Enzymatica’s ColdZyme® Mouth Spray against common cold is registered with the Swedish Medical Product Agency

Regulatory information

Enzymatica AB (publ) has registered ColdZyme ® Mouth Spray with the Swedish Medical Product Agency as a medical device, Class I. The product is intended for the prevention and treatment of common cold, it may also reduce the duration, if used in the early stages of common cold. The ColdZyme® Mouth Spray is based on an enzyme derived from the deep-sea cod that has been shown to have very good therapeutic characteristics. Negotiations are ongoing with the major pharmacy chains and wholesalers in Sweden for the upcoming large-scale launches in Sweden and the other Nordic countries.

  • The registration of ColdZyme® Mouth Spray is very important for the company. We now have two registered medical devices with clear indications and health claims for our customers. We are in negotiations with several national and international distributors, pharmacy chains and wholesalers for the market introduction of our products in early 2013, says Michael Edelborg Christensen, CEO of Enzymatica

The ColdZyme® Mouth Spray has great market potential. Common cold is one of our most common diseases. In Europe the incidence rate of common cold is 1.5 billion per year (EU-27 population of 505.7 million inhabitants, 2010). In Sweden alone, the number of common colds accounts for more than 30 million episodes per year. Enzymatica estimates the market potential in Sweden to about 10 million colds per year, equivalent to one third of colds treated without a prescription today.

Enzymatica is currently evaluating various opportunities for the widest possible dissemination of the portfolio and has just completed a new rights issue. The new rights issue was fully subscribed and raised 8.2 million SEK to the Company for the upcoming market launch of the registered products ColdZyme ® Mouth Spray and PeriZyme® Chewing Gum. Enzymatica will start the launch of the product portfolio in Sweden and in the other Nordic countries, followed by a wider international launch.

The Company has conducted a small user study with the mouth spray on elite-level biathletes and received positive results, but is now planning, as part of the post market surveillance, marketing studies (Phase IV) for ColdZyme® Mouth Spray commencing after the summer.

Enzymaticas strategy is to develop and register medical products based on enzyme technology and then go to the market and launch the products in prioritised markets and channels.

In May, Enzymatica got PeriZyme® Chewing Gum registered with the Swedish MPA as a medical device, Class I. The product is intended as preventive treatment against gingivitis and bad breath, by reducing the formation of dental plaque and oral biofilm.  Products from Enzymatica containing the active enzyme are already marketed in health food stores and para-pharmacies.

For more information, contact:
Michael Edelborg Christensen, CEO, Enzymatica AB (publ), +46 (0) 768 144 166,
michael.christensen@enzymatica.se

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