Roche continues to restructure diabetes unit

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Roche Diagnostics Corp.’s diabetes business continues to restructure, even as the company won its third product approval of the year in the United States.

Roche officials said last week that price competition and lower reimbursement rates are driving a change in its research & development units, first launched this summer, which will trim about 100 positions combined from its R&D hubs in Indianapolis and Mannheim, Germany. Also, Roche is continuing to streamline its U.S. field sales staff, a move first announced in January, in an effort that will trim an unspecific number of employees.

Meanwhile the Swiss company, which operates its North American headquarters out of Indianapolis, continues to clear away the regulatory roadblocks that have held back its diabetes business in recent years.

Roche won approval last week from the U.S. Food and Drug Administration for the next generation of its hospital blood glucose meter, called Inform II.

The product had been held up at the FDA for unknown reasons since late 2010. Roche has had a variety of problems with the FDA that have held back its sales in the United States, forcing the company to compete short-handed against products launched with newer technology and features.

Roche’s North America diabetes sales fell 4 percent last year to about $667 million. The company employs about 2,900 people in Indianapolis, about one-third of whom work in the diabetes business. Roche has roughly 1,000 field sales staff around the country that report to the Indianapolis office.

After Roche acquired insulin pump maker Disetronic in 2003, the FDA said the company’s factory in Switzerland wasn’t up to snuff. That kept Roche’s insulin pumps off the market until 2006, and its sales have suffered ever since.

In 2009, Roche was trying to get a new blood glucose monitor approved for diabetics in the United States. But the FDA objected to the meter’s use of an enzyme that, in rare cases, did not distinguish between glucose and another sugar called maltose. When that happened, the monitor could produce a falsely high reading, leading patients to take a dose of insulin that was too large.

In 2011, Roche retooled its plant in Indianapolis that makes the chemistry strips for blood glucose monitors, eliminating the problem with maltose.

That change helped Roche win approval in January for its new blood glucose monitor, called the Accu-Check Nano SmartView.

The change in strip technology also appears to have helped Roche win approval for the Inform II, which the company began selling this month. The delayed approval of the Inform II played a role in the breakdown of a buyout deal Roche struck two years ago with a company that makes software for its products.

“Accuracy and patient safety are the foremost concerns for blood glucose testing in hospitals and other point-of-care settings,” said Roland Diggelmann, chief operating officer at Roche Diagnostics, in a prepared statement.

Diggelmann touted the launch of the Inform II during a conference call with investors on Oct. 16. But he also said growing pricing pressure from competitors is contributing to slower sales in diabetes. Through the first nine months of this year, Roche’s global diabetes sales fell 5 percent.

“We are addressing this and want to secure long-term profitability via restructuring, addressing both ends: the cost structure side as well as the sales and product and innovation side,” Diggelmann said during the conference call. “We are in the process of doing this in the R&D organization, focusing on competent centers both in Indianapolis and Mannheim. We're also optimizing the [marketing] investments with some field force restructurings, which have already started to take place, mainly in the United States, and also streamlining the operation structure.”

The changes in R&D will move all development of blood glucose monitors to Indianapolis over the next ocuple years, while all R&D on insulin pumps will move to Germany, said Roche spokesman Todd Siesky. The changes in the sales force are making all representatives sell both monitors and pumps, rather than having specialized teams for each porduct line.

Roche only discloses North American diabetes sales results every six months. Through the first half of this year, diabetes products, including blood-glucose monitors and insulin pumps, saw their sales fall by 1 percent, to about $296 million.

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