The Year In New Drugs.
http://cen.acs.org/articles/93/i5/Year-New-Drugs.html
For the pharmaceutical industry, 2014 was one for the record books: sky-high merger and acquisition activity, unprecedented levels of financing, and, last but not least, a peak in new drug approvals.
The Food & Drug Administration’s green light for 41 new molecular entities—the biggest crop in nearly two decades—signaled a return to innovation for an industry that just five years ago seemed stagnant.
As important as the quantity of new products was their quality. In years past, a surge in drug approvals often meant a glut of me-too products and molecules that, after many regulatory setbacks, finally squeaked their way onto the market.
The 2014 class, in contrast, featured numerous examples of scientific breakthrough. An improved regulatory environment allowed some of them to reach patients at breakneck speed, albeit often at hefty price tags. And although the quantity of new drugs might not keep up in 2015, the hope is that the quality will persist.
Among the 41 new molecular entities approved, 17 offer a novel way of treating a disease, in many cases through a new mechanism of action.
MORE BLOCKBUSTERS AHEAD
Regulatory filings to date suggest that this year could bring a similarly strong crop of drugs, again offering quantity and quality. Attention is shifting to the cardiovascular arena, where several drugs with the potential for multi-billion-dollar sales are expected to be approved this year. The most buzz is around a new class of powerful cholesterol-lowering treatments that block PCSK9, a protein that keeps the liver from removing “bad” LDL cholesterol.
Amgen was the first to file for approval of a PCSK9 inhibitor, with FDA setting Aug. 27 as a deadline for review.
Sanofi and its development partner, Regeneron Pharmaceuticals, submitted an application late last year and expect their drug to be on the market in the second half of 2015. Consultancy Datamonitor expects both drugs to rack up $5 billion in annual sales by 2023.
Another highly anticipated cardiovascular therapy is Novartis’s heart failure treatment LCZ696, which combines the active ingredient in the firm’s heart drug Diovan with the novel neprilysin inhibitor sacubitril. The combo made headlines last fall when a Phase III study showed it reduced by 20% the number of cardiovascular deaths compared with the ACE inhibitor Vasotec. Novartis anticipates FDA approval in the second half of the year; Datamonitor forecasts the drug to reach $6 billion in annual sales by 2023.
Beyond cardiovascular treatments, industry watchers anticipate several other innovative drugs this year. Novartis has already gained approval for Cosentyx, a psoriasis treatment that stock analysts expect to reach blockbuster status by 2019. Cosentyx is the first antibody approved to block IL-17A, a cytokine implicated in inflammation. Lilly and Amgen are both working on their own IL-17A inhibitors.
Pfizer expects to win approval for palbociclib, a CDK 4/6 inhibitor for the treatment of breast cancer, in April. Leerink stock analyst Seamus Fernandez predicts that the drug will bring in $4 billion in annual sales by 2020.
And analysts expect
Vertex Pharmaceuticals to win FDA’s nod in the first half of the year for a pill that pairs its cystic fibrosis treatment Kalydeco with the novel molecule lumacaftor to aid roughly 30% of cystic fibrosis patients. On its own, Kalydeco, which Vertex pegged at about $460 million in sales last year, can treat just 5% of patients.
As the next wave of potential blockbusters approaches, battle lines are already being drawn over their cost. Last year’s drugs included many with eye-popping price tags, and a particular furor has risen over the cost of new treatments for hepatitis C. This year more than ever, as companies hail the approval of each new drug—no matter how innovative—they will also need to prove it is worth paying for.