Novartis CEO Outlines Ambitious Pipeline Strategy: 60 Key NDA Submissions and 26 Potential Blockbusters in the Next Three Years

At an event in London on November 5, Novartis CEO Vas Narasimhan showcased the robust strength of Novartis’ R&D pipeline. Vas Narasimhan stated externally that its drugs, cell and gene therapy platforms would contribute no fewer than 60 key new drug applications between 2019 and 2021, with 26 drugs having blockbuster potential already passing through the clinical development stage of conceptual validation.

Novartis CEO Vas Narasimhan

Just a few days ago, Jay Bradner, Head of R&D at Novartis, revealed that “the company has discontinued 90 new drug projects” (see: Novartis Streamlines R&D, Shelving or Transferring 90 New Drug Projects). This development aligns with statements made by Vas Narasimhan. After more than 20 high-quality candidates successfully passed proof-of-concept studies, the upcoming large-scale Phase III confirmatory clinical trials would consume substantial R&D resources, prompting Novartis to make the difficult decision to drop some projects with lower development priorities. In 2017, Novartis’s R&D expenditure exceeded $9 billion, second only to Roche and Merck & Co. Over the next two years, Novartis’s R&D spending is expected to continue rising sharply.

From Novartis’ perspective, a high-quality project is first and foremost Mayzent (siponimod), a blockbuster new drug for multiple sclerosis slated for approval in Q1 2019. A month ago, Novartis simultaneously submitted marketing applications for siponimod to the FDA and the EMA, and utilized a priority review voucher, underscoring the company’s strong commitment to this asset (see: Novartis Submits Marketing Application for Its Blockbuster Multiple Sclerosis Drug; Overview of FDA Priority Review Voucher Issuance and Utilization). Siponimod is an upgraded version of Novartis’ blockbuster drug fingolimod and is poised to become the first therapy capable of delaying disease progression in patients with secondary progressive multiple sclerosis (SPMS).

Another blockbuster investigational drug in Novartis’s multiple sclerosis (MS) pipeline is ofatumumab. Although this agent has already been approved under the brand name Arzerra for the treatment of hematologic cancers, Novartis believes that monthly subcutaneous administration of ofatumumab for MS offers a better safety profile and greater convenience, making it a strong competitor to Roche’s CD20 monoclonal antibody Ocrevus (ocrelizumab). Ocrevus is currently the only approved therapy indicated for both relapsing-remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS), with a dosing regimen of once every six months. Since its launch, Ocrevus has experienced extremely rapid sales growth, achieving global sales of CHF 879 million in 2017.

Novartis considers siponimod and ofatumumab to be drugs capable of challenging existing standard therapies. Additionally, Novartis believes that other investigational drugs with similar potential include the CRTH2 antagonist QAW039 (fevipiprant) for the treatment of moderate-to-severe asthma, the VEGF inhibitor brolucizumab (RTH258) for the treatment of neovascular age-related macular degeneration, the P-selectin antibody drug crizanlizumab (SEG101) for the treatment of sickle cell disease, and the IL-1β antibody drug canakinumab (ACZ885) for the treatment of non-small cell lung cancer.

While streamlining its weight-loss portfolio, Novartis has actually increased its investment in cell and gene therapies, exemplified by the $8.7 billion acquisition of the U.S. gene therapy company AveXis. Novartis currently has 13 cell and gene therapy programs in clinical development, with an additional nine projects scheduled to enter clinical trials in 2019.

In addition to the well-known CAR-T product Kymriah (tisagenlecleucel), other notable candidates in Novartis’s pipeline include AVXS-101, a gene therapy for the treatment of type 1 spinal muscular atrophy (SMA). This asset was acquired through the purchase of AveXis. Novartis expects AVXS-101 to receive regulatory approval in the first half of 2019.

In October last year, Novartis announced the acquisition of Advanced Accelerator Applications (AAA) for $3.9 billion, entering the field of radiopharmaceutical oncology drugs. AAA’s 177Lu-oxodotreotide received FDA approval in January 2018 for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. On October 18 this year, Novartis further announced its $2.1 billion acquisition of Endocyte to continue strengthening its radiopharmaceutical pipeline. Endocyte possesses a first-in-class asset, 177Lu-PSMA-617, currently in Phase III clinical trials for the treatment of metastatic castration-resistant prostate cancer.

John Tsai, Head of New Drug Development at Novartis

John Tsai, who oversees the clinical development of Novartis’ new drug projects, left Amgen to join Novartis in April this year, succeeding Vas Narasimhan in his former role. Undoubtedly, Tsai faces a daunting task, with numerous blockbuster projects needing to advance from pivotal clinical studies to market approval. Just last month, the FDA rejected Novartis’ marketing application for canakinumab, an anti-inflammatory drug, for cardiovascular indications.

However, EvaluatePharma also made a prediction that Novartis will surpass Pfizer and Roche in 2024 to become the world’s largest prescription drug company with $53.2 billion in revenue, driven by its diversified portfolio of innovative drugs as well as a robust pipeline including biosimilars and generics (see: Will Novartis Become the World’s Leading Pharmaceutical Company in 2024?).