Merck Receives Positive CHMP Opinion for New Pergoveris(R) Fertility Pen

          Not intended for U.S. and UK based media

          - Ready-to-use pre-filled pen provides a convenient treatment option for patients
          - Simplified injection device for self-administration comes in multiple doses, addressing individual needs of patients

          Merck, a leading science and technology company, today announced that the European Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for the new Pergoveris(R) Pen.

          "The combination of FSH and LH into a single formulation, Pergoveris(R), has proven to be a valued, unique innovation for patients and the ART field since its first introduction, " said Rehan Verjee, Chief Marketing and Strategy Officer at the biopharma business of Merck. "This new Pen adds to that heritage, demonstrating our commitment to continuously improving our therapeutic and technologies offering, based on feedback from healthcare professionals and patients that we serve."

          The new Pen is comprised of a ready-to-use liquid version of Pergoveris(R) evolved from a freeze-dried powder and solvent combination, available in vials, that required patients to mix the product themselves before injection. By eliminating the need for mixing, the new Pergoveris(R) Pen provides an improved, convenient and easy-to-use treatment option for patients with severe follicle stimulating hormone (FSH) and luteinizing hormone (LH) deficiency. The liquid product will be the only premixed combination of recombinant human FSH and human LH on the market available in a pre-filled injection device for self-administration.

          The new Pergoveris(R) Pen is the third addition to Merck's innovative delivery solution Family of Pens(TM). The simple injection device with improved ease-of-use helps patients feel confident in administering their treatment, knowing they are using the correct product mix and dose. The Pergoveris(R) Pen enables a fine-tuning of treatment allowing for 12.5 IU increments and will be available in three strengths: 300IU, 450IU and 900IU. It enables healthcare professionals to precisely target the dosing to patients' needs.

          About Pergoveris(R) 

          Pergoveris(R) is the first combined product of recombinant human follicle stimulating hormone (r-hFSH or follitropin alfa 150 IU) and recombinant human luteinizing hormone (r-hLH or lutropin alfa 75 IU). It is unique by combining the benefits of two consistent and pure recombinant products, r-hFSH and r-hLH, for the treatment of infertility in specific indications. Pergoveris(R) is indicated for the stimulation of follicular development in adult women with severe luteinizing hormone (LH) and follicle stimulating hormone (FSH) deficiency.

          The Family of Pens(TM)

          The Family of Pens(TM) consists of prefilled ready-to-use pens for GONAL-f(R) 300 IU, 450 IU, and 900 IU, and OVITRELLE(R)/OVIDREL(R) 250 mcg and will include the Pergoveris(R) Pen 300IU, 450IU and 900IU once approved. The Family of Pens(TM) was developed based on feedback from healthcare professionals and those experiencing fertility problems to provide a common injection solution 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 2015, Merck generated sales of EUR 12.85 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.