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business newsNovartis Faces Lung Drug Questions
By
Brett Chase
Mar 04, 2011 3:30 pm
The company hopes to win approval for two dosing levels of inhaler for chronic disease. Safety concerns may trip up the panel of government advisers next week.
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First step: It has to win over a panel of US government advisers next Tuesday as the drug maker presents data on its inhaled treatment Arcapta Neohaler for chronic obstructive pulmonary disease, or COPD. The disease takes two forms: chronic bronchitis and emphysema, but many patients have a combination of both conditions. Smoking is the most common cause of the condition. Novartis is seeking US approval to sell its treatment.
The panel of medical experts will be asked to cast multiple votes on the safety and effectiveness of two different doses of the treatment, according to briefing documents prepared by Food and Drug Administration staff.
Novartis is hoping to win approval for both dosing levels. The panel’s recommendation will be used as the FDA decides whether to approve the treatment. Novartis failed to win FDA approval for the treatment in 2009.
If successful, Novartis enters a fast-growing treatment market with a potential blockbuster product. There are already multi-billion dollar COPD drugs on the market, including Spiriva -- sold by Pfizer (PFE) and Boehringer Ingelheim -- and GlaxoSmithKline’s (GSK) Advair (more than $8 billion in sales last year). Glaxo is developing a second-generation drug, Relovair, with smaller rival Theravance (THRX).
While these are big-selling drugs, Novartis and Glaxo are in a race to create an even more effective treatment. For drug companies, it’s a giant opportunity.
"This could be a $20 billion market and Novartis may set a new standard in COPD," Switzerland-based Helvea analyst Karl-Heinz Koch told Reuters this week. "There is still so much potential to improve what is out there."
Safety of inhaled products is a key issue, especially due to fears about the risk for people with asthma. Novartis’ drug is sold in other
countries by a different name but isn’t sold in the US for any dosing level. Still, it belongs to a class of drugs that may harm asthmatics and that concerns the FDA.
“The use of (the drugs) has come under scrutiny as a result of a safety signal of increased risk of severe exacerbations including
death in patients with asthma,” FDA staff wrote in the document for next week’s panel.
Leerink Swann analyst Howard Liang, who covers Theravance, says the FDA documents suggest that Novartis may have an easier time convincing the advisers next week to approve the lower dose version of its drug (because of safety concerns). That would be only a partial win for the company.
No positions in stocks mentioned.
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