BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Cipher Pharmaceuticals (DND.TO) Submits NDA Amendment For CIP-ISOTRETINOIN


11/28/2011 6:44:37 AM

MISSISSAUGA, ON, Nov. 23, 2011 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND) today announced that it has submitted an amendment to its pending New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for CIP-ISOTRETINOIN, its novel, patented formulation of the acne medication isotretinoin. Cipher is seeking approval to market CIP-ISOTRETINOIN for the treatment of severe, nodular acne.

Cipher's NDA amendment provides additional clinical information requested by the FDA in support of obtaining approval. Subject to FDA acceptance as a complete response to its outstanding comments, Cipher expects the review under the Prescription Drug User Fee Act (PDUFA) to be completed in six months.

FDA acceptance as a complete response will trigger a US$1.0 million milestone payment from Cipher's marketing partner.

About CIP-ISOTRETINOIN

In the pharmacokinetic studies that formed the basis of its original NDA, CIP-ISOTRETINOIN demonstrated more consistent absorption under variable dietary conditions compared with existing isotretinoin products. To achieve optimal absorption, current isotretinoin formulations are prescribed to be taken with meals, which proves to be a compliance challenge for many teenagers. CIP-ISOTRETINOIN uses the patent-protected Lidose® drug delivery system, which delivers more consistent bioavailability for relatively water-insoluble compounds. Cipher was issued a patent for CIP-ISOTRETINOIN by the United States Patent and Trademark Office in 2008.

About Cipher Pharmaceuticals Inc.

Cipher Pharmaceuticals is a growing specialty pharmaceutical company that commercializes novel formulations of successful, currently marketed molecules. Cipher's strategy is to in-license clearly differentiated products, advance them through the clinical development and regulatory approval stages, and out-license to international marketing partners. The Company's first product is a fenofibrate formulation marketed in the United States as Lipofen®. Cipher's second product, an extended-release tramadol, is marketed in the United States as ConZip™ and will be marketed in Canada as Durela™. The Company's third product, a novel formulation of the acne treatment isotretinoin, recently completed its final Phase III safety study, with regulatory submissions planned in the United States and Canada in Q4, 2011.

Cipher is listed on the Toronto Stock Exchange under the symbol 'DND' and has approximately 24 million shares outstanding. For more information, please visit www.cipherpharma.com.

For further information:

Craig Armitage

Investor Relations

The Equicom Group

(416) 815-0700 ext 278

(416) 815-0080 fax

carmitage@equicomgroup.com

Larry Andrews

President and CEO

Cipher Pharmaceuticals

(905) 602-5840 ext 324

(905) 602-0628 fax

landrews@cipherpharma.com



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES