07.20.18
Headquarters: Whitehouse Station, NJ
twitter.com/Merck
www.merck.com
Headcount: 69,000
Year Established: 1889
Revenues: $40,122 (+1%)
Pharma Revenues: $35,390 (+1%)
Net Income: $2,592 (-34%)
R&D: $9,982 (-1%)
TOP SELLING DRUGS
Merck’s worldwide pharma sales were $35.4 billion in 2017. It marks just a 1% increase compared with 2016 driven primarily by the launches of Keytruda, Zepatier and Bridion. In addition, revenue in 2017 benefited from the sale of vaccines in the markets that were previously part of the now-terminated vaccines joint venture with Sanofi Pasteur. Growth in these areas was largely offset by the effects of generic and biosimilar competition that resulted in sales declines for products including Zetia, Vytorin, Cubicin and Remicade.
Strengthening its position in oncology, during the year Merck teamed up with Astrazeneca in a $8.5 billion global oncology pact to co-develop and co-commercialize AstraZeneca’s Lynparza for multiple cancer types. Lynparza is an innovative, first-in-class oral poly ADP ribose polymerase (PARP) inhibitor currently approved for BRCA-mutated ovarian cancer in multiple lines of treatment.
Lynparza’s pipeline has grown significantly in the last few years, with 14 indications currently being developed across several tumor types, including breast, prostate and pancreatic cancers. The strategic collaboration is expected to further increase the number of treatment options available to patients.
The companies will develop and commercialize Lynparza jointly, both as monotherapy and in combination trials with other potential medicines. Independently, the companies will develop and commercialize Lynparza in combinations with their respective PD-L1 and PD-1 medicines, Imfinzi and Keytruda.
The companies will also jointly develop and commercialize AstraZeneca’s selumetinib, an oral, potent, selective inhibitor of MEK, part of the mitogen-activated protein kinase (MAPK) pathway, currently being developed for multiple indications including thyroid cancer.
Merck is paying AstraZeneca $1.6 billion upfront, $750 million for certain license options and up to an additional $6.15 billion in milestones.
More Keytruda collaborations
In addition to the oncology alliance with Astrazeneca, Merck has a number of ongoing research collaborations related to its top selling cancer drug Keytruda. A clinical collaboration with Aduro Biotech is investigating the combination of CRS-207, Aduro’s LADD (live, attenuated double-deleted) based immunotherapy, with Keytruda for the treatment of gastric cancer.
Also, Eli Lilly and Co. expanded its immuno-oncology collaboration with Merck to add a new study of Lilly’s Lartruvo with Keytruda in patients with previously treated advanced or metastatic soft tissue sarcoma. Lilly will conduct the Phase I study, which began mid-2017.
Atara Biotherapeutics entered into a clinical trial collaboration agreement with Merck to evaluate Atara’s allogeneic Epstein-Barr virus (EBV)-specific cytotoxic T lymphocytes (CTL), or ATA129, in combination with Keytruda, in patients with platinum resistant or recurrent EBV-associated NPC. The Phase 1/2 trial will evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the combination.
PDS Biotechnology, a clinical stage biopharma company developing immunotherapies, teamed up with a subsidiary of Merck to evaluate the combination of PDS’ lead Versamune-based immunotherapy, PDS0101, with Keytruda in a Phase II trial. The trial will evaluate the safety and efficacy of the combination in patients with recurrent or metastatic head and neck cancer and high-risk human papillomavirus-16 (HPV16) infection after failure with platinum-based chemotherapy. Further details were not disclosed.
Sellas Life Sciences Group, a development-stage biopharma company focused on cancer immunotherapies, entered a clinical trial collaboration and supply agreement with Merck for the conduct of a combination clinical trial targeting multiple cancers. Sellas’ Wilms tumor-1 (WT1)-targeting peptide immunotherapeutic agent, galinpepimut-S, will be administered in combination with Keytruda in a Phase 1/2 trial enrolling patients in five cancer indications, including both hematologic malignancies and solid tumors.
