BioPharma Dive | By Sy Mukherjee
This
past year was a milestone one in the United States for new
drugs, with novel therapeutics such as Gilead's pricey hep C cures Sovaldi
and Harvoni coming to market (as well as a record 15 approvals for drugs to
treat rare diseases), and huge sales of newer drugs like Roche's breast cancer
med Kadcyla and Biogen Idec's MS blockbuster Tecfidera.
But
according to a new report by EvaluatePharma (gated),
2015 could be equally impressive in terms of drug launches as innovative
candidates in massive medical markets and exciting new drug classes in
cancer immuno-therapy work their way towards approval.
"The
value of 2015 launches will be helped along by penetration into massive yet
already well-trodden sectors like cardiovascular and respiratory disease, along
with diabetes and schizophrenia," wrote the authors. "Drugs treating
high cholesterol and heart failure are set to dominate the year's new products,
with combine 2020 sales forecast at $8bn."
"The
most keenly awaited launches of the year should come from the competing
cholesterol-lowering drugs alirocumab from Sanofi and evolocumab from
Amgen."
EvaluatePharma aggregated
equity analysts' expectations for 2015's biggest potential drug launches,
including their predictions for 2015 and 2020 sales. Here are the 11 expected
launches that the industry should be watching next year:
1. Opdivo/nivolumab (Bristol-Myers Squibb)
Company:
Bristol-Myers Squibb
Pharmaceutical class/therapeutic area: Cancer/anti-PD-1 monoclonal antibody
Current regulatory status: Filed for approval in U.S., EU
Anticipated 2015 sales: $658 million
Anticipated 2020 sales: $7.122 billion
What to watch: Opdivo is projected to be the biggest new drug launch in the U.S. and
one of the biggest launches worldwide this decade. It became the first approved
anti-PD-1 medication when it was cleared in Japan and has shown promise in treating
Hodgkin's lymphoma on
top of multiple myeloma (and is being tested on many other cancers). But the
really good news for BMS is that Opdivo has produced a better response
rate in trials than Merck's competing (and historic) PD-1 inhibitor
Keytruda (pembrolizumab). If that trend continues, then BMS could rule
this exciting new therapeutic class. The FDA is expected to decide on Opdivo
approval by March.
2. Alirocumab (Sanofi/Regeneron)
Company: Sanofi/Regeneron
Pharmaceutical class/therapeutic area: LDL cholesterol reducer/anti-PCSK9
monoclonal antibody
Current regulatory status: Phase III trials
Anticipated 2015 sales: $44 million
Anticipated 2020 sales: $2.179 billion
What to watch: PCSK9 inhibitors, besides anti-PD-1 drugs, are the most exciting new
therapeutic class to come out of the woodwork in recent times. What makes these
LDL-lowering drugs particularly exciting is the timing of their filings, with
doctors' groups in the U.S. and EU having recently endorsed controversial new
guidelines that significantly expand the use of statins. If that course of
action proves too risky, and PCSK9 drugs like alirocumab aren't
prohibitively pricey, these could become the go-to option in an absolutely
critical field.
3. Evolocumab (Amgen/Astellas)
Company: Amgen/Astellas
Pharmaceutical class/therapeutic area: LDL cholesterol
reducer/anti-PCSK9 monoclonal antibody
Current regulatory status: Filed for approval
Anticipated 2015 sales: $77 million
Anticipated 2020 sales: $1.947 billion
4. Toujeo (Sanofi)
Company: Sanofi
Pharmaceutical class/therapeutic area: Diabetes (long-acting insulin)
Current regulatory status: Filed for approval
Anticipated 2015 sales: $139 million
Anticipated 2020 sales: $1.692 billion
What to watch: You can bet that Sanofi execs will be looking closely at how well
Toujeo, the company's successor to the flagship (but now fading) long-acting
insulin Lantus, performs in the market as the company struggles with a flagging
diabetes franchise. What's really giving Sanofi heartburn is the prospect of
competition from Eli
Lilly's Lantus biosimilar, which is being marketed as Abasria in the EU. The goal? $1.7 billion
in sales in 2020.
5. Mepolizumab (GlaxoSmithKline)
Company: GlaxoSmithKline
Pharmaceutical class/therapeutic area: Severe asthma/anti-IL-5 monoclonal
antibody
Current regulatory status: Filed for approval
Anticipated 2015 sales: $28 million
Anticipated 2020 sales: $1.161 billion
6. Cosentyx (Novartis)
Company: Novartis
Pharmaceutical class/therapeutic area: Psoriasis/anti-IL-17A monoclonal
antibody
Current regulatory status: Filed for approval
Anticipated 2015 sales: $133 million
Anticipated 2020 sales: $1.099 billion
7. VX-809 + Kalydeco/ivacaftor (Vertex Pharmaceuticals)
Company: Vertex Pharmaceuticals
Pharmaceutical class/therapeutic area: Cystic fibrosis/CFTR corrector
Current regulatory status: Filed for approval
Anticipated 2015 sales: $575 million
Anticipated 2020 sales: $4.744 billion
8. LCZ696 (Novartis)
Company: Novartis
Pharmaceutical class/therapeutic area: Heart failure/AT1 & ARNI
Current regulatory status: Phase III trials
Anticipated 2015 sales: $251 million
Anticipated 2020 sales: $3.875 billion
What to watch: This one will be huge. If approved (once Novartis moves ahead and files
the drug), LCZ696 will be the first new drug launch with a
hospitalization/death prevention in heart failure patients indication in years.
It has been granted the EU's version of priority review status.
9. Palbociclib (Pfizer)
Company: Pfizer
Pharmaceutical class/therapeutic area: Breast cancer/CDK 4 & 6 inhibitor
Current regulatory status: Filed for approval
Anticipated 2015 sales: $281 million
Anticipated 2020 sales: $3.078 billion
10. Selexipag (Actelion)
Company: Actelion
Pharmaceutical class/therapeutic area: Pulmonary arterial hypertension
(PAH)/prostacyclin agonist
Current regulatory status: Phase III trials
Anticipated 2015 sales: $18 million
Anticipated 2020 sales: $1.245 billion
What to watch: Selexipag has the advantage over Glaxo's mepolizumab in terms
of respiratory launches, according to the EvaluatePharma researchers. As the
report authors note, payers will likely be reticent to prescribe a lung
biologic to a large host of patients.
11. Brexpiprazole (Otsuka Holdings)
Company: Otsuka Holdings
Pharmaceutical class/therapeutic area: Schizophrenia/5-HT1A & D2 &
5-HT2
Current regulatory status: Filed for approval
Anticipated 2015 sales: $95 million
Anticipated 2020 sales: $1.141 billion
What to watch: This could be a game-changer in a field that hasn't seen too many of
them in recent years. The FDA is currently reviewing an NDA for the drug as a first-line
schizophrenia treatment and a secondary therapy for major depression. It would
also be a natural successor to Otsuka's antipsychotic Abilify, whose sales slid
to $1.03 million in Q1 2014.
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