Novartis says Leqvio launch will feature a 'modest initial ramp,' but blockbuster potential awaits

As Novartis creeps toward losing exclusivity for some big-selling medicines, the drugmaker is counting on new launches to replace lost sales and fuel growth. One such launch is cholesterol drug Leqvio, and execs said Wednesday the company is laying the groundwork for a medicine with "multiblockbuster potential."

Novartis' Leqvio won FDA approval in late 2021 as an adjunct treatment to diet and statins to lower the level of bad cholesterol in patients who have failed to control elevated low-density lipoprotein cholesterol (LDL-C) with statins. In presenting fourth-quarter results Wednesday, the company told investors to expect a "modest initial ramp as we lay the foundation" for the treatment.

Speaking on the company's conference call, Novartis' pharma chief Marie-France Tschudin said the company is working with U.S. healthcare systems and countries to “protocolize” the ways patients will end up on Leqvio. That process will vary from place to place, but Novartis aims to work with partners to identify care pathways and appropriate patients.

In the U.S., the company is working with 200 healthcare systems to support the rollout. Novartis has also set up a network of injection centers for added flexibility. 

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Across the pond, Leqvio's launch in the U.K. has been affected by a pause of non-COVID-19 healthcare services as part of officials' pandemic response there. Novartis has been busy in the background getting ready for the green light, Tschudin said. 

“We’re not at a standstill,” Tschudin said. “We’re doing the things that we would have to do anyway and are laying the groundwork for the future.” 

Novartis is launching Leqvio as it pushes for 4% annual growth through 2026. During that time frame, the company expects up to $9 billion in lost sales from generic or biosimilar launches. Vulnerable products include leukemia med Tasigna, eye medicine Lucentis, asthma drug Xolair and several others. 

To help combat those losses, the company is focusing efforts on growth drivers in a variety of diseases including immunology drug Cosentyx, Kesimpta to treat multiple sclerosis, Kisqali for breast cancer, gene therapy Zolgensma and others.

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For all of last year, Novartis generated $51.6 billion, a 4% increase at constant currencies. Notably, higher volumes chipped in eight percentage points of growth, but price erosion ate away two percentage points and so did generic competition.

Meanwhile, Novartis is still reviewing strategic options for generics unit Sandoz. For the first part of 2022, Novartis is separating financials for the unit to provide any interested parties with the relevant info, CEO Vas Narasimhan said Wednesday. Novartis hasn't decided whether to keep, sell or spin off the unit.