Novartis Contemplates Patent Cliff on Top Drugs, Plans for New Products – BioSpace

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Published: Feb 18, 2022 By Mark Terry

 
Like many companies with blockbuster drugs, the clock is ticking on Novartis’ drug patents until generic and biosimilar competition starts eating away at their sales. In the case of Novartis, the company is looking to three specific drugs, as well as the China market, to offset those losses.
Marie-France Tschudin, president of Novartis’ pharmaceuticals division, told S&P Global Market Intelligence that one of those drugs was a next-generation version of its gene therapy Zolgensma (onasemnogene abeparvovec), which runs $2.1 million per treatment. The therapy is used to treat spinal muscular atrophy (SMA), a genetic disease of the central nervous system (CNS) that affects all muscles in the body. The therapy is approved for children under the age of two.
A second drug is remibrutinib, a BTK inhibitor being developed to treat multiple sclerosis. In October 2021, the company reported positive Phase IIb study data in inadequately controlled chronic spontaneous urticaria (CSU). And the third drug is pelacarsen, which it licensed from Akcea Therapeutics, an affiliate of Ionis Pharmaceuticals, in February 2019. It is a targeted cardiovascular therapy for people with elevated levels of inherited lipoprotein(a).
Tschudin said, “We’re focused on U.S. and China. Those are really big growth opportunities for us.”
The company is expected to drop about $14 billion in sales by 2027 from patent expirations of M.S. drug Gilenya, eye drug Lucentis and heart therapy Entresto. That’ll put pressure on the new drugs and the rest of the pipeline to make up for that erosion.
Kerry Holford, an analyst with Berenberg, wrote in a January 28 note to investors, “Novartis must circumnavigate the expiry of a number of patents in its branded pharma business over the next few years. However, growth from its recently launched drugs and its large late-stage pipeline can more than fill the gap.”
The company’s focus has been on cardiovascular, neurological and genetic diseases. Tschudin said, “If there’s one place to start, it’s in cardiovascular disease. It’s top of mind for every single healthcare system worldwide. It’s a massive cost burden to society and when you think of it, 80% of it is preventable.”
Novartis also announced today that its Sandoz generics division launched a generic version of Bristol Myers Squibb’s oncology drug Revlimid (lenalidomide). It is used to treat several hemato-oncology diseases. It will be available in 19 countries across Europe. Lenalidomide is an oral thalidomide analogue.
“We are proud to make life-enhancing cancer treatments more accessible by launching our affordable and effective Sandoz Lenalidomide,” said Rebecca Guntern, Head of Sandoz Europe. “Sandoz is committed to developing and providing generic oncology therapies, to increase patient access to affordable, high-quality medicines. Today, we offer a broad portfolio of more than 50 oncology products, ranging from biologics to chemotherapeutics, hormones and supportive care treatments, covering a wide range of cancer indications.”
Novartis is currently conducting a strategic review of Sandoz and is considering a sale. Sandoz U.S. revenues are expected to continue dropping this year, which is likely to make it harder to sell. Although Novartis has yet to decide what, if any, parts of Sandoz it plans to put on the auction block, the asking price is expected to be about $25 billion or more. Sandoz’s production is so tied up with other parts of Novartis’ business that it may be difficult just to split off products. Chief Executive Officer Vas Narasimhan said he would make a decision on Sandoz by the fourth quarter.
At the company’s 2021 annual report, full year net sales were up 4%, but U.S. Sandoz sales had dropped 8%. However, European sales were up 4% for the Sandoz unit.
 
 
 
 
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