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TAG overview

Results

With our Healthcare research pipeline, we aspire to make a positive difference for patients – always with the purpose to help create, improve, and prolong life. Our main focus areas include oncology, immuno-oncology, and neurology & immunology.

Neurology & Immunology

Multiple sclerosis (MS) is one of the world’s most common neurological disorders. Despite the emergence of a number of therapies in the last two decades, there are still significant unmet needs for MS patients. We have more than 20 years of experience in MS, and we remain committed to finding solutions for patients’ significant unmet medical needs.

We continue to receive regulatory approvals for our oral treatment option Mavenclad® (cladribine tablets) around the world. Mavenclad® is now approved in more than 80 countries worldwide, including those of the European Union, the United States, Australia, Canada, and Switzerland.

New data for both our marketed MS treatments Mavenclad® and Rebif® (interferon beta-1a) and our investigational treatment evobrutinib, the first and only Bruton’s tyrosine kinase inhibitor (BTKi) to demonstrate high and sustained efficacy through 108 weeks in clinical studies, have been presented across key congresses this year, including the 6th Congress of the European Academy of Neurology (EAN). We presented a total of 16 abstracts at this congress, which took place virtually from May 23 – 26.

In June, the U.S. Food and Drug Administration (FDA) cleared our investigational new drug application (IND) for M5049 for the potential treatment of patients with Covid-19 pneumonia. The first patient was dosed in the Phase II trial at end of July. M5049 is a potentially first-in-class small molecule that blocks the activation of Toll-like receptor (TLR)7 and TLR8, two innate immune sensors that detect single-stranded RNA from viruses such as SARS-CoV-2, the virus responsible for Covid-19. The aim of the study is to investigate if M5049 intervention at a critical point in the course of Covid-19 disease may prevent or ameliorate the hyper-inflammatory response in patients with Covid-19 pneumonia and prevent progression to “cytokine storm”. Successful intervention with the investigational drug may reduce life-threatening complications of Covid-19, including severe respiratory symptoms that often necessitate further medical interventions such as mechanical ventilation.

Generating data around our MS treatments and the risk of respiratory viral infections has been important this year to help support clinicians as they make treatment decisions for their patients living with MS. At MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting that took place virtually from September 11 – 13, we presented a total of 54 abstracts across our MS portfolio, including data providing insights on how Mavenclad® and Rebif® do not affect the risk of respiratory viral infections and Covid-19 outcomes in MS patients. Other important data presented at ACTRIMS-ECTRIMS included new efficacy and real-world safety data on Mavenclad®:

  • Early onset of action: Efficacy results from the Phase IV MAGNIFY-MS study, demonstrating an early onset of action from end of month one through a reduction in mean combined unique active (CUA) lesion count in the first six months of Mavenclad® treatment for highly active RMS
  • Sustained efficacy: New data evaluating cumulative relapse incidence over five years in patients enrolled in the CLARITY and CLARITY Extension trials, showing the sustained efficacy of Mavenclad®
  • Late-breaking interim data from the CLASSIC-MS study on the long-term efficacy and real-world treatment patterns for patients receiving Mavenclad®, with eight to 14 years of follow-up
  • Disability improvement: Results from a post hoc analysis from the CLARITY Extension, showing patients receiving early treatment with Mavenclad® had a greater prevalence of disability improvement over five years, as measured by the Expanded Disability Status Scale (EDSS)
  • The global Phase III clinical development program evaluating evobrutinib in relapsing MS includes two pivotal studies, EVOLUTION RMS 1 and 2. Evobrutinib was developed within our own laboratories and further demonstrates our commitment to improving the lives of people with MS and other chronic progressive diseases.

