Amid Pancreatitis and Pancreatic Cancer Concerns, Januvia Sales Plunge

As concerns have mounted in recent months about the risk of pancreatitis and pancreatic cancer from Januvia, sales of Merck’s blockbuster diabetes drug have taken a sudden dive, contributing to reported profits for the drug maker that were well under analyst estimates.

This week Merck announced earnings for the first quarter of 2013, indicating that Januvia sales were 19% less than expected and 4% less than the first quarter of 2012.

While the pharmaceutical company indicates that the drop was due to inventory reductions, many speculate that demand for the diabetes drug has dropped amid recent studies that suggested a potential link between Januvia and pancreatic cancer, as well as investigations launched by the FDA and foreign regulatory agencies to investigate the pancreatic toxicity of Januvia and other incretin mimetic diabetes drugs.

Overall, Merck saw a 9% drop in total first quarter sales, which brought in $10.7 billion. That number is about $1 billion less than analysts predicted, and much of that drop is being attributed to the unexpected fall in Januvia sales.

Janumet, which is a related medication that combines Januvia and metaformin, also posted weak sales, growing by only 4% and bringing in about $409 million. That is significantly less than its stellar growth in last year’s first quarter, which may have also been connected to similar concerns about pancreatic cancer from Janumet.

Pancreatitis Risk and Pancreatic Cancer Review

In recent months, concerns about the effect of incretin mimetic diabetes drugs on the pancreas has resulted in increased media attention and a number of product liability lawsuits against the manufacturers of the drugs, alleging that inadequate warnings were provide for consumers and the medical community.

Byetta (exenatide) was the first member of this class approved by the FDA, introduced by Amylin Pharmaceuticals in 2005 as a twice daily injection. Januvia (sitagliptin) was introduced by Merck the following year as an oral medication, and a combination pill containing Januvia and the older diabetes medication metformin was introduced in 2007 under the brand name Janumet. Victoza(liraglutide) was introduced by Novo Nordisk in 2010 as a daily injection.

In March 2013, the FDA announced it was launching an investigation into whether Januvia and similar drugs increased the risk of pancreatitis and pancreatic cancer. The investigation came following studies that indicated that there may be a link. In one study, researchers found pre-cancerous cellular changes in pancreatic tissue taken from individuals treated with one of the drugs. European health officials have also launched a similar review.

A growing number of pancreatic cancer lawsuits have been filed on behalf of individuals throughout the United States who allege that the manufacturers knew or should have known about the risks associated with the drugs, but withheld information and failed to inform users about the importance of monitoring the pancreas during treatment.

Last month, a motion was filed with the U.S. Judicial Panel on Multidistrict Litigation calling for all Byetta, Januvia, Janumet and Victoza lawsuits filed on behalf of individuals with pancreatic cancer to be consolidated before one judge for coordinated handling during pretrial proceedings.

The motion indicates that at least 53 Januvia lawsuits, Byetta lawsuits or Victoza lawsuits have been filed in 7 different U.S. District Courts, and hundreds of additional complaints are expected to filed in the coming months as more information is learned about the risk of pancreatic cancer.