Roche’s Mircera gets FDA approval
ZURICH , Switzerland The Food and Drug Administration has approved Roche Holdings’ new drug Mircera, which is used for the treatment of anemia associated with chronic renal failure in adults, including patients on dialysis and patients not on dialysis, according to money.cnn.com
The drug though still cannot be launched on the market because of a patent infringement case the company was involved in with another biotech company Amgen. Amgen claims Mircera infringes 11 of its patents and a federal court in Boston last month agreed that Mircera did infringe the patents.
Roche said it is still evaluating its legal options including the possibility of an appeal.
Scientists in Oklahoma are hopeful about Alzheimer’s vaccine
OKLAHOMA CITY Oklahoma City scientists have developed a vaccine that could restrain or even thwart Alzheimer’s Disease, according to The Oklahoman online.
The vaccine, designed to fight dementia in the brain via the human immune system, could reach human clinical trials in three to four years, according to officials at the Oklahoma Medical Research Foundation.
“These results are extremely exciting,” said Jordan Tang, OMRF researcher who led the laboratory study that resulted in the vaccine. “They certainly show that this vaccination approach warrants additional investigation as a therapy for Alzheimer’s disease.”
The illness, a fatal, memory-robbing disease, affects several million Americans, including 70,000 Oklahomans. November is National Alzheimer’s Disease Awareness Month.
Results of OMRF’s vaccine research appeared in the Oct. 21 edition of The Journal of the Federation of American Societies for Experimental Biology. “This is the first time this type of Alzheimer’s vaccine has been produced anywhere. Other types of vaccines have been tried, but have failed,” OMRF spokesman Adam Cohen said.
Tang had pointed out that while the vaccine should be an addition to developments to cure the disease, rather than a substitution, the vaccine is still in its critical stages.
Back 2002, the pharmaceutical company Elan halted trials of a different vaccine after 15 patients suffered swelling of the central nervous system. OMRF president, Dr. Stephen Prescott, said he’s hopeful Tang’s work will avoid the pitfalls that weighed down Elan’s vaccine. “This vaccination stimulates the immune system more gently than previous Alzheimer’s vaccines, so we are optimistic about its prospects going forward,” he said.
Avastin study on pancreatic cancer effects mixed results
ZURICH , Switzerland A new late-stage study of Roche Holding’s Avastin, and its effectiveness to slow down or avert pancreatic cancer in patients, had mixed results, the company said Tuesday.
The Swiss drugmaker said that although the addition of its drug to a Tarceva-chemotherapy combination failed to prolong the lives of patients with advanced pancreatic cancer, certain subjects did have some benefits when using Avastin.
Roche said that the study, which included 607 patients, showed that adding Avastin prolonged the time patients lived without their cancer worsening, as well as adding safety benefits.
An earlier trial, the company said, utilizing the same experiment, concluded that the addition of Avastin had shown no benefit in the treatment of pancreatic cancer.
Roche, which sponsored the study known as AVITA, plans to further analyze the data to determine the extent of the benefit of adding Avastin to the Tarceva-chemotherapy combination. The new details that surfaced from the study will not be published, the drugmaker said.
Pancreatic cancer, deemed the most difficult form of cancer to treat, is frequently resistant to chemotherapy and radiotherapy, and tends to spread quickly to other parts of the body. It leads to the shortest life expectancy of any major tumor.
Avastin, which hinders the growth of tumors by restraining their blood supply, was jointly developed with Genentech, a U.S. biotechnology company (majority-owned by Roche), and is seen as one of Roche’s most important drugs.
Financial experts believe Avastin will eventually become Roche’s best-selling drug, according to Dow Jones, since the drug is expected to be approved to treat several types of cancers.
Avastin was first approved in the U.S. in 2004 for the treatment of advanced colorectal cancer, and was approved for the treatment of lung cancer one year later. It is currently awaiting sanction for use in breast cancer. In Europe, it won approval for the treatment of advanced breast cancer and lung cancer earlier this year.