We have continued to deliver on the strategic evolution of our immunology pipeline this year, which includes out-licensing certain assets to allow us to focus on our priority areas and assets. In September, we announced that we are looking for a partner to take sonelokimab (M1095), an investigational anti-IL-17 A/F Nanobody® that neutralizes both IL-17A and IL-17F in patients with moderate to severe chronic plaque-type psoriasis, into Phase III. In October, we announced the out-licensing of M6495, an anti-ADAMTS5 Nanobody® for the potential treatment of osteoarthritis (OA), to Novartis, and in November, we entered into an out-licensing agreement with Vera Therapeutics for atacicept.

Oncology & Immuno-Oncology

Oncology and immuno-oncology are core focus areas in our R&D portfolio. With an emphasis on biology-driven research, we aim to deliver transformative treatments. 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 2020, we achieved a number of significant milestones across our oncology and immuno-oncology pipeline.

Treating more than 1 million patients since authorization, Erbitux® (cetuximab) is a standard of care for patients with epidermal growth factor receptor (EGFR)-expressing, RAS wildtype metastatic colorectal cancer (mCRC), as well as both recurrent and/or metastatic and locally advanced squamous cell carcinoma of the head and neck (SCCHN). We continue to invest in cetuximab and are committed to making it available to those patients it will benefit most. In March, Erbitux® obtained the approval of the National Medical Products Administration of China for the first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil.

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 we are co-developing and co-commercializing with Pfizer. To date, avelumab has received approval in more than 50 countries across the world under the brand name Bavencio®.

On January 6, we announced top-line results from the Phase III JAVELIN Bladder 100 trial, which showed that patients with previously untreated locally advanced or metastatic urothelial carcinoma (UC) whose disease did not progress on initial chemotherapy and who were randomized to receive first-line maintenance therapy with Bavencio® and best supportive care (BSC) lived significantly longer than those who received BSC only. These results were subsequently published online ahead of print on September 18 in The New England Journal of Medicine simultaneously with the presentation of additional analyses at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, describing the efficacy of Bavencio® as a first-line maintenance treatment across various subgroups of patients and highlighting exploratory biomarkers as well as patient-reported outcomes.

On April 9, Merck KGaA, Darmstadt, Germany, and Pfizer announced that the FDA granted Breakthrough Therapy Designation for Bavencio® in first-line maintenance treatment of locally advanced or metastatic UC, and that the companies had submitted a supplemental Biologics License Application for review under the FDA’s Real-Time Oncology Review (RTOR) pilot program.

On June 22, we announced that the European Medicines Agency (EMA) had validated for review the Type II variation application for Bavencio® for this proposed indication. A supplemental application was also submitted in Japan.

We also have continued to progress our efforts to bring Bavencio® in combination with axitinib to patients with advanced renal cell carcinoma (RCC). On July 31, we and our Alliance partner Pfizer announced that in the United Kingdom, the National Institute for Health and Care Excellence (NICE) recommended Bavencio® in combination with axitinib for first-line treatment of adult patients with advanced RCC. This is the first combination of an immunotherapy with a targeted antiangiogenic therapy to be recommended by NICE as a first-line treatment option for advanced RCC for use within the Cancer Drugs Fund in the United Kingdom.

Other highlights from our development pipeline included the advancement of several potential first-in-class/best-in-class compounds. The development program for tepotinib, our oral MET inhibitor designed to inhibit the oncogenic MET receptor signaling caused by MET (gene) alterations, has continued to see pivotal clinical, regulatory, and commercial milestones in 2020. Discovered in-house at our company, tepotinib underscores our strategic focus on delivering innovative precision medicines to patients with cancer.

On March 25, tepotinib was approved in Japan for the treatment of patients with unresectable, advanced or recurrent non-small cell lung cancer (NSCLC) with METex14 skipping alterations. The treatment, known as TEPMETKO® in Japan, was the first MET inhibitor to have received a regulatory approval for NSCLC with MET gene alterations.

