Merck conducts research and development worldwide in order to develop new products and services designed to improve the quality of life of patients and customers. Also in the first quarter of 2014, we focused on further optimizing the relevance and profitability of our research and development activities and we increased the number of new collaborations with external research and development partners.
Nearly 4,000 employees around the world work for Merck researching innovations to serve long-term health and technology trends in established and emerging markets as well as in developing countries.
Overall, the Merck Group invested around € 379 million in research and development in the first quarter of 2014. In addition, we are focusing on a newly defined mix of in-house research and cost-saving collaborations, which enables us to increase the productivity of our research while simultaneously reducing financial outlay.
The organizational set-up of our research and development activities reflects the divisional structure of the Merck Group. Within the Executive Board, Stefan Oschmann is responsible for the Merck Serono and Consumer Health divisions, and Bernd Reckmann is responsible for the Performance Materials and Merck Millipore divisions.
Apart from the details reported below with regard to the first quarter of 2014, more information on the company’s research and development activities can be found in the Merck Annual Report for 2013.
Merck Serono
During the first quarter of 2014, several clinical projects of Merck Serono advanced through the development pipeline and several agreements were entered into with other organizations.
In the field of Oncology, a new Phase III study called START2 was initiated with tecemotide, a MUC1 antigen specific cancer immunotherapy in non-small-cell lung cancer (NSCLC). Based on the results of pre-clinical work and the ongoing Phase I trial of its C-Met kinase inhibitor, Merck Serono decided to embark on Phase I/II studies in the indications of non-small-cell lung cancer and hepatocellular carcinoma. Studies in both indications were initiated in the first quarter. Following the demonstration of clinical activity of Sym004, a mixture of two chimeric monoclonal antibodies against different parts of the Epidermal Growth Factor Receptor (EGFR), in a clinical study, Merck decided to start a further Phase II study.
In the field of Fertility, a Phase III trial of Pergoveris® was initiated in the first quarter. The study is designed to assess the efficacy and safety of Pergoveris® (follitropin alfa and lutropin alfa) versus Gonal-f® (follitropin alfa) for multifollicular development as part of an Assisted Reproductive Technology (ART) treatment cycle in women who are classified as poor ovarian responders (POR) to previous ART. Generally, in such patients, a low number of follicles develop during treatment and as a consequence, a small number of oocytes are retrieved through ART. The trial, which is known as ESPART (Evaluating the Efficacy and Safety of Pergoveris® in ART), is planned to enroll 946 patients across 17 European countries. The primary endpoint of the study is the total number of retrieved oocytes. Pergoveris® is already available in certain countries where it is indicated for the stimulation of follicular development in women with severe luteinizing hormone (LH) and follicle stimulating hormone (FSH) deficiency.
In the field of Endocrinology, Merck Serono announced in April that the Phase IIIb study of Kuvan® (known as SPARK: Safety Pediatric EfficAcy PhaRmacokinetic with Kuvan®), met its primary endpoint. The study demonstrated that the addition of Kuvan® to a phenylalanine (Phe) restricted diet in children under four years of age who have phenylketonuria (PKU) significantly increases tolerance to Phe compared with a Phe-restricted diet alone. The study was conducted under a Pediatric Investigational Plan and it is planned to submit the results to the EMA in the third quarter of this year. SPARK was requested by the EMA as a Post-Authorisation Measures study at the time of approval of Kuvan®.
In the field of Immunology, the next Phase II study of atacicept (an anti-Blys and anti-APRIL fusion protein) in patients with systemic lupus erythematosus (SLE) was initiated. This study is known as ADDRESS II and follows the promising results of the completed APRIL SLE study which were presented at the Annual Meeting of the European League against Rheumatism (EULAR) in 2013. ADDRESS II is a double-blind, placebo-controlled study of two doses of atacicept (75 mg and 150 mg given subcutaneously once per week) in over 250 patients with SLE, to further assess the efficacy and safety of atacicept in reducing SLE-disease activity in patients receiving standard-of-care therapy.
In early April, an agreement was entered into with Pfizer Inc. and the Broad Institute in Cambridge, Massachusetts. The collaboration is focused on the genomic profiling of patients with SLE and lupus nephritis. The research project will be jointly funded by Merck Serono and Pfizer. The goal is to identify biomarkers to better define target patient populations for future therapies as well as to discover potential novel drug targets for innovative therapies.
Consumer Health
Consumer Health research and development activities focus on constantly improving established and proven formulations consistent with the needs of consumers. At the same time, the division is further developing its established brand-name products by making them easier to use, for example through new forms of applications, and by offering accompanying services. In the first quarter of 2014, the research and development activities of Merck’s Consumer Health division were continued as outlined in the Merck Annual Report for 2013.
Performance Materials
Merck is the undisputed market and technology leader in liquid crystals, which are primarily used in televisions and mobile communication applications. We are also one of the leading suppliers of functional and decorative effect pigments. In the first quarter of 2014, the research and development activities of Merck’s Performance Materials division were continued as outlined in the Merck Annual Report for 2013.
Merck Millipore
Within the Merck Millipore division, Merck is working with its customers to develop innovative solutions for advancing the research, development and production of biopharmaceuticals and biotech processes worldwide. The research and developments activities in Merck Millipore’s the three business units Lab Solutions, Process Solutions and Bioscience were continued as outlined in the Merck Annual Report for 2013.