The Burrill Report

Chelsea Therapeutics announced that all of its corporate officers and members of its board of directors volunteered to receive a 25 percent pay cut until data from its ongoing mid-stage trail of Northera becomes available. Northera, being developed for the treatment of postural hypotension, or the sudden dip in blood pressure when standing, was denied approval by the U.S. Food and Drug Administration earlier this year and Chelsea has been taking measure to save money ever since. “The measures we are taking now to reduce expenses reflect both our professional commitment to patients, shareholders, and the success of our Northera program,” says Simon Pedder, CEO of Chelsea. The company said that, along with the compensation cuts, they would also suspend performance bonuses until Northera is approved in the U.S.

Novartis AG’s unit Sandoz voluntarily recalled 10 lots of generic Introvale birth control pills after a consumer reported a packaging flaw. A message on Sandoz’s website stated that it had decided to recall the birth control pills after a consumer reported that white placebo tablets were mistakenly placed in the wrong row of a 13-row card. “While the white placebo tablets can be clearly distinguished from the peach-colored active tablets, the risk of an unintended pregnancy for a patient taking the wrong tablet over several days cannot be excluded,” said the company.

Amgen announced that a late-stage trial of Sensipar failed to reduce the risk of death and cardiovascular complications in patients with kidney disease. Amgen was evaluating Sensipar’s ability to suppress the risk of death, heart attack, or heart failure in patients suffering from chronic disease and though Sensipar use did lead to fewer such events in patients, the results were deemed statistically insignificant. Sensipar is already approved to treat secondary hyperparathyroidism, a condition in which the body produces too much parathyroid hormone. Amgen’s shares dipped fell about .3 percent in morning trading, June 8, after the news broke.

Targacept’s CEO, J. Donald deBethizy, has bowed out after seeing the company’s value depreciate by more than 81 percent in the last year. Chairman Mark Skaletsky and a trio of Targacept executives will lead operations during the board’s hunt for a new CEO. DeBethizy leaves after a difficult year that saw Targacept’s once promising experimental antidepressant drug, TC-5215, fall flat in late-stage trials. “While I have decided to step down for personal considerations, I leave Targacept well positioned with a talented management team and workforce, diverse Phase 2 first-in-class product candidates, well-developed science and strong balance sheet,” stated deBethizy. Burrill & Company, publisher of The Burrill Report, is an investor in Targacept.

Federal marshals raided Maine’s Global Biotechnologies at the request of the U.S. Food and Drug Administration. “The company has made claims on its website, in promotional materials, and on the products; labels that its products can diagnose, cure, mitigate, treat, or prevent human diseases,” said the FDA. The agency says it urged action from federal marshals after Global Biotechnologies failed to respond to a 2006 warning letter citing numerous infractions in the labeling of its supplements. No illnesses were associated to date with Global Biotechnologies’ products, according to the agency.

The U.S. Food and Drug Administration has extended by three months its review of Novo Nordisk’s long-acting insulin products Degludec and DegludecPlus for the treatment of type 1 and type 2 diabetes so it consider additional data. The new decision date for the drug candidates is October 29. The FDA had requested additional data clarification and analyses and Novo has submitted additional data. But, according to the company, the FDA deemed the new data as a major amendment to the new drug application and pushed the decision date back. Novo Nordisk has also filed for approval of the two products with the European Medicines Agency and regulators in Japan, Canada, Switzerland and other countries.


June 08, 2012
http://www.burrillreport.com/article-chelsea_execs_take_pay_cuts_amid_troubles.html