EMA hands Novartis good news on Xolair but a rebuke for serelaxin

Swiss drugmaker Novartis ($NVS) got a mixed bag of news from European regulators Friday. It got a recommendation for its asthma drug Xolair to treat a chronic form of hives. Regulators, however, slapped down its new heart drug serelaxin, a product that Novartis is counting on bringing in more than a billion dollars a year.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended use of Xolair as an add-on therapy for chronic spontaneous urticaria (CSU) in adult and adolescents at least 12 years old that don't respond well to use of H1 antihistamines. CSU is a particularly nasty form of hives that can cause sufferers to lose sleep and have anxiety and even depression. Novartis partners with Roche's ($RHHBY) Genentech on Xolair, which Novartis reports has worldwide sales of more than $1 billion. The European Commission generally follows the recommendations of CHMP.

While Novartis was touting the Xolair news, it was scrambling to contain damage from the news that CHMP was unimpressed with the trial results presented for serelaxin, a drug candidate that some analysts say should have peak sales of more $1.5 billion. The drugmaker will have to offer up data from another study. The drugmaker said it will do that, but also will seek conditional approval from regulators in the second quarter and then later seek full approval, allowing it to generate some sales sooner. There also is potential the EU findings will influence the FDA, which has given the drug candidate "breakthrough" status.

But not everyone was all that upset, Bloomberg reports. It says that Tim Anderson, an analyst with Sanford C. Bernstein & Co., told investors in a note, "The setback in Europe is only a modest negative. The company has generally been more bullish than investors on this drug's prospects, and while EU regulators may have issued a negative opinion, in the U.S. approval seems more likely."

Still, it is a blow to the drugmaker that is making job cuts and reorganizing itself as it prepares for generic competition for drugs likes its blockbuster blood pressure drug Diovan and cancer fighter Gleevec. The two drugs, Bloomberg points out, generated $9.1 billion of the company's $56.7 billion in 2012 revenue. Earlier this week, Novartis announced it was reshuffling 500 positions as it prepares for new drug launches, launches that ostensibly would have included serelaxin. It said it would let a bunch of people go in support but beef up in consumer healthcare and in its supply chain. It was just the most recent job-hewing for the Swiss drugmaker, which has shed thousands of jobs over the last several years.

- here's Novartis' Xolair release
- and Novartis' serelaxin release 
- see the committee's assessment (PDF)
- read the Bloomberg story

Related Articles:
European regulators hand Novartis a big setback on a top blockbuster prospect
Novartis says asthma blockbuster Xolair also effective against serious hives
Novartis to cut 500 Swiss pharma jobs, then staff up in OTC, generics

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