LONDON, Sept. 12, 2014 /PRNewswire/ — Kind Consumer today announced that it has received a product licence for the Company’s proprietary nicotine inhaler (Voke Inhaler 0.45mg) for General Sale from the UK Medicines and Healthcare products Regulatory Agency (MHRA). This is a key milestone in the journey towards bringing this important innovation to consumers. The next step will be to submit a variation to the licence to support full-scale commercialisation by our commercial partner, Nicoventures Limited.
Dr Chris Moyses, Chief Medical Officer, Kind Consumer, said "We are pleased to announce that the Voke Inhaler has been licensed in the UK as a medicinal product after a detailed review process by the MHRA. It is a great achievement for the team to have successfully navigated the process to marketing authorisation during which we have satisfied all questions raised by the MHRA. The technology contains no electronics, heat or combustion and will rival e-cigarettes and nicotine-replacement therapies when launched."
Voke is licensed for use to relieve and/or prevent craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.
The Marketing Authorisation Application comprised pharmaceutical, non-clinical and clinical data on the Voke Inhaler, including a clinical pharmacokinetic study comparing the Voke Inhaler with a commercially available pharmaceutical product. In addition the Voke Inhaler includes a CE marked medical device.
Alex Hearn, Chief Product Officer, inventor of the technology and founder of Kind Consumer commented, " It took over a decade to design and develop Voke, combining strict pharmaceutical safety standards while retaining the real consumer experience of the product. This invention, promises to make a real difference in offering smokers a safer alternative to smoking."
Paul Triniman, CEO said, "Achieving the first authorisation for the Voke Inhaler as a licensed medicine is a major milestone for the company. The Voke Inhaler will be commercialised by Nicoventures Ltd., now engaged in ensuring that automated manufacturing capacity will be in place, as well as the marketing plans to bring this advance in nicotine technology to smokers."
Notes to Editors:
Kind Consumer Limited is an independent, London based, company backed by some of the leading names in British Industry including Sir Terry Leahy, Sir Peter Davis and Jon Moulton. Kind develops pioneering products and novel inhalation systems for consumer and medical markets.
Voke Inhaler is a licensed medicinal product that will be available on General Sale List (GSL) in the UK. The Voke inhaler delivers a nicotine formulation via a breath operated valve in a cigarette sized medical device. The Kind technology is protected by over 110 granted worldwide patents and contains no electronics, heat or combustion. The product is the subject of a worldwide exclusive distribution agreement with Nicoventures Limited (For more information please visit http://www.nicoventures.co.uk).