Navigation Links
Cipher provides CIP-TRAMADOL ER regulatory update
Date:2/11/2008

Toronto Stock Exchange Symbol: DND

MISSISSAUGA, ON, Feb. 11 /PRNewswire-FirstCall/ - Cipher Pharmaceuticals Inc. (TSX: DND) today announced that the U.S. Food and Drug Administration (FDA) has suggested an additional statistical sensitivity analysis of existing clinical data on CIP-TRAMADOL ER, Cipher's extended-release tramadol formulation, as a means to potentially satisfy the requirements for approval.

In December 2007, Cipher appealed the decision in the Agency's May 2007 Approvable Letter through the Formal Dispute Resolution process. On February 1, 2008, the Company announced that it received a written response from the FDA regarding its first stage of appeal. In the response, the Acting Director of the Office of Drug Evaluation II, Center for Drug Evaluation and Research supported the Division's approvable action. In a subsequent discussion with Cipher, the Agency informed Cipher of the new analysis as an alternative to continuing the Formal Dispute Resolution process.

As a consequence, Cipher is suspending its appeal at this time and expects to meet with the Division in the near future to obtain further details on the additional analysis.

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 ProEthic Pharmaceuticals under the label Lipofen(TM). 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 24 million shares outstanding. For more information, please visit http://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. The Company does not undertake to update any forward-looking statements; such statements speak only as of the date made.


'/>"/>
SOURCE Cipher Pharmaceuticals Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Cipher appoints Stefan Aigner to board of directors
2. Cipher Appeals FDAs Decision On CIP-TRAMADOL ER
3. Cipher reports third quarter fiscal 2007 results
4. Legal Employer Provides Companies with Competitive Edge by Assuring Consumers that Workers are Legally Documented
5. Laser Energetics Provides Joint Venture Update to Shareholders
6. ATS Medical Provides Update on First Generation Tissue Valve Approval
7. OxySure(R) Systems, Inc. Named to 2008 Worlds Best Technologies (WBT) List For its Unique, Safe and Easy to Use Portable Emergency Oxygen Generator, Which Provides Medical Oxygen Without the Need for Compressed Tanks
8. GfK Asia Provides New View on the Optics Industry
9. Young Innovations, Inc. Provides Fourth Quarter Conference Call Details
10. NutraCea Provides Update on Domestic Operations
11. Mylan Provides Update Relating to Ongoing Lorazepam and Clorazepate Litigation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... 13, 2017 , ... The Visiting Nurse Association (VNA) of Somerset Hills is ... vendors and unique items from across the nation, this holiday-themed event will raise funds ... by the VNA. The boutique will be open Saturday, November 4 (10:00 a.m. ...
(Date:10/13/2017)... VA (PRWEB) , ... October 13, 2017 , ... ... of DevOps and Agile Software Development, has been awarded a contract by the ... Blanket Purchase Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies ...
(Date:10/12/2017)... LA (PRWEB) , ... October 12, 2017 , ... Planet ... in the U.S., announced today its plans to open a flagship location in Covington, ... occupy the former Rooms To Go store next to Office Depot in the Holiday ...
(Date:10/12/2017)... Maryland (PRWEB) , ... October 12, 2017 , ... ... magnetic drug delivery system that we intend to develop to enable prevention of ... can lead to severe hearing loss, especially in pediatric patients. For cisplatin, hearing ...
(Date:10/12/2017)... ... October 12, 2017 , ... Women-owned and Grand Rapids-based ... and Brightest in Wellness® by Best and Brightest. OnSite Wellness will be honored ... 20 from 7:30 a.m. to 2 p.m. at the Henry Autograph Collection Hotel, ...
Breaking Medicine News(10 mins):
(Date:9/22/2017)... 22, 2017 AVACEN Medical (AVACEN) announced that ... successfully helping those with the widespread pain associated with ... Amanda in Essex, England commented, ... hair, experiencing no sleep at all, tremendous pain, with ... cannot recommend [the AVACEN 100] enough, how this has ...
(Date:9/18/2017)... Mich. , Sept. 18, 2017  PMD Healthcare ... Specialty Pharmacy of Kalamazoo, Mich. , ... hub service that expedites and streamlines patient and provider ... PD 2.0, and wellness management services.  ... device used to measure lung function for a variety ...
(Date:9/12/2017)... and NEW YORK , Sept. 12, 2017 /PRNewswire/ ... ratings for global supply chains, has published the first annual edition of ... performance of more than 20,400 companies evaluated by EcoVadis, based on Scorecard ... and 2016. ... Global CSR Risk & Performance Index ...
Breaking Medicine Technology: