Enzymatica AB: Court ruling put restrictions on marketing of Enzymatica's cold spray in Germany
July 16 2018 - 2:30AM
Press release
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.
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.
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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