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Research and Development

We conduct research and development (R&D) worldwide in order to develop new products and services designed to improve the quality of life of patients and to satisfy the needs of our customers. Further optimizing the relevance and efficiency of our research and development activities – either on our own or in cooperation with third parties – is one of our top priorities.

In 2018, approximately 7,200 employees worked for our company researching innovations to serve long-term health and technology trends in both established and growth markets (in 2017: approximately 6,800).

Our company spent around € 2.2 billion on research and development (R&D) in 2018 (2017: around € 2.1 billion). In our research and development activities, we focus on both in-house research and external collaborations that enable us to increase the productivity of our research while simultaneously reducing financial outlay. The organizational set-up of our R&D activities reflects the structure of our company with three business sectors.

Healthcare

BIOPHARMA

Oncology and Immuno-Oncology

Oncology and immuno-oncology are core focus areas in our R&D portfolio. With an emphasis on biomarker-driven research, we aim to deliver personalized treatments and a transformative pipeline. Translational research is embedded into the whole R&D process, with several projects addressing unmet needs in hard-to-treat cancers through innovative treatment approaches and novel combinations. In 2018, we achieved a number of significant milestones across our oncology and immuno-oncology pipeline.

We continue to develop much-needed new treatment options for patients with hard-to-treat cancers and have made key progress in this area with avelumab, an anti-PD-L1 antibody that we are co-developing and co-commercializing with Pfizer. To date, avelumab has received approval in 46 countries across the world under the brand name Bavencio®. In 2018, approvals were granted in several countries, including Australia and Brazil, for Merkel cell carcinoma (MCC) as well as Israel for MCC and urothelial carcinoma (UC) and Canada for UC.

In September, we announced positive top-line results from the pivotal Phase III JAVELIN Renal 101 study evaluating avelumab in combination with Inlyta® (axitinib), compared with Sutent® (sunitinib) as initial therapy for patients with advanced renal cell carcinoma (RCC). As part of a planned interim analysis, an independent data monitoring committee confirmed that the trial showed a statistically significant improvement in progression-free survival (PFS) by central review for patients treated with the combination whose tumors had PD-L1+ expression greater than 1% (primary objective), as well as in the entire study population regardless of PD-L1 tumor expression (secondary objective). The detailed analysis of this clinical trial read-out was presented at the 2018 European Society for Medical Oncology (ESMO) Congress. The US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for avelumab in combination with Inlyta® for treatment-naive patients with advanced RCC in December 2017.

Through our strategic alliance with Pfizer, we continue to explore the therapeutic potential of avelumab. Our clinical development program JAVELIN comprises more than 30 clinical programs, including various Phase III trials, involving over 9,000 patients across more than 15 different tumor types. In addition to MCC, UC and RCC, these cancers include breast, gastric/gastro-esophageal junction and head and neck cancers, non-small cell lung cancer and ovarian cancer.

We provided an update on our Phase III JAVELIN Lung 200 trial in February, Phase III JAVELIN Ovarian 200 trial in November and Phase III JAVELIN Ovarian 100 trial in December. While these studies did not meet or were not expected to meet their pre-specified primary endpoints of overall survival (JAVELIN Lung 200), superior overall survival or PFS (JAVELIN Ovarian 200) and PFS (JAVELIN Ovarian 100), the data are being further examined to better understand the results.

As part of our ongoing commitment to developing new treatment options for patients with hard-to-treat cancers who would otherwise have a low chance of survival, and to exploring all potential options, we entered into various new strategic collaborations in 2018 with avelumab. The first was in July, when our collaboration with Vyriad to evaluate avelumab in combination with Voyager-V1, an oncolytic virus therapy, in a Phase I clinical trial in patients with solid tumors was announced. A few days later, we announced a collaboration with Leap Therapeutics to investigate avelumab in combination with Leap Therapeutics’ GITR agonist, TRX518, and chemotherapy in a Phase I/II clinical trial in advanced solid tumors including expansion populations in patients with relapsed/refractory ovarian, breast and prostate cancers.

In September, together with Pfizer, we entered into a clinical trial collaboration and supply agreement with Checkmate Pharmaceuticals to evaluate CMP-001, a TLR9 agonist, in combination with avelumab. The collaboration will evaluate the safety and effectiveness of CMP-001 administered in combination with avelumab in selected previously treated patients with advanced squamous cell carcinoma of the head and neck (SCCHN) whose disease has progressed.

Also in September, we announced a collaboration with Immutep to evaluate avelumab in combination with eftilagimod alpha (‟efti” or ‟IMP321”), an investigational LAG-3Ig fusion protein, in a Phase I trial in patients with advanced solid malignancies. Shortly afterwards, in October we entered into a clinical trial collaboration agreement with Daiichi Sankyo Company to study the combination of avelumab and/or our investigational DNA damage repair (DDR) inhibitor with [fam-] trastuzumab deruxtecan (DS-8201), an investigational HER2-targeting antibody drug conjugate, in patients with HER2-expressing or mutated solid tumors.

Finally, in November, we entered into two collaboration agreements. The first was with Kyowa Hakko Kirin to study avelumab with Kyowa Hakko Kirin's novel IDO inhibitor, KHK2455, in a Phase I clinical trial of patients with solid tumors. The second agreement was with Immunicum to investigate avelumab in combination with ilixadencel, an off-the-shelf, cell-based, cancer immune primer, in a planned multi-indication Phase Ib/II clinical trial of patients with advanced head and neck cancer and gastric adenocarcinoma.

In 2018, we celebrated several important milestones for our leading oncology pipeline molecules we discovered in-house, including tepotinib, an investigational oral MET inhibitor, and M7824, an investigational bifunctional immunotherapy.

In March, tepotinib received its first regulatory designation when the Japanese Ministry of Health, Labor and Welfare (MHLW) granted SAKIGAKE ‟fast-track” designation to tepotinib for patients with advanced non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations. The SAKIGAKE designation promotes research and development in Japan, aiming at early practical application for innovative pharmaceutical products, medical devices and regenerative medicines, and can reduce a drug’s review period down from 12 months to a target of 6 months. The SAKIGAKE designation system is a core component of the MHLW’s ‟Strategy of SAKIGAKE”. The system’s objective is to designate drugs that have the potential of prominent effectiveness against serious and life-threatening diseases in order to make them available to patients in Japan ahead of the rest of the world.

In August, we initiated a trial to investigate M7824 compared with pembrolizumab as a first-line treatment in patients with PD-L1-expressing advanced NSCLC. In December, the FDA and the European Medicines Agency (EMA) granted orphan drug designation (ODD) to M7824 for the treatment of biliary tract cancer (BTC). The FDA's ODD follows the recent presentation of the first clinical data for M7824 in BTC at the ESMO Congress (see below). BTC is a collective term for a group of rare and aggressive gastrointestinal cancers, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma and gallbladder carcinoma. Approximately 16,000 cases of BTC are estimated to occur every year in the United States. These cancers present late in the majority of patients and treatment options are limited. The median survival rate in the advanced setting is less than one year and the objective tumor response with commonly used chemotherapy is typically less than 10% with a short duration of response.

Our integrated R&D capacity is strongly supported by external innovation to complement our pipeline, strengthen our technology base and enhance our scientific capabilities. In 2018, we initiated new pipeline collaborations to further diversify our development risks and enable a more efficient pipeline prioritization.

In January, we announced a multi-project and licensing deal with Cancer Research UK’s Commercial Partnerships Team and The Institute of Cancer Research (ICR), London, to discover and develop new anticancer drugs. Together we will collaborate on three independent research projects spanning discovery to preclinical candidate nomination. This work will progress the discovery and development of potential cancer drugs, as well as develop biomarkers for target engagement and patient selection. Under the terms of the deal, we have worldwide rights to take molecules discovered through the collaboration forward into clinical development. Cancer Research UK and the ICR will receive milestone payments based on the achievement of research and development, regulatory and sales goals plus royalty payments on net sales of future products discovered or developed under the agreement. Any payments made to Cancer Research UK and the ICR will be invested in future lifesaving research.

In April, we announced a development and risk-sharing collaboration with the SFJ Pharmaceuticals Group (SFJ), a U.S.-based company focused on increasing R&D output and productivity through innovative models. In a novel innovation model recently emerging in the biopharma industry, SFJ – one of the pioneers of such collaborations – will finance and be responsible for Phase II/III development of abituzumab, our IgG1 monoclonal antibody, as a first-line treatment for metastatic colorectal cancer (mCRC) in combination with Erbitux® and chemotherapy.

Additionally, we are currently assessing the potential of investigating tepotinib in combination with novel therapies for the treatment of advanced heptocellular carcinoma (HCC) after the two HCC Phase II trials met their primary endpoints, with clinical activity demonstrated both as first-line and second-line treatment and safety findings in line with earlier studies.

