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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Targacept slashes staff by half in wake of PhIII disaster

Posted under AstraZeneca, Blog, Chutes and Ladders, Clinical Trials, Companies, depression, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Targacept, TC-5214, Universities, Videos by john

The late-stage collapse of Targacept's depression drug--TC-5214--will cost the jobs of close to half of the biotech's staffers, with 65 workers getting pink slips today. The news comes a month after Winston-Salem, NC-based Targacept ($TRGT) and AstraZeneca ($AZN), which had once committed to a $1.24 billion licensing pact on the drug, acknowledged that the treatment had failed the last two of four Phase III studies.

Once considered a bright prospect after upbeat Phase II results, 5214 today looks more like the kind of cautionary tale that has helped drive some of the biggest players out of the neurosciences arena. Depression studies are notoriously unreliable, often scuttled by high placebo responses. But investigators didn't even come close to the goal here: Hitting the primary endpoints in two out of four Phase III trials. The black eye at AstraZeneca, which could ill-afford another pipeline setback, has helped inspire a scramble to in-license other programs.

For Targacept, which had been adding staffers in expectations of a marketing launch, the writing was on the wall once the data hit. But company execs insist that with a cash cache of $220 million, Targacept still has a future.

"This painful step is part of an overall plan to align our resources more closely with nearer-term value creation opportunities," says Targacept CEO J. Donald deBethizy. "We remain well capitalized and focused on operating our business efficiently to ensure we are positioned to exploit our diverse clinical-stage pipeline to bring new medicines to patients." 

Among the departures will be CMO Geoffrey C. Dunbar. The trials chief is retiring at the end of this year.

- here's the press release

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Supernus plots product launches as it dusts off $76M IPO attempt

Posted under ADHD, Blog, Companies, depression, Diagnostics, epilepsy, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Pipeline, Startups, Supernus, Universities, Videos by john

After leaving its IPO filing on the shelf for more than a year, Supernus Pharmaceuticals has finally dusted off the paperwork and suggested a $12 to $14 price range on some 5.8 million shares. If it can turn in a successful performance at the middle of that range, the biotech could raise as much as $76 million.

Rockville, MA-based Supernus, though, hasn't been idling on the IPO front without reason. The past year has seen one developer after the next being forced to take a beating on its price, chilling a long lineup of drug developers that has been anxiously eyeing prospects in the public markets. Only a handful, including Verastem, have managed to command a share price in the original range.

Supernus--which was spun off from Shire Pharmaceuticals--is gambling that with two epilepsy treatments at the FDA, with decisions slated for July and October, investors may warm to its offering. The biotech's pipeline includes experimental treatments for ADHD and depression. Most of the money it hopes to raise is being earmarked to market its epilepsy drugs.

"We intend to market our product candidates in the United States through our own focused sales force targeting specialty physicians, including neurologists and psychiatrists," Supernus explains in its S-1. For now, Supernus will have to rely on the prospect of sales to excite the investment community--a tough challenge in risk-averse times.

- here's the S-1
- get the story from the Washington Business Journal

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Supernus pockets $35M from new development pact

Depression drug research goes off the rails (again)

Posted under antidepressant, AstraZeneca, Blog, Companies, depression, Diagnostics, Eli Lilly, Funding, GlaxoSmithKline, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Targacept, Universities, Videos by Ryan McBride

What a bummer for drug developers. In an analysis today, veteran Reuters reporters help us count the ways that R&D of antidepressants has sunk to new lows in recent years, even as mood disorders plague populaces around the world.

AstraZeneca ($AZN) and partner Targacept ($TRGT) this week revealed the latest sad chapter in the pharma industry's saga of failed depression programs, announcing that they're scrapping development of their experimental antidepressant TC-5214. And, as Reuters notes, AstraZeneca made the announcement after ditching its own discovery efforts in the depression field a while back after years of frustration.

AstraZeneca's exit from antidepressant discovery comes amid an exodus from the field across the pharma industry, which has largely turned its attention to safer bets in developing drugs for cancer and rare genetic diseases. In trials for new depression meds, developers have struggled to show that their pills lift patients' moods any better than placebos. Patients in many cases even feel better after taking sugar pills, showing just how delicate the disorder can be.

Meanwhile, researchers have been tossing up all kinds of ideas about new ways of combating the blues. U.K. researchers have seen evidence that a psychoactive compound in magic mushrooms could help people who are out of sorts, and U.S. researchers have been experimenting with the painkiller ketamine--sold on the street as "Special K"--to treat severe depression. 

Amid major cutbacks in antidepressant research among Big Pharma companies, existing depression drugs face increased competition from cheaper generic drugs. Reuters reports that sales of major depression drugs such as Eli Lilly's ($LLY) Prozac and GlaxoSmithKline's ($GSK) Paxil have been in decline, and worldwide revenue growth of antidepressants has collapsed in the process.

- get more in the Reuters analysis

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