FDAnews Drug Daily Bulletin

Report: 2014 May Be Disappointing for R&D

Feb. 7, 2014

Analysts with Evaluate Pharma are predicting that 2014 may shape up to be a disappointment for research and development, with no billion-dollar drugs slated for marketing and only three drugs likely to reach blockbuster status by 2018. “With giant new products needed to restore faith in R&D productivity, how the lack of blockbuster drug launches will affect investor’s views of the biotech sector will be one of the interesting stories of this year,” the report says.

Those three potential blockbusters are GlaxoSmithKline’s Anoro Ellipta (umeclidinium and vilanterol inhalation powder) combination COPD therapy, which was FDA-approved in December, Takeda and Lundbeck’s Brintellix (vortioxetine) for major depressive disorder, approved in January and Celgene’s Otezla (apremilast) for psoriatic arthritis. Otezla’s chances of blossoming into a blockbuster, however, depend on whether it is approved as an overall psoriasis treatment, the report says.

Merck and Bristol-Myers Squibb are holding wild cards in the form of their MK-3475 and nivolumab PD-1 inhibitors for melanoma and squamous non-small-cell lung cancer, respectively. These drugs have huge commercial and clinical potential, the report says, and “will likely represent substantial launches in whatever year they debut.”

Cancer drugs and diabetes therapies represent the greatest launch potential in 2014, Evaluate analysts say. In the cancer space are Eli Lilly’s ramucirumab and Gilead’s idelalisib. Lilly’s dulaglutide and empagliflozin, as well as insulin glargine LY2963016 and MannKind’s Afrezza (insulin human [rDNA origin]), round out 2014’s diabetes potential.

Read the report at www.fdanews.com/ext/resources/files/02/02-07-14-RDReport.pdf. — Lena Freund

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