With the second-quarter earnings season drawing to a close for US and European-based pharmaceutical manufacturers, FirstWord takes a look at those products that delivered the highest rates of absolute sales growth during the first six months of 2012 versus the same period in 2011.
The 20 leading product-level growth drivers are listed below. The growth column represents year-on-year absolute sales growth for the first half of 2012 versus the first half of 2011 in US$m.
Of the 20 products, 12 (or 60 percent) are accounted for by three therapy areas; oncology (six products), diabetes (four products) and immunology & inflammation (two products). Alexion's Soliris - number 20 on the list and the only Orphan product - is indicated for the treatment of paroxysmal nocturnal hemoglobinuria and hemolytic uremic syndrome (uHUS).
The anti-TNF biologics that dominate the immunology and inflammation market remain a force to be reckoned with, represented in the list by Abbott's Humira and Pfizer and Amgen's Enbrel. Among the leading growth driver products, Humira and Enbrel also generated the largest revenues during the first half of 2012, at $4.3 billion and $3.9 billion, respectively, and are now positioned amongst the highest selling products within the industry.
Entrenchment, continued growth momentum and the accumulation of post-approval clinical data for these products will erect notable barriers to entry for future competitors to the immunology & inflammation space, such as Pfizer’s tofacitinib, which the company hopes to secure approval for in rheumatoid arthritis later this year. See Spotlight On: Pfizer's next blockbuster? – The outlook for tofacitinib.
The threat of biosimilars
However, challenges to the anti-TNF biologics will come not only from novel branded therapies, such as tofacitinib, but also biosimilars, which will aim to compete on cost, with many developers targeting this space. Indeed, the first internationally recognised antibody biosimilar product – Celltrion’s Remsima (a biosimilar version of Johnson & Johnson and Merck & Co.’s Remicade) – was approved in South Korea in July, with regulatory clearance also widely anticipated in the EU in late 2012/early 2013. See ViewPoints: World's first biosimilar monoclonal antibody product approved and ViewPoints: EULAR presentation should provide launch pad for first biosimilar MAb approval.
Oncology remains dominant
Unsurprisingly, oncology casts a dominant shadow on the list of key growth drivers, accounting for six products. Of these franchises, Johnson & Johnson's Zytiga delivered the highest level of absolute sales growth for the first six months of the year versus the same period in 2011 at $378 million.
The emergence of Zytiga is illustrative of notable development in the castrate-resistant prostate cancer (CRPC) space, and growth momentum for the franchise will likely be boosted in the second half of 2012 by anticipated approval in the pre-chemotherapy setting (with some off-label use likely to have boosted its performance already in recent months). This is expected to provide further competitive headwind against Provenge, Dendreon’s heavily touted but commercially-disappointing cancer vaccine. Competitor intensity in the prostate cancer market will increase further towards the end of the year, however, due to the anticipated US approval of Medivation and Astellas' enzalutamide (formerly MDV3100), which has been set a PDUFA date of November 22. See Spotlight On: Zytiga trial results and implications in prostate cancer market and ViewPoints: Dendreon revises targets but growth challenges remain.
Big Pharma's ability to deliver new, commercially successful cancer products to the market is further illustrated by the presence of Bristol-Myers Squibb's melanoma treatment Yervoy; which generated sales of $316 million for the first six months of 2012 following its approval in March of last year. Anticipated by analysts to become a blockbuster product, Yervoy is also something of a poster boy for Bristol-Myers Squibb's M&A-enhanced pipeline; considered by many to be the most promising among the large cap players. See ViewPoints: Medarex/BMS-936558 – when M&A comes good.
Herceptin and Rituxan drive Roche's growth momentum
Discussion of growth drivers in the oncology space inevitably turns to Roche, with the Swiss drugmaker represented by both Herceptin and Rituxan, which delivered net absolute growth of $239 million and $219 million for the first half of 2012, respectively. Like the biologic anti-TNF products, Herceptin and Rituxan are now suitably entrenched therapies that continue to deliver robust sales growth despite their maturity.
As a result, the key competitive threat to both these products is the emergence of biosimilar competition over the next few years. Unsurprisingly, both Herceptin and Rituxan have been targeted by a plethora of biosimilar developers ranging from Celltrion – which hopes to file a biosimilar Herceptin product for approval by year end – to Pfizer, which confirmed in its recent second-quarter results that it has begun to develop versions of both antibodies. See ViewPoints: Amgen shows first hand in biosimilars market – key observations.
In turn, a number of commentators have applauded the strategy Roche has put in place to defend its antibody products from biosimilars; this encompasses challenges to regulatory frameworks, an increasingly flexible outlook in terms of pricing and market access for its branded products in emerging markets and innovation via new launches, such as Perjeta and T-DM1, both of which are expected to enhance the Herceptin franchise. See ViewPoints: Roche's half-year report card - enhancing its oncology focus.
The race for diabetes market share
Diabetes remains a key area of investment for the industry, illustrated not only by Bristol-Myers Squibb and AstraZeneca’s recent acquisition of Amylin, but also the reported interest from a handful of other Big Pharma players. See ViewPoints: Bristol-Myers Squib and AstraZeneca acquire Amylin – three key questions.
Those diabetes treatments that were among the fastest growing in the first half of2012 encompass a number of product classes within this disease area, which, again, demonstrates that other players looking to enter this space will face a challenging environment in terms of entrenched therapies.
The Januvia/Janumet franchise was the largest growing product for the period analysed (Januvia and Janumet generated absolute growth of $459 million and $176 million, respectively) and it is no surprise that this franchise is expected to be one of, if not the, largest within the industry by 2016. Other key diabetes brands in terms of growth momentum include Sanofi’s Lantus – another candidate for potential biosimilar competition in the next few years – and Victoza and NovoRapid, both of which are marketed by Novo Nordisk.
The rapid movers
Finally, there are a number of products that have delivered a rapid escalation in sales since launching during the first half of 2011. Among these are Vertex's Incivek for hepatitis C – one of the fastest first-year launches in the US market of all time, but a product that in commercial terms is only expected to burn brightly for a limited time due to the anticipated launch of all-oral hepatitis C therapies. See ViewPoints: Gilead Sciences moves further ahead in race to multi-billion dollar HCV market.
Novartis' Gilenya – the first oral multiple sclerosis treatment – has overcome safety concerns to deliver robust revenues in the first half of 2012, but is expected to face competition from Biogen Idec's competitor drug BG-12 from early next year. Another key launch product is Regeneron's Eylea for age-related wet macular degeneration, uptake of which has surprised analysts and company management (which has twice upgraded its full-year revenue guidance). Eylea has demonstrated that in the face of entrenched competition (Lucentis) and cheaper therapeutic alternatives (off-label Avastin), effective product differentiation – Eylea's less frequent dosing for example – can reap commercial dividends. See ViewPoints: As drug launches go – this is looking special | Regeneron's Eylea.
That said, the list of leading growth drivers during the first half of 2012 is dominated by products that were either launched as first-in-class therapies or which offered notable improvements in efficacy and safety over existing therapies. This is not surprising but offers evidence of the heightened R&D challenge faced by the pharma industry, particularly as the appetite among payers for truly innovative or ‘incremental effective,’ rather than simply new, products is only going to increase. See also ViewPoints: Can Big Pharma cut R&D spending but improve productivity? – Poll Results.
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