Considering past blockbusters-in-waiting that reached the market in recent years, 2014’s R&D prospect is disappointing with only three drugs to be launched this year slated to achieve blockbuster status by 2018. This is described in the newly released report, Biggest Launches 2014, from Evaluate Pharma (EP).
EP warned investors looking for huge returns from the biotech sector’s R&D productivity that 2014 may be a more modest tale than past years. At least six blockbusters-in-waiting have entered the market every year for the last four years. While not each one reached the billion dollar threshold, this year’s projection is a “stark counterpoint” to the stock market’s current exuberance.
Only three potential blockbusters are expected to reach the market this year: GlaxoSmithKline’s Anoro Ellipta (umeclidinium and vilanterol inhalation powder) combination COPD therapy, Takeda and Lundbeck’s Brintellix (vortioxetine) for major depressive disorder (MDD), and Celgene’s Otezla (apremilast) for psoriatic arthritis.
Anoro ellipta is a combination long-acting beta 2 adrenoreceptor agonist (LABA) and long-acting muscarinic antagonist (LAMA). GSK won US approval for the drug last December and plans to launch it in the first quarter of this year. Brintellix is a new inhibitor of serotonin uptake intended for the treatment of MDD. Collaborators Takeda and Lundbeck won US and European approval for Brintellix and launched the drug in January. Apremilast follows Pfizer’s Xeljanx as a novel anti-rheumatic treatment but will focus primarily on the psoriatic arthritis arena. Celgene released high sales guidance ($1.5 - $2 billion) for the drug by 2017, but forecasters say its performance will depend on regulatory approval.
Novartis’ RLX030 (serelaxin) also came close to hitting a blockbuster forecast with expected sales of $903 million by 2018. The drug received a negative opinion from European regulators in January, but was awarded a breakthrough therapy designation by the FDA.
The report says Merck and Bristol-Myers Squibb may hold wild cards in the form of MK-3475 for melanoma and nivolumab PD-1 inhibitors for non-small-cell lung cancer. The two treatments represent huge commercial and clinical potential and are expected to command substantial launches regardless of the year of their debut.
Billion dollar drugs signal the status of the biotech sector’s productivity and their palpable absence in this year’s launch class is an indicator that should be observed closely, the report said.