Merz Announces European Approval of Bocouture for the Treatment of Upper Facial Lines

FRANKFURT AM MAIN–(BUSINESS WIRE)–Merz Pharma Group today announced that Bocouture® has
been approved by European regulatory authorities for the treatment of
upper facial lines, including horizontal frown lines, lateral
periorbital lines and glabellar frown lines. Bocouture is the only
neurotoxin approved in Europe* for this combined upper facial lines

“Merz is a global leader in the aesthetics space and is proud to be able
to provide patients and physicians in Europe with the first and only
aesthetic neurotoxin approved for combination treatment of upper facial
lines,” stated Philip Burchard, CEO of Merz Pharma Group. “This expanded
indication for Bocouture in Europe is a result of our ongoing
investments in research and development and our focus on meeting the
needs of our aesthetic customers.”

Recent market research1 has indicated that the rejuvenation
of upper facial lines is one of the most requested aesthetic procedures
among both existing patients and those considering treatment. In
clinical practice, many patients request combined treatment of upper
facial lines in a single session to achieve optimal treatment outcomes.

“As the only neurotoxin treatment approved for the simultaneous
treatment of upper facial lines, Bocouture supports physicians in their
day to day practice and enables them to provide their patients with safe
and effective treatments with confidence,” said Can Gumus, Vice
President of Global Marketing Aesthetics for Merz Pharmaceuticals. “We
are very proud of the fact that, while Bocouture was not the first toxin
to enter the European market, it is the first product to achieve this
important milestone.”

The approval of this novel treatment indication is based on the results
of a pivotal randomized, double-blind, placebo-controlled Phase 3 study
with 156 patients from France, Germany and United Kingdom receiving
treatment of upper facial lines with Bocouture. Clinical
trial data demonstrates that Bocouture has a favorable safety and
efficacy profile in treating upper facial lines, both combined and
separately, with treatment effects maintained for up to 4 months.

* European regulatory authorities reached consensus on approvability of
Bocouture® for the indication Upper Facial Lines in 15
countries of the EU. After successful completion of the application
procedure national approvals will now be granted by the member states.

For more information on Bocouture and Merz Pharma Group, please click here.

1 A market research study commissioned by Merz Aesthetics
included 2899 aesthetic treatment patients and 2080 treatment
considerers aged 18-64. The treated patient group comprised 2329 women
and 570 men who have undergone cosmetic treatments, including dermal
fillers and botulinum toxin. The respondents were from 10 countries
around the world: Germany, France, United Kingdom, Russia, Australia,
China, South Korea, Argentina, Brazil and Mexico.


Merz Pharma GmbH & Co. KGaA
Global Corporate Communications
Phone +49 69 1503 1176