LONDON (Dow Jones)--Cambridge Antibody Technology Friday acknowledges the announcement by Abbott Laboratories that the European Medicines Evaluation Agency (EMEA) has granted a positive opinion on HUMIRA (TM) (adalimumab, previously known as D2E7) for the treatment of rheumatoid arthritis (RA).
HUMIRA was isolated and optimised by CAT and Abbott Laboratories as part of a broad scientific collaboration. Abbott Laboratories filed for European Union (News - Websites) ( EU) approval in April 2002.
In an announcement dated 22 May 2003, Abbott Laboratories stated that the European Commission (EC) is expected to issue an authorization for marketing HUMIRA in E.U. countries in approximately 90 days.
HUMIRA will be sent to pharmacies in Germany and the U.K. within two weeks of receipt of the marketing authorization.
CAT will receive royalties on the sales of HUMIRA. In addition, approval in a country other than the U.S. will trigger a milestone payment to CAT from Abbott Laboratories.
Abbott Laboratories reported that the positive opinion on HUMIRA, granted through the EMEA's Committee for Proprietary Medicinal Products (CPMP), was based on data obtained in four controlled clinical trials.
In total, 23 trials have been conducted with HUMIRA, involving more than 2,400 RA patients worldwide.
Abbott Laboratories also stated that HUMIRA will become the first human monoclonal antibody approved in Europe for RA, and the first tumour necrosis factor alpha (TNF-a) antagonist approved with an indication for use with methotrexate or as monotherapy.
HUMIRA is indicated for the treatment of moderate to severe active RA when the response to disease modifying anti-rheumatic drugs (DMARDs), including methotrexate, has been inadequate. To ensure maximum efficacy, HUMIRA is given in combination with methotrexate.
As set out in CAT's interim results for the six months ended 31 March 2003, CAT's entitlement to royalties in relation to sales of Humira is governed by an agreement dated 1 April 1995 between Cambridge Antibody Technology Limited and Knoll Aktiengesellschaft (now a subsidiary of Abbott Laboratories).
The agreement allows for offset, in certain circumstances, of royalties due to third parties against royalties due to CAT, subject to a minimum royalty level.
Abbott indicated to CAT in March 2003 its wish to initiate discussions regarding the applicability of these royalty offset provisions for Humira.
CAT believes strongly that the offset provisions do not apply and will seek an outcome consistent with that position... |
