Merck Pipeline Q2 2019 Reflecting Pipeline to May 1st 2019 - Merck.com
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Merck Pipeline Q2 2019 Reflecting Pipeline to May 1st 2019
Lead-in Language
The chart below reflects the Company’s research pipeline as of May 1st 2019.
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.
2Merck Pipeline as of 1st May, 2019
Phase 2 Phase 2 Phase 3 Phase 3 Phase 3
Cancer
Cutaneous Squamous Cell
Carcinoma
Breast
Cervical (EU)
Cancer Colorectal
Advanced solid tumors Esophageal Cough Heart failure
Diabetes mellitus
Prostate Gastric (EU) gefapixant vericiguat
MK-85212
KEYTRUDA® Hepatocellular (EU) MK-7264 MK-12421
MK-3475 Nasopharyngeal
Ovarian
Small Cell Lung (EU)
Mesothelioma
KEYTRUDA®
MK-3475
Cancer
Cancer Endometrial
HABP/VABP3 Pneumoconjugate
Biliary Tract HIV-1 infection NSCLC
SIVEXTRO® vaccine
LENVIMA® MK-8591 Melanoma
MK-1986 V114
MK-79021 LENVIMA®
MK-79021,4
Cancer
Cancer Pediatric neurofibromatosis
Pancreatic
Melanoma type-1
Prostate
CAVATAK® Selumetinib
LYNPARZA®
V937 MK-56181, 5
MK-73391
Cancer
Respiratory syncytial virus
Colorectal Cancer
MK-1654
MK-76904
Cancer
Advanced Solid
Schizophrenia Moved forward since
Tumors
MK-8189
LYNPARZA® last pipeline update.
MK-73391
1. Being developed in a collaboration.
2. Development is currently on hold.
Cytomegalovirus
3. HABP - Hospital-acquired bacterial pneumonia/ VABP - ventilator-associated bacterial pneumonia
vaccine 4. Being developed in combination with Keytruda
V160 5. This is a registrational trialMerck Pipeline as of 1st May, 2019
New Molecular New Molecular New Molecular New Molecular New Molecular
Entities Entities Entities Entities Entities
Under Review Under Review Approvals1 Approvals1 Approvals1
Diabetes mellitus Diabetes mellitus
Bacterial infection Prevention of CMV
Ebola vaccine SUJANU® STEGLUJAN™
relebactam+ infection/disease
V9203 sitagliptin+ ertugliflozin +
imipenem/cilastatin PREVYMIS™
(US, EU) ipragliflozin sitagliptin
MK-7655A MK-8228
MK-0431J MK-8835A
(US, EU) (US, EU)
(Japan)2 (US, EU)2
Diabetes mellitus
Pediatric hexavalent
Diabetes mellitus SEGLUROMET™
combination vaccine
STEGLATRO™ ertugliflozin +
VAXELISTM
MK-8835 metformin
V419
(US, EU)2 MK-8835B
(US)2
(US, EU)2
HIV-1 infection HIV-1 infection
PIFELTRO™ DELSTRIGO™
MK-1439 MK-1439A
(US, EU) (US, EU)
Moved forward since
last pipeline update.
1. Approvals obtained within the last 24 months.
2. Being developed in a collaboration
3. Rolling submission
4Merck Pipeline as of 1st May, 2019
Certain Supplemental Certain Supplemental Certain Supplemental Certain Supplemental
Filings Filings Filings Filings
Under Review Under Review Under Review Under Review
1st line advanced ovarian 1st line head and neck
HABP/VABP 1st line metastatic non-small
cancer cancer (KN048)
ZERBAXA® cell lung cancer (KN042)
LYNPARZA® KEYTRUDA®
MK-7625A2 KEYTRUDA®
MK-73391 MK-3475
(US, EU) MK-3475
(EU) (US, EU)
(EU)
3rd line advanced small cell
1st line advanced renal cell
lung cancer (KN158)
carcinoma (KN426)
KEYTRUDA®
KEYTRUDA®
MK-3475
MK-3475
(US)
(EU)
Moved forward since last pipeline update.
1. Being developed in a collaboration.
2. HABP - Hospital-acquired bacterial pneumonia/ VABP - ventilator-associated bacterial pneumoniaMerck Pipeline as of 1st May, 2019
Moved forward since last
pipeline update.
1. Approvals obtained within
the last 24 months.
2. Being developed in a
collaboration.
Certain Certain Certain Certain Certain Certain
Supplemental Supplemental Supplemental Supplemental Supplemental Supplemental
Approvals1 Approvals1 Approvals1 Approvals1 Approvals1 Approvals1
Previously treated 2nd line metastatic
Relapsed or refractory 1st line cisplatin-
microsatellite bladder cancer 3rd line gastric cancer 2nd line hepatocellular
classical Hodgkin ineligible bladder
instability-high cancer (KN045) (KN059) cancer (KN224)
lymphoma (KN087) cancer (KN052)
(KN158) KEYTRUDA® KEYTRUDA® KEYTRUDA®
KEYTRUDA® KEYTRUDA®
KEYTRUDA® MK-3475 MK-3475 MK-3475
MK-3475 MK-3475
MK-3475 (US, EU) (US) (US)
(EU) (US, EU)
(US)
Combination with In Combination with Once-daily dosing
carboplatin and other antiretroviral option in combination
Adjuvant therapy in
pemetrexed in 1st Line agents, for the 2nd line head and neck 2nd line cervical cancer with other antiretroviral
advanced melanoma
non-squamous non- treatment of HIV-1 cancer (KN040) (KN158) agents
cancer (KN054)
small cell lung cancer infection in newborns KEYTRUDA® KEYTRUDA® for HIV-1 infection
KEYTRUDA®
(KN021G) weighing at least 2 kg MK-3475 MK-3475 ISENTRESS®
MK-3475
KEYTRUDA® ISENTRESS® (EU) (US) MK-0518
(US, EU)
MK-3475 MK-0518 (ISENTRESS HD®)
(US) (US, EU) (US, EU)
Combination with
New tablet Relapsed or refractory
Use in Women and carboplatin and
formulation and 2nd line metastatic Primary Mediastinal B- 1st line merkel cell
Men Ages 27 to 45 pemetrexed in 1st Line
broader approval for breast cancer Cell Lymphoma cancer (KN017)
years of age non-squamous non-small
ovarian cancer LYNPARZA® (KN170) KEYTRUDA®
GARDASIL®9 cell lung cancer (KN189)
LYNPARZA® MK-73392 KEYTRUDA® MK-3475
V503 KEYTRUDA®
MK-73392 (US, EU) MK-3475 (US)
(US) MK-3475
(US, EU) (US)
(US, EU)
1st line metastatic
1st line advanced 1st line metastatic
Alternative dosing non-small cell lung 1st line unresectable 1st line advanced
renal cell carcinoma squamous non-small cell
regimen (Q6W) cancer (KN042) hepatocellular cancer ovarian cancer
(KN426) lung cancer (KN407)
KEYTRUDA® KEYTRUDA® LENVIMA® LYNPARZA®
KEYTRUDA® KEYTRUDA®
MK-3475 MK-3475 MK-79022 MK-73392
MK-3475 MK-3475Forward-Looking Statement This presentation includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’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 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; Merck’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 Merck’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Merck 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 Merck’s 2018 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).
No Duty to Update The information contained in the presentation set forth below was current as of May 1st, 2019. 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 May 1st, 2019. The chart reflects the Merck research pipeline as of May 1st 2019. Candidates shown in Phase III include specific products. Candidates shown in Phase II include the most advanced compound with a specific mechanism in a given therapeutic area. Phase I candidates are not shown.
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