On May 29, The New England Journal of Medicine published the primary analysis of the Phase II VISION study of tepotinib in advanced NSCLC with METex14 skipping alterations. Also presented during the ASCO20 Virtual Scientific Program, results showed consistent response and durable anti-tumor activity across lines of treatment in patients assessed by both liquid biopsy (LBx) and tissue biopsy (TBx).

On August 25, the U.S. FDA accepted and granted Priority Review to our New Drug Application for once-daily, orally dosed tepotinib for the treatment of patients with metastatic NSCLC whose tumors have a mutation that leads to mesenchymal-epithelial transition exon 14 (METex14) skipping. Tepotinib is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program. Tepotinib was granted Breakthrough Therapy Designation by the FDA in September 2019.

Several new clinical studies were initiated in 2020 for bintrafusp alfa (M7824), discovered as a result of our own research and under clinical development through an alliance with GlaxoSmithKline (GSK). Bintrafusp alfa is a potential first-in-class investigational bifunctional fusion protein designed to simultaneously block two immunosuppressive pathways, TGF-β and PD-L1, within the tumor microenvironment. This approach is thought to control tumor growth by potentially restoring and enhancing anti-tumor responses. In preclinical studies, bintrafusp alfa has demonstrated antitumor activity both as monotherapy and in combination with chemotherapy. Based on its proposed mechanism of action, the compound offers a potential targeted approach to addressing the underlying pathophysiology of difficult-to-treat cancers. Studies initiated in 2020 included a new Phase II monotherapy study in mobility group AT-hook 2 (HMGA2) expressing triple negative breast cancer (INTR@PID BREAST 020), a Phase I monotherapy study in metastatic or locally advanced urothelial cancer (INTR@PID UROTHELIAL 152) and two studies in HPV-associated tumors, including the Phase II monotherapy study in platinum-experienced cervical cancer (INTR@PID CERVICAL 017) and Phase I combination study with other anti-cancer therapies in participants with locally advanced or advanced cervical cancer (INTR@PID CERVICAL 046). A Phase I combination study evaluating bintrafusp alfa and M6223, a t-cell immunoreceptor with immunoglobulin and ITIM domains (TIGIT), which is an immune checkpoint receptor thought to inhibit t-cell activation and contribute to t-cell exhaustion was initiated (NCT04457778). Like bintrafusp alfa, M6223 was also discovered in our research labs.

Additionally, bintrafusp alfa is under investigation as a Phase II monotherapy study in patients with locally advanced or metastatic biliary tract cancer (BTC) who did not respond to, or were intolerant to, first line platinum-based chemotherapy (INTR@PID BTC 047) and in a Phase II/III combination study as a first-line treatment of gemcitabine plus cisplatin with or without bintrafusp alfa in BTC patients. It is also being studied in two lung cancer studies a Phase II study of bintrafusp alfa with concurrent chemoradiation therapy (cCRT) in unresectable Stage III non-small cell lung cancer (NSCLC) (INTR@PID LUNG 005), and a Phase Ib/II, open-label study of bintrafusp alfa in combination with chemotherapy in participants with Stage IV NSCLC regardless of PD-(L)1 expression status (INTR@PID LUNG 024). On January 20, 2021, our company announced the discontinuation of the INTR@PID Lung 037 clinical trial, a randomized, open label controlled adaptive Phase III study of bintrafusp alfa compared with pembrolizumab as a first-line (1L) treatment in patients with PD-L1 expressing advanced NSCLC after a review of the totality of clinical data by the independent data monitoring panel concluded that the study was unlikely to meet the co-primary endpoint, specifically progression-free survival.

To date, more than 1,300 patients have been dosed globally in the bintrafusp alfa INTR@PID clinical development program.

