CN Creative Advances Regulatory Initiatives for Its Nicadex(TM) and Intellicig(R) Harm Reduction/Smoking Cessation Products
CN Creative Ltd.
30.05.2012 11:30
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UK Manufacturing Facility Receives 'Pharmaceutical Grade' cGMP Designation
Plans for Clinical Trial of Nicadex Electronic Inhaler Nicotine Replacement
Therapy On TrackWill Leverage MHRA Marketing Submission to Advance European and
US Regulatory Strategy
MANCHESTER, United Kingdom, 2012-05-30 11:30 CEST (GLOBE NEWSWIRE) -- 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(tm)
electronic inhaler nicotine replacement therapy (NRT) product and Intellicig(r)
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(r) electronic cigarette, ECOpure high purity nicotine
preparations and NRT Direct. CNC's Nicadex(tm) electronic inhaler nicotine
replacement therapy product is in development for use as part of medically
supervised smoking cessation programmes. For more information, visit
www.cncbio.com.
CONTACT: CN Creative
Media
Barbara Lindheim, BLL Partners
blindheim@bllbiopartners.com
+1 212 584-2276
Corporate
David Newns, CN Creative
david.newns@cncbio.com
+44 (0) 7834 767 367
News Source: NASDAQ OMX
30.05.2012 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
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Language: English
Company: CN Creative Ltd.
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US9901966690
WKN:
End of Announcement DGAP News-Service
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CN Creative Ltd.
30.05.2012 11:30
---------------------------------------------------------------------------
UK Manufacturing Facility Receives 'Pharmaceutical Grade' cGMP Designation
Plans for Clinical Trial of Nicadex Electronic Inhaler Nicotine Replacement
Therapy On TrackWill Leverage MHRA Marketing Submission to Advance European and
US Regulatory Strategy
MANCHESTER, United Kingdom, 2012-05-30 11:30 CEST (GLOBE NEWSWIRE) -- 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(tm)
electronic inhaler nicotine replacement therapy (NRT) product and Intellicig(r)
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(r) electronic cigarette, ECOpure high purity nicotine
preparations and NRT Direct. CNC's Nicadex(tm) electronic inhaler nicotine
replacement therapy product is in development for use as part of medically
supervised smoking cessation programmes. For more information, visit
www.cncbio.com.
CONTACT: CN Creative
Media
Barbara Lindheim, BLL Partners
blindheim@bllbiopartners.com
+1 212 584-2276
Corporate
David Newns, CN Creative
david.newns@cncbio.com
+44 (0) 7834 767 367
News Source: NASDAQ OMX
30.05.2012 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: CN Creative Ltd.
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US9901966690
WKN:
End of Announcement DGAP News-Service
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