Novartis will eliminate nearly 2,000 jobs in preparation for its hypertension drug, Diovan, losing patent protection later this year. The announcement also comes after a rash of disappointing news on currently marketed drugs and drugs in development. Novartis has had to lower forecasts on its Tekurna hypertension drug, and in December the company stopped the late-stage trials of a drug used in patients with diabetes due to side effects. All the jobs cuts will occur in the United States. The company will eliminate 1,630 sales representatives and another 330 positions at its U.S. headquarters in East Hanover, New Jersey. The drugmaker expects that the cuts will yield annual savings of around $450 million by 2013. The pending layoffs, which are to take place over the next several months, are in addition to extensive job cuts Novartis has made since 2010. Last fall it began eliminating 1,100 jobs at its headquarters in Switzerland and in 2010 the company slashed 1,400 U.S. sales jobs.
CVS Caremark will pay a $5 million fine to settle charges brought by the U.S. Federal Trade Commission over allegedly misrepresenting the prices of various Medicare Part D drugs, including those for treating breast cancer and epilepsy. The misrepresentation of prices led many seniors to pay up to 10 times the actual prices for their drugs and pushed the drugs into a coverage gap where drug costs are not reimbursed. The settlement with the FTC required CVS Caremark to pay $5 million to reimburse the consumers who were affected by the price discrepancies.
A University of Connecticut researcher who studied the links between resveratrol (a substance found in red wine) and aging to support the development of an age-fighting pill has been accused of fabricating or falsifying research data as many as 145 times. The focus of Dipak Das’ work was on resveratrol and its ability to slow the aging process. An anonymous tip led the university to begin investigating Das’ work three years ago and resulted in a 60,000-page-report accounting for all 145 counts of fabricated and falsified data. Other members of Das’ lab may have been involved and are under investigation, according to Reuters. The University of Connecticut has taken steps to minimize the damage done by the falsified data. Reuters reports that the university has alerted 11 medical journals that had published Das’ work, it has declined to accept the $890,000 in federal grants that were awarded to Das, and is in the process of dismissing him.
Human Genome Sciences is planning to eliminate 150 jobs in a wide range of departments, including research and development, as the company’s lupus drug, Benlysta, continues to show disappointing sales numbers. In a press release the company reported Benlysta sales of approximately $25 million in the fourth quarter. That number was in line with consensus expectations of analysts for the fourth quarter, but only after analysts had dramatically lowered forecasts after Benlysta failed to take off as quickly as initially anticipated. The poor sales numbers for Benlysta forced the company to trim costs.
Asthma and chronic objective pulmonary disease drug Relovair, under development by GlaxoSmithKline in partnership with Theravance, was flagged by investigators for troubling safety concerns. In two late stage comparison studies for COPD, Relovair reduced the rate of exacerbations compared with vilanterol alone, but in the one study the reduction was statistically insignificant. GSK is also looking into the incidence of fatal pneumonia at the highest dose of Relovair. In a press release the two companies said that despite the few flags, the study warrants the treatments submission to regulators for approval.
Boehringer Ingelheim’s blood thinner, Pradaxa, received yet some more bad news when a new report showed that there were 505 cases of hemorrhaging reported to the U.S. Food and Drug Administration in the first quarter of 2011. The new incidents of hemorrhaging all came shortly after the Pradaxa was approved for preventing stroke and blood clots in people with atrial fibrillation. The new cases resulted in death, disability, hospitalization or some other serious outcome and the median age of the inflicted patients was 80. The newest findings come just three months after the European Medicines Agency asked doctors to exercise caution about using Pradaxa as a blood thinner. And just earlier this week, an analysis of seven clinical trials that was published in the Archives of Internal Medicine found that Pradaxa was significantly associated with a higher risk of heart attacks and chest pain.
Three of the panelists on the recent panel examining the safety of four of Bayer’s birth control products had significant ties to Bayer, The Wall Street Journal reports. The three doctors had either served as consultants, speakers, or researchers for the company. In that U.S. Food and Drug Administration safety panel, the panelists voted 15-11 that the benefits of the birth-control pills outweigh the blood-clot risk associated with the drugs. All three doctors with ties to Bayer voted in favor of the pills. The FDA advisory committees are designed to give the agency independent judgments on medical issues, says The New York Times. But committee members are only mandated to disclose potential conflicts of interest to the FDA, and not the general public. In picking committees, the FDA weighs “whether a meeting would affect the financial interest of a panelist,” said Jill Warner, an FDA official who oversees advisory committees. In the case of the Bayer birth-control safety panel, the FDA allowed the three doctors to vote, but did remove the rights of another panelist who had publically criticized the drugs’ safety.
January 13, 2012
http://www.burrillreport.com/article-novartis_to_ax_2000_jobs_after_tekturna_development_halted.html