Novartis' (NVS) Sandoz Gets EC Nod for Tysabri's Biosimilar
Novartis’ NVS generic arm Sandoz announced that the European Commission (EC) granted marketing authorization to Tyruko (natalizumab), a biosimilar of Biogen’s BIIB leading multiple sclerosis (MS) drug Tysabri.
The biosimilar has been approved for the same indication as the reference drug Tysabri — as a single disease-modifying therapy in adults with highly active relapsing — remitting MS.
The biosimilar has been developed by Polpharma Biologics. Sandoz entered into a global commercialization agreement for biosimilar natalizumab with Polpharma Biologics in 2019. Per the terms, Polpharma Biologics is responsible for the development of medicine, manufacturing and supply of drug substances and Sandoz has the rights to commercialize and distribute the same in all markets through an exclusive global license.
Last month, the FDA also approved Tyruko as a monotherapy to treat all indications covered by the branded drug Tysabri for relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS and active secondary progressive disease, as well as Crohn’s disease in adults.
Tysabri is one of the leading drugs in Biogen’s strong MS portfolio, which comprises Tecfidera, Vumerity, Avonex, Plegridy and Fampyra. Sales of Tysabri came in at $955.9 million in the first half of 2023. Hence, the biosimilar approval in the EU and the United States provides a strong opportunity for Sandoz.
Shares of Novartis have risen 12.2% year to date compared with the industry’s 6.1% growth.
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Of late, the going has been good for Sandoz, which boasts a strong portfolio with eight marketed biosimilars and a pipeline of 25 compounds in various stages of development.
Sandoz earlier announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending marketing authorization for biosimilar trastuzumab (breast and gastric cancer), developed by EirGenix, Inc.
Earlier in the month, Sandoz entered into a development and commercialization agreement with Samsung Bioepis to commercialize biosimilar SB17.
Biosimilar SB17 is an investigational biosimilar of Johnson & Johnson’s JNJ Stelara (ustekinumab). Stelara is approved for the treatment of autoimmune disorders, including Crohn's disease, plaque psoriasis, psoriatic arthritis and ulcerative colitis. Sales of the drug came in at $5.2 billion.
Per the terms, Sandoz will obtain exclusive rights to commercialize the biosimilar SB17 in the United States, Canada, the EEA, Switzerland and the U.K.
Per the release, the deal will further strengthen its immunology franchise. In May, J&J settled litigation with Amgen, as a result of which J&J does not anticipate the launch of a biosimilar version of Stelara until January 2025.
Novartis AG Price, Consensus and EPS Surprise
Novartis AG price-consensus-eps-surprise-chart | Novartis AG Quote
Novartis recently confirmed plans for the 100% spin-off of Sandoz, with trading of new Sandoz Group AG shares and American Depositary Receipts (ADRs) to commence on Oct 4, 2023.
The spin-off will be completed via the distribution of a dividend-in-kind by Novartis. Each Novartis shareholder will receive one Sandoz share for every five Novartis shares and each Novartis ADR holder will receive one Sandoz ADR for every five Novartis ADRs.
Novartis shareholders and ADR holders will receive a cash amount for any fractional interest. The spin-off is expected to be tax-neutral for Swiss tax and US federal income tax purposes.
Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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