Merck KGaA : Set to Launch New Version of Fertility Pens

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Bettina Frank +49 6151 72-4660

February 3, 2016

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Merck Set to Launch New Version of Fertility Pens

• The Fertility Leader Merck receives market authorization from EMA for its advanced GONAL-f® prefilled pen for improved ease-of-use
• Patients, nurses and doctors help to innovate and improve the design of a product which has already helped bring over two million babies into the world1

Darmstadt, Germany, February 3, 2016 - Merck, a leading science and technology company, today received European approval for the GONAL-f® prefilled pen 2.0 from the European Medicines Agency. Originally launched in 2011, the new version of the pen includes various advanced features, designed to bring an increased level of confidence to patients during their fertility treatment.

"Similarly to the development of the previous version of the prefilled pens, we listened to our patients and healthcare professionals, understanding that the best insights come from the people using and working with our fertility treatment portfolio. Being the world leader in fertility treatment, we were carefully assessing their needs, using our knowledge gained from working with the community for many decades to identify new solutions," said Luciano Rossetti, Head of Global Research and Development, at the biopharma business of Merck. "The new GONAL-f® prefilled pen was developed with a focus on improving the patient treatment experience using the pen. This ensures that the pen is simple to handle so that patients feel confident they are getting the highest possible chance to become pregnant."

Since its launch 20 years ago, more than two million babies have been brought to the world with the help of GONAL-f®1. The prefilled pen provides patients with a simplified self-administrating injection platform for Merck's gonadotropins. Its

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enhanced design has made the new GONAL-f® prefilled pen easier to handle with a larger display window that improves the readability of the dosage information. Together with a graduated scale on a transparent cartridge, these new features provide increased clarity for the patient, reassuring them that the correct preset dose has been administered.2 These enhanced qualities add to the strong original key features of the prefilled pen: dosing accuracy3,4 and the ability to improve treatment outcomes by enabling individualized dosing.5

With a high need for specialized and innovative solutions, patients suffering from infertility is one of Merck's core focus areas in healthcare. The new GONAL-f® prefilled pen is the most recent addition to our growing portfolio to support fertility treatment. Using its long heritage and in-depth knowledge in the area, Merck continues to drive innovation to help further improve fertility treatment outcomes.

References

1. Market Data Analytics

2. GONAL-f® prefilled pen, Instructions for use. EU product information for GONAL-f® solution for injection in a prefilled pen December 2015

3. Christen, M. et al. Expert Opin Drug Deliv. 2011;8(6):833-839

4. Schertz, J.C. et al. Expert Opin Drug Deliv. 2011;8(9):1111-1120

5. Popovic-Todorovic, B. et al. Human Reproduction. 2003;18(11):2275-2282

About GONAL-f®

GONAL-f® (follitropin alfa) is a recombinant human follicle-stimulating hormone (r-hFSH) approved for the treatment of both male and female infertility. It is prescribed to supplement or replace naturally occurring follicle-stimulating hormone (FSH), an essential hormone to treat infertility in both women and men. GONAL-f® has been approved for use in the treatment of infertility in Europe since 1995 and since 1997 in the United States, and is available in more than 100 countries worldwide. It is the most widely prescribed gonadotropin in the world.

The Family of Pens™

The Family of Pens™ consists of prefilled ready-to-use pens for GONAL-f® 300 IU, 450 IU, and 900 IU, and OVITRELLE®/OVIDREL® 250 mcg. The Family of Pens™ was developed based on feedback from healthcare professionals and those experiencing fertility problems to provide a common injection platform for Merck's gonadotropins, in order to ease the teaching, learning and use of the pens.

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About Merck

Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 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 2014, Merck generated sales of € 11.3 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, Darmstadt, Germany 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.