At the 2018 ASCO Annual Meeting (June 1 – 5 in Chicago, Illinois, United States), we shared results from our increasingly broad oncology portfolio, from immuno-oncology to DDR approaches, in a wide range of hard-to-treat cancers. Representing seven therapeutic agents and eight tumor types, we showcased the significant potential in not only later-stage priority programs, but also in early pipeline programs that could make a real difference for patients. We presented data across our oncology and immuno-oncology pipeline for molecules including avelumab and Erbitux®, and pipeline updates on M7824, tepotinib, the p70S6K/AKT targeted agent M2698, the DNA-PK inhibitors M3814 and M6620.

Multiple presentations on avelumab at ASCO included two-year safety and efficacy data in metastatic MCC for avelumab from the pivotal JAVELIN Merkel 200 trial, as well as data in NSCLC and UC. Pipeline updates at ASCO also included early clinical results for tepotinib patients with NSCLC harboring MET exon 14 skipping mutations, M7824 in patients with HPV-associated cancers and NSCLC, M6620 in NSCLC and advanced solid tumors as well as data for M3814 and M2698 in solid tumors.

At the 2018 ESMO Congress (October 19 – 23 in Munich, Germany), we presented a total of 41 abstracts representing eight therapeutic agents and 14 tumor types. The data presented showcased the diversity of our pipeline, with results from a number of high-priority clinical development programs.

They included the first presentation of data from the pivotal Phase III study JAVELIN Renal 101 evaluating avelumab in combination with axitinib compared with sunitinib as initial therapy for patients with advanced RCC. For avelumab, updated data in MCC and advanced gastric or gastroesophageal junction cancer were also presented.

Additionally, new data for M7824 were presented from expansion cohorts of two ongoing Phase I clinical trials, including the first presentation data for SCCHN, BTC and esophageal cancers. In addition, updated data for M7824 in NSCLC and gastric cancer were shared. Data presented for tepotinib included results from three Phase II trials, two in advanced HCC and one in NSCLC, providing further evidence of this precision medicine’s promising clinical activity in solid tumors. In DDR, results were presented from a Phase I trial investigating M6620 (formerly VX-970) in combination with gemcitabine in patients with advanced NSCLC; and two Phase I trials of DNA-dependent protein kinase inhibitor M3814. From the broader pipeline, results were also shared from the Phase I/II trial of M7583, a Bruton’s tyrosine kinase (BTK) inhibitor, in patients with B cell malignancies, as well as a retrospective analysis of the Phase I/II Poseidon study investigating abituzumab in patients with mCRC.

Moreover, data from our legacy brand Erbitux® (cetuximab) were presented, adding to the growing body of real-world evidence supporting the therapy’s role as a standard of care in RAS wild-type mCRC, first-line recurrent or metastatic SCCHN and for patients with locally advanced SCCHN who may not be able to tolerate cisplatin-based regimens in full.

Neurology & Immunology

Multiple sclerosis (MS) is one of the world’s most common neurological disorders. Despite the emergence of several therapies in the last two decades, there are still significant unmet needs for MS patients, particularly those with highly active relapsing MS (RMS).

On July 30, we announced that a resubmission of the New Drug Application (NDA) for cladribine tablets as a potential treatment for patients with relapsing forms of MS was accepted for review by the FDA. The acceptance indicates that the FDA found the company’s resubmission sufficiently complete to permit a substantive review. The resubmission was in response to the Complete Response Letter issued by the FDA in 2011 requesting an improved understanding of safety risks and the overall benefit-risk profile. The NDA acceptance follows global approvals of cladribine tablets under the trade name Mavenclad® in more than 40 countries since August 2017, including the European Union (EU), Canada, Australia, Israel, Argentina, United Arab Emirates, Chile and Lebanon. In 2018, Mavenclad® was approved in a total of 11 countries. Additional filings in other countries are planned.

The results from the key magnetic resonance imaging (MRI) findings of the CLARITY Extension study of Mavenclad® (cladribine tablets) were published in January in the journal Therapeutic Advances in Neurological Disorders. The findings suggest that two-year treatment with Mavenclad® (given over 20 days) has a durable effect on MRI during observation in years 3 and 4.

On March 7, we announced positive results from our Phase IIb study in RMS of evobrutinib, an investigational, highly specific, oral BTK inhibitor and the first BTK inhibitor to show clinical proof-of-concept in RMS. The study met its primary endpoint, demonstrating that oral evobrutinib resulted in a clinically meaningful reduction of gadolinium-enhancing T1 lesions on MRI scans measured at weeks 12, 16, 20 and 24 in comparison to patients receiving placebo.

