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Merck's Januvia Sales Drop, Investor Worries Cited

May 17, 2013

Drug maker Merck & Co. Inc. just reported an unexpected drop in the quarterly sales of its Type II diabetes drug Januvia.

Januvia is Merck’s fastest- and greatest-selling product since it was approved in 2006. It is the one product that often drives the drug maker’s quarterly earnings, according to a Reuters report. But that has not been the case recently.

Merck’s shares fell 1.6 percent in the face of investor concern about slower Januvia growth. "This was an inflection point for Januvia," Morningstar analyst Damien Conover told Reuters. "The drug is maturing and will see significant but slower growth over the next few years as the market gets more competitive." Januvia sales fell 4 percent to $884 million.

Januvia is one of a number of diabetes medicines under investigation by the U.S. Food and Drug Administration (FDA) over links to pancreatic cancer.

Diabetes drugs manufactured by Merck & Company Inc., AstraZeneca PLC, and other drug makers are involved in claims that the medications, when compared to other diabetes drugs, are 25 times likelier to increase pancreatic cancer rates, according to a prior Law360 report. Watchdog group the Institute for Safe Medication Practices (ISMP) reviewed a year of adverse event reports made to the FDA related to five Type 2 diabetes medications, including Merck’s Januvia; Byetta, manufactured by AstraZeneca and Bristol-Myers Squibb Co.; and Tradjenta, made by Eli Lilly & Co.

According to the research, 105 cases of pancreatic cancer were reported in patients taking these drugs compared to two cases of patients being treated with drugs from a different class of diabetes medication.

This March, the FDA initiated a probe based on a medical journal study that found that the drugs, known as incretin mimetics, may lead to increased risks for pancreatitis, as well as precancerous cellular changes known as pancreatic duct metaplasia, said Law360. The European Medicines Agency (EMA), Europe’s top drug watchdog group, implemented its own recommendation following the FDA’s probe.

Incretin mimetic drugs include Byetta and Bydureon (exenatide); Victoza (liraglutide); Januvia, Janumet, Janumet XR, and Juvisync (sitagliptin); Onglyza and Kombiglyze XR (saxagliptin); Nesina, Kazano, and Oseni (alogliptin); and Tradjenta and Jentadueto (linagliptin). Incretin mimetics increase certain natural substances that lower raised blood sugar levels.

Diabetics either have abnormally low insulin levels or their bodies are unable to utilize insulin efficiently. Incretin mimetics imitate the body’s incretin hormones, which are supposed to stimulate insulin release following meal consumption. These hormones are also typically used in collaboration with diet and exercise to lower blood sugar in adults diagnosed with Type 2 diabetes.

In 2009, the FDA required a label update on these drugs that warned of the risk of acute pancreatitis, a painful, potentially fatal disorder and a known risk factor for pancreatic cancer. Pancreatitis is an inflammation of the pancreas linked to cancer and kidney failure. Chronic pancreatitis is painful, potentially fatal, and a known risk factor for pancreatic cancer.

Merck is the focus of a wrongful death lawsuit being heard in Illinois state court; it alleges that three people developed pancreatic cancer from taking Januvia. The plaintiffs claim that Januvia is defectively designed and lacks adequate warnings about its alleged association with a significantly increased risk of developing pancreatic cancer, said Law360.

Prior research revealed that Januvia and Byetta have been associated with reports of increased risks for pancreatic and thyroid cancers. Another new study also found that the drugs may double patients’ risks for developing pancreatitis, the first time a study numbered the ones at risk. In the United States, about 8.6 percent of the population—or some 25 million people—were diagnosed with diabetes in 2010, based on prior Bloomberg News data. That number is expected to rise to more than 34 million by 2020.

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