The Burrill Report

Just a week after Chelsea Therapeutics said that the U.S. Food and Drug Administration recommended that it run an additional trial for its hypotension drug, Northera, likely delaying the launch of the drug for up to two years, it now has announced that its CEO, Simon Pedder, will step down. Chelsea will also significantly reduce its workforce as it attempts to explore its strategic options. The job cuts are expected to occur in the third quarter of 2012 and will result in annual salary reductions of at least $3.5 million.

Actelion, a Swiss biotech company, will cut 135 jobs in its research and development department as it refocuses on new therapies for rare disease and specialty pharmaceuticals. The decision comes as sales for the company’s best-selling product, Tracleer for the treatment of blood pressure, have declined. Most of the job cuts will occur at the company’s headquarters in Allschwil, Switzerland and though Actelion will take a charge against its 2012 earnings, it has yet to determine the amount. The job cuts amount to 5.3 percent of the company’s workforce of about 2,570. Actelion’s shares fell 1.8 percent in Zurich soon after the announcement.

Eli Lilly says that its experimental drug for the treatment of schizophrenia, mGlu2/3, failed to hit its primary end-points in a late-stage trial. The trial was intended to be the first of two-late stage tests of the drug as a stand-alone treatment for schizophrenia; a second trial is ongoing and the company expects to conduct an interim analysis later this year. Mark Schoenebaum, an analyst at ISI Group, said that Wall Street expectations had been low and the news of the late-stage failure shouldn’t hurt the company’s stock significantly. “Unfortunately, negative studies are common in the field of psychiatry and a reality of biopharmaceuticals innovation,” said Jan Lundberg, president of Lilly Research Laboratories. Lilly had been hoping to show that its experimental drug could work without some of the side effects associated with existing treatments, such as weight gain, elevation of lipids, and reproductive hormone irregularity.

BioInvent has hit another major roadblock just one month after seeing its shares plummet when its lead drug failed in a head-to-head study with Xarelto, Bayer and Johnson & Johnson’s drug for the treatment of blood clots. Now, one of the drugs the company has said it would shift its focus to, BI-204 for the treatment of arterial vessel inflammation, failed to meet the primary endpoint in a mid-stage trial. “We concluded that BI-204 did not meet the primary objective set out in the study,” said Svein Mathisen, CEO of BioInvent. “Before deciding on the future of BI-204, we and our partner Genentech need to finalize the full data analysis. We expect to provide an update later this year.” Shares of BioInvent fell 67 percent after the announcement.

Ipsen said that the U.S. Food and Drug Administration has ordered a hold on two late-stage trials of IB1001, for the treatment of hemophilia, after its partner, Inspiration Biopharmaceuticals, found that patients taking the experimental drug developed antibodies to a protein in the drug. Ipsen was quick to note that no adverse events have been linked to the antibodies. “While this finding may be a potential safety concern, no evidence suggests a change in the current overall clinical benefit and risk profile of IB1001,” said Ipsen in a release. The news, however, worried investors as shares of Ipsen plunged 11 percent and caused some analysts to readjust their “best case” launch date to the second half of 2013, with the “worst case” being discontinuation.

Eisai said that its experimental breast cancer drug, Halaven, failed to hit its primary endpoints in a late-stage head-to-head trial against the breast cancer drug Xeloda. Halaven has already received approval in the U.S., Europe, and other countries as a third-line treatment for patients with locally advanced or metastatic breast cancer who have already received chemotherapy. Eisai had been hoping that Halaven could be used earlier in the treatment pathway, but the initial results from the trial have put that further from reach. Despite the news, Eisai said health authorities in France have agreed to reimburse Halaven within its licensed indication as a third-line treatment.


July 13, 2012
http://www.burrillreport.com/article-chelsea_therapeutics_ceo_steps_down.html