Merck Receives Recommendation for Approval in 21 EU Countries for the New Formulation of Euthyrox®

Darmstadt, Germany (ots/PRNewswire) -

Not intended for UK- or US-based media

- German Federal Institute for Drugs and Medical Devices (BfArM)
recommends new formulation of Euthyrox® for approval in 21 EU
countries
- BfArM is acting as a representative of all 21 EU countries involved
in the EU worksharing procedure

Merck, a leading science and technology company, today announced
that the German Federal Institute for Drugs and Medical Devices has
recommended to approve Merck's new formulation of Euthyrox®
(levothyroxine) in 21 EU countries. National approvals will be issued
following this recommendation.

"The tighter specification of the active ingredient in the new
formulation of Euthyrox® aims to help patients have better control
over their individual levothyroxine dosage," said Steven Hildemann,
Global Chief Medical Officer at the Biopharma business of Merck.
"Following the positive recommendation from BfArM, Merck will
continue to collaborate closely with local Health Authorities,
healthcare professionals and patient groups in preparation for the
roll out of the new formulation in the 21 countries. Together with
the respective stakeholders, and in full compliance with the local
regulations, we aim to ensure that patients are appropriately
informed. Therefore it is our first priority to support physicians
and help them provide their patients with the best possible
transition to the new formulation of Euthyrox® ."

The German BfArM decision to recommend the approval of the new
formulation of Euthyrox® across 21 EU states was based on a study
demonstrating bioequivalence between the old and new formulations.

Levothyroxine is a synthetically produced hormone that corresponds
to the natural thyroid hormone Thyroxin (T4). It is used to treat
hypothyroidism, goiter and to suppress TSH in the post-treatment of
differentiated thyroid cancer.

The new formulation came at the request of several health
authorities worldwide. It was introduced in France in March 2017 and
Switzerland in April 2018. Turkish authorities have approved the new
formulation and Merck expects to launch the medicine there in the
course of 2018.

For thyroid drugs a small dosage variation might impact the
patient's thyroid balance. Prescribing doctors are therefore
encouraged to monitor patients closely when prescribing the new
formulation and to adjust the individual dosage if medically
required. Along with Health Authorities, Merck recommends that all
patients do not switch or stop their treatment without medical advice
and refer to their prescribing physician to potentially adjust the
medication dose to their individual need during the transition phase.

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About Merck

Merck is a leading science and technology company in healthcare,
life science and performance materials. Almost 53,000 employees work
to further develop technologies that improve and enhance life - from
biopharmaceutical therapies to treat cancer or multiple sclerosis,
cutting-edge systems for scientific research and production, to
liquid crystals for smartphones and LCD televisions. In 2017, Merck
generated sales of EUR 15.3 billion in 66 countries.

Founded in 1668, Merck is the world's oldest pharmaceutical and
chemical company. The founding family remains the majority owner of
the publicly listed corporate group. Merck holds the global rights to
the Merck name and brand. The only exceptions are the United States
and Canada, where the company operates as EMD Serono, MilliporeSigma
and EMD Performance Materials.

Sara Yussefi

+49-151-14546690

Sara.yussefi@merckgroup.com

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