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As Of Filer Filing For·On·As Docs:Size Issuer Agent 11/07/14 Cipher Pharmaceuticals Inc 40FR12B 84:13M Merrill Corp-MD/FA |
Document/Exhibit Description Pages Size 1: 40FR12B Registration of Securities of a Canadian Issuer -- HTML 97K SEA'34 §12(b) 2: EX-99.01 Miscellaneous Exhibit HTML 31K 3: EX-99.02 Miscellaneous Exhibit HTML 376K 4: EX-99.03 Miscellaneous Exhibit HTML 154K 5: EX-99.04 Miscellaneous Exhibit HTML 44K 6: EX-99.05 Miscellaneous Exhibit HTML 61K 7: EX-99.06 Miscellaneous Exhibit HTML 317K 8: EX-99.07 Miscellaneous Exhibit HTML 32K 9: EX-99.08 Miscellaneous Exhibit HTML 32K 10: EX-99.09 Miscellaneous Exhibit HTML 23K 11: EX-99.10 Miscellaneous Exhibit HTML 557K 12: EX-99.11 Miscellaneous Exhibit HTML 28K 13: EX-99.12 Miscellaneous Exhibit HTML 444K 14: EX-99.13 Miscellaneous Exhibit HTML 27K 15: EX-99.14 Miscellaneous Exhibit HTML 29K 16: EX-99.15 Miscellaneous Exhibit HTML 45K 17: EX-99.16 Miscellaneous Exhibit HTML 27K 18: EX-99.17 Miscellaneous Exhibit HTML 264K 19: EX-99.18 Miscellaneous Exhibit HTML 131K 20: EX-99.19 Miscellaneous Exhibit HTML 28K 21: EX-99.20 Miscellaneous Exhibit HTML 28K 22: EX-99.21 Miscellaneous Exhibit HTML 44K 23: EX-99.22 Miscellaneous Exhibit HTML 41K 24: EX-99.23 Miscellaneous Exhibit HTML 25K 25: EX-99.24 Miscellaneous Exhibit HTML 344K 26: EX-99.25 Miscellaneous Exhibit HTML 169K 27: EX-99.26 Miscellaneous Exhibit HTML 29K 28: EX-99.27 Miscellaneous Exhibit HTML 29K 29: EX-99.28 Miscellaneous Exhibit HTML 40K 30: EX-99.29 Miscellaneous Exhibit HTML 27K 31: EX-99.30 Miscellaneous Exhibit HTML 35K 32: EX-99.31 Miscellaneous Exhibit HTML 351K 33: EX-99.32 Miscellaneous Exhibit HTML 174K 34: EX-99.33 Miscellaneous Exhibit HTML 28K 35: EX-99.34 Miscellaneous Exhibit HTML 28K 36: EX-99.35 Miscellaneous Exhibit HTML 41K 37: EX-99.36 Miscellaneous Exhibit HTML 23K 38: EX-99.37 Miscellaneous Exhibit HTML 23K 39: EX-99.38 Miscellaneous Exhibit HTML 24K 40: EX-99.39 Miscellaneous Exhibit HTML 28K 41: EX-99.40 Miscellaneous Exhibit HTML 406K 42: EX-99.41 Miscellaneous Exhibit HTML 173K 43: EX-99.42 Miscellaneous Exhibit HTML 45K 44: EX-99.43 Miscellaneous Exhibit HTML 40K 45: EX-99.44 Miscellaneous Exhibit HTML 42K 46: EX-99.45 Miscellaneous Exhibit HTML 29K 47: EX-99.46 Miscellaneous Exhibit HTML 28K 48: EX-99.47 Miscellaneous Exhibit HTML 310K 49: EX-99.48 Miscellaneous Exhibit HTML 32K 50: EX-99.49 Miscellaneous Exhibit HTML 32K 51: EX-99.50 Miscellaneous Exhibit HTML 559K 52: EX-99.51 Miscellaneous Exhibit HTML 27K 53: EX-99.52 Miscellaneous Exhibit HTML 424K 54: EX-99.53 Miscellaneous Exhibit HTML 26K 55: EX-99.54 Miscellaneous Exhibit HTML 264K 56: EX-99.55 Miscellaneous Exhibit HTML 156K 57: EX-99.56 Miscellaneous Exhibit HTML 29K 58: EX-99.57 Miscellaneous Exhibit HTML 29K 59: EX-99.58 Miscellaneous Exhibit HTML 44K 60: EX-99.59 Miscellaneous Exhibit HTML 28K 61: EX-99.60 Miscellaneous Exhibit HTML 35K 62: EX-99.61 Miscellaneous Exhibit HTML 32K 63: EX-99.62 Miscellaneous Exhibit HTML 33K 64: EX-99.63 Miscellaneous Exhibit HTML 29K 65: EX-99.64 Miscellaneous Exhibit HTML 33K 66: EX-99.65 Miscellaneous Exhibit HTML 340K 67: EX-99.66 Miscellaneous Exhibit HTML 195K 68: EX-99.67 Miscellaneous Exhibit HTML 29K 69: EX-99.68 Miscellaneous Exhibit HTML 29K 70: EX-99.69 Miscellaneous Exhibit HTML 46K 71: EX-99.70 Miscellaneous Exhibit HTML 354K 72: EX-99.71 Miscellaneous Exhibit HTML 202K 73: EX-99.72 Miscellaneous Exhibit HTML 29K 74: EX-99.73 Miscellaneous Exhibit HTML 29K 75: EX-99.74 Miscellaneous Exhibit HTML 44K 76: EX-99.75 Miscellaneous Exhibit HTML 23K 77: EX-99.76 Miscellaneous Exhibit HTML 369K 78: EX-99.77 Miscellaneous Exhibit HTML 32K 79: EX-99.78 Miscellaneous Exhibit HTML 32K 80: EX-99.79 Miscellaneous Exhibit HTML 23K 81: EX-99.80 Miscellaneous Exhibit HTML 425K 82: EX-99.81 Miscellaneous Exhibit HTML 32K 83: EX-99.82 Miscellaneous Exhibit HTML 32K 84: EX-99.83 Miscellaneous Exhibit HTML 22K
