Biogen Idec’s oral multiple sclerosis therapy Tecfidera – approved last week by the FDA – is expected to emerge as one of the industry’s leading growth drivers over the next few years; according to consensus estimates compiled by FirstWord, global sales will reach $3.3 billion by 2017.
The presence of Tecfidera on such a list provides a confidence boost to the biotech sector and the broader pharmaceutical industry as it seeks to deliver on the promise of increased innovation, as will the presence of three products approved last year (Roche’s Perjeta, Gilead Sciences’ Stribild and Medivation/Astellas’ Xtandi) and two products approved in 2011 (Bristol-Myers Squibb/Pfizer’s Eliquis and Regeneron’s Eylea).
The biggest growth driver – Gilead’s sofosbuvir – is yet to launch (initial roll-out is expected in 2014), while the top 10 list is also populated by a number of older products expected to demonstrate enviable commercial longevity – AbbVie’s Humira and Celgene’s Revlimid. Merck & Co.’s Januvia – the current best example of an ‘old school’ blockbuster – completes the line-up.
Sofosbuvir – Hepatitis C – Gilead (sales growth 2012-17 +$4.3 billion)
Integrated into Gilead’s pipeline via its $11 billion acquisition of Pharmasset, the NS5B nucleotide inhibitor sofosbuvir is firmly established as the most advanced ‘cornerstone’ therapy that will facilitate the treatment of hepatitis C without the need for interferon and ribavirin (both of which commonly cause unpleasant side-effects). Furthermore, in combination with Gilead’s NS5A inhibitor – GS-5885 – sofosbuvir appears poised to provide a once-daily, single tablet (oral) treatment option that will effectively cure hepatitis C in most patients. In those with harder to treat genotypes, this combination is likely to prove equally effective when prescribed with older therapies. Key to driving expected revenue growth for the sofosbuvir franchise is the ‘warehouse’ effect – i.e. usage of the treatment among patients whom have been ‘held back’ by physicians. According to analysis by FirstWord, US gastroenterologists are currently warehousing around a third of diagnosed patients for treatment with all-oral therapies. See Physician Views Poll Results – Oral interferon-free treatments highly anticipated by physician community.
Perjeta (pertuzumab) – HER2-positive breast cancer - Roche (+$3.5 billion)
Approved by the FDA in mid-2012 as a first-line treatment for HER2-positive metastatic breast cancer in combination with Herceptin, Roche’s Perjeta (pertuzumab) represents a key launch for the Swiss pharmaceutical manufacturer. At the crux of Perjeta’s anticipated commercial performance is a simple case of mathematics; combined use of Herceptin (wholesale cost of $4500 per month) with Perjeta (wholesale cost of $5900 per month) increases both the cost and duration of therapy (a typical course of therapy being 18 months). Physician enthusiasm for Perjeta appears high; a survey carried out by Deutsche Bank analysts shortly after launch indicated that a third of oncologists expected to prescribe the combination therapy in the first-line setting by the end of 2012, with cost somewhat blunting use (Roche has spoken about the concept of ‘personalised pricing’ to counter market access concerns tied to the high cost of combinational therapy). Longer term, Perjeta is likely to cement first line status in the HER2-positive setting via combinational use with Kadcyla (trastuzumab emtansine), Roche’s antibody drug conjugate recently approved in the second-line setting. Results from the ongoing MARIANNE study read out in 2014; approval in the first-line setting would significantly enhance Roche’s insulation from biosimilar competitors targeting the older Herceptin franchise. See ViewPoints: Roche banks on disruptive innovation to counter competitive headwinds.
Januvia (sitagliptin) – diabetes – Merck (+$3.4 billion)
Given its status as a small-molecule drug targeting a large primary care market (diabetes), Januvia stands out as something of an anachronism among its key growth driver peers – a throwback to the golden days of the blockbuster that defined Big Pharma a decade ago. That is not to take anything away from Merck, however, particularly as Januvia is forecast to match its historical predecessors in terms of revenue growth; sales are expected to reach around $8 billion by 2017, thereby positioning the drug as one of the biggest selling of all time. A first-in-class launch (it is a DPP-IV inhibitor), Januvia secured this status given Merck’s willingness to streamline some elements of the late-stage development process. Analysts remain confident that Januvia will remain the entrenched market leader despite intensifying competition and sales could expand if post-approval outcome studies demonstrate a cardiovascular benefit. See FirstWord Lists: The 20 biggest growing pharma products in 2012 - Sanofi's Lantus leads the way.
Tecfidera (dimethyl fumarate) – multiple sclerosis – Biogen Idec (+$3.3 billion)
Approved in March 2013, consensus among analysts, key opinion leaders (KOLs) and physicians indicates that Biogen Idec’s Tecfidera will emerge as the first-line therapy of choice for multiple sclerosis over the next few years, despite being the third-to-market oral treatment (behind Novartis’ Gilenya and Sanofi’s Aubagio). With global sales expected to reach around $3.3 billion by 2017, Tecfidera is poised to be the ‘biggest’ launch of 2013 and alongside Tysabri – which was fully acquired by Biogen Idec earlier this year – will allow the biotech player to enhance its position in the multiple sclerosis market. See Spotlight On: Five key facts about Biogen Idec's Tecfidera.
