Pharma news, 23 July

Money troubles for European drug makers? Check out the latest buzz in the pharmaceutical industry.

Roche May Lose $1 Billion a Year on Avastin Change
The anti-cancer drug Avastin (bevacizumab)suffered a setback in the US that will cost its manufacturer Roche an estimated US $1 billion annually, according to Bloomsberg Businessweek. Avastin has been approved by the US FDA for metastatic  colorectal cancer, non‑squamous non‑small cell lung cancer (NSCLC) and metastatic Breast Cancer (MBC). However, an FDA advisory panel voted earlier this week “to rescind Avastin’s clearance in breast cancer after finding the drug paired with chemotherapies didn’t work better than other medicines alone.” Although the FDA is not required to act on recommendations of the panel , the regulatory body usually does. The recommendations are based on poor performance of Avastin on breast cancer clinical trials.

Glaxo Said to Have Paid $1 Billion Over Paxil Suits
The UK-based drug maker GlaxoSmithKline (GSK) has reportedly agreed to pay more than US $1 billion in connection with cases related to the anti-depressant Paxil. The drug has supposedly caused birth defects in more 800 cases. Paxil was approved in the US in 1992 but the company supposedly failed to warn patients of potential birth defects when taking the drug during pregnancy. Some of the defects reported are quite serious including congenital heart defects. There are accusations that the company decided to bury “negative studies about Paxil’s links to birth defects and that its own scientists were alarmed by the rising number of children who had been affected by the drug in the womb.”

News report links Avandia panelists to drug makers
GSK is also bracing for more substantial settlements, this time regarding the antidiabetis drug Avandia (rosiglitazone). According to the Wall Street Journal, one of the panellists who was in the FDA committee who reviewed the safety of Avandia (and who later voted to keeping the drug on the market) had a connection with GSK as a paid speaker, thus, pointing to a potential conflict of interest. However, the panellist Dr David Capuzzi (Lankenau Institute for Medical Research, Philadelphia, PA denies any conflict of interest as he never gave any talks promoting Avandia. In fact, he is also a paid speaker for other  pharma companies, including Takeda Pharmaceuticals, the makers of  Avandia’s rival pioglitazone (Actos).

AstraZeneca Said to Pay $2 Million in Seroquel Cases
AstraZeneca is another UK drug maker who is paying lots of money for a drug’s unexpected side effect. The company is facing lawsuits about its antipsychotic drug Seroquel which supposedly causes diabetes. The settlement is expected to be about US$2 million, much lower than expected. Definitely less than what was paid in a similar case of Zyprexa by Eli Lilly.