At the 2020 American Society of Clinical Oncology (ASCO) Annual Virtual Meeting held on May 31 and June 4, we had a significant presence at the Virtual Scientific Program. Potential first-in-class early and late stage pipeline compounds, and investigational uses of our approved medicines were featured at the meeting:

  • Data from the Phase III JAVELIN Bladder 100 study (Abstract# LBA1) of Bavencio® in the first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) were highlighted in the ASCO embargoed presscast on May 26 and at the plenary session on May 31. The data showed that Bavencio® as first-line maintenance significantly improved overall survival in the primary population of all randomized patients by 7.1 months, with a 31% reduction in the risk of death compared with initial chemotherapy followed by BSC alone.
  • In addition, a late-breaking oral presentation of results of the investigator-sponsored, multicenter Phase II TROPHIMMUN study of Bavencio® for the treatment of chemotherapy-resistant gestational trophoblastic tumors (Cohort A), was also featured in the ASCO press program.
  • Several oral presentations for both the TPExtreme ISS and the independent BEACON-CRC study data featuring Erbitux®, the standard of care for patients with epidermal growth factor receptor (EGFR)-expressing, RAS wildtype metastatic colorectal cancer (mCRC), as well as both recurrent and/or metastatic and locally advanced squamous cell carcinoma of the head and neck (SCCHN), demonstrated its steady role across the continuum of care in mCRC and as the backbone of treatment of SCCHN.
  • For oral MET inhibitor tepotinib, results from the primary analysis of the Phase II VISION study showed consistent response and durable anti-tumor activity across lines of treatment in patients assessed by both liquid biopsy (LBx) and tissue biopsy (TBx).
  • For bintrafusp alfa, two-year follow-up data from a Phase I global study of bintrafusp alfa, an investigational bifunctional fusion protein targeting TGF-β and PD-L1, in second-line treatment of patients with NSCLC (INTR@PID SOLID TUMOR 001) were presented. These data highlighted the potential of this dual-targeting proposed mode of action in NSCLC, and additionally, the potential to offer new ways to fight difficult-to-treat cancers beyond PD-1/PD-L1 in the future.
  • Abstracts also showcased the scientific innovation and diversity of our pipeline, with results from a number of high-priority clinical development programs, including tepotinib, bintrafusp alfa and our comprehensive DNA Damage Response (DDR) portfolio.
  • At the 2020 European Society of Medical Oncology Annual Virtual Meeting in September, we had a significant presence at the ESMO20 Virtual Scientific Program. Data from more than 30 abstracts across multiple tumor types highlighted our biology-driven approach with breakthrough innovations and significant advances in cancer care across our oncology assets.
  • Data from the Phase III JAVELIN Bladder 100 study (Presentations #6990; 704MO; 745P) of Bavencio® in the first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) versus best supportive care were presented. In addition, the primary results of the Phase III JAVELIN Head and Neck 100 (Presentation #9110) were presented.
  • For tepotinib, three posters were presented from VISION, the largest study in patients with NSCLC harboring METex14 skipping treated with tepotinib, with data highlighting durable clinical activity consistent across clinically relevant subgroups (Poster #1283P); health-related quality of life shown to be maintained, with clinically meaningful delays in the time to deterioration of cough, dyspnea, and chest pain (Poster #1286P); and a safety profile consisting of mostly mild to moderate adverse events with few treatment discontinuations. Additionally, trial in progress data was presented from the INSIGHT 2 study assessing the combination of osimertinib and tepotinib in patients with EGFR-mutant NSCLC that has developed resistance to first-line osimertinib treatment due to MET amplification is ongoing and actively recruiting patients (Poster #1415TiP).
  • Erbitux® (cetuximab) demonstrated its steady role across the continuum of care in mCRC, and as the backbone of treatment of SCCHN. And a number of investigator-sponsored studies (ISS), including in combination with Bavencio® (avelumab), demonstrating the role of Erbitux® as a promising combination partner. Data was presented in an oral presentation investigating avelumab plus cetuximab in pre-treated RAS wild type metastatic colorectal cancer patients as rechallenge strategy: the phase II CAVE (cetuximab-avelumab) mCRC study (Presentation #397O).
  • For bintrafusp alfa, our investigational bifunctional fusion protein targeting TGF-β and PD-L1, two long-term follow-up studies in BTC and NSCLC assessing the efficacy of and safety from the INTR@PID clinical trial program were presented. These data highlighted notably the potential to offer new ways to treat difficult-to-treat cancers beyond PD-1/PD-L1 in the future.
  • Three-year follow-up results from a global Phase I study (INTR@PID SOLID TUMOR 001) of bintrafusp alfa as a second-line treatment for patients with NSCLC represent the longest treatment and observational period with bintrafusp alfa in this setting to date and further deepen the understanding of bintrafusp alfa’s potential long-term efficacy and safety profile. Results demonstrated a promising duration of response (DOR) and long-term clinical benefit, especially in patients with high PD-L1 expression, as well as a manageable safety profile in a setting of high medical need where there is no globally accepted standard of care. Data presented at ESMO reinforced prior two-year follow-up results for this study presented at ASCO 2020.
  • Data presented at ESMO 2020 for bintrafusp alfa in patients with pretreated BTC represent the longest treatment and observational period to date in this setting and further deepen the understanding of the long-term efficacy and safety profile of bintrafusp alfa in BTC. Results presented were from an expansion cohort in an ongoing Phase I, open-label trial in patients with locally advanced/metastatic BTC for which first-line chemotherapy failed (INTR@PID SOLID TUMOR 008). After 28 months, bintrafusp alfa demonstrated a manageable safety profile with durable responses and long-term survival in patients with pre-treated BTC.
  • Our investigational ATR inhibitor berzosertib (M6620), was first presented as a late-breaking oral presentation from a randomized Phase II study of M6620, in combination with gemcitabine compared with gemcitabine alone in patients with platinum-resistant high-grade serous ovarian cancer, as well as published in The Lancet Oncology, in June. The study is sponsored by the National Cancer Institute (NCI) under its Cooperative Research and Development Agreement with our company for M6620, and these results were the first-ever randomized data to be presented for an ATR inhibitor.

