As we reach the mid-way point of 2014, FirstWord takes a look at forecast revenues for new molecular entities that were approved over the course of 2013 and the past six months; and looks ahead to anticipated new drug approvals by year-end.
At the beginning of 2014 there was some consternation that the FDA's approval rate of novel pharmaceutical and biologic products – the most frequently cited barometer of industry productivity – had demonstrated a notable year-on-year decline; the administration approved 33 new products in 2013 versus 43 in 2012.
The class of 2013
The 'quality' of the class of 2013 has never been in doubt, however. Each of the 10 largest growth drivers – based on consensus sales in 2018 – are expected to become blockbuster products within five years of approval. By FirstWord's estimations, using consensus data sourced from Bloomberg, these 10 products are expected to generate combined global sales of $34 billion by 2018.
By comparison, the 10 largest growth drivers approved in 2012 are expected to generate combined sales of around $15 billion by 2017 (five years post-approval).
While the 'class of 2012' included some notable approvals – such as Roche's Perjeta (HER2-positive breast cancer), Vertex Pharmaceuticals' Kalydeco (cystic fibrosis) and Medivation/Astellas' Xtandi (prostate cancer) – a handful of products were launched in the same year for which forecast sales have subsequently been revised significantly downwards; both Bristol-Myers Squibb/Pfizer's Eliquis and Pfizer's Xeljanz have seen their 2017 forecasts halved since the products were approved by the FDA.
Can the momentum provided by 2013's novel launches be maintained?
This year has already seen a handful of products approved by the FDA for which consensus forecasts indicate blockbuster status by 2019; these include Celgene's Otezla for psoriatic arthritis, AstraZeneca's Farxiga for diabetes and Eli Lilly's Cyramza for stomach cancer.
Key regulatory action is likely to occur over the next six to 12 months, however, and will see the December 2013 approval of Gilead Sciences' hepatitis C treatment Sovaldi – which is currently demonstrating the strongest new drug launch of all time – enhanced by an anticipated October approval for the company's fixed-dose combination of Sovaldi and ledipasvir.
AbbVie's all-oral hepatitis C regimen also has a December PDUFA and is forecast to generate 2019 sales of $2.5 billion, while Bristol-Myers Squibb's daclatasvir and asunaprevir compounds are expected to gain approval at a similar time.
Gilead's blockbuster-in-waiting idelalisib is expected to gain approval for chronic lymphocytic leukaemia in the next few months, while the launch of Biogen Idec's Plegridy is expected to enhance its leadership of the multiple sclerosis market.
Significantly, the latter months of 2014 should see the US market debut for a PD-1/PD-L1 inhibitor in the form of Merck & Co.'s pembrolizumab for Yervoy-refractory melanoma. Bristol-Myers Squibb's competing nivolumab should reach the US market in the early months of 2015.
With the second half of 2014 also set to witness a handful of important indication extensions for key growth driver franchises (i.e. Johnson & Johnson/Pharmacyclics' Imbruvica, Roche's Gazyva and Medivation/Astellas' Xtandi) and the first half of the year witness to a number of exciting data releases and licensing deals, pharma's much maligned performance in R&D shows sustained levels of recovery.
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