Novartis makes its case on why RTH258 can grab a blockbuster piece of Regeneron’s AMD market

Vasant Narasimhan, Novartis’ CEO-designate Bloomberg

Soon-to-be Novartis $NVS CEO Vas Narasimhan has peeled back the cover on more detailed Phase III data for their blockbuster Eylea rival RTH258 (brolucizumab), explaining why he believes the pharma giant has a new drug for wet age-related macular degeneration that has proven to be considerably better than Regeneron’s $5 billion franchise therapy Eylea. But he has one other hurdle to clear before making a slightly paused arrival at the FDA.

In a preview of data being released at the American Academy of Ophthalmology conference in New Orleans, the pharma giant’s development chief once again hit on the 52% to 57% success rate for their two big Phase IIIs. That handily cleared the 40% to 50% bar needed to qualify for an impressive success set by some analysts covering the company.

Novartis is betting that moving patients from once every 8 weeks for Regeneron’s flagship therapy to a 12-week regimen will win over a big slice of the market. But they’re backing up the appeal to patients with a pitch to payers and physicians, offering evidence of the drug’s ability to reduce the fluid that builds up behind the retina as the disease progresses, which damages the eye and leads to blindness.

“Payers wants to see fluid issues resolved to make sure the disease is controlled,” noted Narasimhan in a conference call with reporters. The drug, he explains, is a novel antibody fragment that is built in a way that allows an injection to squirt a high concentration of therapy into the eye. Better penetration is a key part of its argument that this drug can be more effective at longterm care than Eylea as well as the Novartis/Roche drug Lucentis.

At week 16 the two RTH258 arms had 33% and 35% fewer patients with damaging retinal fluid, and at 48 weeks one arm had 41% fewer patients in the danger zone, compared to the competitor. Active disease was observed in 23.5% of brolucizumab 6 mg patients versus 33.5% of aflibercept patients in HAWK, and in 21.9% of brolucizumab patients versus 31.4% of aflibercept patients in HARRIER.

The drug, says Narasimhan, “was consistently superior to Eylea.” And there’s a lot at stake, with Regeneron taking in $953 million in US Eylea sales in Q3.

But there is one potential hitch. Novartis obtained the drug through the acquisition of a small company, through which they inherited one manufacturing process. Novartis subsequently developed its own process and now regulators want the pharma team to run some patients through a small test to see if the new process holds up equally well.

As a result, Narasimhan says the company plans to file at the end of next year, rather than hustling the drug to the agency now, as most manufacturers would prefer. That’s toward the end of the H2 2018 schedule that Novartis has told investors, putting back any commercial showdown with Regeneron until later in 2019, after Narasimhan moves into his new job assuring investors that the company knows how to develop big new products.

That will buy Regeneron some more time to line up a possible competitive response. They’re working on nesvacumab (Ang2)/Eylea Phase II studies in DME and wet AMD that analysts are watching closely. And a spokesperson notes that Regeneron is also pushing ahead with its own quarterly dosing regimen of Eylea.

Regeneron is one of the most aggressive biotechs in the industry. They won’t simply stand aside as Novartis zeroes in on their big franchise.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
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Atlas Venture Cambridge, MA

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