Roche Delays Diabetes Drug by at Least 12 Months Amid Side Effects in Test
Roche Holding AG delayed development of the experimental diabetes drug taspoglutide by at least 12 to 18 months after more people than expected suffered from side effects such as skin reactions and digestive symptoms.
Some patients also experienced heart and respiratory problems, though everyone recovered without complications, the Basel, Switzerland-based company said today in an e-mailed statement. Roche said it needs additional time to identify the people more likely to be sensitive to the medicine and to remove them from clinical trials.
The delay is a setback for Roche’s efforts to expand outside of cancer drugs, which account for the company’s three best-selling products and about 50 percent of pharmaceutical sales. Roche had planned to ask regulators to approve the diabetes drug, which it licensed from Ipsen SA in 2006, next year. The once-weekly injection would compete with the twice- daily Byetta shot from Eli Lilly & Co. and Amylin Inc., as well as Novo Nordisk A/S’s Victoza.
“A delay of 12 to 18 months is not good,” Andrew Weiss, an analyst at Bank Vontobel AG in Zurich, said in an interview. “It’s an important drug for Roche and they need it on the market to balance out the oncology franchise, which is starting to slow down.” Weiss recommends buying the stock.
Roche shares fell as much as 2.8 percent, the most in almost a month in Zurich trading, and declined 2.3 percent to 155.3 Swiss francs as of 9:34 a.m. Ipsen fell as much as 20 percent, the most since Dec. 7, 2005, and dropped 16 percent to 26.98 euros in Paris trading. Novo Nordisk rose as much as 5.2 percent, the most in almost five months in Copenhagen trading, and gained 3.2 percent to 504.5 kroner.
Roche is seeking to determine which patients are most at risk through a test to identify anti-drug antibodies, which are the body’s immune response to a medicine and can result in allergic reactions. The company said it will remove patients whose levels of antibodies exceed a certain level. The incidence of the response, which is common in protein-based medicines, is less than 1 percent with taspoglutide, Roche said.
“Given the fact that the hypersensitivity is a low event rate, it’s OK, but anti-drug antibodies are something to be taken seriously,” Weiss said.
Lilly and Amylin have asked the U.S. Food and Drug Administration to approve a once-a-week version of Byetta called Bydureon. The FDA asked March 15 for clarification of manufacturing processes, labeling and a risk-management plan. Antibodies are also a concern for Bydureon, Weiss said.
The Swiss company wants to expand beyond its best-selling cancer drugs and take a share of the $24 billion-a-year diabetes market. The number of people with the condition is expected to rise to 366 million by 2030, according to the World Health Organization
Taspoglutide is a GLP-1 analogue, a newer class of diabetes medicine that boosts insulin production after meals. The Roche medicine helped lower blood sugar levels and promote weight loss in late-stage studies of patients with type-2 diabetes.