To: keokalani'nui who wrote (76 ) 6/16/2003 3:35:58 AM From: nigel bates Respond to of 123 Research update: 16 June 2003 CELLTECH GROUP PLC ONCOLOGY PIPELINE UPDATE Celltech Group plc (LSE: CCH; NYSE: CLL) is today providing a comprehensive update on recent developments within its oncology pipeline and discovery programmes, including new elements resulting from the integration of OGS. In-house oncology development pipeline • CDP 791 CDP 791 is an extremely high affinity PEGylated antibody fragment targeting the VEGF pathway. Data published at the recent ASCO meeting from a clinical trial in colorectal cancer with an anti-VEGF antibody have highlighted the potential for this class of drugs as adjunctive agents to be used alongside existing chemotherapeutic regimens. CDP 791 will this month enter Phase I clinical studies in patients. Preclinical studies with CDP 791, highlighted at Celltech's R&D day in October 2002, have demonstrated potent anti-angiogenic activity. CDP 791 is produced using Celltech's proprietary microbial manufacturing technology and is expected to have a competitive cost of goods profile, along with the potential for subcutaneous dosing. • CDP 860 CDP 860, an anti-PDGF-beta receptor PEGylated antibody fragment, has recently completed a small Phase II proof-of-concept study to determine whether it is able to increase the permeability of tumours, which may facilitate an increased uptake of chemotherapeutic agents, thereby increasing their effectiveness. The effects observed in this study, in which a single dose of CDP 860 was administered to patients with colorectal and ovarian cancer, were consistent with the proposed mechanism of action and confirmed the potent biological activity of this molecule. The side effects observed in this study were also consistent with the mechanism of action, including reversible edema. Celltech intends to partner CDP 791 and CDP 860 with companies possessing significant oncology development expertise that have the ability to explore their utility in a broad range of tumour types alongside existing chemotherapeutic regimens. Celltech is currently pursuing discussions about potential partnerships that enable it to maximise its return from these programmes. Partnered oncology development pipeline • BMS-275291 Celltech's partner, Bristol-Myers Squibb company (BMS), has been evaluating this selective matrix metalloproteinase inhibitor in a large Phase II study in non-small cell lung cancer (NSCLC) in combination with Taxol (paclitaxel) and Paraplatin (carboplatin). Following a planned interim analysis BMS and Celltech were informed by the Drug Safety Monitoring Committee that BMS-275291 was unlikely to reach its pre-determined efficacy end point. Accordingly, this study was interrupted and treatment ceased in nearly all patients. BMS does not plan to develop BMS-275291 further in this indication. BMS-275291 continues to be evaluated in small pilot studies in hormone-refractory prostate cancer and Kaposi's sarcoma. Dr. Goran Ando, Chief Executive Officer, commented: 'It has long been widely understood that this was a high-risk programme, undertaken at no cost to Celltech, with a compound in a class of treatments that have previously failed to show benefits.' • CMC-544 CMC-544 is an anti-CD22 antibody linked to calicheamicin, a potent cytoxic drug, using technology developed for the FDA-approved drug Mylotarg. Celltech's partner, Wyeth, will shortly initiate Phase I studies in Non-Hodgkin's lymphoma with CMC-544. Under the terms of Celltech's collaboration, Wyeth funds the majority of clinical trial for CMC-544, with Celltech receiving a significant royalty on future sales of the product, if successfully commercialised. Discovery programmes • Integration of Oxford GlycoSciences (OGS) oncology activities Celltech's integration of OGS has included a detailed review of scientific skills and programmes, with a particular focus on its oncology research activities. Through this review, Celltech has identified both a highly skilled research team and a number of established oncology research programmes, in both the antibody and small molecule areas. In support of Celltech's corporate objective of enhancing its oncology activities as a strong second franchise alongside its existing research in immune disorders and inflammatory diseases, Celltech will adopt a number of these oncology research programmes within its own pipeline. The most advanced of these programmes would be expected to yield antibody development candidates within two years. In addition, Celltech plans to retain a significant number of research staff working in the oncology area, and is pleased to report 100% acceptance of positions offered to date. These early-stage activities will be incorporated within Celltech's existing R&D budget, reflecting Celltech's previously stated goal of an earnings- and cash-neutral acquisition of OGS. Dr. Goran Ando, Chief Executive Officer, commented: 'We are very excited about the prospects for Celltech's early stage pipeline, and are focused on strategies to maximise value from these programmes by progressing them rapidly through the clinic ourselves, where we have the requisite capabilities, or in collaboration with other leading companies. Celltech's partnering approach, which enables us to limit our exposure to development costs in large scale clinical programmes, remains an important component of maintaining an appropriate risk/reward profile for the company. Through increased research productivity we see a number of exciting opportunities to further expand Celltech's oncology development pipeline, which should be further enhanced in the mid-term through the addition of OGS' promising early stage research portfolio.'