Humira (adalimumab) – rheumatoid arthritis – AbbVie (+$3.0 billion)
Among the 10 largest sales growth drivers over 2012-17, AbbVie’s Humira is the oldest product, having first been launched in 2003. Its longevity – reflected by continued strong growth over the next five years – is owed in part to its biologic status, but primarily to a faster accumulation of market share across a number of inflammatory conditions (rheumatoid arthritis, psoriatic arthritis and Crohn’s disease) versus rival biologic therapies Enbrel and Remicade. Given anticipated revenue expansion by analysts through to 2017, Humira looks set to become one of the industry’s biggest selling products of all time – potentially catching Pfizer’s statin therapy Lipitor. The issue for AbbVie is to limit its dependence on the Humira franchise, which currently accounts for around 40 percent of sales (set to rise to 60 percent by 2017). See FirstWord Lists: The best selling drugs of all time – Humira joins the elite and FirstWord Lists – Big Pharma's Blockbuster dependency rates.
Eliquis (apixaban) - Venous thromboembolism – Bristol-Myers Squibb/Pfizer (+$2.9 billion)
Management at both Bristol-Myers Squibb and Pfizer hope that the anticoagulant Eliquis will fulfill the multi-billion dollar blockbuster potential that analysts have ascribed to it. For Pfizer in particular, the role of Eliquis and Xeljanz (rheumatoid arthritis) as new product growth drivers is seen as critical given the recent lack of US patent exclusivity for Lipitor. Although the market for next-generation anticoagulant products has yet to deliver the scale of revenues that many had anticipated, analysts have cited Eliquis as a potential best-in-class product that could effectively displace warfarin. Others – citing a lack of sufficient additional efficacy, coupled with the cheaper cost and decades-long entrenchment of warfarin - are less confident. The performance of Eliquis over the next 12 months will provide some indication as to the correct assessment. See ViewPoints: Can Eliquis deliver growth momentum for the new generation of anticoagulants?
Eylea (aflibercept) – wet age-related macular degeneration (AMD) – Regeneron/Bayer (+$2.8 billion)
Launched in late 2011, Regeneron’s wet age-related macular degeneration (AMD) treatment Eylea emerged over the course of 2012 as one of the most successful new drug launches of all time. This performance has been all the more impressive given that Eylea has competed not only with Roche’s blockbuster AMD treatment Lucentis, but also with the widespread use of off-label Avastin, which is provided to patients at a significantly lower cost (at approximately $50 per injection, some 37 times cheaper than Eylea). Growth for the franchise through to 2017 will be driven by continued uptake in the US market – boosted by approval in additional indications such as diabetic macular oedema (DME) – and launch in Europe where Eylea will be marketed by Bayer. See ViewPoints: How to join the blockbuster club.
Revlimid (lenalidomide) – multiple myeloma – Celgene (+$2.8 billion)
Continued strong revenue expansion for Celgene’s multiple myeloma treatment Revlimid remains closely tied to approval in Europe as a front-line therapy suggest analysts, while management continues to talk up the financial impact of formal front-line status in the US. Regulatory decisions in both territories will be driven by data from the MM-020 clinical trial, with results expected before mid-2013.
Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir) – HIV – Gilead (+$2.7 billion)
Investor focus at Gilead Sciences is notably sharpened on the company’s late-stage hepatitis C programme (and with good reason, given its commercial opportunity); but with catalyst news flow for sofosbuvir set to slow over the next 12 months as Phase III trials progress, it is the company’s core position in HIV that will regain some attention. This business should accelerate in 2013, note analysts at JP Morgan, with Stribild, to date, having delivered a better than expected performance since launch during the second half of 2012.
Xtandi (enzalutamide) – prostate cancer – Medivation/Astellas (+$2.4 billion)
The prostate cancer market continues under significant transformation, driven heavily by uptake of Johnson & Johnson’s Zytiga (one of the key launches of 2011) and more recently Medivation and Astellas’ Xtandi. Medivation CEO David Hung noted that 88 percent of oncologists said they were aware of Xtandi just four weeks after launch and although second-to-market behind Zytiga, the blockbuster potential of Xtandi is clear – as is, say analysts, its future position among the standard of care in the metastatic setting. Focus in 2013 will be on both the quarterly sales uptake trend for Xtandi and Medivation’s efforts to differentiate the brand from Zytiga – central to this strategy is the push to demonstrate overall survival in the pre-chemotherapy setting, where Zytiga gained FDA approval in December. See ViewPoints: Incremental data disclosures could broaden commercial opportunity for blockbuster-in-waiting Xtandi (updated).
To read more List articles, click here.