Peptech expects to cash in on Abbott drug approval
Thursday, 11 April, 2002
A rheumatoid arthritis treatment developed by Sydney biotech Peptech could become the first of its monoclonal antibodies to hit the market, if drug giant Abbott Laboratories wins approval to market the drug Adalimumab in the US and Europe.
Abbott has forecasted sales of up to $US1 billion for the D2E7 monoclonal antibody and expects European and US market approval by 2003.
Peptech MD Stephen Kwik said if Abbott was successful, D2E7 would be the first fully human antibody to reach the market.
The drug is designed to specifically block the activity of tumour necrosis factor alpha (TNF), which plays a central role in the inflammation in autoimmune diseases such as rheumatoid arthritis. TNF accumulates in the joint, causing inflammation and joint destruction.
The submission is based on data from 23 clinical trials involving more than 2,300 rheumatoid arthritis patents in North America, Europe and Australia, making the D2E7 the most studied anti-TNF agent at the time of submission for regulatory approvals, Peptech said in a statement.
Clinical trials involved patients with moderate to severe rheumatoid arthritis who had inadequate responses to the traditional diseases modifying anti-rheumatic drugs (DMARDS). Dosed every other week, D2E7 was studied with and without Methotextrate and other commonly used DMARDS.
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