Market Insight: Drugs to Watch in 2014
Last year, Thomson Reuters Cortellis Competitive Intelligence highlighted five drugs to watch that were predicted to achieve significant regulatory milestones that year and make sales of over $1 billion within five years. This report takes a look at where those drugs are now, and discusses the drugs to watch in 2014.
Where the 2013 Drugs-to-Watch are now
January 2013 saw the US launch of Amarin’s Vascepa (icosapent ethyl ester) for severe hypertriglyceridemia. This was followed in February 2013 by the US approval of Celgene’s relapsed/refractory multiple myeloma drug Pomalyst (pomalidomide); US launch, plus European approval and launch, followed later that year. February 2013 also saw the US approval and launch of Roche’s Kadcyla (trastuzumab emtansine, previously referred to as T-DM1) for the second-line treatment of HER2-positive metastatic breast cancer; Japanese and European approvals were also obtained that year. In March 2013, Celgene’s apremilast was filed for US approval for psoriatic arthritis, and a PDUFA date of March 21, 2014, was set. In May 2013, GlaxoSmithKline (GSK) and Theravance’s Relovair (fluticasone furoate plus vilanterol trifenatate) gained US approval for COPD; US launch, European approval for asthma as well as COPD, and Japanese approval and launch for asthma (although a COPD filing was withdrawn) followed a few months later.
At this time last year, Consensus sales forecasts for Vascepa were $2.070 billion in 2016, rising to $2.963 billion in 2017. However, in October 2013, an FDA panel recommended against approval of the February 2013 sNDA to broaden the indication to include mixed dyslipidemia. By the end of 2013, the FDA had rescinded the SPA for the ANCHOR mixed dyslipidemia trial, which Amarin appealed. A new PDUFA date has not been set. Consensus sales forecasts for the drug now only reach $574.6 million by 2019. In contrast, 2019 sales for Pomalyst, Kadcyla, apremilast and Relovair are forecast to be $1.802 billion, $4.102 billion, $1.212 billion and $2.747 billion, respectively.
What to Watch in 2014
In last year’s report, Thomson Reuters predicted that 2013 would be an interesting and challenging year for the pharmaceutical industry, and questioned whether the five drugs discussed above would demonstrate the enduring power of the blockbuster model of R&D, or whether they would be some of the few remaining such agents in a dwindling supply. The Consensus sales forecasts for the drugs expected to enter the market in 2014 tend to suggest that the latter scenario is playing out, with the vast majority of these drugs predicted to make sales of less than $1 billion by 2019. However, Gilead Sciences’ Sovaldi (sofosbuvir), GS K/Theravance’s Anoro Ellipta (umeclidinium plus vilanterol) and Gilead’s idelalisib are bucking this trend, with 2019 Consensus sales forecasts of $7.518 billion, $3.081 billion and $1.100 billion, respectively.
Continue reading this report to take a look at these drugs more closely.