Merck Annual Report 2013 - Overview compounds (optimized for printing)

XLS

Merck Serono pipeline, as of December 31, 2013

Therapeutic area

Compound

Indication

Status

1	Combined with PI3K/mTOR inhibitor (SAR245409) from Sanofi, conducted under the responsibility of Merck
2	Combined with hDM2 inhibitor (SAR405838) from Sanofi, conducted under the responsibility of Sanofi
3	Sponsored by the National Cancer Institute (USA)
4	START2 study in preparation, INSPIRE study ongoing
5	ADDRESS II study in preparation
6	FORWARD study
7	Post-approval request by the European Medicines Agency

More information on the ongoing clinical trials can be found at www.clinicaltrials.gov

S1P: Sphingosine-1-phosphate
MEK: Mitogen-activated protein kinase
PI3K: Phosphoinositide 3-kinase
hDM2: Human double minute 2 oncogene
C-Met: Mesenchymal-epithelial transition proto-oncogene
EGFR: Epidermal growth factor receptor
Akt: Protein kinase B
PD-L1: Programmed cell death ligand
PKU: Phenylketonuria
MUC1: Mucin 1
Blys: B-lymphocyte stimulator
APRIL: A B cell proliferation-inducing ligand
FGF: Fibroblast growth factor

Neurodegenerative diseases

ONO-4641 (ceralifimod, oral S1P receptor modulator)

Multiple sclerosis

Phase II

Plovamer acetate (PI-2301, second-generation peptide copolymer)

Multiple sclerosis

Phase II

ATX-MS-1467 (immune-tolerizing agent)

Multiple sclerosis

Phase I

Oncology

Erbitux® (cetuximab, anti-EGFR mAb)

Head and neck cancer

Filed in China

TH-302 (hypoxia-targeted drug)

Soft tissue sarcoma

Phase III

TH-302 (hypoxia-targeted drug)

Pancreatic cancer

Phase III

TH-302 (hypoxia-targeted drug)

Hematological malignancies and solid tumors

Phase I

DI17E6 (Anti-integrin mAb)

Colorectal cancer

Phase II

DI17E6 (Anti-integrin mAb)

Castration-resistant prostate cancer

Phase II

Pimasertib (MEK inhibitor)/gemcitabine combination

Pancreatic cancer

Phase II

Pimasertib (MEK inhibitor)

Malignant melanoma

Phase II

Pimasertib/PI3K inhibitor novel combination

Low grade ovarian cancer

Phase II¹

Pimasertib/PI3K inhibitor novel combination

Solid tumors

Phase I¹

Pimasertib/hDM2 inhibitor combination

Solid tumors

Phase I²

C-Met kinase inhibitor

Solid tumors

Phase I

Sym004 (anti-EGRF mAb mixture)

Head and neck cancer

Phase II

Sym004 (anti-EGRF mAb mixture)

Solid tumors

Phase I

P7056K and Akt inhibitor

Solid tumors

Phase I

Immuno-Oncology

NHS-IL2 (cancer immunotherapy)

Solid tumors

Phase I

NHS-IL12 (cancer immunotherapy)

Solid tumors

Phase I³

Anti-PD-L1 mAb

Solid tumors

Phase I

Tecemotide (L-BLP25, MUC1-antigen-specific cancer immunotherapy)

Non-small cell lung cancer

Phase III⁴

Immunology

Atacicept (anti-Blys/anti-APRIL fusion protein)

Systemic lupus erythematosus

Phase II⁵

Sprifermin (FGF-18)

Osteoarthritis

Phase II⁶

Endocrinology

Kuvan® (sapropterin dihydrochloride)

PKU in pediatric patients < 4 years

Phase III⁷