Navigation Links
Cipher provides regulatory update for CIP-TRAMADOL ER
Date:5/13/2008

Toronto Stock Exchange Symbol: DND

MISSISSAUGA, ON, May 13 /PRNewswire-FirstCall/ - Cipher Pharmaceuticals Inc. (TSX: DND) today announced that a revised New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) for CIP-TRAMADOL ER, its extended-release formulation of tramadol. In May 2007, the Company received an approvable letter from the FDA pertaining to its NDA for CIP-TRAMADOL ER.

Cipher's revised NDA includes data from additional pharmacokinetic studies conducted by the Company comparing CIP-TRAMADOL ER to Ultram(R) ER.

After considering feedback from the FDA appeal process and the results of the additional statistical sensitivity analysis of existing data suggested by the FDA, Cipher and its advisors concluded that submitting the revised NDA provided the most expeditious path to final regulatory approval.

Subject to FDA acceptance for filing, Cipher expects the review to be completed by October 2008. It is possible that the submission could trigger patent infringement litigation and a stay of up to 30 months under the Hatch-Waxman Act.

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(R). In addition, Cipher is developing formulations of the pain reliever tramadol (FDA approvable letter in May 2007) and the acne treatment isotretinoin (FDA approvable letter in April 2007).

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 provides CIP-TRAMADOL ER regulatory update
2. Cipher appoints Stefan Aigner to board of directors
3. Cipher Appeals FDAs Decision On CIP-TRAMADOL ER
4. Cipher reports third quarter fiscal 2007 results
5. Innolife Pharma Provides Initial Update on Negotiations for Significant Product Joint Venture
6. InfuSystem Holdings Provides Business Update and Comments on First Quarter 2008 Financial Results
7. Revised AVMA Policy on Castrating and Dehorning Cattle Provides Additional Guidance for Managing Pain
8. Dubai Provides Aid for Cyclone Nargis Victims In Myanmar
9. New Evidence Provides Clinicians With Better Tools to Help Smokers Quit
10. Cholera study provides exciting new way of looking at infectious disease
11. Study finds that minimally invasive robotic bypass surgery provides health and economic benefits
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... FL (PRWEB) , ... February 05, 2016 , ... ... the largest domestic franchisees of Popeyes Louisiana Kitchen restaurants, launched the 14th annual ... awareness for kids and adults with muscular dystrophy, ALS and related diseases that ...
(Date:2/5/2016)... ... February 05, 2016 , ... Freed-Hardeman University President ... have signed a joint enrollment and degree completion agreement. The agreement, which ... baccalaureate degrees at FHU|Dickson. , The agreement allows students to be jointly ...
(Date:2/5/2016)... ... February 05, 2016 , ... US Sports Camps , official operators of ... direct high-performance kids yoga training. ChildLight Yoga Studio is centrally situated in the picturesque ... , ChildLight Yoga Studio founder Lisa Flynn expresses her excitement, “We are thrilled to ...
(Date:2/5/2016)... ... February 05, 2016 , ... Regular gym users know the routine: each ... longer to access the treadmills. It’s a predictable trend. After the excesses of November ... get in shape by joining gyms, starting new walking or running routines, or signing ...
(Date:2/5/2016)... WA (PRWEB) , ... February 05, 2016 , ... ... firm, ranked #3 in the 2015 Best in KLAS: Software & Services for ... The annual Best in KLAS report independently ranks vendor performance by healthcare executives, ...
Breaking Medicine News(10 mins):
(Date:2/4/2016)... 4, 2016 Wegener Polyangiitis - Pipeline ... Direct,s, ,Wegener Polyangiitis - Pipeline Review, H2 2015, ... pipeline. This report provides comprehensive information on ... comparative analysis at various stages, therapeutics assessment by ... administration (RoA) and molecule type, along with latest ...
(Date:2/4/2016)... 2016 Frontier Pharma: Chronic Obstructive Pulmonary ... Chronic Obstructive Pulmonary Disease (COPD) ... of the airways and lungs. Persistent breathing difficulties ... disease one of the leading causes of morbidity ... world. COPD is linked to cumulative exposure to ...
(Date:2/4/2016)... -- In response to the opioid abuse epidemic, today Dr. ... Products and Tobacco, along with other FDA leaders, called for ... opioid medications. The plan will focus on policies aimed at ... to effective relief. --> ... risk-benefit paradigm for opioids and ensure that the agency considers ...
Breaking Medicine Technology: