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Lundbeck buoyed by data on new antidepressant

LU AA21004 could help company cope with loss of patent protection for Cipralex/Lexapro

Lundbeck's antidepressant Cipralex/Lexapro (escitalopram)

Lundbeck has reported positive phase III data on LU AA21004, a new antidepressant that could help it cope with the impact of generic competition to flagship product Cipralex/Lexapro.

Shares in the Danish pharma company rose almost 9 per cent yesterday on the strength of the announcement of three new phase III studies looking at higher doses of the drug, which all showed that LU AA21004 significantly reduced symptoms in patients with major depressive disorder compared to placebo, but was still generally well-tolerated. 

LU AA21004 is described as a 'multimodal' antidepressant, causing enhanced levels of serotonin, noradrenaline, dopamine, acetylcholine and histamine neurotransmitters in specific areas of the brain. The drug is being co-developed with Takeda in the US and Japan.

"We are very pleased with the consistency of the efficacy and tolerability profile across the programme that we have obtained so far," said Anders Gersel Pedersen, Lundbeck's head of R&D.

LU AA21004 has now been tested at a range of doses from 5mg to 20mg, with efficacy shown at all dose levels. 

Lundbeck and Takeda said that with 10 placebo-controlled trials now complete - eight of which show efficacy for LU AA21004 - they are set to file for approval of the antidepressant in the US, Canada and Europe in the second half of the year.

Lundbeck needs LU AA21004 to succeed as the company is at the start of a difficult period, with revenues under pressure thanks to the expiry of patent protection for Cipralex/Lexapro (escitalopram) in the US and other markets such as Spain. 

Sales of Lexapro in the US - where it is marketed by Forest Labs - plummeted by more than 50 per cent in 2011 as generic competition took hold.

Analysts at Jyske Markets said in a recent research note that LU AA21004 could achieve sales of 10 billion kroner ($1.8bn) in 2018, assuming a market entry in 2013 which looks increasingly likely if Lundbeck's assessment of its phase III data stands up to scrutiny. Last year, combined sales of Cipralex/Lexapro were 8.5bn kroner.

Jyske believes that one of the major draws for LU AA21004 will be its safety profile, including a lack of sexual side effects which affect a number of other antidepressant classes. In the phase III trials, the most common side effects were nausea, headache, diarrhoea and vomiting.

15th May 2012

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