If Genzyme gets its way, it will be eating Biogen Idec’s lunch in a few more years. The two Cambridge, MA-based companies, the largest independent biotechs in the state, could be duking it out with competing multiple sclerosis treatments, in a market worth an estimated $8 billion to $9 billion annually by 2011. It would also be the first time the companies have faced off in a direct competition for patients with the same disease.
Genzyme (NASDAQ: GENZ) is recruiting patients in two final-stage clinical trials of Campath, currently approved as a leukemia drug, for patients with multiple sclerosis. Biogen (NASDAQ: BIIB) is already entrenched as the world’s largest maker of drugs for multiple sclerosis, offering both the current market-leader, Avonex, and Tysabri, a newer and more effective drug co-marketed with Ireland-based Elan.
It’s hard for Wall Street to see this far ahead, but Genzyme envisions Campath as a key to driving its future growth, beyond the financial forecasts the company has given analysts through 2011. The company says Campath, which works by knocking out overactive B cells and T cells of the immune system, may be the most effective agent yet against multiple sclerosis, a disease in which immune cells attack the insulating coating on nerve fibers. About 400,000 Americans suffer from the condition, which can rob patients’ of their ability to walk, see, or speak.
In a mid-stage clinical trial, Campath was able to cut the risk of MS flare-ups by 73 percent over a three-year period, while lowering the risk of progressive disability about 70 percent when compared with a standard treatment. “We’ve actually seen improvement in disability in patients, and that may be unprecedented,” says Terry Murdock, Genzyme’s senior vice president for Campath, from his offices in San Antonio, in a telephone interview. Genzyme will finish enrollment in one of the current Phase III trials in the first half of 2009 and aims to have data ready to send to the FDA for approval in 2011, Murdock says.
The MS patient community is following these late-stage trial closely, particularly since Genentech and Biogen’s Rituxan showed early promise, then failed this spring in a study of patients with the toughest form of MS to treat. And the mid-stage study of Campath was indeed promising. It followed 334 patients with the relapsing/remitting form of MS, who randomly got the drug, or a standard interferon medicine, Merck Serono’s Rebif—its findings caught the attention of researchers because MS drugs usually attempt to clear a lower hurdle, by simply out-performing a placebo.
“The numbers would have been impressive when compared with placebo and thus are even more impressive when compared with a currently approved disease-modifying agent,” said John Richert, executive vice president of research and clinical programs for the National MS Society, in an e-mail. “The Phase III data will be very important.”
Like Biogen’s Tysabri, Campath is an engineered antibody, but it hits a different target on immune cells than Tysabri does. Campath was approved for relapsed patients with chronic lymphocytic leukemia in 2001, and Genzyme obtained it as part of its $1 billion acquisition of San Antonio-based Ilex Oncology in 2004.
The drug, like any other, has side effects. The Phase II trial showed … Next Page »