Lundbeck soars on PhIII success for blockbuster hopeful

Posted under Blog, Clinical Trials, Companies, depression, Diagnostics, Funding, Lexapro, Lundbeck, Medical Devices, Medical Supply, Pharmaceuticals, Pipeline, Regulatory, Startups, Takeda, Universities, Videos by john

Lundbeck shares spiked 9% this morning on the news that three late-stage studies of its new depression drug had delivered the data needed to support upcoming regulatory filings. The developer badly needs new therapeutics to replace Lexapro, an antidepressant that now faces generic competition.

"Lu AA21004 statistically significantly reduced depression symptoms in patients with (major depression) compared to placebo as measured by the Montgomery-Asberg Depression Rating Scale," the company reported. "In total, out of the ten large, placebo-controlled studies of Lu AA21004 completed in patients with MDD, eight have shown effect of Lu AA21004. Further analysis of the data is ongoing and data are expected to be presented at upcoming medical conferences." 

Lundbeck and its partner, Takeda, now plan to jointly file for an approval in the U.S. in the second half of the year, while Lundbeck will push ahead on its own in Europe and Canada. Bloomberg notes that Lundbeck has estimated potential annual revenue from the drug at about $2 billion.

It's standard operating procedure to mount a series of clinical studies for any new depression drug, as high placebo responses have been known to torpedo studies. Takeda and Lundbeck plan to jointly continue studies examining the drug's impact on cognitive dysfunction in depression.

- here's the press release
- read the Bloomberg piece

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Lundbeck banks on pipeline as antidepressant sales skid

Posted under Abilify, antidepressant, Blog, Companies, Diagnostics, Funding, generic competition, Lundbeck, Medical Devices, Medical Supply, Pharmaceuticals, Pipeline, Selincro, Startups, Treanda, Universities, Videos by rmcbride

Lundbeck executives touted the future products in the Danish drugmaker's pipeline after reporting a faster-than-expected decline in revenue from its best-selling antidepressant, Cipralex, which faces generic rivals. The company is banking on a lineup of late-stage drugs and soon-to-be launched meds to cover lost revenue from the drug, Reuters reported.

Lundbeck's CFO Anders Gotzsche emphasized the prospects of drugs such as Selincro for alcohol dependence, the experimental antidepressant Lu AA21004 in late-stage development and a long-lasting formulation of Abilify. Both Selincro  and the version of Abilify, a schizophrenia treatment, are under review for approval. According to Reuters, Gotzsche says those drugs as well as Treanda, which Lundbeck licensed from Cephalon, could hit the market within the next year and a half to boost revenue.

"Investors should focus on Lundbeck's pipeline," said Sydbank analyst Soren Hansen, as quoted by Reuters.

Lundbeck's pipeline includes 7 drugs that are in Phase III or registration for approvals, according to the company's website. The drugmaker, of course, is among many companies that are turning to their pipelines in hopes of recovering from the loss of key drugs to low-cost generic rivals.

- read Reuters' article

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Lundbeckfond contributes to $25M B round for AlloCure’s Phase II stem cell study

Posted under AC607, acute kidney injury, AlloCure, Blog, Companies, Diagnostics, Funding, Lundbeck, Lundbeckford Ventures, Medical Devices, Medical Supply, Pharmaceuticals, Pipeline, Startups, stem cell, SV Life Sciences Advisers, Universities, Videos by john

New investor Lundbeckfond Ventures has contributed to a $25 million venture round for AlloCure, a Burlington, MA-based stem cell company. The Series B cash will be used to advance AC607--AlloCure's lead program--into a mid-stage study for acute kidney injury. SV Life Sciences and Novo A/S also contributed to the round.

AC607 landed fast track designation at the FDA earlier this year, after the company touted the successful conclusion of an early-stage study of its treatment, a stem cell therapy derived from bone marrow cells. There are no effective treatments for AKI, says AlloCure, and that puts the company in line to develop a new treatment for a key unmet medical condition.  

"Building on the encouraging AC607 Phase I results presented last fall at the American Society of Nephrology annual meeting, AlloCure is poised to conduct a multicenter, randomized, double-blind, placebo controlled trial of AC607 for the treatment of AKI beginning this summer at a number of the leading academic institutions and hospitals in the United States," says CEO Robert M. Brenner. "We are very pleased to have secured the necessary financing to support the company through the completion of this critical work, and we welcome Lundbeckfond Ventures and Mette Kirstine Agger to the AlloCure board of directors."

Lundbeckfond Ventures is the venture arm of the Lundbeck Foundation, which owns a controlling interest in Lundbeck. The venture group operates independently of the pharma company.

- here's the press release

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Stem cell player moves to Mass.

PhIII placebo response complicates Lundbeck’s case for anti-drinking drug

Posted under alcohol dependence, BioTie Therapies, Blog, Companies, Diagnostics, Funding, H. Lundbeck, Lundbeck, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Lundbeck has taken the wraps off its Phase III data for the alcohol dependence drug nalmefene. And while its partner, Biotie, stoutly maintains the drug's "significant" edge over a placebo in reducing alcohol intake, the pharma company will likely have plenty of explaining to do before it can gain European approval for the drug--or a commitment on the part of stingy payers to cover the therapy.

Nalmefene, christened Selincro for commercial purposes, has been repeatedly cited as a potential blockbuster by the company, which believes it's on track to gain an approval for the first treatment to counter heavy drinking. Biotie's release spotlights an impressive 66% reduction in total alcohol consumption. But the treatment--which is designed to eliminate the brain's pleasure response to drinking--doesn't fare so well when you shift from percentages to numerical comparisons with a placebo.

In one trial the drug was linked with a drop in the number of heavy drinking days from 19 to 7, with total alcohol consumption sliding from 84g to 30g after 6 months. In the placebo arm binge drinking days slid from 20 to 10 and total alcohol consumption dropped from 85g to 43g. In a separate study, heavy drinking days slid from 20 to 7 while consumption dropped from 93g to 30g, while the placebo group registered an 18 to 7-day drop in drinking days and an 89g to 33g drop in consumption. In a third study, the drug arm barely edged the placebo at 6 months. All the subjects in the trial were given medical advice about their drinking habits.

"The results presented today reinforce the efficacy and safety of Selincro in patients with alcohol dependence," maintained Timo Veromaa, the CEO of Biotie, which is partnered on the drug. "Selincro has the potential to transform the way alcohol dependence is managed by both physicians and patients and we look forward to working with our partner Lundbeck and the regulators to make this important new treatment option available in Europe."

Analysts at Jefferies, however, weren't as optimistic, noting that the numbers could complicate Lundbeck's European application, which is under review. They also aren't likely to do much for peak sales projections. Bloomberg notes that Jefferies believes the drug can rack up as much as $300 million in annual sales at the top end, if it is approved. That is far below the blockbuster potential Lundbeck has seen for a treatment it considers one of its top prospects.

Further limiting the drug's potential: Lundbeck won't be making a case for the drug in the U.S., where it could only hope for a 5-year market window. None of that is likely to encourage analysts, who have been frowning at Lundbeck's efforts to counter the effects of upcoming generic competition for Lexapro.

- here's the press release
- here's the Bloomberg report

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