CDP 870 contd.
...Pfizer delay to CDP 870 RA trials In light of its continuing review of the CDP 870 RA clinical development programme Pfizer has indicated to Celltech that Pfizer will not initiate the remaining Phase III registration trials until it has seen the results of the two large ongoing studies, due in the first and second quarters of 2004, respectively. The remaining studies, the longest of which had been scheduled to start in the second half of 2003, will determine the filing date of CDP 870 in RA. Based upon the current Pfizer timelines, this will lead to a delay of up to one year from the originally envisaged timelines. A substantial number of RA patients continue to be treated with CDP 870 in ongoing long-term safety studies.
Renegotiation of CDP 870 commercial terms In addition, Pfizer has requested to review with Celltech the financial terms of its collaboration and initial discussions have been held. The outcome of these discussions is not known, and the product rights to CDP 870 may or may not revert to Celltech.
Dr Goran Ando, Chief Executive Officer of Celltech commented: "We will work rapidly to conclude our ongoing discussions with Pfizer, whilst moving ahead aggressively with our development in Crohn's disease, where we believe CDP 870 will be the second biological to reach the market. When combined with the recent substantial growth in this market, we believe that Crohn's disease represents a much larger commercial opportunity for Celltech than originally envisaged. We firmly believe that CDP 870 has considerable potential in RA and intend to maximise this value, either through a successful resolution with Pfizer or through alternative partnering arrangements. A further opportunity for Celltech is the potential for accelerated development in other indications where TNF inhibitors have shown substantial promise, such as psoriasis."
Celltech Group plc (LSE: CCH; NYSE: CLL) is one of Europe's largest biotechnology companies, with an innovative development pipeline funded by its profitable, cash-generative pharmaceutical business. Celltech also possesses drug discovery capabilities of exceptional strength, including a leading position in antibody engineering. More details can be found at www.celltechgroup.com.
Celltech desires to take advantage of the 'Safe Harbor' provisions of the US Private Securities Litigation Reform Act of 1995, with respect to forward-looking statements contained within this document. In particular certain statements with regard to the anticipated timing of clinical trials and regulatory filings with CDP 870 in RA and Crohn's disease, the ability of Celltech to successfully develop and launch CDP 870 in Crohn's disease independently of Pfizer, and the potential outcomes of ongoing discussions with Pfizer...etc |