In April, data for Mavenclad® and Rebif® (interferon beta-1a) were presented at the American Academy of Neurology (AAN) 70th Annual Meeting, April 21 – 27 in Los Angeles, (California, United States). Mavenclad® data presented included poster presentations highlighting analyses of the CLARITY, CLARITY Extension and ORACLE-MS trials evaluating long-term safety and durable efficacy in patients with MS.

In May, the Multiple Sclerosis Journal published data outlining the effects of Mavenclad® treatment on patients with highly active RMS. The data showed that Mavenclad® reduced the risk of 6-month Expanded Disability Status Scale (EDSS) progression by 82% vs placebo.

In June, 14 abstracts were presented further characterizing the complementary profiles of Mavenclad® and Rebif® at the 4th Congress of the European Academy of Neurology (EAN) in Lisbon, Portugal.

In October, we presented 23 abstracts, including new safety and efficacy data on Mavenclad®, Rebif® and investigational therapy evobrutinib at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Berlin, Germany. The data presented at ECTRIMS build on the existing real-world and clinical evidence around the safety and efficacy of Mavenclad® and reaffirm a positive benefit-risk profile of the oral treatment, which is taken for a maximum of 20 days over two years. Based on an integrated analysis of patients from the CLARITY, CLARITY EXT and ORACLE-MS trials, including two additional years of data from the long-term PREMIERE Registry, the treatment emergent adverse event (TEAE) profile associated with Mavenclad® in patients with RMS was confirmed, with no new safety findings. Late-breaking data from the multi-sponsored European IFNβ Pregnancy Registry and Nordic health registers demonstrated that treatment with interferon beta formulations – including Rebif® – before conception or during pregnancy did not affect outcomes for the pregnancy or for the infant. Positive late-breaking data from the 24-week results of the double-blind, randomized, placebo-controlled, 48-week, Phase II study of evobrutinib in patients with RMS were presented at ECTRIMS. The study met its primary endpoint, with evobrutinib 75mg QD (once daily) and 75mg BID (twice daily) significantly reducing the number of gadolinium-enhancing T1 (T1 Gd+) lesions measured at weeks 12, 16, 20 and 24 in comparison to patients receiving placebo.

In addition, following the #MSInsideOut campaign launch on World MS Day at the end of May, we premiered the MS Inside Out Documentary film executively produced by Shift.ms during an event on October 11. At the event, we shone a light on the untold stories of MS, as well as revealing the findings from a new global MS carers survey conducted in collaboration between leading international carer organizations IACO (International Alliance of Carer Organizations) and Eurocarers. The data presented at ECTRIMS further demonstrated the need for a deeper understanding of those affected by MS and their carers.

We also announced in Berlin (Germany) the winners of the annual Grant for Multiple Sclerosis Innovation (GMSI) Award, which supports the advancement of science and medical research in the field of MS and provides a grant of up to € 1,000,000 per year to one or more selected research projects. The winners were Professor Franca Deriu of the University of Sassari (Italy); Professor Jennifer Gommerman and Dr. Valeria Ramaglia of the University of Toronto (Canada); Professor Edgar Meinl of the Institute of Clinical Neuroimmunology of the University of Munich (Germany); as well as Dr. Gerd Meyer zu Hörste and Professor Heinz Wiendl of Münster University Hospital (Germany).

At the Osteoarthritis Research Society International (OARSI) 2018 World Congress – held in April in Liverpool (United Kingdom) – 16 abstracts, including two oral presentations, were presented. Our presence at OARSI reflects the company’s dedication to helping optimize outcomes for patients living with chronic progressive diseases, with the goal of developing novel disease-modifying therapies for osteoarthritis (OA). Oral presentations on sprifermin offer further insights supporting its dose-response structural effect in patients with knee OA, observed in earlier studies.

At the European Lupus Society in March (Düsseldorf, Germany), data were presented on atacicept, a recombinant fusion protein thought to target the cytokines APRIL and BLyS. Two oral presentations of analyses of the Phase II ADDRESS II clinical trial assessing atacicept in patients with systemic lupus erythematosus (SLE) reported attainment of low-disease activity and reduction of flares in patients with high SLE disease activity.

Fertility

At the Grant for Fertility Innovation (GFI) ceremony at the annual meeting of the European Society of Human Reproduction and Embryology (ESHRE) in Barcelona, Spain, we confirmed our commitment to supporting potential breakthrough research projects in the field of fertility. With an amount of € 300,000, the GFI is again supporting the advancement of medical science, aiming to bring innovation to life. The two winners – Louise Glover from Ireland and Cinzia Di Pietro from Italy – received their awards during the ceremony, which was also attended by Louise Brown, the world’s first person to be conceived using in vitro fertilization (IVF), as well as IVF pioneer Professor Bruno Lunenfeld.

