MISSISSAUGA, ON, Jan. 26 /PRNewswire-FirstCall/ - Cipher Pharmaceuticals Inc. today updated the market on its clinical and regulatory progress and its expected milestones for CIP-Tramadol Extended Release (ER), its once-daily, sustained release formulation of the pain medication tramadol. Cipher expects to file the New Drug Application with the U.S. Food and Drug Administration (FDA) in the second quarter of 2006. Cipher has been advised by the FDA that its existing clinical data package meets the requirements to file a NDA.
“The fact that our existing data meets the requirements to file with the FDA now allows us to complete the preparation of the submission and moves us one step closer toward commercialization of CIP-Tramadol ER,” commented Larry Andrews, President of Cipher Pharmaceuticals Inc. “We intend to complete our ongoing Phase III study to further support both the regulatory and commercial success of the product.”
The submission of the NDA application in the second quarter of 2006 is consistent with the update the Company provided as part of its third quarter report. Meanwhile the Company has completed enrollment of its ongoing Phase III efficacy trial (the 02.05 trial) of CIP-Tramadol ER. The Company expects results from the Phase III trial to be available in the third quarter of 2006 along with results from a Phase I trial to investigate the potential for a clinically relevant interaction between CIP-Tramadol ER and high levels of alcohol.
In biopharmaceutical trials, Cipher’s capsule formulation of tramadol has demonstrated both rapid absorption and an extended release profile over a 24-hour timeframe. It has also demonstrated comparable bioavailability under both fed and fasted conditions, which will allow the product to be taken without regard to meals.
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. Cipher currently has three late-stage drugs in its pipeline. The Company’s lead compound, CIP-Fenofibrate, received final approval from the U.S. Food and Drug Administration in January 2006. In addition, Cipher is developing formulations of the pain reliever tramadol and the acne treatment isotretinoin.
Cipher is listed on the Toronto Stock Exchange under the symbol ‘DND’ and has approximately 21 million shares outstanding. For more information, please visit www.cipherpharma.com.
Statements made in this news release, other than those concerning historical financial information, should be considered forward-looking and subject to various risks and uncertainties. Such forward-looking statements are based on management’s beliefs and assumptions regarding the information currently available. The Company’s actual results could differ materially from those expressed in the forward-looking statements. Factors that could cause results to vary include, among other things, those expressed in the Company’s filings with Canadian securities regulatory authorities. All information presented herein should be read in conjunction with such filings.
Cipher Pharmaceuticals Inc.
CONTACT: Ross Marshall, Investor Relations, The Equicom Group, (416)815-0700 ext 238, (416) 815-0080 fax, rmarshall@equicomgroup.com; LarryAndrews, President, Cipher Pharmaceuticals, (905) 602-5840 ext 24, (905)602-0628 fax, landrews@cipherpharma.com
