Enzymatica AB: Appeal on Enzymatica's cold spray in Germany overruled
December 10, 2018
Appeal on Enzymatica's cold spray in Germany overruled
Enzymatica has been informed that the Frankfurt Higher Regional Court - OLG (Oberlandesgericht) has overruled the appeal on a previous court ruling regarding the marketing of the mouth spray ViruProtect® in Germany. The OLG court claims that no new information has been brought forward to change the verdict from July, 2018. Enzymatica continues to strengthen the clinical documentation with the aim that ViruProtect should be relaunched in Germany during 2019.
Enzymatica's ColdZyme® Mouth Spray is sold under the brand name ViruProtect in Germany, Belgium and Austria. On July 16th, 2018 Enzymatica announced that the regional court of Frankfurt put restrictions of the marketing of ViruProtect. The court decision applied only to the German market, and did not affect marketing of ViruProtect or ColdZyme in other markets. The reasons for the court decision were the strict requirements on the design of clinical studies under German legislation for medical products, namely that marketing claims need to be supported by scientific data of a standard similar to that for pharmaceuticals, despite that ColdZyme is CE marked and can be placed on the market within the EU.
At the end of August, 2018 Enzymatica's German distributor appealed the court decision on the grounds that existing clinical data for ColdZyme's efficacy were sufficient. The OLG court in Frankfurt was expected to respond to the appeal during 2019 but has already reviewed the matter and has today dismissed the appeal by claiming that no new sufficient data has been brought forward to change the verdict from July, 2018.
Enzymatica continues to strengthen the documentation of ColdZyme. On October 1, 2018 Enzymatica announced the preliminary result of a single-blinded, prospective, and controlled multicenter study in Germany on the usage of ColdZyme for naturally occurring common cold. The study, which was conducted at six German sites during the cold season 2018 and enrolling 400 participants, showed a significant reduction of disease duration and symptoms with ColdZyme usage, and less use of concomitant symptom-relieving self-medications, compared to a control group without ColdZyme intervention.
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 14.30 CET on December 10, 2018.
For more information, please contact:
Fredrik Lindberg, CEO, Enzymatica AB
Tel: +46 (0)708-86 53 70 | Email: [email protected]
Carl-Johan Wachtmeister, Head of Corporate Communications, Enzymatica AB
Tel: +46 (0)701-88 50 21 | Email: [email protected]
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.
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