Over the past year the R&D group at Novartis $NVS has developed one of the most muscular late-stage pipeline strategies in Big Pharma. They kept their lead in CAR-T and drove home the first approval in the field, and they have 4 Phase III efforts underway which they are showcasing during today’s R&D day in London.
The spotlight illustrates where this pharma giant — one of the top three among the global R&D players with a budget of about $9 billion — plans to invest the greatest energy in winning new approvals. And while a whole long slate of rivals are either struggling to demonstrate that they are on to new drugs of real importance or find some way to inspire innovation, Novartis development chief Vas Narasimhan is underscoring with this list why he was selected to take the CEO’s job.
None of these drugs have a lock on big new markets. But if they fall short, it won’t be for lack of trying.
Novartis’ top 4:
The scoop: Novartis execs kicked out the latest data on Friday demonstrating that this drug not only lined up well against Regeneron’s Eylea in wet AMD, but also looked better in some respects regarding disease modification. With a once-every-12-weeks versus a once-every-8 weeks dosing regimen for a therapy that’s injected into the eye, Novartis thinks it can steal a big chunk of a multibillion-dollar market for itself.
Second thoughts: Regeneron isn’t about to roll over on this one. They are working on their own 4X per year treatment regimen and have a next-gen drug in the pipeline that will look to do Eylea — and RTH258 — one better.
AMG 334 (erenumab):
The scoop: Novartis is partnered with Amgen on this CGRP migraine drug, which is looking to help set a whole new standard of care in treating a crippling ailment. And they have the late-stage data to prove it works safely. No wonder Novartis reworked its deal earlier this year to grab a share of the all-important US market.
Second thoughts: They’re not alone. Eli Lilly, Teva and Alder are all lining up their own rivals, meaning that commercialization is likely to take place amid some brutal competition, with payers playing them off against each other.
The scoop: Novartis grabbed the lead with this drug, gaining an approval for psoriasis 5 years ago. This year it followed up with some strong data backing up its durability, adding impressive extension data for ankylosing spondylitis and psoriatic arthritis. And Novartis has big plans to rack up new approvals for more indications. Next stop: spondyloarthritis.
Second thoughts: Once again, Novartis is not alone. There are other head-to-head rival drugs out there, including therapies from J&J (Tremfya), Eli Lilly and even Valeant. Novartis is in a strong position, but it can’t take anything for granted.
The scoop: This was Novartis’ dark horse, the cardio drug that surprised analysts with a win in demonstrating how it could help a huge market of heart patients. Cardio remains one of the biggest disease fields on the planet, with massive commercial potential. And Novartis has been concentrating on one segment of the market in coming up with the kind of targeted data that payers won’t be allowed to ignore. An update on that score is expected quite soon.
Second thoughts: Cardio is big, it’s also been massively disappointing for developers. Amgen tried and failed (so far) to win over payers with its own data on PCSK9, and Merck just walked away from the only successful CETP drug because the benefit for patients was too marginal to generate any commercial expectations. To win here, Novartis will have to prove value — far beyond what it takes to win an approval.
Image: Novartis. Shutterstock
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