General Medicine & Endocrinology

During 2018, we received further authorizations for Glucophage® (metformin) for the reduction in the risk or delay of the onset of type 2 diabetes when intensive lifestyle changes have failed. We now have this indication in 40 countries, among them Brazil, United Kingdom, Singapore and Saudi Arabia. Global roll-out in other countries is ongoing.

In July, the EU worksharing procedure was finalized and the German Federal Institute for Drugs and Medical Devices (BfArM) recommended the approval of our new formulation of Euthyrox® (levothyroxine) in 21 EU countries. The German BfArM decision was based on a study demonstrating bioequivalence between the old and new formulations and a dose form proportionality study with the new formulation. 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. Since October the product has been available on the Turkish market. Following the positive recommendation from BfArM, which is acting as a representative of all 21 EU countries involved in the EU worksharing procedure, we expect the new formulation of Euthyrox® to be available in these countries from 2019 onwards.

On September 28, we announced the recipients of the Grant for Growth Innovation (GGI) for 2018 during the 57th European Society of Paediatric Endocrinology (ESPE) meeting in Athens, Greece. Applications were reviewed by an independent scientific steering committee consisting of six internationally renowned endocrinologists and researchers. Research groups based in Finland and Italy were each awarded a grant for innovation projects in the field of growth and growth disorders.

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BIOPHARMA PIPELINE

as of December 31, 2018

Therapeutic area
Compound Indication Status
Neurology    
Cladribine tablets (lymphocyte-targeting agent) Relapsing multiple sclerosis Registration1
Evobrutinib (BTK inhibitor) Multiple sclerosis Phase II
   
Oncology    
Tepotinib (MET kinase inhibitor) Non-small cell lung cancer Phase II
Tepotinib (MET kinase inhibitor) Hepatocellular cancer Phase II
M2698 (p70S6K and Akt inhibitor) Solid tumors Phase I
M3814 (DNA-PK inhibitor) Solid tumors Phase I
M6620 (VX-970, ATR inhibitor) Solid tumors Phase I
M4344 (VX-803, ATR inhibitor) Solid tumors Phase I
M3541 (ATM inhibitor) Solid tumors Phase I
M8891 (MetAP2 inhibitor) Solid tumors Phase I
M7583 (BTK inhibitor) Hematological malignancies Phase I
   
Immuno-Oncology    
Avelumab (anti-PD-L1 mAb) Non-small cell lung cancer, 1st line Phase III
Avelumab (anti-PD-L1 mAb) Gastric cancer, 1st line maintenance Phase III
Avelumab (anti-PD-L1 mAb) Ovarian cancer, 1st line Phase III2
Avelumab (anti-PD-L1 mAb) Urothelial cancer, 1st line maintenance Phase III
Avelumab (anti-PD-L1 mAb) Renal cell cancer, 1st line Phase III
Avelumab (anti-PD-L1 mAb) Locally advanced head and neck cancer Phase III
Avelumab (anti-PD-L1 mAb) Merkel cell carcinoma, 1st line Phase II
Avelumab (anti-PD-L1 mAb) Solid tumors Phase II3
Avelumab (anti-PD-L1 mAb) Non-small cell lung cancer Phase II3
Avelumab (anti-PD-L1 mAb) Urothelial cancer Phase II3
Abituzumab (pan-αν integrin inhibiting mAb) Colorectal cancer, 1st line Phase II4
M7824 (anti-PD-L1 / TGF-β trap) Non-small cell lung cancer, 1st line Phase II
Avelumab (anti-PD-L1 mAb) Solid tumors Phase I
Avelumab (anti-PD-L1 mAb) Hematological malignancies Phase I
M9241 (NHS-IL12, cancer immunotherapy) Solid tumors Phase I
M7824 (anti-PD-L1 / TGF-β trap) Solid tumors Phase I
   
Immunology    
Sprifermin (fibroblast growth factor 18) Osteoarthritis Phase II
Atacicept (anti-BLyS / anti-APRIL fusion protein) Systemic lupus erythematosus Phase II
Atacicept (anti-BLyS / anti-APRIL fusion protein) IgA nephropathy Phase II
Evobrutinib (BTK inhibitor) Rheumatoid arthritis Phase II
Evobrutinib (BTK inhibitor) Systemic lupus erythematosus Phase II
M1095 (ALX-0761, anti-IL-17 A/F nanobody) Psoriasis Phase II5
M6495 (anti-ADAMTS-5 nanobody) Osteoarthritis Phase I
M5049 (immune receptor inhibitor) Immunology Phase I
   