Lastly, Aeglea BioTherapeutics, a biotechnology company developing enzyme-based therapeutics to treat rare genetic diseases and cancer, entered into a clinical collaboration agreement with Merck to evaluate the combination of Aeglea’s AEB1102 with Keytruda for the treatment of patients with small cell lung cancer.
While 2017 wasn’t a big year on the M&A front for Merck, it did bolster its cancer pipeline with the purchase of Rigontec, a biotechnology company developing cancer immunotherapies, for €115 million upfront and as much as €349 million in milestone payments. Rigontec’s lead candidate, RGT100, is currently in Phase I development for the treatment of various tumors.
Approvals and pipeline progress
As Merck continues to expand its focus in oncology by further advancing the development program for Keytruda specifically, it received positive news from various studies and regulatory authorities in 2017.
It announced the pivotal Phase III Keynote-189 trial investigating Keytruda in combination with pemetrexed (Alimta) and cisplatin or carboplatin, for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), met its dual primary endpoints of overall survival and progression-free survival.
Merck and The European Organization for Research and Treatment of Cancer (EORTC) revealed the Phase III EORTC1325/Keynote-054 trial investigating Keytruda as monotherapy for surgically resected high-risk melanoma met the primary endpoint of recurrence-free survival and, based on an interim analysis and following review by the Independent Data Monitoring Committee, resulted in significantly longer recurrence-free survival than placebo.
The U.S. FDA accepted for review the supplemental Biologics License Application (sBLA) for Keytruda for the treatment of adult and pediatric patients with refractory primary mediastinal B-cell lymphoma, or who have relapsed after two or more prior lines of therapy. The FDA granted Priority Review status with a PDUFA date of April 3, 2018, and previously granted Breakthrough Therapy Designation to Keytruda in January 2017 for this indication.
The FDA also granted Breakthrough Therapy Designation for Keytruda in combination with Eisai’s multiple receptor tyrosine kinase inhibitor Lenvima for the potential treatment of patients with advanced and/or metastatic renal cell carcinoma, which is being jointly developed as part of a collaboration between Merck and Esai. This marks the 12th Breakthrough Therapy Designation granted to Keytruda.
In terms of approvals, the FDA gave the ok to Lynparza for use in patients with germline BRCA-mutated, HER2-negative metastatic breast cancer who have been previously treated with chemotherapy either in the neoadjuvant, adjuvant or metastatic settings. Lynparza is the first PARP inhibitor approved for breast cancer. A supplemental New Drug Application (NDA) was submitted to Japan’s Pharmaceuticals and Medical Devices Agency for the same use.
The Japanese Ministry of Health, Labor and Welfare approved Lynparza for use as a maintenance therapy for patients with platinum-sensitive relapsed ovarian cancer, regardless of their BRCA mutation status, who responded to their last platinum-based chemotherapy. Lynparza is also the first PARP inhibitor approved in Japan.
Together with Pfizer, Merck announced during the year that the FDA approved Steglatro tablets, an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, the fixed-dose combination Steglujan and the fixed-dose combination Segluromet to help improve glycemic control in adults with type 2 diabetes. Additionally, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion for these medicines.
Additionally, the FDA and European Commission approved Prevymis, once-daily tablets for oral use and injection for intravenous infusion, indicated for prevention of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant.
