Compounds to watch - PharmaLive

Frost & Sullivan’s Life Sciences consultants have named seven developmental compounds as the most promising therapeutics to watch in 2015.

Puma Biotechnology Inc.’s tyrosine kinase inhibitorneratinib, for extended adjuvant treatment of breast cancer: In its Phase III ExteNET clinical trial, neratinib demonstrated significantly higher disease-free survival rates compared to placebo after adjuvant treatment with Herceptin for early-stage HER2-positive breast cancer. This therapy is awaiting FDA filing in first-half 2015, and potential approval and launch in the second half.

Bristol-Myers Squibb Co.’s PD-1 immune checkpoint inhibitor Opdivo (nivolumab), for previously treated advanced melanoma patients: In its Phase III trial, CheckMate-066, the primary endpoint of overall survival was met. It emerged that the one-year survival rate was 73 percent for nivolumab against 42 percent for the chemotherapy dacarbazine (DTIC) in patients with treatment-naïve BRAF wild-type advanced melanoma. The PDUFA goal date was March 30, 2015, but FDA approved the new medicine in December 2014.

Novartis AG’s selective IL-17A inhibitor secukinumab, for the treatment of plaque psoriasis: In the Phase III trial FIXTURE, the drug was shown to be significantly more effective in clearing skin lesions than Pfizer Inc.’s Enbrel. In October 2014, FDA’s advisory committee recommended approval for secukinumab. Anticipate a successful product launch in the first quarter of 2015.

Novartis’ angiotensin receptor neprilysin inhibitor (ARNi)LCZ696, for the treatment of heart failure: LCZ696 has exhibited statistically superior data to enalapril. Expect this treatment to be introduced in the second half of 2015.

AbbVie Inc.’s ABT-450/ritonavir co-formulated withombitasvir (ABT-267), and dasabuvir (ABT-333) with or without ribavirin for the treatment of hepatitis C: This interferon-free, all-oral regimen is supported by six Phase III clinical trials. This triple combination therapy will likely be commercially launched in first-quarter 2015.

GlaxoSmithKline plc’s RTS,S is expected to be the first malaria vaccine to reach the market. GlaxoSmithKline submitted a regulatory application to the European Medicines Agency in July 2014; launch is anticipated in 2015.

Sanofi Pasteur SA’s Dengue Vaccine is also expected to have a first-mover advantage, with FDA approval in 2015.

Ebola virus vaccines consisting of cAd3-ZEBOV by GlaxoSmithKline, PSC-1001 by NewLink Genetics Corp., and potentially an unnamed vaccine developed by Johnson & Johnson are anticipated to be entering Phase III trials in 2015. medadnews