Merck Pipeline Q3 2021 Reflecting Pipeline to Jul 27, 2021
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Merck Pipeline Q3 2021 Reflecting Pipeline to Jul 27, 2021
Lead-in language
The chart below reflects the company’s research pipeline as of Jul 27, 2021.
Candidates shown in Phase 3 include specific products and the date such
candidate entered into Phase 3 development. Candidates shown in Phase 2
include the most advanced compound with a specific mechanism or, if listed
compounds have the same mechanism, they are each currently intended for
commercialization in a given therapeutic area. Small molecules and biologics are
given MK-number designations and vaccine candidates are given V-number
designations. Except as otherwise noted, candidates in Phase 1, additional
indications in the same therapeutic area (other than with respect to cancer and
certain other indications) and additional claims, line extensions or formulations
for in-line products are not shown.
21. Being developed in a collaboration.
2. Being developed in combination with Keytruda
Merck pipeline as of Jul 27, 2021
3. Being developed as monotherapy and/or in combination with
Keytruda
Moved forward since last pipeline update.
Phase 2 Phase 2 Phase 2 Phase 2 Phase 2 Phase 2 Phase 2 Phase 2 Phase 2
Cancer Cancer
Cancer Advanced HIV-1 Infection Chikungunya
Respiratory RCC Cancer Overgrowth Cancer
Hematological solid tumors Islatravir+MK- virus
syncytial virus favezelimab+ NSCLC syndrome Melanoma
malignancies KEYTRUDA® 8507 Vaccine
MK-1654 pembrolizumab MK-58902 MK-7075 MK-76842
MK-1026 MK-3475 MK-8591B V184
MK-4280A
Cancer Cancer
Breast Colorectal
Cancer
NSCLC Gastric
Breast
SCLC Advanced Solid Cancer
Cutaneous
Cancer Treatment Cancer HNSCC Tumors Biliary Tract Pneumococcal
Squamous
NSCLC Resistant NASH NSCLC Esophageal Endometrial Glioblastoma Vaccine
Cell Carcinoma
quavonlimab Depression MK-3655 SCLC Gastric NSCLC Pancreas Adult
HNSCC
MK-13082 MK-1942 MK-4830 Prostate Bladder LENVIMA® V116
Melanoma
Melanoma BTC MK-7902 1,2
Solid Tumors
ladiratuzumab Cervical
V937
vedotin TUKYSA®
MK-64401,3 MK-71191
Cancer
CRC
Cancer
HCC Cancer
Cancer Hematological Pulmonary Cancer
Melanoma Advanced solid Cytomegalovirus
Breast malignancies Arterial VHL aRCC Schizophrenia
Advanced Solid tumors vaccine
NSCLC NSCLC Hypertension (EU) MK-8189
Tumors LYNPARZA® V160
MK-2140 favezelimab MK-5475 MK-6482 3
quavonlimab+ MK-73391.3
MK-42802
pembrolizumab
MK-1308A
31. Being developed in a collaboration.
2. Being developed in combination with Keytruda
Merck pipeline as of Jul 27, 2021
3. Being developed as monotherapy and/or in combination with
Keytruda
Moved forward since last pipeline update.
Phase 3 Phase 3 Phase 3
Cancer
Bladder
Cancer HNSCC
RCC Cancer Melanoma
quavonlimab+ RCC Colorectal
pembrolizumab MK-64823 NSCLC
MK-1308A Gastric
LENVIMA®
MK-79021,2
Cancer
Biliary tract Cancer
HIV-1 prevention
Cervical (EU) Breast
islatravir
Cutaneous Squamous Cell Carcinoma (EU) TUKYSA®
MK-8591
Gastric (EU) MK-71191
Hepatocellular (EU)
Mesothelioma
Cancer
Ovarian
NSCLC HIV-1 infection
Prostate
Colorectal doravirine+
SCLC
SCLC islatravir
KEYTRUDA®
LYNPARZA® MK-8591A
MK-3475
MK-73391,3
Anti-Viral
COVID-19 Cancer
molnupiravir NSCLC
MK-44821 MK-7684A
41. Approvals obtained within the last 24 months.
2. Being developed in a collaboration
Merck pipeline as of Jul 27, 2021 Moved forward since last pipeline update.
