In a bid to enter the promising checkpoint inhibitor field, Novartis NVS entered into a strategic collaboration agreement with commercial-stage biotechnology company, BeiGene, Ltd. BGNE, per which the former will in-license the latter’s anti-PD-1 antibody, tislelizumab, in major markets outside of China.
We note that tislelizumab is an anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. It is approved in China as a treatment for certain patients with classical Hodgkin’s lymphoma and metastatic urothelial carcinoma.
In addition, BeiGene has filed three supplemental new drug applications for tislelizumab in China — for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy, first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy and previously treated unresectable hepatocellular carcinoma (HCC).
Per the terms, Novartis will obtain the development and commercialization rights to tislelizumab in the United States, Canada, Mexico, the European Union, the United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia and Japan for an upfront payment of $650 million.
BeiGene is eligible to receive up to $1.3 billion upon the achievement of regulatory milestones, $250 million upon the achievement of sales milestones, and royalties on future sales of tislelizumab in the licensed territory. BeiGene will retain the rights to tislelizumab in China and other countries.
The agreement will expand Novartis’ oncology portfolio, adding late-stage PD-1 for monotherapy and potential proprietary PD-1 combinations, driving mid- and long-term growth. In addition, Novartis and BeiGene have identified multiple tislelizumab in combination with Novartis’ drugs for various indications.
Currently, 15 potentially registration-enabling studies on tislelizumab in a dozen indications, including NSCLC, HCC, esophageal squamous cell carcinoma, gastric cancer and nasopharyngeal carcinoma, are underway. The first ex-China regulatory filing is expected in 2021.
Novartis has gained 0.7% in the past year compared with the industry’s growth of 5.4%.
The company has a strong oncology portfolio and adding a late-stage PD-1 candidate will strengthen its pipeline.
Meanwhile, solid performance of other drugs like Cosentyx and Entresto and contributions from gene therapy, Zolgensma, have boosted Novartis’ top line but competition is stiff.
Cosentyx maintains momentum for the company on recent label expansions, despite stiff competition from AbbVie’s ABBV Humira and Johnson & Johnson’s JNJ Tremfya.
New launches like Piqray and Beovu are projected to fuel growth for Novartis as well.
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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