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Cipher Pharmaceuticals Inc – ‘40FR12B’ on 11/7/14 – ‘EX-99.29’

On:  Friday, 11/7/14, at 4:15pm ET   ·   Accession #:  1104659-14-78399   ·   File #:  1-36734

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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

Registration of Securities of a Canadian Issuer — SEA’34 §12(b)   —   Form 40-F
Filing Table of Contents

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 


EX-99.29   —   Miscellaneous Exhibit


This Exhibit is an HTML Document rendered as filed.  [ Alternative Formats ]



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

 



Dates Referenced Herein   and   Documents Incorporated by Reference

This ‘40FR12B’ Filing    Date    Other Filings
Filed on:11/7/14F-X
9/19/13
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Filing Submission 0001104659-14-078399   –   Alternative Formats (Word / Rich Text, HTML, Plain Text, et al.)

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