Exhibit 99.29
99.29 News Release Dated September 19, 2013
Cipher’s Partner Ranbaxy receives Paragraph IV Certification
Toronto Stock Exchange Symbol: DND
MISSISSAUGA, ON, Sept. 19, 2013 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND) (“Cipher”) today announced that its sales and distribution partner, Ranbaxy Laboratories Inc. (“Ranbaxy”) has received a Paragraph IV Certification Notice of filing from Watson Laboratories Inc. of an Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug Administration (“FDA”) for a generic version of Absorica™ (isotretinoin capsules).
Ranbaxy and Cipher intend to vigorously defend Absorica’s intellectual property rights and pursue all available legal and regulatory pathways in defense of the product. Absorica is currently protected by two issued patents listed in the FDA’s Approved Drug Products List (Orange Book), which expire in September 2021. Ranbaxy shall take appropriate actions in response to the Paragraph IV notice letter, and FDA approval of the ANDA shall then be governed by the Hatch-Waxman Act.
Absorica was approved by the FDA in May 2012, and granted a three-year market exclusivity period, which expires in May 2015.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals (TSX: DND) is a growing specialty pharmaceutical company with three commercial products and a fourth in development. Our product candidates are typically improved formulations of successful, currently marketed drugs. We in-license a product, manage the required clinical development and regulatory approval process, and either out-license it to a marketing partner, or, in Canada, we may market the product ourselves. Our core capabilities are in clinical and regulatory affairs, product licensing, supply chain management, and marketing and sales. Since Cipher was founded in 2000, we have achieved final regulatory approval in the U.S. and Canada for all three of our original products and completed six marketing partnerships, generating growing licensing revenue.
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. The words “may”, “will”, “could”, “should”, “would”, “suspect”, “outlook”, “believe”, “plan”, “anticipate”, “estimate”, “expect”, “intend”, “forecast”, “objective”, “hope” and “continue” (or the negative thereof), and words and expressions of similar import, are intended to identify forward-looking statements. 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. These factors include, but are not limited to; the applicability of patents and proprietary technology; possible patent litigation; approval of products in the Company’s pipeline; marketing of products; meeting projected drug development timelines and goals; product liability and insurance; dependence on strategic partnerships and licensees; concentration of the Company’s revenue; substantial competition and rapid technological change in the pharmaceutical industry; the publication of negative results of clinical trials of the Company’s products; the ability to access capital; the ability to attract and retain key personnel; changes in government regulation or regulatory approval processes; dependence on contract research organizations; third party reimbursement; the success of the Company’s strategic investments; the achievement of development goals and time frames; the possibility of shareholder dilution; market price volatility of securities; and the existence of significant shareholders. 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.
SOURCE Cipher Pharmaceuticals Inc.
Craig Armitage
Investor Relations
TMX Equicom
(416) 815-0700 ext 278
(416) 815-0080 fax
carmitage@tmxequicom.com
Larry Andrews
President and CEO
Cipher Pharmaceuticals
(905) 602-5840 ext 324
(905) 602-0628 fax
landrews@cipherpharma.com
This ‘40FR12B’ Filing | Date | Other Filings | ||
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Filed on: | 11/7/14 | F-X | ||
9/19/13 | ||||
List all Filings |