The Burrill Report

Chelsea Therapeutics’ shares fell 28 percent with its announcement that the U.S. Food and Drug Administration did not approve Northera, its experimental drug for the treatment of hypotension in patients with nervous-system disorders. The FDA recommended that Chelsea submit data from an additional study that would be designed to demonstrate the durability, or sustained efficacy, of Northera over a two-to three-month period. Although Chelsea says it’s already conducting a clinical trial that may meet some of the FDA’s requests, it will likely have to invest in another trial, which could mean a two-year delay and lead to a late 2014 product introduction, assuming approval. The FDA also hinted at the possibility that if Northera were to gain approval later, it may carry a so-called “black-box” warning, related to a type of hypertension that could occur when patients use the drug.

Forest Laboratories and Almirall said that the U.S. Food and Drug Administration has extended the review period for their experimental drug for the treatment of lung disease. The FDA will require three more months to complete its review of data on aclidinium bromide. The companies are seeking approval for the treatment of chronic obstructive pulmonary disease, often caused by cigarette smoking. The FDA did not request any additional data.

Targacept announced that it will drop development of its drug candidate, TC-6987, for the treatment of diabetes after a disappointing experimental study. The announcement comes just a week after Targacept and AstraZeneca scrapped plans to continue development of Targacept’s lead drug candidate, an experimental anti-depressant drug. Although the announcement added to a string of bad news resulting in Targacept’s shares dropping more than 70 percent since October 2011, the company did come away with some good news, noting that TC-6987 showed promising results as a treatment for asthma in a separate trial. Burrill & Company, publisher of The Burrill Report, is an investor in Targacept.

Shares of Map Pharmaceuticals fell after the U.S. Food and Drug Administration rejected the company’s orally inhaled drug, Levadex, for the treatment of migraines. Levadex is an inhaled version of dihydroergotamine, a 60-year-old migraine drug usually given by injection. In a conference call, Map CEO Tim Nelson said that the drug wasn’t rejected because of safety or efficacy reasons, but rather due to manufacturing issues. MAP plans to request a meeting to discuss the FDA’s concerns and though Nelson declined to identify the manufacturer during the conference call, he did say Map is lining up a second potential supplier. Initial reaction to the announcement scuttled the company’s shares by more than 25 percent, but they have since rebounded to close at 16.19 at the time of this writing.

IntelliCell BioSciences, a small stem cell company based in New York, received a warning letter from the U.S. Food and Drug Administration regarding the violation of multiple federal regulations. The company’s business model is built on physicians removing fat from patients and sending it to IntelliCell, which then removes the fat and returns the remaining cells to the doctors who can administer the “soup” to their patients to treat various ailments on an off-label basis. In the warning letter to the company, the FDA wrote, “your processing alters the relevant characteristic of the adipose tissue relating to the tissue’s utility for reconstruction, repair, or replacement. Therefore the processing would not meet the definition of minimal manipulation for structural tissue such as adipose tissue.” Furthermore, the agency found that some of the treatments offered by the company do not comply with the definition of homologous use, meaning that the biological used to repair, reconstruct, or replace a patient’s cell must perform the same basic function in the recipient as in the donor. Effectively, the FDA says, IntelliCell’s product is a biologic and the company is operating without an approved biologics license application thus placing the company in violation of the Food, Drug & Cosmetic Act, as well as the Public Health Service Act.


March 29, 2012
http://www.burrillreport.com/article-chelsea_therapeutics%e2%80%99_falls_on_fda_rejection_of_northera.html