Denmark's Lundbeck has received some overdue good news with the announcement of positive results from a mid-stage trial of a compound to treat major depressive disorder which could become the firm’s next blockbuster.
The firm unveiled results from a 426-patient Phase II study of Lu AA21004 which showed “highly significant improvements” on the primary efficacy endpoints with both 5mg and 10 mg compared to placebo and had an attractive safety profile. The compound is being developed with Japan’s Takeda Pharmaceutical Co and is the lead product in the firms’ pact to develop several drugs in Lundbeck's pipeline for the treatment of mood and anxiety disorders, an alliance that could be worth up to $345 million to the Danish drugmaker.
Anders Gersel Pedersen, head of development at Lundbeck, said Lu AA21004 is the most advanced project within the new bis-aryl-sulphanyl amine class of compounds for the treatment of mood disorders and anxiety “and we look forward to further exploiting the potential of these novel projects." Phase III trials are expected to begin in the next few months.
The announcement sent Lundbeck shares up 8% to 154.50 Danish kroner and takes some pressure off the firm which has had a tough time recently. It has suffered a couple of late-stage failures of late, most recently with the stroke drug desmoteplase, and it is concerned about looming patent expiries starting in 2012 of the blockbuster Lexapro (escitalopram), sold in the USA by licensee Forest Laboratories, and its own Cipralex brand of the antidepressant.
To prop up its product portfolio, Lundbeck recently licensed exclusive rights for the major European markets for the insomnia treatment Circadin (melatonin) from Israel's Neurim Pharmaceuticals.
Under the terms of the agreement, Neurim, which is responsible for manufacturing the drug, received an undisclosed upfront payment and a share of revenue. Circadin was approved by the European Commission in June and Lundbeck, which expects to launch Circadin during 2008, has also acquired an option to evaluate commercialisation on markets outside of Europe.