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Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

SPECIAL REPORT #43

Novartis R&D Day

On Thursday December 5, Novartis, the largest European Biopharmaceutical company, with 2019 expected sales nearing $55 billion, has detailed its development efforts during its annual R&D Day, in London. In terms of approval 2019 will be a great year for the Swiss giant and the company told investors that they could even expect more in the coming years.

In 2019, Novartis received approvals for five potential blockbusters: Mayzent for the treatment of multiple sclerosis, Zolgensma a gene therapy for treating spinal muscular atrophy, Pigray a treatment for breast cancer, Beovu, a treatment for patients with wet age related macular degeneration and Adakvea to treat sickle cell disease. This year was a “breakthrough” year for Novartis, Vas Narasimhan, its CEO said in his opening statement and he added that “the near term brings yet another catalyst-rich period with pipeline progress across the portfolio that can sustain long-term growth”.

Looking ahead, the company is planning 80 major drug submissions from 2020 to 2022 in the US, Europe, Japan with as many as 50 submissions in China alone in the 2019 to 2023 period. According to management, of that group 25 approvals could become new blockbusters or extensions for existing drugs and the new treatments are ranging over almost of Novartis’ core areas : oncology, CRM (cardiovascular, renal and metabolism), IHD (immunology, dermatology and haematology) neuroscience, ophthalmology, repiratory and global health.

The current development portfolio is also highly impressive with 160 projects in clinical trials and more than 500 ongoing clinical trials. Novartis also announced that it is heavily investing into cell, gene and radioligand therapy platforms with 16 identified clinical candidates already emerging from those technologies.

Key filings expected in 2020 are:

Alpesilib for multiple other tumours and breakthrough designation for PROS (PIK3CA related overgrowth spectrum)

AVSX-101 as a treatment for spinal muscular atrophy of type 2/3 (IT formulation)

Entresto as a treatment for chronic heart failure with reduced ejection fraction

177Lu-PSMA-617, a radioligand for the treatment of metastatic castration-resistant prostate cancer   

Feviprant for the treatment of asthma

Spartalizumab combo (Sparta-Datram) as a treatment for unresectable or metastatic melanoma

The Year 2019 would have been even shinier for Novartis without the bemoaned issues related to Zolgensma : pricing, data manipulation scandal and safety scare all appearing over the summertime. Still, Vas Narasimhan made clear that building trust and getting rid from the past scandals were top priorities for him.

December 6, 2019

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