Our broad portfolio of small-molecule DDR inhibitors represents multiple development paths, including combinations with other agents and modalities, and we are investing in this promising approach with the objective of becoming a leader in this therapeutic class. Peposertib inhibits DNA-dependent protein kinase (DNA-PK), a key enzyme needed for DNA repair, which may enhance the efficacy of agents such as radiotherapy and chemotherapy. Ataxia telangiectasia and rad3-related (ATR) kinase inhibitors target the ATR protein believed to be a key sensor for DNA damage and may enhance the efficacy of DNA-damaging agents and potentially also be efficacious as monotherapy against tumors with high levels of replication stress induced by overexpression of oncogenes.

Fertility

The Pergoveris® Pen, a convenient and ready-to-use fertility combination treatment option for women with severe follicle-stimulating hormone and luteinizing hormone deficiency, was successfully launched in several countries in Europe, Asia-Pacific, and Latin America in 2019.  

During the Covid-19 pandemic, we supported patients with advancing their treatment at home with the release of our Gonal-f® (follitropin alfa) 150 IU pen. In January, the European Commission granted Marketing Authorization for the Gonal-f® 150 IU pen. Since then, it was launched in Germany, Spain and Sweden. Further launches are planned next year. A series of studies conducted with fertility patients and nurses highlighted both the ease of use and the patient-friendliness of our Gonal-f pen®

We continue to support efforts to save the northern white rhinoceros from extinction. We are a partner of the BioRescue Project of the Leibniz Institute for Zoo and Wildlife Research (Leibniz-IZW) in the Forschungsverbund Berlin e.V., donating technology and financial support, as well as sharing expertise and experience in fertility.

General Medicine & Endocrinology

The new formulation of Euthyrox® (levothyroxine) for the treatment of hypothyroidism obtained further regulatory approvals in 2020, resulting in a total of 65 countries where this incremental innovation is registered, allowing for more precise dosing. The product is currently launched in 31 countries worldwide such as Germany, Spain, China, United States and Colombia.

