Now that Alcon is officially off on its own, what is Novartis’ remaining eye medicine business looking at next? According to Nikos Tripodis, Novartis Ophthalmology’s worldwide franchise head, it's focusing on some cutting-edge innovations outlined by CEO Vas Narasimhan.
The business has a trio of top priorities, Tripodis said in an email interview. Bringing potential blockbuster brolucizumab to a successful launch in wet age-related macular degeneration, for one thing. Expanding in gene therapy, as spearheaded by the Luxturna treatment Novartis licensed from Spark Therapeutics, for another. And finally, exploring digital solutions in eye care—and possibly some M&A movements there.
Anyone who follows Novartis will notice that the two-pronged strategy—novel treatment platforms and a digital push—are an exact reflection of Narasimhan’s broader vision for the company.
AMD challenger brolucizumab
First up, the near-term focus is definitely brolucizumab, a potential rival to Bayer and Regeneron’s Eylea. Novartis paid up for a priority review voucher to speed FDA review and prep for a launch in 2019, and the company is already staffing up on sales reps in key regions, Tripodis said. In a February report, Evaluate Pharma projected the drug could reach sales of $1.38 billion by 2024.
The long-acting VEGF drug matched Eylea in best-corrected visual acuity (BCVA), the primary endpoint in two phase 3 trials dubbed Harrier and Hawk. And brolucizumab hit that mark when more than half of trial patients were dosed every quarter. Eylea is meant for dosing every eight weeks.
When the data were unveiled in mid-2017, analysts at Jefferies described the Novartis med's dosing schedule as "a significant differentiator and competitive advantage."
Brolucizumab also beat Eylea in some secondary endpoints, having consistently dried retinal fluid and reduced central subfield thickness (CST) over two years. But not all industry watchers are impressed; some argued that those markers aren't that important for wet AMD, otherwise known as neovascular AMD (nAMD). Tripodis disagrees.
"In nAMD, retinal fluid is a key marker of disease activity used by physicians to determine injection frequency in clinical practice," he told FiercePharma. "An increase in CST in nAMD is an important measure of abnormal fluid accumulation and edema and may be associated with reduced vision."
Novartis is counting on brolucizumab to expand its ophthalmology pharma portfolio, which now comprises more than 70 brands across many indications. And the franchise, which ranks as Novartis' second-largest in innovative medicines, does need help. Its $4.56 billion in 2018 sales amounted to a 2% decline from 2017 levels, thanks to stepped up U.S. competition for its travoprost products for glaucoma patients and generic rivals in Europe.
Lucentis, the Roche nAMD drug Novartis markets outside the U.S., offered the lion’s share of that revenue, with sales of $2.05 billion. But should Novartis be concerned of potential cannibalism after brolucizumab?
"We will manage both products as we always do when we have more than one product in an indication," Tripodis said. Besides, as he pointed out, Novartis’ head-to-head clinical trials against Eylea already indicated brolucizumab’s marketing rival.
Novartis’ eye therapy pipeline looks relatively thin compared to its immunology and oncology programs, where the Swiss drugmaker is enjoying rapid growth. Besides additional late-stage trials in diabetic macular edema and retinal vein occlusion for brolucizumab, there are also ECF843, a recombinant form of human lubricin Novartis licensed from Lubris, and UNR844, a potentially first-in-class topical treatment in phase 2 development for presbyopia.
Now that Alcon is officially off on its own, what is Novartis’ remaining eye medicine business looking at next? According to Nikos Tripodis, Novartis Ophthalmology’s worldwide franchise head, it's focusing on some cutting-edge innovations outlined by CEO Vas Narasimhan.
The business has a trio of top priorities, Tripodis said in an email interview. Bringing potential blockbuster brolucizumab to a successful launch in wet age-related macular degenera...
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