Which pharmaceutical products – both marketed and in the pipeline – will dictate industry news flow over the next 12 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' (2015 Preview: Big biotech exits JPM on a roll – where to from here?).
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 (Spotlight On: Where will US payers strike next?).
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? (ViewPoints: Bristol-Myers Squibb passes through key Opdivo checkpoint with Merck & Co. hot on its heels).
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 (ViewPoints: All signs point to key breast cancer approval for Pfizer).
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 (ViewPoints: CAR T takes centre stage – but with big money comes big expectations).
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 (Physician Views: The FDA gives a thumbs-up to the first potential US biosimilar, but what do oncologists think?).
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 (Spotlight On: Approval of the first US biosimilar recommended, but many challenges await).
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 (ViewPoints: Sanofi promises a new dawn, but Viehbacher's shadow looms large).
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 (2014 in review – Did new drug launches meet expectation and for what pipeline drugs have revenue forecasts grown the most?.
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 (ViewPoints: Questions linger about the initial 'success' of Biogen Idec's anti-LINGO mAb).
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 (Physician Views: Celgene's mongersen continues to impress in Crohn's – is it too good to be true?).
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 (Physician Views Poll Results: New data for Novartis' LCZ696 set the Street abuzz, but how do cardiologists see it fitting into highly genericised heart failure market?).
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 (ViewPoints: With European approval secured, is it full steam ahead for Eli Lilly's Trulicity?).
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 (ViewPoints: Is MannKind's challenging route to market for inhaled insulin set to continue? (Updated)).
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 (ViewPoints: More obesity drugs hitting the market – but any reason to expect heavier usage?).
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