November 1, 2004

FDA APPROVES LABELING SHOWING XENICAL DELAYS ONSET OF TYPE 2 DIABETES

The Food and Drug Administration approved new labeling for Hoffmann-La Roche Inc.'s weight-loss drug Xenical (orlistat), which indicates the compound delays the onset of type 2 diabetes in obese patients with impaired glucose tolerance.

"The label change makes Xenical the first weight loss medication to show a reduction in the risk of developing type 2 diabetes, important news for obese adults in the U.S. with impaired glucose tolerance," said Dr. Marc Jacobson, of the North Shore-Long Island Jewish Health System, in a Roche press release.

Approval of the new labeling was based on a four-year study involving 3,304 obese patients with normal (n=2,643) or impaired glucose tolerance (n=661).

Results at four years showed the pharmaceutical brand name drug Xenical reduced the relative risk of developing type 2 diabetes by 42 percent in patients with impaired glucose tolerance as compared with placebo. The brand name drug Xenical did not reduce the risk among patients who had normal glucose tolerance at baseline.

Furthermore, at four years, 21 percent of Xenical-treated patients had lost 10 percent of their body weight or more and 45 percent had lost more than 5 percent, compared with 10 percent and 28 percent, respectively, among placebo-treated patients.

Roche said this study marks the first time a weight-loss drug has been shown to prevent or delay the onset of type 2 diabetes. This effect is believed to be due to the weight loss itself rather than any independent effect of the pharmaceutical brand name drug Xenical on glucose or insulin metabolism, the company noted.

The proprietary name drug Xenical was approved by the FDA in 1999 for use in conjunction with a reduced-calorie diet for obesity management, including weight loss and weight management, as well as to reduce the risk of weight regain following weight loss.

July 20, 2004

IN BRIEF: GLAXOSMITHKLINE PLC

GlaxoSmithKline Plc acquired exclusive over-the-counter marketing rights in the United States to F. Hoffman-La Roche Ltd.'s Xenical (orlistat). Currently, the proprietary name drug Xenical is approved as a prescription drug for obesity management. GSK will begin marketing the OTC version once approval is received from the Food and Drug Administration. Roche will continue to manufacture and market the prescription version in the United States. In 2003, U.S. sales of the pharmaceutical brand name drug Xenical totaled $122 million, according to a press release. Financial terms of the agreement were not disclosed.

June 29, 2004

BAYER REPORTEDLY IN EXCLUSIVE TALKS TO PURCHASE ROCHE'S OTC DRUGS UNIT

Bayer AG is reportedly engaged in exclusive talks with F. Hoffman-La Roche Ltd. to purchase Roche's over-the-counter drugs business, according to Reuters.

A source close to the talks told Reuters that Roche is no longer considering offers from four private equity firms, including Kohlberg Kravis Roberts & Co. The source also said that Bayer was prepared earlier this month to pay approximately $2.4 billion for Roche's OTC drugs business.

Roche is selling the unit in order to focus on high-margin prescription medicines, and Bayer views the transaction as an opportunity to build its presence in the rapidly growing consumer health care market, according to Reuters.

Reportedly, the deal does not include an existing joint venture with Bayer or OTC rights to obesity drug Xenical (orlistat).

Both parties declined to comment, but a representative for Roche told Reuters, "We expect a decision in the second half of the year."

Reuters reported that Roche's OTC drugs unit had sales of approximately $32.8 million in 2003.