Event – Lundbeck forecast to get happy with Brintellix pills

While most companies facing the loss of $1bn a year in revenue would struggle to fill the gap, analysts and industry observers are expecting Denmark's Lundbeck to clear this hurdle with ease early next month.

A US marketing decision on the group’s depression project, and biggest future growth driver, is due by October 2 and few are predicting anything but for success for Brintellix. This is already forecast to become a blockbuster by 2018, despite entering into the heavily genericised antidepressant market, and is expected to kick-start Lundbeck’s return to growth.

Company Lundbeck  Takeda
Product Brintellix
Market cap $4bn $36.9bn
Product NPV $1.9bn $756m
% of market cap 47% 2%
Event type PDUFA
Date October 2, 2013

Despite going off patent more than a year ago Lundbeck’s lead marketed drug, the antidepressant Cipralex, is not forecast to see a drop in sales until 2014. Then its annual billion-dollar contribution will end, with sales falling from $1.01bn in 2012 to $511m in 2018, according to EvaluatePharma.

The decline in Cipralex is naturally mirrored in the dip in Lundbeck revenues from 2014 to 2015 and also the wider falls in the depression market. According to EvaluatePharma the sector is set to experience an 8% fall in annual compound growth over the next six years, with total sales falling almost 40% to $7.10bn in 2018.

Amid this carnage Brintellix sales are forecast to grow to $1.04 by 2018 for Lundbeck and its partner Takeda, making it the lead branded drug in the space by that date.

Antidepressants: Top 5 products in 2018 
Annual WW sales
Rank Product Generic name Company Pharmacology class Patent expiry 2012 2018 CAGR Total change Status
1 Brintellix vortioxetine Lundbeck/Takeda 5-HT3 & 5-HT7 (serotonin) antagonist, 5-HT1B (serotonin) partial agonist, 5-HT1A (serotonin) agonist & 5-HT (serotonin) re-uptake transporter (SERT) inhibitor - - 1,038 n/a 1,038 Filed
2 Pristiq desvenlafaxine succinate Pfizer 5-HT (serotonin) & selective norepinephrine reuptake inhibitor (SNRI) Feb 2022 630 862 5% 232 Marketed
3 Cipralex escitalopram oxalate Lundbeck Selective 5-HT (serotonin) reuptake inhibitor (SSRI) Feb 2012 1,007 511 (11%) (496) Marketed
4 Viibryd vilazodone hydrochloride Forest Laboratories Selective 5-HT (serotonin) reuptake inhibitor (SSRI) & 5-HT1A (serotonin) partial agonist Apr 2028 163 491 20% 328 Marketed
5 Cymbalta duloxetine hydrochloride Eli Lilly 5-HT (serotonin) & norepinephrine reuptake inhibitor (SNRI) Dec 2013 4,994 442 (33%) (4,552) Marketed
Other 3,431 2,637 (4%) (794)
Total 11,638 7,097 (8%) (4,541)

Analysts believe that the project will be given an edge by its clean side-effect profile, especially around nausea and sexual dysfunction. It is estimated that 50-60% of patients fail on their first depression treatment owing to tolerability issues, and many go on to fail on subsequent drugs.

Brintellix could have better tolerability thanks to it is mechanism of action. Antidepressants are mostly made up of two drug classes, the SSRIs and the SNRIs, which increase levels of serotonin or serotonin and norepinephrine. Brintellix, on the other hand, while also increasing serotonin and norepinephrine, ups levels of acetylcholine, dopamine and histamine. It is also thought that this multiple mode of action is behind the drug’s side effect profile and could have an impact on cognition.

Additional cognition and sexual dysfunction studies are due to read out in the first half of 2014, and if positive could put even more clear blue water between Brintellix and its branded and generic competitors (Brintellix data improve Lundbeck’s mood, May 20, 2013).

The dream, however, would be a cognition claim on the label, which would help with first-line use. At the moment it is thought the drug will be used as a first-line treatment in the elderly and as a second-line treatment after failure on generic SSRIs or SNRIs.

Selling the dream

Ahead of the cognition data read-out is potential European approval, which could come by November. Lundbeck will be commercialising Brintellix itself in Europe using its Cipralex sales force, while Takeda is expected to do most of the heavy lifting in the US by targeting primary care physicians who make up the bulk of prescribers. According to JP Morgan, Lunbeck will also have 200 psychiatric sales reps in the US to help it target key opinion leaders.

If it all goes to plan – and the FDA has not requested an adcom for the project, reinforcing confidence – the approval of Brintellix will be a significant catalyst for Lundbeck, allowing a return to revenue growth in 2016, according to forecasts.

The group also has other late-stage candidates in the form of phase III desmoteplase for stroke and phase II Lu AE58054 for Alzheimer's. If these too are successful over the next couple of years Lundbeck could have a lot to smile about.

To contact the writer of this story email Lisa Urquhart in London at [email protected] or follow @LisaEPVantage on Twitter

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