Lastly, the FDA approved Isentress, the company’s integrase inhibitor, for use in combination with other antiretroviral agents for the treatment of HIV-1 in newborn patients from birth to four weeks of age weighing at least 2 kg.
twitter.com/Merck
www.merck.com
Headcount: 69,000
Year Established: 1889
Revenues: $40,122 (+1%)
Pharma Revenues: $35,390 (+1%)
Net Income: $2,592 (-34%)
R&D: $9,982 (-1%)
TOP SELLING DRUGS
| Drug | Indication | 2017 Sales | (+/-%) |
| Keytruda | cancer | $3,809 | 171% |
| Januvia | diabetes, obesity | $3,737 | -4% |
| Gardasil | HPV vaccine | $2,308 | 6% |
| Janumet | diabetes, obesity | $2,158 | -2% |
| Proquad | vaccines | $1,676 | 2% |
| Zepatier | hepatitis C | $1,660 | 200% |
| Zetia | cholesterol | $1,344 | -48% |
| Isentress | HIV/AIDS | $1,204 | -13% |
| Remicade | rheumatoid arthritis | $837 | -34% |
| Simponi | rheumatoid arthritis | $819 | 7% |
Merck’s worldwide pharma sales were $35.4 billion in 2017. It marks just a 1% increase compared with 2016 driven primarily by the launches of Keytruda, Zepatier and Bridion. In addition, revenue in 2017 benefited from the sale of vaccines in the markets that were previously part of the now-terminated vaccines joint venture with Sanofi Pasteur. Growth in these areas was largely offset by the effects of generic and biosimilar competition that resulted in sales declines for products including Zetia, Vytorin, Cubicin and Remicade.
Strengthening its position in oncology, during the year Merck teamed up with Astrazeneca in a $8.5 billion global oncology pact to co-develop and co-commercialize AstraZeneca’s Lynparza for multiple cancer types. Lynparza is an innovative, first-in-class oral poly ADP ribose polymerase (PARP) inhibitor currently approved for BRCA-mutated ovarian cancer in multiple lines of treatment.
Lynparza’s pipeline has grown significantly in the last few years, with 14 indications currently being developed across several tumor types, including breast, prostate and pancreatic cancers. The strategic collaboration is expected to further increase the number of treatment options available to patients.
The companies will develop and commercialize Lynparza jointly, both as monotherapy and in combination trials with other potential medicines. Independently, the companies will develop and commercialize Lynparza in combinations with their respective PD-L1 and PD-1 medicines, Imfinzi and Keytruda.
The companies will also jointly develop and commercialize AstraZeneca’s selumetinib, an oral, potent, selective inhibitor of MEK, part of the mitogen-activated protein kinase (MAPK) pathway, currently being developed for multiple indications including thyroid cancer.
Merck is paying AstraZeneca $1.6 billion upfront, $750 million for certain license options and up to an additional $6.15 billion in milestones.
More Keytruda collaborations
In addition to the oncology alliance with Astrazeneca, Merck has a number of ongoing research collaborations related to its top selling cancer drug Keytruda. A clinical collaboration with Aduro Biotech is investigating the combination of CRS-207, Aduro’s LADD (live, attenuated double-deleted) based immunotherapy, with Keytruda for the treatment of gastric cancer.
Also, Eli Lilly and Co. expanded its immuno-oncology collaboration with Merck to add a new study of Lilly’s Lartruvo with Keytruda in patients with previously treated advanced or metastatic soft tissue sarcoma. Lilly will conduct the Phase I study, which began mid-2017.
Atara Biotherapeutics entered into a clinical trial collaboration agreement with Merck to evaluate Atara’s allogeneic Epstein-Barr virus (EBV)-specific cytotoxic T lymphocytes (CTL), or ATA129, in combination with Keytruda, in patients with platinum resistant or recurrent EBV-associated NPC. The Phase 1/2 trial will evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the combination.
PDS Biotechnology, a clinical stage biopharma company developing immunotherapies, teamed up with a subsidiary of Merck to evaluate the combination of PDS’ lead Versamune-based immunotherapy, PDS0101, with Keytruda in a Phase II trial. The trial will evaluate the safety and efficacy of the combination in patients with recurrent or metastatic head and neck cancer and high-risk human papillomavirus-16 (HPV16) infection after failure with platinum-based chemotherapy. Further details were not disclosed.
