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 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.
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