New approvals in TNF-blocker class
pharmafile | October 20, 2005 | News story | Sales and Marketing |
Competition in one of the industry's fastest growing markets is intensifying with new approvals for two TNF-blocker drugs.
Schering-Plough and Centocor's Remicade (infliximab) received European approval for the treatment of moderate to severe plaque psoriasis, as it seeks to catch the market leader Enbrel (etanercept).
Remicade is the second TNF-blocker, after Wyeth and Amgen's Enbrel, to be licensed for the indication in Europe.
The third and newest TNF-blocker on the market, Abbott's Humira (adalimumab), is in phase III clinical development for a psoriasis indication.
US regulators have just approved Humira as a first line treatment for moderate to severe rheumatoid arthritis and as a treatment for psoriatic arthritis.
Abbott, which refers to Humira as a 'pipeline in a product' because of its potential indications, has also submitted the drug as a treatment for ankylosing spondylitis to regulators in the US and Europe.
Humira has been Abbott's most successful product launch to date, in terms of its speed to blockbuster status, which it will achieve this year, and its overall sales to date since it was first approved in 2003.
Peter Isakson, divisional vice president, discovery at Abbott, said: The idea with a pipeline in a product is that you can start with one disease, in Humira's case rheumatoid arthritis, and then look at other inflammatory autoimmune diseases to potentially give it a much broader therapeutic focus.
"That's why we are conducting trials in psoriasis and Crohn's disease so that Humira can be used to treat a larger variety of patients."
All three manufacturers are following the same strategy of pursuing multiple indications for their TNF-blocker drugs.
The TNF-a (tumour necrosis factor alpha) protein is thought to play a role in the development of rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, juvenile rheumatoid arthritis and Crohn's disease.
Enbrel's indications encompass all seven diseases in some form, following its first approval in 1998 for rheumatoid arthritis.
Enbrel continued its market lead in 2004 with sales of $2.5 billion, ahead of Remicade with $2 billion and Humira with $850 million.
A newer class of rheumatoid arthritis treatments called selective modulators of T-cell co-stimulation could eclipse sales of the TNF-blockers.
The first drug in this new class is Bristol-Myers Squibb's Orencia (abatacept), which received a recommendation from an FDA committee last month.
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