Press Release.
UK Manufacturing Facility Receives “Pharmaceutical Grade” cGMP Designation
Plans for Clinical Trial of Nicadex Electronic Inhaler Nicotine Replacement Therapy on Track
Will Leverage MHRA Marketing Submission to Advance European and US Regulatory Strategy
MANCHESTER, UK, May 30, 2012 – CN Creative, Ltd. (CNC), a healthcare company providing innovative and sustainable solutions to reduce smoking and smoking-related illnesses, today reported advances in the company’s regulatory and market initiatives for its Nicadex™ electronic inhaler nicotine replacement therapy (NRT) product and Intellicig® electronic cigarettes.
Nicadex is being developed for use as part of medically supervised smoking harm reduction programmes, with a Marketing Authorisation Application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) targeted for year-end. CN Creative plans soon to initiate a UK clinical trial of Nicadex that will provide data for the MAA submission. The company also intends to apply the data and materials generated for the MAA submission in the UK to its regulatory strategy for Europe and the US, in consultation with its expert advisors, European regulatory authorities and the US Food and Drug Administration.
Intellicig is a high quality electronic cigarette currently marketed in 26 countries. The nicotine containing cartridge for both Intellicig and Nicadex is manufactured in the company’s own facilities in the UK using pharmaceutical grade materials that are now fully certified as cGMP, meaning that the manufacturing process adheres to the rigorous guidelines required for medically regulated products such as pharmaceuticals and medical devices. In addition, the electronic device components of Nicadex will be produced in the UK under ISO 13485 standards.
“From the start, our strategy has been to engineer and produce our electronic inhaler nicotine delivery products to medical standards, and we believe this approach is especially appropriate in view of the evolving regulatory situation,”
said David Newns, a co-founder and Company Director of CN Creative.
“Our plans for a clinical trial of Nicadex in the UK are proceeding well and we are on track to file an MAA around the end of this year. We plan to use data and materials from our UK dossier to support Nicadex and Intellicig regulatory filings in Europe and the US, where regulatory requirements are currently being formulated and where the rapidly growing demand for high quality electronic cigarettes is providing considerable traction as we ramp up Intellicig’s market presence.”
About CN Creative
CN Creative has developed a portfolio of products and services focused on harm reduction and smoking cessation including user-friendly nicotine delivery systems and patient-focused smoking cessation and support services such as QuitDirect,, the Intellicig® electronic cigarette, ECOpure high purity nicotine preparations and NRT Direct. CNC’s Nicadex™ electronic inhaler nicotine replacement therapy product is in development for use as part of medically supervised smoking cessation programmes.
For more information, please contact:
CN Creative
Media Corporate
Barbara Lindheim, BLL Partners
David Newns, CN Creative
blindheim@bllbiopartners.com
david.newns@cncbio.com
+1 212 584-2276 +44 (0) 7834 767 367
