Novartis expects 10 NME filings by end-2016

Novartis told investors today that it is entering a particularly fruitful period of product development, with 10 new molecular entities (NMEs) due to be submitted for approval in 2015 and 2016.

The hike in R&D output for the company’s pharmaceuticals division comes after a transitional year for the company which saw it divest animal health and vaccines operations and set up a joint venture for over-the-counter drugs, allowing it to focus on its prescription medicine and eyecare businesses.

The new crop of filings – which includes potential blockbusters for cancer and heart failure – is coming through while Novartis is still enjoying buoyant growth for recently launched products, including oral multiple sclerosis therapy Gilenya (fingolimod), Jakavi (ruxolitinib) for myelofibrosis and its stable of therapies for chronic obstructive pulmonary disease (COPD).

Moreover, the company has just scored approvals in the US, EU and Japan for Cosentyx (secukinumab), a first-in-class interleukin-17 inhibitor with blockbuster potential in psoriasis and related disorders, and has also filed LCZ696, a much-anticipated new drug for chronic heart failure that at least one analyst has suggested could be an $8 billion product.

This year should see regulatory filings for buparlisib (BKM120), a P13K inhibitor for breast cancer, LCQ908 for the rare disease familial chylomicronemia syndrome (FCS) and acute myeloid leukaemia candidate midostaurin (PKC412), an orally-active FLT3 inhibitor.

During 2016 Novartis is expecting no fewer than seven marketing applications, including RLX030 for acute heart failure and – arguably most notably – CAR T cell therapy CTL019 for acute lymphoblastic leukaemia (ALL).

Novartis chief executive Joe Jimenez told investors today that the new product cycle is setting up the company for strong revenue growth in the coming years.

“We delivered solid sales growth with margin expansion, strengthened innovation, and advanced our quality and productivity agendas,” he said.

His comments came as Novartis reported declines in both revenues and profits in the fourth quarter of 2014 on the back of generic competition, restructuring costs and currency factors. The company earned net profit of $1.49 billion – down almost 27 per cent – on revenues that fell 2 per cent to $14.63 billion.

Turnover of Novartis’ biggest selling drug Glivec/Gleevec (imatinib) for chronic myeloid leukaemia and gastrointestinal stromal tumours (GIST) was largely flat at $1.24 billion in the quarter, while follow-up Tasigna (nilotinib) climbed 30 per cent to $428 million.

Among Novartis’ other new products, Gilenya rose 32 per cent to $666 million, kidney cancer drug Afinitor (everolimus) brought in $426 million – a rise of 24 per cent – and Jakavi leaped by more than 70 per cent to $84 million.

Novartis’ COPD franchise – including recently-introduced combination product Ultibro (indacaterol/glycopyrronium) – also put in a strong showing with full-year sales almost doubling to reach $484 million.

In 2015, Novartis is forecasting mid-single digit sales growth and a high-single digit rise for core operating income.

Image courtesy of Shutterstock/Lisa S.


Jimenez hails ‘New Novartis’

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