Glucophage®, containing the active ingredient metformin, is now approved in 61 countries for prediabetes when lifestyle intervention is not enough to control the condition. With the successful submission and launch in Brazil of Glucophage® XR 850 for prediabetes in July 2019, in 2020 this project was expanded at the global level to be rolled out to additional countries to serve prediabetes patients, and we have successfully submitted in the Central America Region (El Salvador, Guatemala, Honduras, Nicaragua, Dominican Republic, Panama) according to our rollout plan for this product indication. 

Concor® AM, a fixed-dose combination of Bisoprolol and Amlodipine, continues its worldwide rollout to include new countries, taking the total number to 59.

The number of patients taking Saizen® (somatropin) enrolled on Easypod® Connect continued to grow in 2020, reaching 23,762 in October. Saizen® is our main endocrinology product and is indicated for the treatment of growth hormone deficiency in children and adults, while Easypod® Connect is a unique web-based platform that allows HCPs to monitor their patients’ adherence to treatment with real-time injection data collected and transmitted from their Easypod® devices.

The launch of Aluetta®, our new pen for the injection of Saizen®, complements our device portfolio and supports the growth of Saizen® by expanding our business in key geographies like Germany. Aluetta® is currently available in 23 countries.

Building for the Future

As part of our commitment to speed up the availability of new medicines for patients in need, we are investing € 250 million from 2019 to 2022 in a new facility in Corsier-sur-Vevey, Switzerland – our Biotech Development Center – dedicated to biotech development and manufacturing for clinical studies. Driven by the growth of our Healthcare business sector R&D pipeline, this investment will help to sustainably secure capacity and high agility to deliver clinical trial material in a cost-effective way, contribute to accelerated development timelines of new biological entities, and address the increasing manufacturing complexity of the next generations of biotech compounds. The Biotech Development Center adds to recent investments aiming to further increase our capacities in the research, development, and manufacturing of medicines, such as the expansions of the R&D facility of Billerica, Massachusetts, United States, of the biotech manufacturing site of Aubonne, Switzerland, and of the pharma manufacturing site of Darmstadt, Germany.

Healthcare pipeline

As of: December 31, 2020

 

 

 

 

Therapeutic area
Compound

 

Indication

 

Status

Neurology

 

 

 

 

Evobrutinib (BTK inhibitor)

 

Multiple sclerosis

 

Phase III

 

 

 

 

 

Oncology

 

 

 

 

Tepotinib (MET kinase inhibitor)

 

Non-small cell lung cancer, METex14 skipping1,2

 

Registration

Tepotinib (MET kinase inhibitor)

 

Non-small cell lung cancer, METex14 skipping

 

Phase II

Tepotinib (MET kinase inhibitor)

 

Non-small cell lung cancer, EGFR mutant, MET amplified3

 

Phase II

Peposertib (M3814) (DNA-PK inhibitor)

 

Rectal cancer

 

Phase II

Peposertib (M3814) (DNA-PK inhibitor)

 

Solid tumors4

 

Phase I

Berzosertib (M6620) (ATR inhibitor)

 

Solid tumors5

 

Phase I

M1774 (ATR inhibitor)

 

Solid tumors

 

Phase I

M3258 (LMP7 inhibitor)

 

Multiple myeloma

 

Phase I

M4344 (ATR inhibitor)

 

Solid tumors

 

Phase I

M8891 (MetAP2 inhibitor)

 

Solid tumors

 

Phase I

 

 

 

 

 

Immuno-Oncology

 

 

 

 

Avelumab (anti-PD-L1 mAb)

 

Urothelial cancer, 1st line maintenance6

 

Registration

Avelumab (anti-PD-L1 mAb)

 

Non-small cell lung cancer, 1st line

 

Phase III

Bintrafusp alfa (TGFbeta trap/anti-PD-L1)