General Medicine
M5717 (PeEF2 inhibitor) Malaria Phase I
More information on the ongoing clinical trials can be found at www.clinicaltrials.gov. Pipeline products are under clinical investigation and have not been proven to be safe and effective. There is no guarantee any product will be approved in the sought-after indication.
1
As announced on July 30, 2018, the US Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application (NDA) for cladribine tablets.
2
Avelumab in combination with talazoparib.
3
Avelumab combination studies with talazoparib, axitinib, ALK inhibitors, chemotherapy or novel immunotherapies.
4
As announced on May 2, 2018, in an agreement with SFJ Pharmaceuticals Group, abituzumab will be developed by SFJ for colorectal cancer through Phase II/III clinical trials.
5
As announced on March 30, 2017, in an agreement with Avillion, anti-IL-17 A/F nanobody will be developed by Avillion for plaque psoriasis and commercialized by our company.
ADAMTS-5
A disintegrin and metalloproteinase with thrombospondin motifs
Akt
Protein kinase B
APRIL
A proliferation-inducing ligand
ATM
Ataxia Telangiectasia Mutated kinase
ATR
Ataxia Telangiectasia and Rad3-related kinase
BLyS
B-lymphocyte stimulator
BTK
Bruton’s tyrosine kinase
IgA
Immunoglobulin A
IL
Interleukin
mAb
Monoclonal antibody
MetAP2
Methionine aminopeptidase 2
PD-L1
Programmed cell death ligand 1
PeEF2
Plasmodium eukaryotic elongation factor 2
PK
Protein kinase
TGFβ
Transforming growth factor β

Allergopharma

Allergopharma, our allergy business, is one of the leading manufacturers of diagnostics and prescription drugs for allergen immunotherapy. As experts, we are determined to fully understand allergies as well as be able to discover new solutions and therapeutic concepts. In close cooperation with research institutions and other partners throughout the world, we gain valuable insights regarding the complex immunological mechanisms responsible for allergy development. And we pursue new paths in developing innovative treatments. Thus, we want to create the best conditions today for the next generation of products for optimally taking care of patients suffering from allergies.

Life Science

Across our three Life Science business units of Research Solutions, Process Solutions and Applied Solutions, our R&D teams are dedicated to finding innovative solutions to our customers’ toughest challenges. In our Life Science business sector, we invest significantly in R&D, with more than 1,750 employees working in various R&D functions around the world.

In 2018, we continued to focus on delivering the promise of accelerating access to health for people everywhere. We launched nearly 13,000 products, including nearly 6,000 chemicals, while aiming to:

  • Improve and expand our portfolio
  • Invest in new and disruptive technologies for the long term
  • Partner with the global scientific community
  • Meet customer needs
Advancing the global availability of our CRISPR technology

In early 2018, we received two patents for our CRISPR technology: the first from the Korean Intellectual Property Office and the second from the Israel Patent Office. These patents address cutting of the chromosomal sequence of eukaryotic cells (such as mammalian and plant cells) and insertion of an external or donor DNA sequence into those cells using CRISPR.

In April, we were granted a patent for this CRISPR insertion technology in China. Shortly thereafter, a paper we co-authored entitled, ‟Ethical Considerations in the Manufacture, Sale and Distribution of Genome-Editing Technologies,” was published in The American Journal of Bioethics. The paper highlights the importance of science-based bioethics in genome editing and novel processes to ensure products meet the highest standards.

To complete an active year advancing the intellectual property (IP) of our CRISPR technology, in October and December, respectively, we were awarded Australian and European CRISPR patents for foundational genome-editing technology. The patents covered paired Cas9 nickase technology to reduce off-target effects, advance gene therapy and research. A second patent covering CRISPR insertion was also awarded to our company by the European Patent Office in December.

These patents expand the foundational CRISPR cutting and integration IP necessary to correct genetic defects in gene therapy patients and to fix diseased genes while not affecting healthy ones. Further, this allows us to license CRISPR-related patents to interested parties and further supports genome-editing research under ethical and legal standards. In total, we have achieved foundational CRISPR patents in seven markets, including Canada and Europe.

