Roche, based in Basel, Switzerland, said the study, dubbed OPTION, showed that a greater proportion of patients treated with Actemra in combination with traditional drugs achieved a significant improvement in disease signs and symptoms after 24 weeks, compared to those treated with the traditional drugs alone.
Sufferers of rheumatoid arthritis, or RA, begin to experience progressive joint damage early in the disease. The disease differs from what is popularly known as arthritis, typically associated with age-related joint pain; RA is a far more serious inflammatory disease that leads to destruction of cartilage and bone, and can lead to disability.
Patients have a big number of treatment options to chose from, but many drugs merely relieve pain, in some cases at the cost of severe long-term side effects including osteoporosis and high blood pressure.
Actemra works by inhibiting the activity of interleukin-6, a protein that plays a major role in the inflammation process of rheumatoid arthritis; it's generally well tolerated, Roche said.
If approved, Actemra will compete with other biological drugs called anti-TNF medicines. These medicines target a compound known as tumor necrosis factor, which is overproduced in many patients with inflammatory disease.
Johnson & Johnson's (JNJ) Remicade and the drug Enbrel, which is co-marketed by Amgen Inc. (AMGN) and Wyeth (WYE), are all part of this class.
In the study, four times the number of patients in the Actemra group experienced a 50% improvement in disease symptoms compared to the control group, while more than ten times the number of Actemra patients achieved 70% improvement in disease signs and symptoms compared to the control group. In addition, 28% of patients achieved the ultimate goal of remission in the Actemra group against only 1% of patients in the control group.
At 0950 GMT, Roche shares were up CHF1.60, or 0.7%, at CHF219.90, in a higher broader market.
Actemra, also known as tocilizumab, was developed by Japanese pharmaceutical company Chugai Pharmaceutical Co. (4519.TO), which is controlled by Roche. Roche owns the rights to market Actemra outside Japan.
The drug has shown very good results in trials conducted in Japan, and Roche hopes to replicate these early data from the Japanese trial in large American and European studies. The study presented Friday, is is the first of five international late-stage trials that are investigating Actemra's efficacy and safety.
Roche plans to file Actemra for regulatory approval in Europe and the U.S. by the end of 2007. It usually takes around a year for regulators to review data submitted by a company and decide on approving a new drug.
In Japan, where the approval process usually takes somewhat longer, Actemra was filed for regulatory approval in April 2006.
2 comments:
Roche is really a great company
I admire their strategy - the personlized medicini
I think they do believe that in 20 years everybody is going to get his own tailored made medicine
That is why they keep pumping the diagnostics devision too
A key group of senators reached a deal over how to create a legal pathway for approving generic versions of biotechnology drugs, a breakthrough that increases the chances that a bill might become law this year.
The agreement, between Democratic Sens. Edward Kennedy of Massachusetts and Hillary Clinton of New York, and Republicans Michael Enzi of Wyoming and Orrin Hatch of Utah, is an important step because the four represent a broad political spectrum on health issues. Kennedy chairs the Senate's health committee; Enzi is the ranking Republican. The next step for the new proposal would be a vote from the full health committee, likely to occur next week.
In crafting a bill to allow for what they call "biosimilars," or copycat versions of biotech drugs, the four lawmakers agreed to provisions important to both the generic and the biotech industries
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