As sector pain continues Roche leads the blockbuster charge

It is hard to argue against Roche’s atezolizumab and Roche/AbbVie’s venetoclax as being this year’s most keenly awaited new drug launches, so it should come as a surprise that in terms of expected sales neither features as the most impressive 2016 introduction.

Among biologicals atezolizumab is edged out by Roche’s Rituxan follow-on ocrelizumab, for multiple sclerosis, while in the small-molecule arena a Merck & Co hepatitis C laggard has venetoclax beat by a wide margin. In total 2016 could see the launches of 11 drugs that are on course to become blockbusters by 2020, EvauatePharma reveals, providing some comfort to investors bemoaning the year’s appalling start.

Of course biopharma has come off because of macroeconomic rather than sector-specific concerns, though it could also be argued that, after four years of pumping up, it was not going to take much to bring down the market. On the plus side, however, much of the past few years’ enthusiasm has been down to the US FDA’s readiness to approve oncology drugs – something that looks unlikely to change.

As such the focus remains on Roche’s atezolizumab, which this year is set to become the first anti-PD-L1 MAb to be launched, likely for NSCLC and/or bladder cancer. It will follow in the footsteps of Bristol-Myers Squibb’s and Merck & Co’s anti-PD-1 agents, Opdivo and Keytruda respectively, which are already established as pillars of cancer immunotherapy.

Among other oncology projects, AbbVie/Bristol’s Empliciti, the first anti-SlamF7 MAb, for multiple myeloma, features among 2016’s biggest-selling biological launches, with a US PDUFA date of February 29. So does Celltrion’s Herzuma, notable for being a biosimilar version of Roche’s Herceptin, and facing potentially its first Western approval, presumably in the EU.

However, in terms of forecast 2020 sales the biggest drug expected to come to market is the one that tops the list of biologicals: Roche’s anti-CD20 MAb ocrelizumab, which last year impressed in phase III (Roche progresses into MS white space, October 12, 2015).

The analysis is based on EvaluatePharma’s consensus forecasts from sellside analysts, and extracts the top 10 biotechnology and small-molecule drugs likely to reach the market this year.

Clearly it makes no allowance for risk, as shown by the presence in the list of Biomarin’s Duchenne muscular dystrophin project Kyndrisa, which received a complete response letter this month, and Celltrion’s Herzuma. The South Korean company has yet to confirm whether the agent has been filed for approval, illustrating how these forecasts are frequently based on best case scenarios.

A conventional approach

Oncology also features in the biggest expected small-molecule launches, in the form of venetoclax, which Roche/AbbVie quietly filed with the US FDA last November. Earlier problems with tumour lysis syndrome seem to have been ironed out, and this Bcl-2 inhibitor is now the most keenly awaited chronic lymphoblastic leukaemia agent since Johnson & Johnson/AbbVie’s Imbruvica.

However, the biggest launch is seen as Merck & Co's hepatitis C doublet grazoprevir/elbasvir, which is expecting FDA approval on January 28 (Therapy focus – Merck and AbbVie still trail in Gilead's hep C wake, January 26, 2016).

Two new entries to Gilead’s HIV franchise are also forecast to become blockbusters, and although the company is pitching safety advantages over the incumbents it will still have to work hard to push through substantially higher prices. The former is a Truvada follow on, also known as F/TAF, which has a PDUFA date of April 7; the latter, R/F/TAF, is a line extension to Complera, and approval could come any time now.

Intercept will find out by May 29 whether the FDA will allow obeticholic acid onto the market in its first indication – primary biliary cirrhosis. PBC only represents a third of sales forecasts in 2020, however, so the product will have to succeed in the arguably more controversial indication of NASH for these numbers to turn into real sales.

Acadia too has much to prove with its much-delayed Nuplazid, its treatment for Parkinson’s disease psychosis; the FDA has set a PFUFA of May 1. And Shire will be very keen to receive a green light second time round for Lifitegrast, its dry eye therapy that was knocked back by the FDA last year. The company re-filed in January, and word is awaited on whether the application has been accepted; the project is its most valuable pipeline asset.

Another optimistic launch projection on the list is Merck’s post-menopausal osteoporosis candidate odanacatib, a molecule whose future has been clouded by safety concerns (Long-awaited Loft data justify sellside’s odanacatib caution, September 16, 2014). A filing was expected last year but the company has remained largely tight-lipped about its progress.

More certain is the future for Actelion’s Uptravi, which was launched in the first week of the year. But, for those still awaiting regulatory judgements, the future is far from determined.

This article has been amended to correct the PDUFA date for obeticholic acid.

To contact the writer of this story email Amy Brown or Jacob Plieth in London at [email protected], or follow @AmyEPVantage or @JacobPlieth on Twitter