New Molecular Entities New Molecular Entities New Molecular Entities New Molecular Entities
Under Review Approvals1 Approvals 1 Approvals 1
Heart failure Fungal infection HPV Vaccine
Cough
VERQUVO® NOXAFIL® Girls and women
gefapixant
MK-12422 MK-5592 SILGARD®9
MK-7264
(US, JPN, EU) (JPN, CHN) V503
(US, JPN, EU)
(JPN)
Pneumococcal
HIV-1 infection Pediatric neurofibromatosis type-1 Ebola vaccine
Vaccine
PIFELTRO™ KOSELUGO® ERVEBO®
Adult
MK-1439 MK-56182 V920
V-114
(JPN, CHN) (US, EU) (US, EU)
(EU)
HIV-1 infection Bacterial infection
Pneumococcal
VHL- aRCC DELSTRIGO™ RECARBRIO™
Vaccine
belzutifan doravirine + lamivudine+ tenofovir relebactam+
Adult
MK-6482 disoproxil fumarate imipenem/cilastatin
VAXNEUVANCE™
(US) MK-1439A MK-7655A
V-114
(CHN) (EU, JPN)
(US)
51. Being developed in a collaboration
2. In combination with KEYTRUDA
3. In July 2020, the FDA issued a CRL for Merck’s and Eisai’s
applications. Merck and Eisai intend to submit additional data when
Merck pipeline as of Jul 27, 2021
available to the FDA.
Moved forward since last pipeline update.
Certain Supplemental Certain Supplemental Certain Supplemental Certain Supplemental
Filings Filings Filings Filings
Under Review Under Review Under Review Under Review
Unresectable or Metastatic Advanced unresectable
cSSTI and Sepsis for pediatric use MSI-H or dMMR Colorectal Cancer Metastatic Esophageal Cancer Invasive Aspergillosis
CUBICIN® (KN177) (KN590) NOXAFIL®
MK-3009 KEYTRUDA® KEYTRUDA® MK-5592
(JPN) MK-3475 MK-3475 ( EU, JPN)
(JPN) (JPN)
Advanced endometrial cancer
MSI-H or dMMR Metastatic TNBC (KN775) 1st line metastatic
Endometrial Cancer (KN158) (KN355) LENVIMA® hepatocellular cancer (KN524)
KEYTRUDA® KEYTRUDA® MK-79021,2 LENVIMA ®
MK-3475 MK-3475 (EU, JPN) MK-79021,2,3
(US) (EU,JPN) (US)
Adjuvant Advanced unresectable renal cell
TMB-H carcinoma (KN581)
Renal Cell Cancer
(KN158) LENVIMA®
(KN564)
KEYTRUDA® MK-79021,2
KEYTRUDA®
MK-3475 (US, EU, JPN)
MK-3475
(JPN)
(EU)
61. Approvals obtained within the last 24 months.
2. EMA recommended results be included in the medicine’s product
Merck pipeline as of Jul 27, 2021
information but did not recommend an extension of indication
Moved forward since last pipeline update.
Certain Supplemental Certain Supplemental Certain Supplemental Certain Supplemental Certain Supplemental
Approvals1 Approvals1 Approvals1 Approvals1 Approvals1
1st line metastatic non- Recurrent LA or metastatic 1st line metastatic
Alternative dosing regimen 1st line esophageal
small cell lung cancer esophageal squamous non-small cell
(Q6W) cancer (KN590)
(KN042) cancer (KN180/KN181) lung cancer (KN407)
KEYTRUDA® KEYTRUDA®
KEYTRUDA® KEYTRUDA ® KEYTRUDA®
MK-3475 MK-3475
MK-34752 MK-3475 MK-3475
(US,CHN,JPN, EU) (US, EU)
(EU) (US, CHN, JPN) (CHN)
Refractory classical Recurrent LA or metastatic
Previously treated tumor
1st line head and neck Hodgkin lymphoma 1st line advanced renal cell cutaneous squamous
mutational burden-high
cancer (KN048) (rrcHL) carcinoma (KN426) cell carcinoma
(KN158)
KEYTRUDA® (KN204) KEYTRUDA® (KN629)
KEYTRUDA®
MK-3475 KEYTRUDA® MK-3475 KEYTRUDA®
MK-3475
(EU, JPN, CHN) MK-3475 (JPN) MK-3475
(US)
(US, EU) (US)
Non-muscle invasive Unresectable or Metastatic Metastatic HER2+
Metastatic TNBC High-risk early stage TNBC
bladder cancer (NMIBC) MSI-H or dMMR Colorectal Gastric Cancer
(KN355) (KN522)
(KN057) Cancer (KN177) (KN811)
KEYTRUDA® KEYTRUDA®
KEYTRUDA® KEYTRUDA® KEYTRUDA®
MK-3475 MK-3475
MK-3475 MK-3475 MK-3475
(US) (US)
(US) (US, EU, CHN) (US)
71. Approvals obtained within the last 24 months.
2. Being developed in a collaboration.
Merck pipeline as of Jul 27, 2021
3. In combination with KEYTRUDA
Moved forward since last pipeline update.
Certain Certain Certain Certain Certain Certain Certain
Supplemental Supplemental Supplemental Supplemental Supplemental Supplemental Supplemental
Approvals1 Approvals1 Approvals1 Approvals1 Approvals1 Approvals1 Approvals1
DPT, hepatitis B,
1st line Metastatic prostate Differentiated Thymic Carcinoma HPV Vaccine invasive disease due
HIV-1 + virologically
advanced ovarian cancer (PROfound) Thyroid (NCCH1508/REMO Girls & Women to Haemophilus
suppressed
cancer (SOLO-1) LYNPARZA® cancer RA) (9-45yrs.) influenzae type b
PIFELTRO™
LYNPARZA® MK-73392 LENVIMA® LENVIMA ® GARDASIL® VAXELIS™
MK-1439
MK-73392 (US, EU, MK-79022 MK-79021, 2 V501 V419
(US)
(CHN) JPN, CHN) (CHN) (JPN) (CHN) (US)
HIV-1 + virologically
suppressed
DELSTRIGO™ 1st line gBRCAm HABP/VABP HPV Vaccine
Endometrial Neuromuscular
doravirine + Pancreatic Cancer ZERBAXA® HPV related anal
cancer blockade reversal
lamivudine+ (POLO) ceftolozane+ disease in men
LENVIMA ® Pediatric
tenofovir LYNPARZA® tazobactam GARDASIL®
MK-79022,3 BRIDION®
disoproxil MK-73392 MK-7625A V501
(US) MK-8616
fumarate (US, EU, JPN) (EU, JPN) (JPN)
MK-1439A
(US)
1st
line maintenance Advanced
HABP/VABP HPV Vaccine
Invasive newly diagnosed endometrial cancer
RECARBRIO™ Diabetes Certain HPV related
Aspergillosis advanced ovarian (not-MSI-H/dMMR)
relebactam STEGLATRO® H&N cancers
NOXAFIL® cancer (KN775)
+imipenem/cilastatin MK-88352 GARDASIL®9
MK-5592 (PAOLA) LENVIMA®
MK-7655A (CHN) V503
(US) LYNPARZA® MK-79021,2
(US, EU) (US)
MK-73392 (US)
(US, EU, JPN)
8Forward-looking statement
This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements”
within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These
statements are based upon the current beliefs and expectations of the company’s management and are subject to
significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will
receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set
forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic
factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel
coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the
United States and internationally; global trends toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent in new product development, including obtaining
regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or
delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the
company’s patents and other protections for innovative products; and the exposure to litigation, including patent
litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new
information, future events or otherwise. Additional factors that could cause results to differ materially from those
described in the forward-looking statements can be found in the company’s 2020 Annual Report on Form 10-K and the
company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site
(www.sec.gov).
9No duty to update
The information contained in the presentation set forth below was current as of July 27,
2021. While this presentation remains on the company’s website the company assumes no
duty to update the information to reflect subsequent developments. Consequently, the
company will not update the information contained in the presentation and investors
should not rely upon the information as current or accurate after Jul 27, 2021.
The chart reflects the Merck research pipeline as of July 27, 2021.
Candidates shown in Phase 3 include specific products. Candidates shown in Phase 2
include the most advanced compound with a specific mechanism in a given therapeutic
area. Phase 1 candidates are not shown.
10You can also read
