Amarin has been teasing big plans for Vascepa marketing when—and if—the med wins a new cardiovascular prevention approval this fall. And now we know just how big those plans are.
With an expedited FDA review underway and a record six months of sales under its belt, Amarin aims to double its Vascepa sales force to 800 by October. And it’s upping its 2019 revenue forecast in the meantime, to $420 million on the high end—a 20% increase.
The updated forecast follows a streak for Amarin driven by Vascepa’s booming sales, with the Irish drugmaker raking in between $170 million and $174 million in the first half, roughly 80% better than the year before.
Amarin’s treading carefully on long-term Vascepa forecasts, though, particularly with the FDA’s decision on its label expansion still yet to come. The agency is expected to rule on the new label by September 28.
“While Amarin remains optimistic that Vascepa will generate billions of dollars in revenue in the years to come, the history of other therapies for chronic conditions suggests that growth builds over multiple years, and thus, the company is not prepared to provide quantified guidance regarding revenue levels beyond 2019,” the company said in a release.
Shareholders and analysts aren’t so reluctant to place big hopes on Vascepa, seeing the potential for a blockbuster backed by landmark trial data in patients with high LDL cholesterol with elevated persistent triglycerides.
In pre-market trading Tuesday, Amarin’s share price jumped 9.2% from Monday’s close to $20.36 per share on the back of the updated revenue forecast, a more than 600% increase from the year before.
Jefferies analyst Michael Yee, for his part, said Amarin’s boosted forecast of $420 million at the high end could still be an undershot. And that’s despite some uncertainty about whether the FDA will call an advisory committee to discuss Vascepa’s label—and potentially some uncertainty about the drug’s trial results.
“Bottom line—we think there won’t be a panel,” Yee said in a Tuesday note to investors. “If they get notified of a panel, the stock may pause due to recent strong run-up and rally.” Investors would likely be nervous about topics up for discussion at a panel review—and about what might happen there, despite widespread expectations of a green light.
Amarin’s application to the FDA follows its massive CV prevention data win from a phase 3 trial, dubbed Reduce-It, that was released in September. In that study, Vascepa lowered the risk of a major adverse CV event by 26% in patients previously untreated with statins compared with placebo. In statin-treated patients, the drug cut those risks by 30%. In both instances, patients were followed for a median of 4.9 years.
Vascepa is currently approved to reduce triglyceride levels in adults with severely high triglycerides.
Immediately after the Reduce-It trial result, Amarin hired 265 new employees to tout Vascepa to physicians, the company said. Despite the rapid growth in staff, Amarin hasn’t yet incorporated the stepped-up marketing into its revenue forecast.
“Based on available data, it typically requires multiple months for newly hired sales representatives to become meaningfully productive particularly if they are calling on healthcare professionals who also are new to Vascepa, which will be the case for a large part of such sales force expansion,” the company said.
However, the Reduce-It trial wasn’t all roses for some market watchers. Critics pointed to elevated LDL levels in the trial’s control arm as a sign that Vascepa’s data could have been skewed. But outside investigators said those figures had little effect on the drug’s overall performance, according to Yee.
Even with an FDA nod still up in the air, Vascepa has benefited from booming uptake with physicians and a vote of confidence from the American Diabetes Association, which recommended the drug to cut heart risks in patients with diabetes and atherosclerotic cardiovascular disease and high triglyceride levels.
Amarin could capitalize on that growing swell of support with a direct-to-consumer advertising campaign now up for review by the FDA’s Office of Prescription Drug Promotion. That advertising push would follow Vascepa’s new approval if it comes as expected.
Cantor analyst Louise Chen said the new ad campaign could roll in the second quarter of 2020, based on similar timelines for new campaigns.
By Kyle Blankenship
Source: Fierce Pharma
The Serum Institute of India (SII) expects to soon receive World Health Organisation (WHO) emergency use authorisation for the Oxford University/AstraZeneca Covid-19 vaccine, produced for mid and low-income countries.
According to the deal, Sanofi will gain full global rights to Kymab’s fully human monoclonal antibody, KY1005 that attaches to OX40-Ligand and can potentially treat various immune-mediated diseases and inflammatory ailments.
Moderna tapped veteran Amgen executive Corinne Le Goff to spearhead that effort as chief commercial officer.