Lundbeck celebrates Brintellix approval with job cuts
Perhaps it is fitting that one of the last things the FDA did before the US government shut down was approve an antidepressant.
Lundbeck is counting on the multi-mechanism, potential blockbuster Brintellix to aid its return to growth, and yesterday upped its revenue guidance for 2013 to DKr14.8bn-15.2bn ($2.7-$2.7bn) from an earlier estimate of DKr14.6bn-15bn. Despite this secure-looking future, though, the company is pressing on with a reorganisation that will see it cut around 200 jobs in the next two years.
Top of the list
Coincidentally, Lundbeck has made 200 new hires recently: the US sales force for Brintellix. Now approved for major depressive disorder, which affects around 7% of adults in the US each year according to the National Institutes of Health, the Takeda-partnered drug is forecast to sell $43m this year. Half of this estimate comes from US sales, where Lundbeck will co-promote with Takeda.
This is predicted to grow to over $1bn in 2018, putting Brintellix at the top of the list of bestselling, branded antidepressants (Event – Lundbeck forecast to get happy with Brintellix pills, September 16, 2013). By then, Lundbeck’s current biggest selling drug, Cipralex (citalopram), will have the number three position despite its patent expiring in 2012.
Lundbeck’s efforts in depression will now switch focus to brexpiprazole, the 5-HT1A and dopamine D2 partial agonist and 5-HT2 antagonist it licenced from Otsuka. Under development for schizophrenia and attention deficit hyperactivity disorder as well as depression, the drug is predicted to be a near-blockbuster in 2018 (Upcoming events: Otsuka looks beyond Abilify and the HFSA meeting, September 19, 2013).
Despite the approval of Brintellix and the boosted revenues, Lundbeck still feels the need for belt-tightening. Its forthcoming shakeup is designed to save it more than DKr500m ($90.5m) per year from 2016, and will see it divide its operations into six regions: Europe, the US, Canada, Asia, Latin America and the Middle East. Within Europe, the company's commercial structure will be organised into 10 business units from the more than 30 affiliates from which it is currently formed.
The €94m ($127m) fine Lundbeck received last month for anti-competitive behaviour will have added to the costcutting impetus. In June, the European Commission found that the company had collaborated with generic firms to delay the entry of generic citalopram and hit it with the fine. Lundbeck has protested vociferously and is appealing the judgement, but it could take as long as six years for the case to be resolved.
Lundbeck has cause to be grateful that Brintellix was approved on September 30. If the FDA had waited for the final PDUFA deadline of October 2, the federal shutdown means Lundbeck might have had to wait weeks before seeing its first US revenues.