Sale of vaccine to increase revenue at GSK delayed by FDA letter
WASHINGTON The Food and Drug Administration is delaying GlaxoSmithKline, the world’s second-largest drugmaker, from selling a new pediatric booster vaccine called Kinrix, according to published reports.
Kinrix is indicated to prevent four childhood diseases, Diphtheria, Tetanus, Whooping cough and Polio. The company received a complete response letter from the FDA, which, according to agency spokesperson Karen Riley, is a request for more information about the vaccine.
The U.S. Centers for Disease Control and Prevention recommends that children get vaccines for each of these diseases between the ages of four and six, and GSK is hoping that this new booster will be able to cover all the risks for children contracting these specific diseases.
GSK’s intention to quickly market this new vaccine is in partial reaction to the company’s drop in revenue from top-selling products and new competition from generic companies. According to published reports, the sale of vaccines will help offset the declines in sales by 20 percent in 2007. It is also expected to be one of the key drivers in the company’s growth for the next couple of years.
Biogen Idec, Icahn trade snipes
CAMBRIDGE, Mass. Biogen Idec chief executive officer Jim Mullen has called statements made by investor Carl Icahn, who said Biogen did not do enough to find a potential buyer last year, “Monday morning quarterbacking,” according to the Boston Globe.
Though Mullen didn’t specifically say Icahn’s name, his comments came just a week after Icahn publicly blasted last year’s efforts as “flawed.” Icahn, who owns more than 4 percent of Biogen’s stock, last month nominated three people to sit on the company’s board, as part of his continuing efforts to pressure it to find a buyer. Recently, Icahn told CNBC that he continues to believe Biogen should be sold to a major pharmaceuticals company.
Mullen said the company would be open to considering takeover offers, but he said it needs to “get back” to running its business. “I don’t think the right way to run the business, for anyone’s sake, is to have a permanent ‘for sale’ sign out on the front lawn,” he said. Mullen also said that problems with the company’s multiple sclerosis drug Tysarbi, which was taken off the market in 2005 because of links to a rare brain disease before being reintroduced in 2006, has kept potential buyers drawn back.
FDA issues adverse reaction warning about Botox
WASHINGTON The Food and Drug Administration has notified the public that Botox, Botox Cosmetic and Myobloc (botulinum toxin type b) have been linked to adverse reactions in patients including respiratory failure and death.
The agency has stated that early indications, based on review of materials, links the reactions to overdosing of the medications and not defects in the products.
The adverse effects were found in FDA-approved and nonapproved products. The most severe adverse effects were found in children treated for spasticity in their limbs associated with cerebral palsy. Treatment of spasticity is not an FDA-approved use of Botox products in children or adults.
The adverse reactions appear to be related to the spread of the drug to areas distant from the site of injection, and copy symptoms of botulism, which may include difficulty swallowing, weakness and breathing problems.
The FDA is not advising health care professionals to discontinue prescribing these—Allergan and Solstice Neurosciences—products and stated that it is currently reviewing safety information from clinical studies performed by the manufacturers of the drugs.