The ongoing legal saga between Cambridge Antibody Technology of the UK and Abbott Laboratories over the rheumatoid arthritis drug, Humira (adalimumab), took another turn last Friday, as Abbott tried to launch an appeal in the case.
Abbott has made a written application for permission to appeal an earlier verdict, handed down on December 20, 2004, which found Abbott at fault for only paying CAT the minimum 2% royalty rate in their agreement on Humira rather than 5% [[20/12/04c]].
The difference amounts to a lot of money: sales of Humira were running at around $1.3 billion dollars in 2004, its first full year on the market. Meanwhile, CAT reported widening losses of £11.7 million in the first quarter of this year. The loss does not reflect £24 million in royalty arrears from Abbott, plus £1.3 million in interest, awarded to CAT in the Humira case [[07/02/05f]].
Abbott has already been refused leave to appeal in a hearing on January 28. In the latest twist, Abbott’s application will be considered by one Court of Appeal judge. If successful, the company will be allowed to proceed with the appeal. If unsuccessful, it will be entitled to request a hearing.
CAT first took Abbott to court back in October 2003 after receiving the minimum level of royalty payments for Humira. The UK company had argued that it should receive a full royalty, but Abbott claimed that royalties could be shared with third parties.
- Meanwhile, Abbott says that the US Food and Drug Administration has agreed to file the New Drug Application for Xinlay (atrasentan) for the treatment of advanced prostate cancer patients whose disease has spread to other parts of the body, such as the bone, and no longer responds to hormone treatment. The dossier contains data from Phase II and III clinical trials in men with the disease, showing that the product delays disease progression and the onset of bone pain versus placebo [[15/12/04d]], and Abbott is expecting a regulatory decision in the fourth quarter of 2005.
Among American men, prostate cancer is the second most common cancer, after skin cancer, and is the second leading cause of cancer death. An estimated 230,000 men will be diagnosed with prostate cancer, this year in the US alone, and 30,000 will die from the disease. The incidence of prostate cancer is expected to increase to more than 300,000 annually over the next decade, as baby boomers begin to reach the target age for detection.