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Novartis says pipeline is "industry leading"

Touts 14 drug candidates with $1bn-plus sales potential

Novartis building

Novartis appears to be keeping faith in the blockbuster approach to pharma, saying at its R&D update meeting this week that it could have 14 drug candidates with $1bn-plus sales potential on the market within five years.

The pharma major said it currently has 139 R&D projects on the go involving 73 new molecular entities (NMEs), which chief executive Joe Jimenez described as a "leading pipeline in all phases of development" and which "positions us well for continued future growth".

Like its peers in the pharma sector Novartis is coping with patent expirations on some of its earlier generation of blockbuster products, notably antihypertensive Diovan (valsartan) and cancer drug Glivec (imatinib).

At the meeting in Boston, US, Novartis highlighted a range of late-stage drug candidates, including serelaxin and LCZ686 for acute heart failure. The former is due for filing in early 2013 (although there has been some debate about the data in its phase III trial) while LCZ686 is earmarked for regulatory submission in 2014.

Cancer has been another productive area for the company, with 13 new drugs across 19 indications coming through the pipeline to help grow the business following Glivec's patent expiry.

Among these, Afinitor (everolimus) is expected to reach $2bn in breast cancer alone by 2017, with a supporting cast of just-approved myelofibrosis drug Jakavi (ruxolitinib) – as well as late-stage candidates BKM120 for various tumours and LDK378 for lung cancer – expected to add another $1bn to the tally.

Meanwhile, fast-growing chronic myeloid leukaemia (CML) drug Tasigna (nilotinib) – billed as a Glivec replacement – is emerging as a "major paradigm shift in CML treatment" according to Novartis, which said it is starting trial next year to see if it can achieved sustained, treatment-free remission in patients living with the disease.

Away from oncology, chronic obstructive pulmonary disease (COPD) drug QVA140 (indacaterol maleate and glycopyrronium bromide) "has the potential to establish a new standard of care", said Novartis, while it also has high expectations for AIN457, a novel IL-17 inhibitor with potential across multiple disease areas including psoriasis, ankylosing spondylitis, rheumatoid arthritis and multiple sclerosis.

"In 2012 alone, the pharmaceuticals division has received nine approvals or positive recommendations to date," said the company in a statement released ahead of the meeting.

"For the next 12 months, pharmaceuticals expects data read-out on 13 pivotal studies, nine filings and seven regulatory decisions".

9th November 2012

From: Research



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