Enzymatica AB: Appeal of court ruling on Enzymatica's cold spray in Germany
Press release
August 29, 2018
Appeal of court ruling on Enzymatica's cold spray in Germany
Enzymatica's distributor in Germany has appealed to the regional court of Frankfurt on their decision to put restrictions on the marketing of the mouth spray ViruProtect® in Germany. In the meantime the distributor will not place any further orders to Enzymatica of ViruProtect.
Enzymatica's ColdZyme® Mouth Spray is sold under the brand name ViruProtect in Germany, Belgium and Austria. On July 16th Enzymatica announced that the regional court of Frankfurt put restrictions of the marketing of ViruProtect. The court decision applies only to the German market, and does not affect marketing of ViruProtect or ColdZyme in other markets. The reasons for the court decision are the strict requirements on the design of clinical studies under German jurisdiction for medical products, namely that marketing claims need to be supported by scientific data of a standard similar to that for pharmaceuticals.
The German distributor has now analyzed the verdict and appealed the court decision on the grounds that existing clinical data for ColdZyme's efficacy are sufficient.
The court is expected to respond to the appeal during 2019. As a consequence of the court decision Enzymatica's distributor will not be able to place any orders of ViruProtect on the German market for the remaining part of 2018. However, the German pharmacies are allowed to sell out the product in its present form in stock to the consumers. As stated in the press release on July 16th, Enzymatica estimates that the net effect of sales not appearing in Germany, and continuous sales increase in other markets, will result in a downturn of about 10 per cent of this year's turnover compared to the turnover of SEK 59 million in 2017.
The information in this press release is information that Enzymatica is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 08.30 a.m. CET on August 29, 2018.
For more information, please contact:
Fredrik Lindberg, CEO, Enzymatica AB
Tel: +46 (0)708-86 53 70 | Email: fredrik.lindberg@enzymatica.com
Carl-Johan Wachtmeister, Head of Corporate Communications, Enzymatica AB
Tel: +46 (0)701-88 50 21 | Email: carl-johan.wachtmeister@enzymatica.com
About Enzymatica AB
Enzymatica AB is a Swedish life science company that develops and sells medical devices for infection-related diseases. The products are based on a barrier technology that includes marine enzymes. The company's first product is ColdZyme® Mouth Spray, which can prevent colds and reduce the duration of disease. The product has been launched in about ten markets. The strategy is to continue to grow by strengthening the Company's position in existing markets and expanding into new geographic markets through established partners. The company has its headquarters in Lund and is listed on Nasdaq First North. For more information, visit: www.enzymatica.com.
Enzymatica's certified adviser is Erik Penser Bank.För mer information, kontakta:
Om Enzymatica AB
Enzymaticas Certified Adviser är Erik Penser Bank.