in milestone payments related to the achievement of certain U.S. net sales targets of Intermezzo, as well as a royalty on U.S. net sales of Intermezzo that ranges from the mid-teens to the mid-20% level.
This patent adds to the Intermezzo intellectual property portfolio, which includes two previously issued U.S. patents that are currently listed in the Orange Book. In addition, the USPTO issued a Notice of Allowance on July 18, 2012, for an Intermezzo patent application directed to compositions for treating middle-of-the-night insomnia. Intermezzo was also granted three years of Hatch-Waxman regulatory exclusivity by the FDA.
Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience. Intermezzo® (zolpidem tartrate) sublingual tablet C-IV is the first FDA approved Transcept product. Purdue holds commercialization and development rights for Intermezzo in the United States. Transcept is currently conducting a Phase 2 study of an investigational product, TO-2061, in patients with obsessive-compulsive disorder. For further information about Transcept, please visit www.transcept.com.
Forward Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our expectations and future results, including statements of strategy, future operations, future financial position, future revenues, projected expenses, prospects, plans and objectives of management, are forward-looking. Examples of such statements include, but are not limited to, our expectation that we are eligible for $10 and $70 million milestone payments and additional royalties from Purdue; the ability of our granted patents and patent applications currently under review to provide intellectual property protection for Intermezzo; expectations regarding the duration of certain Transcept patents related to Intermezzo; expectations with regard to Hatch-Waxman regulatory exclusivity; and the potential favorable outcome of additional patent prosecution and issuance efforts in favor of Intermezzo. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, possible claims of patent invalidity; obtaining patent issuance, maintaining adequate patent protection and successfully enforcing such patent claims against third parties; commercializing Intermezzo without violating the intellectual property rights of others; obtaining and maintaining Hatch-Waxman exclusivity for Intermezzo and other difficulties or delays in market acceptance and the commercialization of Intermezzo. Transcept may not actually achieve the plans, carry out the intentions, meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Transcept makes, include, but are not limited to, the following: achieving acceptance of Intermezzo by physicians, patients and third party payors; supplying sufficient quantities of Intermezzo from third party manufacturers and suppliers to meet anticipated market demand; the impact of competitive products and the market for Intermezzo generally; our dependence on our collaboration with Purdue; and obtaining, maintaining and protecting regulatory exclusivity and intellectual property protection for Intermezzo. These and other risks are described in greater detail in the "Risk Factors" section of Transcept's Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on May 13, 2012, and other periodic reports filed with the SEC. Forward-looking statements do not reflect the potential impact of any future in-licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments Transcept may enter into or make. Transcept does not assume any obligation to update any forward-looking statements.
Sr. Director, Corporate Communications
Transcept Pharmaceuticals, Inc.
SOURCE Transcept Pharmaceuticals, Inc.