Roche has delayed development of its potential blockbuster type 2 diabetes drug taspoglutide for up to 18 months due to hypersensitivity problems observed in trial subjects, including skin reactions and digestive symptoms. Heart and respiratory events were also observed in some patients. Roche will use the additional time to identify patients who are sensitive to the treatment and remove them from clinical trials. The Swiss drugmaker, which is developing the once-weekly injection in conjunction with French company Ipsen, had originally planned on filing for approval in 2011. A Jefferies industry analyst told Reuters that an approval may not come until 2014.

“A delay of 12 to 18 months is not good,” Andrew Weiss, an analyst at Bank Vontobel, told BusinessWeek. “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.” Cancer blockbusters Rituxan, Herceptin and Avastin make up 50 percent of the drugmaker’s sales.

When positive results from a large Phase III trial were revealed earlier this year, analysts projected the drug could reach $2.8 billion a year in sales. But tolerability problems unveiled at a recent diabetes conference, in conjunction with this delay, have cause industry experts to adjust taspoglutide’s market potential to just $490 million in 2014. If approved taspoglutide will compete with Novo Nordisk’s Victoza, which is already on the market, and Amylin’s Bydureon.

Source: FierceBiotech

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Follow-up data from a Phase II trial of Campath (alemtuzumab) for multiple sclerosis revealed that about 71 percent of patients remain free the disease for up to three years after receiving their last dose of the drug. The study compared Campath to the Merck KGaA’s approved MS therapy Rebif in early, active, relapsing-remitting multiple sclerosis patients who had received no prior therapy. Genzyme presented the positive data at the American Academy of Neurology annual meeting.

The study results are terrific news for the beleaguered biotech. Genzyme has been locked in battle with Carl Icahn following problems at one of its manufacturing plants last year. Those problems have interfered with production of the company’s top-selling drug and cut into Genzyme’s bottom line. That’s brought about calls for a change in Genzyme’s management, including the resignation of CEO Henri Termeer.

Icahn, who holds a 1.8 percent stake in Genzyme, managed to get himself and three associates nominated to the biotech’s board this year. But the foursome are also stakeholders in Biogen Idec, which has its own MS treatments–Avonex and Tysabri–that would compete with Campath if the blood cancer drug were approved for MS. Non-Icahn appointed board members also are concerned that there’s a conflict of interest if Icahn’s nominees are making decisions about an MS drug that could compete with one from their other companies.

“Directors owe shareholders a duty of loyalty and a duty of care,” Peter Wirth, head of Genzyme’s legal department, said in a telephone interview with BusinessWeek. “When you have people who are on the board of a competitor or have a billion-dollar stake of a competitor, they can’t satisfy either.”

Icahn’s board member Alexander Denner fired back at Wirth, saying that Genzyme is raising possible conflict-of-interest problems to distract shareholders from problems elsewhere in the company. “To the extent that conflicts do come up at the board level, which we don’t expect very often, we obviously will not participate,” said Denner.

Two Phase III trials of Campath are currently under way, with data expected by 2011.

Source: FierceBiotech

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Overall, corporate America cut R&D spending in the first half of this year — no surprise, given the tenor of the times. But some companies bucked the trend.

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BusinessWeek is out with a list of 25 companies that aggressively increased R&D spending, and drug makers snagged the top spots.

Merck was number one on the list, boosting its R&D spending by more than $370 million. But much of that spending wasn’t the traditional pharma R&D work of paying its own scientists to discover and develop new drugs; instead, it was licensing payments to small biotech shops and the like for rights to promising experimental compounds.

Biogen Idec, Eli Lilly, Bristol-Myers Squibb and Gilead rounded out the top five, for varying reasons. Lilly folded in ImClone after last year’s big acquisition; Gilead has more drugs in late-stage trials, which include lots of patients and are very expensive to run.

Source: The Wall Street Journal

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The insurance program for the poor has decided to cover tests for mutations in BRCA1 and BRCA2, genes that when altered, as the NIH explains, are risk factors for breast and ovarian cancer.

Doctors participating in Illinois Medicaid can order the genetic test, the Chicago Tribune reports, and the state will also pay for genetic counseling for women considered at high risk of developing either type of cancer. Read the full story

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