Even as Novartis takes home a partial win in court tied to its key blockbuster Entresto, the Swiss drugmaker continues to tighten its belt in anticipation of a generic heart med incursion later this year.
Novartis is laying off 427 U.S. employees who report into the company's East Hanover, New Jersey, headquarters, according to a Worker Adjustment and Retraining Notification alert filed (PDF) with the state this month. The job cuts will commence in mid-June and continue through late October, the filing states.
The staff shakeup can be attributed to changes Novartis is making to its cardiovascular commercialization model that are designed to “simplify and strengthen” how the drugmaker works with customers, a company spokesperson told Fierce Pharma over email.
“Our CV portfolio is evolving with both the upcoming loss of exclusivity (LoE) for Entresto and the continued growth of Leqvio and new product launches on the horizon, including pelacarsen,” the spokesperson explained.
Novartis plans to implement the new cardiovascular commercial structure April 1 and is encouraging employees whose jobs are cut to apply for open positions in other sectors of the company, the spokesperson said.
Entresto, approved in heart failure since 2015, has long been one of Novartis’ top growth drivers, bringing home $4.05 billion in U.S. sales in 2024. That said, a key combination patent on the drug—known generically as sacubitril and valsartan—is set to expire in July, with Novartis warning in a recent earnings presentation that the drug could lose U.S. market exclusivity in “mid-2025.”
Multiple drugmakers, including Torrent, Dr. Reddy’s Laboratories, Zydus, MSN Pharmaceuticals, Alkem and Lupin have already bagged FDA approvals for their generic Entresto offerings, prompting Novartis to go on the attack in a series of patent lawsuits. Many of those efforts have resulted in confidential settlements with generics filers, though the outcomes in the cases haven’t always favored Novartis.
Meanwhile, in an opinion signed Monday, a federal judge in New Jersey granted Novartis’ motion for a preliminary injunction to block the launch of MSN's proposed Entresto copycat, which would go by the name Novadoz.
The judge agreed with Novartis that the design of MSN’s Novadoz pills looks eerily similar to that of branded Entresto, with the Swiss drugmaker arguing in its case that the resemblance was an intentional move on MSN’s part to “deceive the marketplace.”
Still, the judge stopped short of siding with Novartis’ assertion that the Novadoz brand name is meant to inspire an association with Novartis and its generic spinoff Sandoz, asserting that the name is “likely not confusingly similar to Novartis.”
While the legal decision muddies the waters for now, MSN was slated to be the first manufacturer to launch its generic version of Entresto in the U.S., according to court documents concerning the injunction.
As for the other cardio drugs at the heart of Novartis’ new commercial strategy, Leqvio—approved in December 2021 to help lower levels of bad cholesterol in patients who’ve failed to do so with statins alone—pulled down $754 million in total sales last year, growing a whopping 114% at constant currencies over the sum it generated in 2023.
Back in August, Novartis rolled out positive late-stage data suggesting Leqvio could broaden its reach by moving into patients at low or moderate risk of developing atherosclerotic cardiovascular disease (ASCVD), which the company says accounts for 85% of all cardiovascular disease fatalities.
The drug’s current approval covers patients who already have ASCVD or heterozygous familial hypercholesterolemia who require additional lowering of low-density lipoprotein cholesterol.
Regarding pelacarsen, Novartis is currently testing the medication in a phase 3 study in patients with elevated lipoprotein(a) levels, which are considered a genetic driver of cardiovascular disease. The company is also running a late-stage test on the drug in Germany to assess pelacarsen’s ability to reduce patients’ need for lipoprotein apheresis, wherein lipoprotein is physically removed from the blood.
Novartis’ practice of initiating layoffs as it reworks marketing priorities is nothing new for the company.
In November, the Swiss pharma said it would lay off a total of 139 staffers—also in East Hanover—in a move slated to primarily affect the company’s commercial field sales associates working on Xolair for asthma and allergies and the oncology cocktail Tafinlar and Mekinist.
While a spokesperson stressed at the time that those drugs remain important brands for the company, Novartis said it elected to whittle down those commercial teams as it prioritizes a planned 15 new drug launches over the next several years.
Prior to that, Novartis in June 2021 said it was cutting 186 jobs supporting its migraine drug Aimovig. That round of cuts also took a toll on brand marketing and field sales positions based at the company’s East Hanover location.