Partnerships and agreements to broaden our reach

In March, we signed a Memorandum of Understanding (MoU) with Schneider Electric, a global specialist in energy management and automation. The MoU aims to automate biopharmaceutical processes for China’s biopharmaceutical industry and to help our biopharma customers in their quest for reliable, less expensive and better medical solutions.

In May, we announced a collaboration with Solvias, a Swiss contract research and service provider, to offer our PyroMAT™ System, a new Monocyte Activation Test (MAT) kit for pyrogen detection. The system offers a high-quality, ready-to-use in vitro method that does not require live animal testing and detects the broad spectrum of pyrogens. The new kit also eliminates the laboratory work required to maintain the cell line.

In June, we signed an agreement with HistoCyte Laboratories Ltd, Tyne and Wear, United Kingdom, to be the exclusive multinational distributor of the company’s portfolio of cell lines in the United States and other select geographies. For our customers, the agreement provides a cost-effective and practical solution to the problem of tissue heterogeneity.

As we began the second half of 2018, we entered into a global cooperation agreement with InnoCore Pharmaceuticals to provide its proprietary SynBiosys® biodegradable polymer platform to develop sustained release solutions for biologicals in injectable formulations. This proprietary technology allows the development of injectable sustained release biological formulations with conserved bioactivity of these sensitive molecules.

An expanded portfolio to benefit our customers

We launched innovations across all segments of our portfolio throughout 2018. In January, Applied Solutions released Steritest NEO, a new product that replaces the current Steritest EZ for sterility testing, which is a flagship for our business. In February, Process Solutions introduced Viresolve® Barrier capsule filters designed to remove viruses, mycoplasma and bacteria from cell culture media, protecting against bioreactor contamination. These filters are a key component of our Viral Safety Assurance program to mitigate the risk of viral contamination in upstream bioprocesses and minimize the potential impact on drug supply and patient safety.

In April, Applied Solutions launched our new CellStream™ benchtop flow cytometry system, a compact, customizable flow cytometer that uses a camera for detection. The system expands the limits of sensitivity, allowing scientists to tailor their instruments to their needs in immunology, cancer research and many other areas.

In May, Applied Solutions also released its new PyroMAT™ in vitro system for Pyrogen Detection, a new robust and sensitive solution for pyrogen detection. It is the only cell-line based Monocyte Activation Test (MAT) provided as a ready-to-use kit on the market, providing an alternative to animal-based testing. In July, we released Milli-Q® HX 7000 SD, a new series of all-in-one water purification systems to purify, store, distribute, monitor and control a type 2 pure water supply entirely from one Milli-Q® HX 7000 SD system.

Over the course of 2018, we expanded our nanomaterials portfolio with the launch of more than 250 new products. Our portfolio includes inorganic and carbon nanomaterials for biomedical applications, novel 2D inorganics and alternative energy materials for use in flexible electronics, implantable wearable sensors, batteries and solar energy generation.

Nanomaterials possess unique properties that drive the development of advanced technology. In biomedical research, nanomaterials are used to develop probes for high-sensitivity assays and imaging. In theranostics, innovative nanomaterials enable breakthroughs in nanomedicines for cancer therapies by improving therapeutic efficacy and tumor-specific delivery, and minimize side-effects to improve patient care. In applications beyond life science such as energy and electronics, the unique properties of nanomaterials enable more vibrant displays; they will also make enhanced energy storage and flexible and wearable electronics a reality.

In September, Process Solutions announced three new products to help biomanufacturers navigate the evolving biopharma landscape with increased speed, greater flexibility and enhanced quality. The Eshmuno® CP-FT resin is a first-of-its kind CEX chromatography resin for the flow-through removal of aggregates from mAb therapeutics. Two modified amino acids (Phospho-L-Tyrosine Disodium Salt EMPROVE® EXPERT, L-Cysteine S-Sulfate Sodium Sesquihydrate EMPROVE® EXPERT) simplify feeding and reduce total volume in cell culture.

In October, Applied Solutions released the new Milli-Q® IQ 7003/7005 Integrated Ultrapure & Pure Water System. It is a fully integrated Type 1 and Type 2 water purification solution that is intelligent, easy to use and environmentally friendly.

In November, Process Solutions launched its new BioContinuum™ platform to advance biotherapeutic drug manufacturing through improved efficiency, simplified plant operations, and greater quality and consistency. This continuous bioprocessing platform integrates what are typically batch-based, separate manufacturing steps into a connected process, enabling continuous flow from the addition of raw materials through product harvest, purification and testing. Pilot studies suggest that conversion to continuous manufacturing may reduce manufacturing costs by up to 50%.