Sellas Life Sciences Group, a development-stage biopharma company focused on cancer immunotherapies, entered a clinical trial collaboration and supply agreement with Merck for the conduct of a combination clinical trial targeting multiple cancers. Sellas’ Wilms tumor-1 (WT1)-targeting peptide immunotherapeutic agent, galinpepimut-S, will be administered in combination with Keytruda in a Phase 1/2 trial enrolling patients in five cancer indications, including both hematologic malignancies and solid tumors.
Lastly, Aeglea BioTherapeutics, a biotechnology company developing enzyme-based therapeutics to treat rare genetic diseases and cancer, entered into a clinical collaboration agreement with Merck to evaluate the combination of Aeglea’s AEB1102 with Keytruda for the treatment of patients with small cell lung cancer.
While 2017 wasn’t a big year on the M&A front for Merck, it did bolster its cancer pipeline with the purchase of Rigontec, a biotechnology company developing cancer immunotherapies, for €115 million upfront and as much as €349 million in milestone payments. Rigontec’s lead candidate, RGT100, is currently in Phase I development for the treatment of various tumors.
Approvals and pipeline progress
As Merck continues to expand its focus in oncology by further advancing the development program for Keytruda specifically, it received positive news from various studies and regulatory authorities in 2017.
It announced the pivotal Phase III Keynote-189 trial investigating Keytruda in combination with pemetrexed (Alimta) and cisplatin or carboplatin, for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), met its dual primary endpoints of overall survival and progression-free survival.
Merck and The European Organization for Research and Treatment of Cancer (EORTC) revealed the Phase III EORTC1325/Keynote-054 trial investigating Keytruda as monotherapy for surgically resected high-risk melanoma met the primary endpoint of recurrence-free survival and, based on an interim analysis and following review by the Independent Data Monitoring Committee, resulted in significantly longer recurrence-free survival than placebo.
The U.S. FDA accepted for review the supplemental Biologics License Application (sBLA) for Keytruda for the treatment of adult and pediatric patients with refractory primary mediastinal B-cell lymphoma, or who have relapsed after two or more prior lines of therapy. The FDA granted Priority Review status with a PDUFA date of April 3, 2018, and previously granted Breakthrough Therapy Designation to Keytruda in January 2017 for this indication.
The FDA also granted Breakthrough Therapy Designation for Keytruda in combination with Eisai’s multiple receptor tyrosine kinase inhibitor Lenvima for the potential treatment of patients with advanced and/or metastatic renal cell carcinoma, which is being jointly developed as part of a collaboration between Merck and Esai. This marks the 12th Breakthrough Therapy Designation granted to Keytruda.
In terms of approvals, the FDA gave the ok to Lynparza for use in patients with germline BRCA-mutated, HER2-negative metastatic breast cancer who have been previously treated with chemotherapy either in the neoadjuvant, adjuvant or metastatic settings. Lynparza is the first PARP inhibitor approved for breast cancer. A supplemental New Drug Application (NDA) was submitted to Japan’s Pharmaceuticals and Medical Devices Agency for the same use.
The Japanese Ministry of Health, Labor and Welfare approved Lynparza for use as a maintenance therapy for patients with platinum-sensitive relapsed ovarian cancer, regardless of their BRCA mutation status, who responded to their last platinum-based chemotherapy. Lynparza is also the first PARP inhibitor approved in Japan.
Together with Pfizer, Merck announced during the year that the FDA approved Steglatro tablets, an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, the fixed-dose combination Steglujan and the fixed-dose combination Segluromet to help improve glycemic control in adults with type 2 diabetes. Additionally, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion for these medicines.
Additionally, the FDA and European Commission approved Prevymis, once-daily tablets for oral use and injection for intravenous infusion, indicated for prevention of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant.
Lastly, the FDA approved Isentress, the company’s integrase inhibitor, for use in combination with other antiretroviral agents for the treatment of HIV-1 in newborn patients from birth to four weeks of age weighing at least 2 kg.
