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Incyte shares fall on fears over Jakafi-related infection
March 18 |
March 18 (Reuters) - Incyte Corp said a 75-year-old male patient taking its lead drug to treat a rare bone marrow disease developed a brain infection but that it was not immediately clear whether the drug, ruxolitinib, caused it.
The company's shares fell 13 percent to $21.61 on Monday as the lack of clarity on the cause of the infection, progressive multifocal leukoencephalopathy (PML), led to concern among investors.
Some media reports suggested that the patient had died of the infection, but Incyte's Chief Drug Development and Medical Officer Richard Levy told Reuters that the patient was still alive.
Incyte said it would be premature to doubt whether the drug's benefits outweighed its risks, and most analysts agreed.
The reason for the infection had not been determined, and this case was observed in only one of the nearly 10,000 patients who have been treated with ruxolitinib around the world, Cowen and UBS analysts said.
Incyte said in a regulatory filing that an independent assessment to determine the cause of the infection was planned and that it had informed the U.S. Food and Drug Administration about the episode. (r.reuters.com/mah76t)
Ruxolitinib is sold as Jakafi by Incyte in the United States and as Jakavi by Swiss firm Novartis AG in other countries to treat patients with intermediate or high-risk myelofibrosis - a rare bone-marrow disease for which no other therapy exists.
"One cannot rule out that there may be an association between Jakafi and PML, and that over time the risk of PML escalates to the point where it becomes a deterrent to use in patients with less severe disease," Cowen & Co's Eric Schmidt wrote in a note to clients, retaining his "outperform" rating on Incyte stock.
The PML infection is caused by the JC virus, often seen in AIDS patients whose immune systems are generally weak. The infection causes further weakness and can lead to life-threatening disability and death.
The proven tendency of Biogen Idec's big-selling multiple sclerosis drug Tysabri to cause PML is considered as a major downside of the treatment.
Incyte's Levy said the first development of PML-related symptoms in the patient occurred within the first two months of his treatment, and that was "unusual."
"(It) probably means that the patient had an underlying problem with the JC virus that is the cause of PML, before the patient was started on our drug," he added.
Jakafi added $136.0 million to Incyte's total revenue of $297.1 million in 2012, and last month the company forecast it would rise to between $210 million and $225 million this year.
Analysts on average expect Jakafi to bring in sales of $223 million this year, according to Thomson Reuters Pharma.
Shares of the Wilmington, Delaware-based company closed down 4.2 percent on the Nasdaq. Nearly 9 million shares changed hands, over six times their 10-day average trading volume. (Reporting by Zeba Siddiqui in Bangalore; Additional reporting by Balaji Sridharan; Editing by Sriraj Kalluvila)
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