THE 2012 PHARMACEUTICAL PIPELINE
Table 2 Key Drugs in the 2012 Pipeline, by Clinical Category, through June 8, 2012 Drug
Drug type, potential indication, route
Expected timeline/comment
Pomalidomide
Next-generation IMiD for relapsed/refractory multiple myeloma, oral
NDA: 6/8/2012 PDUFA: 2/10/2013
Marqibo
Philadelphia negative ALL, IV
Updated PDUFA: 8/12/2012
CANCER
Taltorvic (ridaforolimus) Sarcomas, IV
CRL: 6/5/2012
Carfilzomib
Proteasome inhibitor for refractory multiple myeloma, IV
PDUFA: 7/27/2012
Zaltrap (aflibercept)
Colorectal cancer, IV
PDUFA: 8/4/2012
Ponatinib
First-in-class BCR-ABL inhibitor for CML and ALL, oral
NDA: 3Q 2012
Bosutinib
Leukemia, oral
NDA: 1/27/2012
Enzalutamide (MDV3100)
Androgen receptor antagonist for chemotherapyrefractory prostate cancer, oral
NDA: 5/21/2012; fast track and approval by end of year
CARDIOVASCULAR DISEASES
Eliquis (apixaban)
Factor Xa inhibitor for prevention of VTE and stroke in patients with AF, oral
CRL: 6/25/2012
AMR101
Therapy for very high (>500 mg/dL) triglycerides, oral
PDUFA: 7/26/2012
Lomitapide
Inhibitor of MTP-I for homozygous familial hypercholesterolemia, oral
NDA: 4/30/2012 PDUFA: 12/29/2012
Kynamro (mipomersen)
Apo-B synthesis inhibitor for homozygous familial hypercholesterolemia, SC
NDA: 3/29/2012 PDUFA: 1/29/2013
Edoxaban
Factor Xa inhibitor for AF and VTE, oral
US filing strategy unknown
SAR236553
PCSK9 inhibitor for hypercholesterolemia, SC
Phase 3 trial starting 2Q 2012
CENTRAL NERVOUS SYSTEM DISORDERS
Levadex (dihydroergotamine)
Dihydroergotamine via oral inhaler for migraine
CRL: 3/26/2012
Adasuve (loxapine)
Loxapine in a single-dose inhaler for agitation in patients with schizophrenia or bipolar mania
CRL: 5/3/2012
Suvorexant
Orexin receptor antagonist for primary insomnia, oral
NDA in 2012
Cariprazine
Atypical antipsychotic for schizophrenia and bipolar mania, oral
NDA in 2012
Levomilnacipran
SNRI for depression, oral
NDA: 3Q 2012 Continued
June 2012
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