Recognized for award-winning innovation

As a result of our long-standing efforts in Asia, in March we were named the ‟Best Bioprocessing Supplier” and we received the ‟Best Bioprocessing Supplier Award for Single-use Systems” at the Asia-Pacific Bioprocessing Excellence Awards 2018 ceremony in Singapore.

In April, our Millistak+® HC Pro portfolio won an INTERPHEX Exhibitor Award for Best Technological Innovation. The Millistak+® HC Pro portfolio is a family of synthetic depth filters providing cleaner, more consistent depth filtration media than other DE- and cellulose-based filter offerings.

In October, we won two 2018 Convention on Pharmaceutical Ingredients (CPhI) awards. Our Parteck® MXP Excipient won the ‟Excellence in Excipients” category and our modified amino acids won the ‟Excellence in Bioprocessing and Manufacturing” category.

In November, our BioReliance® Viral and Gene Therapy Assay Portfolio and proxy-CRISPR technology took top honors for innovation at the R&D 100 Awards. These awards honor the 100 most innovative and significant technologies introduced in the past year. Over the past six years, we have won nine R&D 100 awards.

Performance Materials

With our Performance Materials business sector, we are the market and technology leader in most of our businesses. As a science and technology company we are, in many cases, able to offer innovative products and solutions, which allow us to stand out from the competition. Successful Research & Development (R&D) is therefore a material part of the strategy deployed by Performance Materials. In 2018, the part of our R&D activities that is not close to the products in the business units was combined with a central innovation unit, Early Research & Business Development. Our goals in taking this step were to sharpen our focus on our customers’ needs as well as to centrally decide on the assessment of projects and the related use of resources as part of an integrated approach to research and development.

The unit develops a technology vision for Performance Materials and supports the business units in identifying projects with growth potential and tapping new markets. We evaluate the economic success of our projects and expand our activities to encompass neighboring areas in growing markets.

Display Solutions

In our Display Solutions business unit, our liquid crystal technology UB-FFS (ultra-brightness fringe-field switching) continues its successful growth thanks to new product qualifications and rising demand in the liquid crystal displays (LCD) sector for mobile devices, especially mobile phones and tablet PCs.

The development of high-resolution 4K and 8K TV sets continues to pose a challenge to the light efficiency of LC displays. We are therefore actively working to expand UB-FFS technology with our UB-Plus liquid crystal materials.

Our aim is to increase the efficiency of applications for large-format TV sets and display panels by 10% to 15%. The liquid crystal technology PS-VA (polymer-stabilized vertical alignment) remains predominant when it comes to large-format TV sets. Here, our latest materials provide additional performance benefits and improve the processing efficiency in the production of TV sets that are based on PS-VA technology. Moreover, we have successfully demonstrated our manufacturing expertise with respect to the new liquid crystal technology SA-VA (self-aligned vertical alignment). We are now focusing our attention on applications for spezialized display products from the premium segment through to TV applications produced in large numbers, as this technology offers the high contrast and image quality of the PS-VA technology while also enabling improvements in display design and panel production, for example through the reduction of waste and energy consumption in the production of LCDs.

Semiconductor Solutions

The technology area of gas-phase deposition materials (such as atomic layer deposition, ALD) is an area with high growth rates for our Semiconductor Solutions business unit. Thanks to increased research activities in collaboration with original equipment manufacturers and chip producers, we are steadily improving our positioning. Our research projects seek to identify new materials for metallization processes with low resistance and various dielectric characteristics for faster and better processors, servers and data storage density.

We have also invested in the development of advanced removers used in the photolithographic process to provide customers with a green alternative in compliance with upcoming environmental regulations.

We are currently refocusing our product portfolio to better meet the requirements of our customers operating in various compound semiconductor markets such as sensors, radio frequency filters or integrated circuits. Our conductive paste materials offer value propositions to our customers as compared with existing interconnect materials, which are reaching end-of-life status.

To better support our customers, we have expanded our research capacities in the United States, Germany and Taiwan, and are planning further research and production capacity expansions in Korea, Japan and China.

Surface Solutions

In our business with pigments for the automotive industry, we are currently focusing on the development of achromatic pigments. The latest example is our Iriodin® Icy White Pristine for silky, three-coat white stylings. Furthermore, we have expanded our regional application labs to better support the marketing of our innovative clear-coat additives, for example those manufactured on a polysilazane basis. As part of the Smart Effects initiative, we are focusing the development of cosmetic pigments on matte effects (Allure series) and luster effects (Lights series). In addition, active ingredients of natural origin are a focal topic for new cosmetic solutions.