Enzymatica AB: Appeal of court ruling on Enzymatica's cold spray in Germany
29 August 2018 - 4:30PM
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.
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
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
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