Enzymatica AB Court ruling put restrictions on marketing of Enzymatica's cold spray in Germany
July 16, 2018
Court ruling put restrictions on marketing of Enzymatica's cold spray in Germany
A decision in the regional court of Frankfurt has put restrictions on the marketing of the mouth spray ViruProtect® in Germany. Enzymatica's ColdZyme® Mouth Spray is sold under the brand name ViruProtect in Germany, Belgium and Austria. The reasons for the court decision - as they are known after the oral hearing - seem to be the strict requirements on the design of clinical studies under German jurisdiction. Enzymatica's distributor in Germany, STADA Arzneimittel, and Enzymatica will now wait for the official explanatory statement of the Courts verdict to analyze the options and possible next steps. The verdict only applies to the German market and does not affect marketing of ViruProtect or ColdZyme in other markets.
The German jurisdiction for the proof of valid scientific evidence of medical devices is stricter than for most countries in Europe. Before making a product claim for medical devices the German jurisdiction requires scientific data of a standard similar to that for pharmaceuticals.
In relation to the court ruling of restrictions on the marketing of ViruProtect the sales of the product on the German market might suffer and in worst case be ceased until new clinical data has been presented, which would have a negative impact on Enzymatica's sales and result for 2018. If STADA should not place any more orders during 2018 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.
As soon as STADA and Enzymatica have received more information about the verdict, and analyzed the consequences, Enzymatica will communicate on how to handle the sales of ViruProtect in Germany. Enzymatica continues to undertake clinical studies to strengthen the documentation of ColdZyme.
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 above, at 08.30 a.m. CET on July 16, 2018.
Fredrik Lindberg, CEO, Enzymatica AB
Tel: +46 (0)708-86 53 70 | Email: firstname.lastname@example.org
Carl-Johan Wachtmeister, Head of Corporate Communications, Enzymatica AB
Tel: +46 (0)701-88 50 21 | Email: email@example.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.
Enzymaticas Certified Adviser är Erik Penser Bank.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Enzymatica AB via Globenewswire