The top 10 (possible) blockbusters that (might) launch this year

Print 01 February 2016
John Carroll / FierceBiotech

Can't get enough of sell-side estimates on the big new drugs in the late-stage pipeline? Then we have a treat for you today.

EvaluatePharma gathered the consensus numbers on projected 2020 sales for the drugs being watched for a 2016 launch and came up with separate tallies on the top 10 biologics and top 10 small molecules. We mashed them together and came up with a top 10 for the new therapies up for a make-or-break kickoff.

Who comes out ahead? Roche, by a country mile, with about $6.6 billion of the $16.4 billion total in estimates tracked by Evaluate. (Though one of those drugs is partnered with AbbVie.) Keep a bucket of salt handy while you review the list, though. Sell-side projections can be notoriously inaccurate, and at least one of these drugs is anything but a sure thing when it gets to an FDA review.

Analyst beware.

Ocrelizumab, Roche--2020: $2.7 billion

Roche figures prominently on this list of sell-side superstars, starting with ocrelizumab, a new drug being positioned for both relapsing/remitting as well as primary progressive multiple sclerosis, offering a possible major advance in the field that could well shake up the entire market. Some analysts are much more ambitious about potential sales, eyeing rival drugs that present serious safety issues. Phase III data for the twice-yearly IV therapy has looked solid, and regulators may be eager to push this through. Biogen had been partnered on this drug in the past but dropped out several years ago.

Atezolizumab, Roche--2020: $2.5 billion

Roche has been positioning this leading anti-PD-L1 cancer drug, better known as atezo in the biz, as the third entrant to the hot checkpoint inhibition field. Unleashing an immune system attack on cancer has broad applications in oncology, so you can expect plenty of follow-up combos to come along. The two pioneers in this field (Keytruda and Opdivo) are PD-1 drugs, so there's lots of interest in whether this complementary target works better for some patients with high expression levels.

Grazoprevir/elbasvir, Merck--2020: $1.9 billion

This new hep C combo drug from Merck is up for a likely approval at any moment today. Merck is late to the party with its combo approach, well behind market leaders Gilead and AbbVie. But its easier dosing regimen is expected to allow Merck to carve out a better market share than AbbVie. Gilead, though, remains the company to beat in hep C. As the dominant company in hep C, Gilead is expected to keep a dominant share of the market. But even a portion of this market, with declining pricing, is worth a mint. 

Dupilumab, Regeneron/Sanofi--2020: $1.8 billion

A lot of credit on this drug goes to Regeneron, so we're adding the company to Evaluate's analysis. Regeneron and its close partner Sanofi are coming through Phase III with dupilumab, an IL-4/IL-13 contender which some analysts believe can earn as much as $2.5 billion for eczema and asthma. Sarilumab has already been filed by the partners, though, and may just make it to blockbuster status as well. 

Obeticholic acid, Intercept Pharmaceuticals--2020: $1.6 billion

Intercept won priority review status for OCA for primary biliary cirrhosis, but a bad case of the jitters set in for this therapy last fall when it failed a Phase II in Japan for liver disease. NASH, a huge potential market, is the big opportunity for Intercept. Sell-side analysts are high on OCA's blockbuster potential, but the company has a long way to go before fully establishing its top side.

Venetoclax, AbbVie/Roche--2020: $1.4 billion

Venetoclax just won its third breakthrough therapy designation from the FDA, a helpful sign of regulators' expectations. The partners are widely expected to win a first approval for chronic lymphocytic leukemia, or CLL, this summer, with solid data from reliable developers aimed at regulators who have proven very receptive to quick approvals for oncology drugs. For Roche, it's another step forward in a core field; for AbbVie, it's a chance to grow their cancer drug revenue, on top of Imbruvica.

Emtricitabine/Tenofovir Alafenamide Fumarate, Gilead--2020: $1.3 billion

Gilead has been racking up some significant regulatory successes in HIV, including the approval for its cocktail last November. The pharma giant built its fortunes in HIV and has been hard at it in coming up with nicely tailored improvements to its product line. The move in HIV now is coming up with easier dosing regimens to keep the virus in check, with some gains on efficacy, as scientists continue a hunt for a way to eliminate it altogether. In the meantime Gilead has to compete with GlaxoSmithKline's ViiV, which is coming on strong.

Empliciti, Bristol-Myers Squibb/AbbVie--2020: $1.08 billion

Empliciti was approved in 2015 but gets credited as a 2016 launch. The FDA handed out its "breakthrough" designation for this drug in 2014, inspired by solid Phase II data for multiple myeloma. The Phase III, which combined the drug in a cocktail with Celgene's ($CELG) Revlimid and generic dexamethasone, outperformed the pair. 

Uptravi, Actelion--2020: $1.08 billion

Uptravi was also approved last year, just a few days before Christmas. The FDA's decision to green-light selexipag near the end of the year marked another key win for Actelion, which has been steadily building its franchise in pulmonary arterial hypertension. The Swiss biotech demonstrated the usefulness of the oral drug in a Phase III study involving more than 1,000 patients. 

Ixekizumab, Eli Lilly--2020: $1.03 billion

Psoriasis R&D has been a busy field in recent years, but Lilly's IL-17 drug has stayed in the spotlight throughout. Lilly has been doing head-to-heads with established drugs in the field and clearly wants to expand on any initial approval it gets, which could raise its peak sales prospects. Some concerns were raised after AstraZeneca and Amgen bailed on brodalumab after tracking suicidal thinking among patients, as analysts fretted about some potential class effect for Lilly's drug. Novartis was the leader in the new wave of drugs, with an approval for Cosentyx. And Merck and J&J both have potential rivals coming along.

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