Drug Development

Regeneron makes a blockbuster case for its PhIII drug pipeline

While Biogen is struggling to get its pipeline to perform, Regeneron execs put on a demonstration today on how a biotech company with a second-tier R&D budget can perform better on the late-stage front than much bigger companies spending much more on research. And it led off with bullish remarks on a pair of would-be blockbusters, including their top Phase III drug dupilumab.

During their second quarter review, the executive team noted:

— Sarilumab is up for an October 30 PDUFA date at the FDA, with a recent European filing at the EMA to follow up on. Peak sales estimates top $1 billion for this drug, which beat megablockbuster Humira in a head-to-head study on rheumatoid arthritis. This will likely be the second drug partnered with Sanofi to hit the market – the first was the PCSK9 drug Praluent, which has had a slow uptake since its introduction.

— It’s dupilumab, though, that is getting the full red carpet treatment at Regeneron. The IL-4/IL-13 blocking drug – also partnered with Sanofi – is expected to get approved in the first half of 2017. Most analysts note that with stellar Phase III data from a slate of atopic dermatitis studies, along with the FDA’s breakthrough drug designation to help speed things along, that approval is likely to land early. Peak sales estimates tend to hover around $2.5 billion a year, making it a contender to become a top 2017 drug. Some optimistic sell-siders have pushed their peak estimates to $4 billion or $5 billion.

R&D chief George Yancopoulos

R&D chief George Yancopoulos

“Dupilumab is really a franchise unto itself,” says R&D chief George Yancopoulos in the Q2 call with analysts today. The positive data in atopic dermatitis has spurred their belief that the drug has “huge” potential. There’s already significant pentup demand from patients who either don’t respond to currently available remedies or can’t tolerate them, says Regeneron’s executive team. There’s also no other competition in the late-stage pipeline to contend with.

“This really has a chance to provide something to patients that don’t have any other alternatives at this point,” says Yancopoulos. And the company is pushing ahead in asthma and other indications, looking to push the boundaries on its franchise potential.

— Then there’s REGN 2810, a PD-1 checkpoint drug also partnered with Sanofi which is already in a possible pivotal study. This is part of another ambitious collaboration deal with Sanofi, which is looking to finally get things going in the cancer arena.

Regeneron also has a brand new alliance of its own with Adicet and its CEO, Aya Jakobovits, who earned a big endorsement from Yancopoulos.

“We really believe in people and we believe in synergies,” says the R&D chief, touting a match-up on Adicet’s off-the-shelf approach to developing cell therapies. “We have had a longstanding interest to work with Aya Jakobovits. We have enormous respect for her and her capabilities.”

Beyond that, though, Yancapoulos wasn’t saying much about the technology and what distinguishes it from rivals in the field.

— And finally there’s fasinumab (REGN475), an anti-NGF pain drug for osteoarthritis, which is up against some competition after Pfizer and Eli Lilly got things going again after a long pause to assess safety issues. Patients had a bad habit of blowing out their joints after taking the drug, and developers had to be careful to exclude patients at risk.

Put it all together, and Regeneron’s relatively modest $1.5 billion R&D budget – augmented by Sanofi – is outperforming most of its peers, and many much larger companies that have yet to nail down a successful R&D strategy.

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