07.11.16
Headquarters: Darmstadt, Germany
twitter.com/emdserono
www.merck.de
Headcount: 50,000
Year Established: 1668
Revenues: $14,034 (+13%)
Net Income: $1,218 (-4%)
R&D: $1,867 (flat)
TOP SELLING DRUGS
Merck KGaA strengthened its drive to become a leading oncology company by taking full promotional responsibility for Erbitux (cetuximab) in Japan in 2015. The move ended the co-promotion agreement it had with Bristol-Myers Squibb. Merck KGaA said expanding its oncology presence in Japan is an important strategic step along achieving its long-term goal to become a leading global player in oncology and immune-oncology. The transfer of promotional responsibilities for Erbitux in Japan further increases the presence of the company in this strategic market, where it has already positioned Japan as its regional research and development hub for South East Asia.
Also during the year, Merck KGaA and Pfizer finalized an agreement allowing the companies to co-promote Pfizer’s anaplastic lymphoma kinase (ALK) inhibitor Xalkori (crizotinib), the first ALK inhibitor approved in the U.S., Japan and the EU. The drug is supported by two positive global randomized trials in the first- and second-line ALK-positive advanced non-small cell lung cancer (NSCLC) treatment settings. Globally more than 8,000 patients have been treated with Xalkori, including those who received Xalkori in clinical trials. This co-promotion relationship is related to the announcement in November 2014 of a global strategic alliance between Merck KGaA and Pfizer to jointly develop and commercialize avelumab, an investigational anti-PD-L1 monoclonal antibody. The immuno-oncology alliance will also advance Pfizer’s PD-1 antibody.
By the end of 2015, the two companies had advanced clinical development program with two additional Phase III trials of avelumab. The Javelin Ovarian 200 trial is the first Phase III study of a PD-L1 inhibitor investigated as a treatment for platinum resistant/refractory ovarian cancer. The alliance also announced that the FDA provided approval to move forward with a Phase III study of avelumab as a maintenance treatment, in the first-line setting, in patients with locally advanced or metastatic urothelial cancer.
The clinical development program for avelumab now includes more than 1,500 patients who have been treated across more than 15 tumor types, including breast cancer, gastric/gastro-esophageal junction cancers, head and neck cancer, melanoma, Merkel cell carcinoma, non-small cell lung cancer, ovarian cancer, renal cell carcinoma and urothelial (bladder) cancer. The alliance has initiated six pivotal trials, reaching its goal for 2015, with additional trials expected to initiate in 2016.
Also on the regulatory front, Merck KGaA was granted Fast Track designation for the development of evofosfamide (previously known as TH-302), administered in combination with gemcitabine, for the treatment of previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer. Evofosfamide is an investigational hypoxia-activated prodrug thought to be activated under severe tumor hypoxic conditions, a feature of many solid tumors. The compound, currently in Phase III trials, is being developed in collaboration with Threshold Pharmaceuticals.
twitter.com/emdserono
www.merck.de
Headcount: 50,000
Year Established: 1668
Revenues: $14,034 (+13%)
Net Income: $1,218 (-4%)
R&D: $1,867 (flat)
TOP SELLING DRUGS
Drug | Indication | 2015 Sales | (+/-%) |
Rebif | multiple sclerosis | $1,964 | -11% |
Erbitux | oncology | $982 | -2% |
Gonal-f | fertility | $748 | 4% |
Concor | cardiovascular disease | $506 | 9% |
Glucophage | type 2 diabetes | $477 | 20% |
Euthyrox | hormone therapy | $341 | 5% |
Merck KGaA strengthened its drive to become a leading oncology company by taking full promotional responsibility for Erbitux (cetuximab) in Japan in 2015. The move ended the co-promotion agreement it had with Bristol-Myers Squibb. Merck KGaA said expanding its oncology presence in Japan is an important strategic step along achieving its long-term goal to become a leading global player in oncology and immune-oncology. The transfer of promotional responsibilities for Erbitux in Japan further increases the presence of the company in this strategic market, where it has already positioned Japan as its regional research and development hub for South East Asia.
Also during the year, Merck KGaA and Pfizer finalized an agreement allowing the companies to co-promote Pfizer’s anaplastic lymphoma kinase (ALK) inhibitor Xalkori (crizotinib), the first ALK inhibitor approved in the U.S., Japan and the EU. The drug is supported by two positive global randomized trials in the first- and second-line ALK-positive advanced non-small cell lung cancer (NSCLC) treatment settings. Globally more than 8,000 patients have been treated with Xalkori, including those who received Xalkori in clinical trials. This co-promotion relationship is related to the announcement in November 2014 of a global strategic alliance between Merck KGaA and Pfizer to jointly develop and commercialize avelumab, an investigational anti-PD-L1 monoclonal antibody. The immuno-oncology alliance will also advance Pfizer’s PD-1 antibody.
By the end of 2015, the two companies had advanced clinical development program with two additional Phase III trials of avelumab. The Javelin Ovarian 200 trial is the first Phase III study of a PD-L1 inhibitor investigated as a treatment for platinum resistant/refractory ovarian cancer. The alliance also announced that the FDA provided approval to move forward with a Phase III study of avelumab as a maintenance treatment, in the first-line setting, in patients with locally advanced or metastatic urothelial cancer.
The clinical development program for avelumab now includes more than 1,500 patients who have been treated across more than 15 tumor types, including breast cancer, gastric/gastro-esophageal junction cancers, head and neck cancer, melanoma, Merkel cell carcinoma, non-small cell lung cancer, ovarian cancer, renal cell carcinoma and urothelial (bladder) cancer. The alliance has initiated six pivotal trials, reaching its goal for 2015, with additional trials expected to initiate in 2016.
Also on the regulatory front, Merck KGaA was granted Fast Track designation for the development of evofosfamide (previously known as TH-302), administered in combination with gemcitabine, for the treatment of previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer. Evofosfamide is an investigational hypoxia-activated prodrug thought to be activated under severe tumor hypoxic conditions, a feature of many solid tumors. The compound, currently in Phase III trials, is being developed in collaboration with Threshold Pharmaceuticals.