Success for depression pill gladdens Lundbeck and Takeda

Depression pill Lu AA21004 (vortioxetine) looks like it will help Lundbeck to fix the hole in its revenue from the loss of Cipralex’s market exclusivity. The Danish group reported positive topline results from two US trials and one European trial, setting the stage for regulatory filings on both sides of the Atlantic in the second half of 2012.

Shares rose 10% to DKr118.60 on the news yesterday following the announcement of the positive results before the Danish market’s close, an increase likely held back by otherwise negative news on global exchanges. Higher dosing in heavier US patients may have helped Lundbeck recover from past failure with the multi-modal antidepressant (Lundbeck disappointment highlights absence of value, June 8, 2009). The company believes its milder side effect profile will help it gain traction in an increasingly genericised antidepressant space.

Happy news

Success for ‘21004 is a defining catalyst for Lundbeck (Event - Lundbeck hoping to get happy with pill trial success, March 13, 2012). Depression pill Cipralex lost patent protection in February; this is already being felt by the company, which reported a 55% decline in revenue for the product in the US, where it is sold as Lexapro by partner Forest Laboratories. Lundbeck’s first quarter 2012 revenue declined 8%, to DKr 3.78bn ($650m) when compared with the first quarter of 2011.

Alzheimer’s drug Ebixa, the company’s third-biggest moneymaker, loses patent protection this month. In all, Lundbeck has a remarkable 65% of its sales at risk to generic competition this year, the most in the industry (As patent storm peaks Lilly and Astra have furthest to fall, February 9, 2012).

Thus it needs to span a rather yawning gap and as '21004 is the company’s biggest growth driver, trial success was essential. Likewise with US partner Takeda, which has 67% of its sales exposed to patent expiry risk in the next three years.

Acting on several targets to modulate neuronal firing and neurotransmitter release to increase levels of serotonin, noradrenaline, dopamine, acetylcholine and histamine in specific areas of the brain, ‘21004 is forecast to have risk adjusted worldwide sales of $573m in 2018, according to EvaluatePharma data. Of that, Lundbeck will earn $356m through its US co-marketing partnership with Takeda, ex-US sales and Japanese royalties, while Takeda will pocket $279m from the US and Japan, analysts believe.

With trial success, those numbers may see an uplift as the risk of failure fades. The company has forecast peak sales of DKr5-10bn ($860-$1.72bn), depending on how widely ‘21004 is able to be prescribed under approved labelling.

Lundbeck expects European filing in the third quarter and US filing in the fourth, the latter of which will trigger a DKr250m milestone.

More detail needed

Lundbeck executives disclosed little beyond headline data: success in three phase III trials, two in the US and one in Europe, covering nearly 1,700 patients; the three trials tested doses ranging from 10 to 20mg and measured improvements in the Montgomery-Åsberg depression rating scale after eight weeks of treatment. One of the US-based trials used Eli Lilly’s Cymbalta as a reference drug in addition to placebo.

Analysts from UBS reckon the two successful US trials will be enough to garner FDA approval, although full data are not expected to be disclosed until a medical meeting in 2013. Thus it will be hard to say exactly how it measures up to established products like Pristiq or Cymbalta, not to mention off-patent products like Zoloft and Prozac.

Company executives and analysts believe there is still a medical need for depression products, in spite of the many generic and branded products still on the market, as demonstrated by the number of patients who see no or little clinical benefit from first-line medications and discontinuations from adverse effects. Pfizer’s Pristiq, forecast as the biggest branded seller in 2018, launched in 2009 and Forest Laboratories’ Viibryd in 2011; neither is a first-in-class drug, indicating that regulators are willing to approve more drugs in the category.

Amongst its differentiating factors, Lundbeck hopes, will be a better side-effect profile. It has shown little of the insomnia, sedative or sexual dysfunction side effects of many marketed drugs.

There is no doubt that Lundbeck has cleared an important hurdle, and has stoked hopes that it will return to sales growth following launch of ‘21004. How much of a patch it is to the company’s sales revenue will depend on its label, not to mention what value insurers and government health programmes place on the pill. Thus, additional data will be eagerly awaited.

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