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FDA fast-tracks Elan’s Alzheimer’s drug

Speeds up regulatory process for ELND005 for the treatment of neuropsychiatric symptoms

FDA headquarters White Oak

Elan's limited pipeline received a boost yesterday with the decision by the US Food and Drug Administration (FDA) to grant fast-track status to its Alzheimer's disease candidate ELND005.

The designation is reserved for drugs that address unmet medical need in serious conditions, and will speed up the regulatory process for ELND005 in Alzheimer's patients with neuropsychiatric symptoms (NPS).

The FDA's decision is based on a phase II study in which ELND005 demonstrated a decrease in the emergence and severity of specific NPS, which are thought to occur in 90 per cent of patients with Alzheimer's and include agitation and aggression.

Additional clinical trials are ongoing to further demonstrate the safety and effectiveness of the drug and support the FDA submission.

The announcement will be warmly welcomed by Elan, which has few pipeline options after selling its lead product, multiple sclerosis drug Tysabri (natalizumab), to Biogen Idec in February 2013 for $3.25bn plus a royalty stream.

Since then, Elan has attempted to boost its revenue prospects, and protect itself from acquisition, by paying $1bn for a royalty interest in four respiratory drugs developed by Theravance and GlaxoSmithKline, including Breo.

On top of this, the past few months have seen Elan acquire Austrian company AOP Orphan for more than $500m, and take stakes in drug developers Newbridge Pharmaceuticals and Speranza Therapeutics worth $284m and $78m respectively.

These deals have yet to provide Elan with definitive pipeline prospects, and have been roundly criticised by Royalty Pharma – a firm that specialises in buying up intellectual property assets in the drug sector and is engaged in an ongoing battle to add Elan to its portfolio.

Royalty's interest in Elan was first noted in February this year when it proposed a deal that valued Elan at about $6bn.

Since then, things have turned somewhat ugly, with Elan continuing to spurn Royalty's advances before winning a temporary restraining order forcing Royalty put its hostile takeover bid on hold.

18th July 2013

From: Research, Sales



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