Business
Cipher's Partner Ranbaxy receives Paragraph IV Certification
Toronto Stock Exchange Symbol: DND MISSISSAUGA, ON , Sept. 19, 2013 /CNW/ - Cipher...
About this update from Cipher Pharmaceuticals Inc.
[{"type":"text","content":"\n\n\nToronto Stock Exchange Symbol: DND\n\n\nMISSISSAUGA, ON, Sept. 19, 2013 /CNW/ - Cipher Pharmaceuticals Inc.\n (TSX: DND) (\"Cipher\") today announced that its sales and distribution\n partner, Ranbaxy Laboratories Inc. (\"Ranbaxy\") has received a Paragraph\n IV Certification Notice of filing from Watson Laboratories Inc. of an\n Abbreviated New Drug Application (\"ANDA\") to the U.S. Food and Drug\n Administration (\"FDA\") for a generic version of Absorica™ (isotretinoin capsules).\n\n\nRanbaxy and Cipher intend to vigorously defend Absorica's intellectual\n property rights and pursue all available legal and regulatory pathways\n in defense of the product. Absorica is currently protected by two\n issued patents listed in the FDA's Approved Drug Products List (Orange\n Book), which expire in September 2021. Ranbaxy shall take appropriate\n actions in response to the Paragraph IV notice letter, and FDA approval\n of the ANDA shall then be governed by the Hatch-Waxman Act.\n\n\nAbsorica was approved by the FDA in May 2012, and granted a three-year\n market exclusivity period, which expires in May 2015.\n\n\nAbout Cipher Pharmaceuticals Inc.\n\n\nCipher Pharmaceuticals (TSX: DND) is a growing specialty pharmaceutical\n company with three commercial products and a fourth in development. Our\n product candidates are typically improved formulations of successful,\n currently marketed drugs. We in-license a product, manage the required\n clinical development and regulatory approval process, and either\n out-license it to a marketing partner, or, in Canada, we may market the\n product ourselves. Our core capabilities are in clinical and regulatory\n affairs, product licensing, supply chain management, and marketing and\n sales. Since Cipher was founded in 2000, we have achieved final\n regulatory approval in the U.S. and Canada for all three of our\n original products and completed six marketing partnerships, generating\n growing licensing revenue.\n\n\nForward-Looking Statements\n\n\nStatements made in this news release, other than those concerning\n historical financial information, may be forward-looking and therefore\n subject to various risks and uncertainties. The words \"may\", \"will\",\n \"could\", \"should\", \"would\", \"suspect\", \"outlook\", \"believe\", \"plan\",\n \"anticipate\", \"estimate\", \"e...