 

Non-small cell lung cancer, 1st line

 

Phase III

Avelumab (anti-PD-L1 mAb)

 

Non-small cell lung cancer7

 

Phase II

Avelumab (anti-PD-L1 mAb)

 

Urothelial cancer7

 

Phase II

Avelumab (anti-PD-L1 mAb)

 

Solid tumors7

 

Phase II

Bintrafusp alfa (TGFbeta trap/anti-PD-L1)

 

Non-small cell lung cancer 1st and 2nd line

 

Phase II

Bintrafusp alfa (TGFbeta trap/anti-PD-L1)

 

Locally advanced non-small cell lung cancer

 

Phase II

Bintrafusp alfa (TGFbeta trap/anti-PD-L1)

 

Biliary tract cancer 1st line

 

Phase II

Bintrafusp alfa (TGFbeta trap/anti-PD-L1)

 

Biliary tract cancer 2nd line

 

Phase II

Bintrafusp alfa (TGFbeta trap/anti-PD-L1)

 

Cervical cancer 2nd line

 

Phase II

Bintrafusp alfa (TGFbeta trap/anti-PD-L1)

 

Triple negative breast cancer

 

Phase II

Bintrafusp alfa (TGFbeta trap/anti-PD-L1)

 

Cervical cancer 1st line

 

Phase I

Bintrafusp alfa (TGFbeta trap/anti-PD-L1)

 

Solid tumors

 

Phase I

M6223 (anti-TIGIT mAb)

 

Solid tumors8

 

Phase I

 

 

 

 

 

Immunology

 

 

 

 

Atacicept (anti-BLyS/anti-APRIL fusion protein)

 

Systemic lupus erythematosus9

 

Phase II

Atacicept (anti-BLyS/anti-APRIL fusion protein)

 

IgA nephropathy9

 

Phase II

Sprifermin (fibroblast growth factor 18)

 

Osteoarthritis

 

Phase II

Sonelokimab (M1095) (anti-IL-17 A/F nanobody)

 

Psoriasis10

 

Phase II

M5049 (TLR7/8 antagonist)

 

Covid-19 pneumonia

 

Phase II

M5049 (TLR7/8 antagonist)

 

Immunology

 

Phase I

 

 

 

 

 

Global Health

 

 

 

 

M5717 (PeEF2 inhibitor)

 

Malaria

 

Phase I

Unless noted otherwise, clinical programs conducted in collaboration with external partners are not shown unless we are the sponsor of that respective trial. 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 August 25, 2020, the US Food and Drug Administration (FDA) has accepted and granted Priority Review to the new drug application (NDA) in non-small cell lung cancer (NSCLC).

2

As announced on November 26, 2020, the European Medicines Agency (EMA) has validated for review the application for Tepotinib for the treatment of adult patients with advanced non-small cell lung cancer.

3

In combination with Osimertinib.

4

Includes studies in combination with Avelumab.

5

Includes studies (phase I/II) in collaboration with NCI.

6

As announced on December 11, 2020, the Committee for Medicinal Products for Humans Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending approval of Avelumab as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma.

7

Avelumab combination studies with Talazoparib, Axitinib, ALK inhibitors, Cetuximab or chemotherapy.

8

Includes study in combination with Bintrafusp alfa.

9

As announced on November 09, 2020, our company has entered into an out-licensing agreement with Vera Therapeutics.

10

Pending Phase III initiation in 2021.

APRIL: A proliferation-inducing ligand

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

METex14: MET exon 14

MET: MET proto-oncogene, receptor tyrosine kinase

PD-L1: Programmed cell death ligand 1

PeEF2: Plasmodium eukaryotic elongation factor 2

PK: Protein kinase

TGFbeta: Transforming growth factor beta

TIGIT: T cell immunoreceptor with Ig and ITIM domains

TLR7/8: Toll-like receptors 7 and 8

* The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically.