MSD Pipeline Q3 2019 Reflecting Pipeline to JULY 31st 2019 - MSD.com
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MSD Pipeline Q3 2019 Reflecting Pipeline to JULY 31st 2019
Lead-in Language
The chart below reflects the Company’s research pipeline as of JULY 31st 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.
2
MSD Pipeline as of 31st JULY, 2019
Phase 2 Phase 2 Phase 3 Phase 3
Cancer
Prostate
Cancer Cancer Cutaneous Squamous Cell
RCC Solid Tumors Carcinoma
MK–6482 MK-71232 Breast
Cervical (EU)
Colorectal Cough
Gastric (EU) gefapixant
Hepatocellular (EU) MK-7264
Cancer Nasopharyngeal
Advanced solid tumors HIV-1 infection Ovarian
KEYTRUDA® Islatravir Small Cell Lung (EU)
MK-3475 MK-8591 Mesothelioma
KEYTRUDA®
MK-3475
Cancer
Endometrial
Cancer Pediatric neurofibromatosis Heart failure
NSCLC
Biliary Tract type-1 vericiguat
Melanoma
LENVIMA® Selumetinib MK-12421
Bladder
MK-79021 MK-56181, 3
LENVIMA®
MK-79021,2
Cancer
Cancer Pancreatic Pneumoconjugate
Melanoma Respiratory syncytial virus Prostate vaccine
CAVATAK® MK-1654 NSCLC V114
V937 LYNPARZA®
MK-73391
Cancer Schizophrenia
Colorectal Cancer MK-8189
MK-76902 Moved forward since
last pipeline update.
Cancer
Cytomegalovirus
Advanced Solid
vaccine 1. Being developed in a collaboration.
Tumors
V160 2. Being developed in combination with Keytruda
LYNPARZA®
3. This is a registrational trial
MK-73391MSD Pipeline as of 31st JULY, 2019
New Molecular New Molecular New Molecular New Molecular New Molecular
Entities Entities Entities Entities Entities
Under Review Under Review Approvals1 Approvals1 Approvals1
Bacterial infection Diabetes mellitus Diabetes mellitus
Prevention of CMV
Ebola vaccine RECARBRIO™ SUJANU® STEGLUJAN™
infection/disease
V9203 relebactam+ sitagliptin+ ertugliflozin +
PREVYMIS™
(US, EU) imipenem/cilastatin ipragliflozin sitagliptin
MK-8228
MK-7655A MK-0431J MK-8835A
(US, EU)
(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
Bacterial infection HIV-1 infection
RECARBRIO™ DELSTRIGO™
HIV-1 infection
relebactam+ doravirine +
PIFELTRO™
imipenem/cilastatin lamivudine+ tenofovir
MK-1439
MK-7655A disoproxil fumarate
(US, EU)
(US) MK-1439A
Moved forward since
(US, EU)
last pipeline update.
1. Approvals obtained within the last 24 months.
2. Being developed in a collaboration
3. Rolling submission
4MSD Pipeline as of 31st JULY, 2019
Certain Supplemental Certain Supplemental Certain Supplemental Certain Supplemental
Filings Filings Filings Filings
Under Review Under Review Under Review Under Review
1st line metastatic non-small 1st line advanced renal cell Recurrent LA or metastatic
HAP/VAP
cell lung cancer (KN042) carcinoma (KN426) esophageal cancer
ZERBAXA®
KEYTRUDA® KEYTRUDA® (KN180/KN181)
MK-7625A2
MK-3475 MK-3475 KEYTRUDA®
(EU)
(EU) (EU) MK-3475
(EU)
1st line head and neck Alternative dosing regimen
cancer (KN048) (Q6W)
KEYTRUDA® KEYTRUDA®
MK-3475 MK-3475
(EU) (US)
Moved forward since last pipeline update.
1. Being developed in a collaboration.
2. HABP - Hospital-acquired pneumonia/ VABP - ventilator-associated pneumoniaMSD Pipeline as of 31st JULY, 2019
Moved forward since last pipeline update.
1. Approvals obtained within the last 24 months.
2. Being developed in a collaboration.
Certain Supplemental Certain Supplemental Certain Supplemental Certain Supplemental Certain Supplemental
Approvals1 Approvals1 Approvals1 Approvals1 Approvals1
2nd line metastatic bladder 2nd line cervical cancer 1st line cisplatin-ineligible Alternative dosing regimen 1st line head and neck
cancer (KN045) (KN158) bladder cancer (KN052) (Q6W) cancer (KN048)
KEYTRUDA® KEYTRUDA® KEYTRUDA® KEYTRUDA® KEYTRUDA®
MK-3475 MK-3475 MK-3475 MK-3475 MK-3475
(US, EU) (US) (US, EU) (EU) (US)
1st line metastatic non- Relapsed or refractory
3rd line gastric cancer 1st line merkel cell cancer 3rd line advanced small cell
small cell lung cancer classical Hodgkin lymphoma
(KN059) (KN017) lung cancer (KN158)
(KN042) (KN087)
KEYTRUDA® KEYTRUDA® KEYTRUDA®
KEYTRUDA® KEYTRUDA®
MK-3475 MK-3475 MK-3475
MK-3475 MK-3475
(US) (US) (US)
(US) (EU)
Combination with
Adjuvant therapy in 1st line metastatic carboplatin and pemetrexed Relapsed or refractory Recurrent LA or metastatic
advanced melanoma squamous non-small cell in 1st Line non-squamous Primary Mediastinal B-Cell esophageal cancer
cancer (KN054) lung cancer (KN407) non-small cell lung cancer Lymphoma (KN170) (KN180/KN181)
KEYTRUDA® KEYTRUDA® (KN189) KEYTRUDA® KEYTRUDA®
MK-3475 MK-3475 KEYTRUDA® MK-3475 MK-3475
(US, EU) (US, EU) MK-3475 (US) (US)
(US, EU)
Combination with
carboplatin and
2nd line hepatocellular 2nd line head and neck 1st line advanced renal cell
pemetrexed in 1st Line
cancer (KN224) cancer (KN040) carcinoma (KN426)
non-squamous non-small
KEYTRUDA® KEYTRUDA® KEYTRUDA®
cell lung cancer (KN021G)
MK-3475 MK-3475 MK-3475
KEYTRUDA®
(US) (EU) (US)
MK-3475
(US)MSD Pipeline as of 31st JULY, 2019
Moved forward since last pipeline
update.
1. Approvals obtained within the last 24 months.
2. Being developed in a collaboration.
Certain Supplemental Certain Supplemental Certain Supplemental Certain Supplemental Certain Supplemental
Approvals1 Approvals1 Approvals1 Approvals1 Approvals1
Use in Women and Men
2nd line metastatic breast
Ages 27 to 45 years of
cancer
age
LYNPARZA®
GARDASIL®9
MK-73392
V503
(US, EU)
(US)
In Combination with other
antiretroviral agents, for
1st line advanced ovarian
the treatment of HIV-1
cancer
infection in newborns
LYNPARZA®
weighing at least 2 kg
MK-73392
ISENTRESS®
(EU, US)
MK-0518
(US, EU)
1st line unresectable
HAP/VAP
hepatocellular cancer
ZERBAXA®
LENVIMA®
MK-7625A2
MK-79022
(US)
(US, EU)
New tablet formulation
and broader approval for
ovarian cancer
LYNPARZA®
MK-73392
(US, EU)Forward-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 MSD’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; MSD’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 MSD’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. MSD 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 MSD’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 July 31st, 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 July 31st, 2019. The chart reflects the MSD research pipeline as July 31st, 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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