MISSISSAUGA, Ontario, November 2, 2009 – Cipher Pharmaceuticals Inc. today announced that Purdue Pharma Products L.P. and Napp Pharmaceutical Group Ltd. have filed a complaint against Cipher in the United States District Court for the Eastern District of Virginia, for alleged infringement of two U.S. patents. The action relates to Cipher’s New Drug Application (“NDA”) filed with the U.S. Food and Drug Administration (“FDA”) for CIP TRAMADOL ER, the Company’s extended-release tramadol product.
Cipher filed a revised NDA for CIP-TRAMADOL ER in Q2 2008, and received tentative FDA approval in February 2009. In Q3 2009, the Company filed a so-called “Paragraph IV Certification” with the FDA, which states that the relevant patent listed in the FDA’s “Orange Book” for Ultram® ER is invalid, unenforceable, and/or will not be infringed by the manufacture or sale of Cipher’s drug product. Under the applicable provisions of the Hatch-Waxman Act, this patent challenge can delay final FDA approval of Cipher’s NDA by 30 months, or until the patent challenge is resolved, whichever occurs first.
Cipher management believes that this type of litigation is common and considers it to be within the ordinary course of business. Cipher intends to vigorously defend itself against the suit and is confident in the strength of its application.
On August 14, 2009, the United States District Court for the District of Delaware issued a decision and final judgment invalidating certain claims of the Orange Book-listed patents for Ultram® ER in litigation filed against Par Pharmaceutical, Inc. That judgment in the Par litigation is currently on appeal before the United States Court of Appeals for the Federal Circuit.
About Cipher Pharmaceuticals Inc. Cipher Pharmaceuticals is a drug development company focused on commercializing novel formulations of successful, currently marketed molecules using advanced drug delivery technologies. Cipher’s strategy is to in-license products that incorporate proven drug delivery technologies and advance them through the clinical development and regulatory approval stages, after which the products are out-licensed to international partners. Because Cipher’s products are based on proven technology platforms applied to currently marketed drugs, they are expected to have lower approval risk, shorter development timelines and significantly lower development costs. The Company’s lead compound, CIP-FENOFIBRATE, received final approval from the U.S. Food and Drug Administration and Health Canada in the first quarter of 2006. The product is being marketed in the United States by Kowa Pharmaceuticals America under the label Lipofen(R). In addition, Cipher is developing formulations of the pain reliever tramadol (tentative FDA approval in February 2009) and the acne treatment isotretinoin (FDA approvable letter in April 2007).
Cipher is listed on the Toronto Stock Exchange under the symbol ‘DND’ and has approximately 24 million shares outstanding. For more information, please visit www.cipherpharma.com.
Forward-Looking Statements
Statements made in this news release, other than those concerning historical financial information, may be forward-looking and therefore subject to various risks and uncertainties. Some forward-looking statements may be identified by words like “may”, “will”, “anticipate”, “estimate”, “expect”, “intend”, or “continue” or the negative thereof or similar variations. Certain material factors or assumptions are applied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements. Factors that could cause results to vary include those identified in the Company’s Annual Information Form and other filings with Canadian securities regulatory authorities, such as the applicability of patents and proprietary technology; possible patent litigation; regulatory approval of products in the Company’s pipeline; changes in government regulation or regulatory approval processes; government and third-party payer reimbursement; dependence on strategic partnerships for product candidates and technologies, marketing and R&D services; meeting projected drug development timelines and goals; intensifying competition; rapid technological change in the pharmaceutical industry; anticipated future losses; the ability to access capital to fund R&D; and the ability to attract and retain key personnel. All forward-looking statements presented herein should be considered in conjunction with such filings. Except as required by Canadian securities laws, the Company does not undertake to update any forward-looking statements; such statements speak only as of the date made.
For more information, please contact: Craig Armitage Investor Relations The Equicom Group (416) 815-0700 ext 278 815-0080 fax carmitage@equicomgroup.com Larry Andrews President and CEO Cipher Pharmaceuticals (905) 602-5840 ext 324
