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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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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AstraZeneca buries one program as second drug stumbles again in PhIII

Posted under antidepressant, AstraZeneca, Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, olaparib, ovarian cancer, Pharmaceuticals, Startups, Targacept, TC-5214, Universities, Videos by John Carroll

AstraZeneca ($AZN) has back-to-back setbacks to report on a pair of key drug development programs. The pharma giant reported that it's burying the ovarian cancer drug program for olaparib after concluding that a mid-stage trial failure made it impossible for investigators to push ahead to the next stage. And investigators had more bad news to report to AstraZeneca and Targacept ($TRGT) about TC-5214, their partnered drug for depression. The treatment flunked its second of four Phase III trials, signaling some deep trouble for a treatment AstraZeneca promised to pay up to $1.24 billion for in their pact.

Those trial woes prompted AstraZeneca to add a $381.5 million impairment charge to its fourth quarter numbers, with $96.5 million of that representing the rapidly dwindling chance of success for the anti-depressant.

The trial failures mark another setback for the development execs at AstraZeneca, who have been struggling to overcome a lackluster record in the clinic. And it's another major blow to Targacept, which already had to deal with the departure of GlaxoSmithKline ($GSK) in the biggest biopharma deal breakup of 2011. Targacept's already battered shares fell 27% this morning.

"AstraZeneca seems to have had more than its fair share of misfortune when it comes to the development pipeline," Barclays Capital noted. "Additional development failures increase the probability that management will reassess the likely return on investment from additional R&D investment and cut costs further."

As in the first Phase III study, TC-5214 could not beat out a placebo in treating depression. Their target measure was a change in the Montgomery-Asberg Depression Rating Scale total score after eight weeks of treatment with TC-5214 as compared to placebo.

Back in 2009 olaparib, a PARP inhibitor, had been one of the stars of the ASCO show, as investigators unveiled significant tumor shrinkage. And the pharma giant isn't giving up on either program. Olaparib will be studied in other cancers while the TC-5214 treatment still has two other late-stage studies to complete.

- read the press release
- here's the Bloomberg report
- get the Dow Jones story

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