See the pharmaceutical products - both marketed and in the pipeline - that will
dictate industry news flow over the next months.
Harvoni | Viekira Pak – hepatitis C (Gilead Sciences/AbbVie)
AbbVie upturned the apple cart in December when it agreed a significant
discount with Express Scripts to secure formulary access for its newly approved
Viekira Pak. The narrative here is no longer about hepatitis C – access to both
drugs is improved and both products will generate billions of dollars in 2015 –
but is one of treatment costs and the broader implications of a Harvoni/Viekira
'price war'.
Alirocumab | evolocumab – dyslipidaemia (Sanofi & Regeneron/Amgen)
Both products – expected to be the first approved from the PCSK9 inhibitor
class – should reach the market during the second half of 2015. The
statin-intolerant population is large enough to support multi-billion dollar
revenue forecasts for both products, argue analysts, although outcomes study
data – expected in 2017 – are likely to prove critical in shaping uptake. One
fly in the ointment; pharmacy benefit managers (PBMs) are already targeting the
PCSK9s for aggressive price negotiation following their successes in hepatitis
C.
Opdivo | Keytruda – melanoma/non-small-cell lung cancer (Bristol-Myers
Squibb/Merck & Co.)
2015 will witness the first transition of clinical promise into the commercial
arena for the PD-1 inhibitors, with both Opdivo and Keytruda approved last year
for melanoma. Simultaneously, the race to market in non-small-cell lung cancer
will reach a climax; Bristol-Myers Squibb appears to have the most advanced
data in this indication, but can Merck & Co. pull another surprise out of
the hat?
Palbociclib – breast cancer (Pfizer)
2014 was a challenging year for Pfizer- the world's largest drug company
does not often fail to get what it wants (in this case the acquisition of AstraZeneca).
A bright spot was palbociclib, which now looks set to gain approval in the
second quarter on the strength of Phase II data; it could be Pfizer's biggest
drug launch for some time.
CTL019 – acute lymphocytic leukaemia (Novartis)
Chimeric antigen receptor therapies (CAR-T) are likely to remain the most
closely-watched emerging technology in 2015, with Novartis the most advanced
player. Following the publication of compelling data for CTL019 (being
co-developed with the University of Pennsylvania) in acute lymphocytic
leukaemia at the annual meeting of the American Society of Hematology (ASH) in
December, Novartis aims to initiate pivotal-stage studies this year with a view
to regulatory filings in 2016.
Zarxio – various cancer indications (Novartis)
Novartis' Zarxio has already generated headlines in 2015, having been
unanimously recommended for approval by an FDA AdCom. As potentially the first
biosimilar to secure approval in the US (it is a biosimilar of Amgen's
Neupogen), this is a big deal, particularly as the FDA has backed extrapolated
approval for each of Neupogen's five indications. Will it launch this year? –
it remains to be seen; the ongoing 'patent dance' between Amgen and Novartis
will also inform how the US biosimilar landscape is developing.
Remicade | Remsima – various inflammatory conditions (Merck &
Co./Celltrion & Hospira)
In Europe, the biosimilar agenda is more advanced and 2015 should witness
the launch of Celltrion and Hospira's Remsima – a biosimilar version of the
anti-TNF monoclonal antibody Remicade – in the region's five largest markets
(France, Germany, Italy, Spain and the UK). In the US, the most bullish
biosimilar fans may hope to see FDA approval for Remsima by year-end.
Toujeo – diabetes (Sanofi)
Successful approval (likely from next month) and launch of the long-acting
basal insulin Toujeo would help Sanofi to erase memories of a difficult 2014
(as would a new CEO), but the difficulties faced last year may undermine this
potential blockbuster launch. Sanofi continues to talk up the opportunity for
premium pricing, but the legacy left by a wounded Lantus franchise may signal
that such aspirations are no longer achievable in the US diabetes market, where
pricing pressures continue to increase.
Breo Ellipta – chronic obstructive pulmonary disorder/asthma
(GlaxoSmithKline)
Similarly, the performance of GlaxoSmithKline's Breo Ellipta will be
closely scrutinised following a much weaker-than-expected launch last year;
defined in part by lack of differentiation versus Advair and weakened formulary
positioning for GlaxoSmithKline's flagship brand (versus improved coverage for
AstraZeneca's Symbicort). Expectations for Breo have fallen substantially,
although some analysts believe that approval for asthma could provide a
catalyst for growth.
Anti-LINGO – multiple sclerosis (Biogen Idec)
With mixed results recently released for the compound in acute optic
neuritis (AON), the jury is still out on whether anti-LINGO will prove
effective in multiple sclerosis, where data will be released in the second half
of the year. Speculation is certain to continue, however, given the potentially
transformational impact that anti-LINGO could have on MS; a disease area
already dominated by Biogen Idec.
GED-0301 - Crohn's disease (Celgene)
Celgene appeared to put its status as one of the most accomplished
in-licensor's on the line last year when it spent $710 million upfront to
secure the global marketing rights for GED-0301, a little known Crohn's disease
treatment being developed by the Italian player Nogra Pharma. Phase II data
supports the view that the orally dosed GED-0301 could replace anti-TNF
therapies in the first-line setting and Phase III studies begin this year.
LCZ696 – chronic heart failure (Novartis)
Despite warnings from Novartis CEO Joseph Jimenez last week that investors
should not read too much into early quarter sales for LCZ696, there are few who
don't believe the Swiss company has another blockbuster cardiovascular drug on
its hands. Data from the PARADIGM study exceeded expectations when announced
last year, and although there have been some subsequent criticisms of the study
design and how results have been presented, LCZ696 is also being studied in
other cardiovascular indications beyond heart failure, which could boost
long-term revenue potential further.
Trulicity | semaglutide – diabetes (Eli Lilly/Novo Nordisk)
Having secured a handful of new drug approvals in 2014, Eli Lilly's
commercial execution will be a key focus over the next 12 months. Having
demonstrated non-inferiority versus Novo Nordisk's market leading GLP-1 agonist
Victoza, Eli Lilly's Trulicity represents an intriguing opportunity; one too
that emboldened US payers may look to exploit for their own benefit if the
company is willing to offer greater discounting for market share gain. Novo
Nordisk's own strategy in the GLP-1 space depends partially on developing an
oral product in this class with Phase II data for semaglutide due to be
released later this year.
Afrezza – diabetes (Sanofi & MannKind)
Is there a place in the diabetes market for an inhaled insulin product?
Sanofi and MannKind certainly hope so. The Afrezza product – dosed via a small
and convenient inhaler – appears to have raised the bar versus Pfizer's
previous (and unsuccessful) foray into this market with Exubera.
Simultaneously, however, the injection devices for leading insulin brands have
progressed markedly over the past decade. Throw into the mix pricing headwinds
in the US diabetes space and the launch of Afrezza – due later this quarter –
will be an intriguing one to watch.
Saxenda – obesity (Novo Nordisk)
Significant commercial success in the obesity market remains elusive, but
Novo Nordisk is hoping that a higher dosage of its successful diabetes therapy
liraglutide (Victoza) can change that. Approved late last year, uptake during
2015 will be keenly watched.