Ranked by highest sales forecast for 2021, the expected blockbuster 2017 launches are Roche’s Ocrevus (ocrelizumab) for multiple sclerosis (MS), Regeneron and Sanofi’s Dupixent (dupilumab) for allergic conditions, AstraZeneca’s durvalumab for cancer, Novo Nordisk’s semaglutide for type 2 diabetes, Lilly and Incyte’s Olumiant (baricitinib) for rheumatoid arthritis (RA), Novartis’s ribociclib for cancer, Merck Serono and Pfizer’s avelumab for cancer, TESARO’s niraparib for cancer and Novartis’s ribociclib for cancer. Kite Pharma’s KTE-C19 for hematological cancer, while not yet quite reaching blockbuster status, is included in this report for the interest it is generating among industry observers.
Ocrevus for multiple sclerosis
Topping the ranking for 2017’s blockbusters by 2021 sales is Roche’s Ocrevus, which is expected to materially disrupt the MS market when it launches in 2Q17. The MS market is a fascinating one, as it has been transformed by oral options since 2010, yet older injectable mainstays such as the interferons have ceded market share relatively slowly. The first generics (eg Momenta’s glatiramer generic, Glatopa) have not altered the market to much extent, but the first oral generics are on the horizon which will have a greater impact. Despite this maturing market, significant need remains for treatment options with novel mechanisms and an optimal combination of improved potency, tolerability and convenience. Ocrevus is a first-in-class anti-CD20 antibody which met its endpoints in two pivotal trials in relapsing remitting MS (OPERA 1 & 2) according to data reported in 2015. Compared with Rebif (recombinant interferon beta-1a), Ocrevus reduced the annualized relapse rate by 47 percent at week 96, with secondary endpoints also met, including delayed confirmed disability progression and reduced new brain lesions; safety and tolerability data were favorable. Perhaps more interestingly, the drug is also the first ever to prove effective in primary progressive MS, as seen in the ONTARIO trial where the risk of progression of clinical disability was reduced by 24 percent. Initial market share gains are likely in the second line behind oral options and in severe patients on Tysabri (natalizumab) who are at risk of progressive multifocal leukoencephaolopathy, but adoption in naive patients may be expected in the medium term as prescriber familiarity builds.
Dupixent for dermatitis Regeneron’s
IL-4 alpha subunit inhibitor Dupixent was successful in several phase III studies in its first development setting of atopic dermatitis (AD), and is expected to launch in 2Q17 shortly after its PDUFA date of March 29. In the SOLO-1 & 2 trials in mild to moderate AD patients inadequately controlled with topical medications, 37 and 36 percent patients saw clearance or near clearance of skin lesions at 16 weeks, respectively. Co-administration with a corticosteroid was also superior to corticosteroid therapy alone (39 versus 12 percent).
These strong short-term outcomes, combined with the lack of existing treatment options, are expected to drive wide adoption, despite the unfamiliar mechanism of action. A phase II trial in pediatric patients is also completing; unmet need in this setting is particularly notable, and approval in pediatrics would drive upside. Benefit has also been seen in phase III trials in eosinophillic asthma, although severe asthma is a competitive space and the impact of approval in this setting does not appear clear cut.
Durvalumab for cancer
The first BLA filing for AstraZeneca’s PD-L1 antibody durvalumab was accepted in December 2016 in bladder cancer, and through Priority Review it is now expected to launch in 2H17. While the drug will provide a meaningful treatment option in the bladder cancer setting, it is in lung cancer where the most notable sales are expected.
AstraZeneca had initially aimed to be entering the lung cancer market in 2016, through its ATLANTIC study in the third-line non-small-cell lung cancer (NSCLC) setting, but the company was delayed when monotherapy data were not strong enough to warrant continued development in the t...
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