Cambridge Antibody Technology Announces Financial Results for the Nine Months Ended 30 June 2004
Wednesday September 8, 2:00 am ET
CAMBRIDGE, UK, Sept. 8 /PRNewswire-FirstCall/ -- Cambridge Antibody Technology (LSE: CAT - News; Nasdaq: CATG - News) today announces financial results for the nine months ended 30 June 2004 and a business update for the period since the interim results on 17 May 2004.
Summary:
* Completed enrolment of 236 patients in US clinical trial of Trabio(R)
* Regulatory approval received to commence a Phase I clinical trial with
CAT-354
* Wyeth progressing MYO-029, licensed from CAT, into a Phase I clinical
trial
* Abbott increased 2004 sales expectations for HUMIRA(TM) to more than
$800 million
* Continued progress of licensed product candidates by partners HGSI and
Abbott
* New Non-Executive Director appointed -- Professor Christopher Marshall
* Net cash and liquid resources of 101.0 million Pounds Sterling at 30
June 2004 (112.8 million Pounds Sterling at 30 June 2003)
* Net cash outflow before management of liquid resources and financing:
20.7 million Pounds Sterling for the nine months ended 30 June 2004
compared with 19.0 million Pounds Sterling for the nine months ended
30 June 2003
CAT Product Candidates
The treatment phases of two pivotal trials with CAT's lead proprietary product Trabio (lerdelimumab), a human anti-TGFalpha2 monoclonal antibody being developed for improving outcomes in glaucoma filtration surgery (trabeculectomy), have been completed. Preliminary results are expected during the next six months.
In the Phase II/III European clinical trial of Trabio in 344 patients undergoing first time trabeculectomy, preliminary data at one year follow-up remain on schedule for release in the fourth quarter of 2004.
Enrolment is complete in the Phase III International clinical trial of Trabio in 393 patients undergoing first time trabeculectomy. Data from this trial are expected in early 2005 when all patients have completed at least one year of follow-up post surgery.
In the US clinical trial of Trabio compared to 5-fluorouracil (5FU), enrolment has now been completed, with 236 patients randomised. One year follow-up data are expected to be available towards the end of 2005.
In the collaboration between CAT and Genzyme, substantial research and analysis has been carried out in the last six months with the objective of finalising future clinical development plans for anti-TGFbeta antibodies by the end of 2004.
In August, results from the Phase I/IIa clinical trial of CAT-192 (metelimumab), a human anti-TGFbeta1 monoclonal antibody, were presented at the International Scleroderma Workshop in Cambridge, UK.
CAT and Genzyme are currently considering the development of GC-1008, a pan-specific human anti-TGFbeta monoclonal antibody, for oncology indications. Meanwhile pre-clinical safety studies of GC-1008 are continuing prior to initiating a clinical trial in idiopathic pulmonary fibrosis. Further pre- clinical work in other potential indications is also under way.
Regulatory approval to commence a clinical trial has been granted for CAT- 354, a human anti-IL13 monoclonal antibody being developed as a potential treatment for severe asthma. The Phase I clinical trial is expected to begin shortly in the UK. The objective of the trial is to evaluate safety, tolerability and pharmacokinetics of a single intravenously administered dose of CAT-354.
HUMIRA(TM)
HUMIRA (adalimumab) is a human anti-TNFalpha monoclonal antibody which was isolated and optimised by CAT in collaboration with Abbott Laboratories. Abbott has reported that HUMIRA is now approved for sale in 51 countries for the treatment of rheumatoid arthritis and achieved sales for the first half of 2004 of $351 million. Abbott is currently forecasting sales of HUMIRA of more than $800 million in 2004 and more than $1.2 billion in 2005.
Abbott has recently presented data on HUMIRA at two major international conferences. At the European League Against Rheumatism (EULAR) meeting in Berlin in June 2004, positive data from three studies were presented: a ten- patient study in ankylosing spondylitis, a 15-patient study in psoriatic arthropathy and the 2,000 patient ReAct (Research in Active rheumatoid arthritis) study. At the American Academy of Dermatology (AAD) meeting in New York in July 2004, encouraging data from a Phase II, 137-patient study in chronic plaque psoriasis were also presented.
In August 2004, Abbott announced that the US Food and Drug Administration (FDA) had approved an expanded indication for HUMIRA to include improvement in physical function for adult patients with moderately to severely active RA.
In November 2003, CAT commenced legal proceedings against Abbott Biotechnology Limited and Abbott GmbH in the High Court in London concerning the level of royalties due to CAT. The Court has ordered that the trial will commence in late November 2004, with an estimated length of three weeks.
Licensed Product Candidates
ABT-874, a human anti-IL12 monoclonal antibody isolated and optimised by CAT in collaboration with Abbott, and licensed by CAT to Abbott under the same 1995 agreement between CAT and Knoll Aktiengesellschaft as HUMIRA, is in Phase II clinical trials. In June 2004, Abbott announced the initiation of a Phase II study evaluating the potential of ABT-874 in the treatment of multiple sclerosis, an autoimmune disease characterised by the body's immune system attacking the brain and spinal cord.
In July 2004, Human Genome Sciences, Inc (HGSI) announced that it had completed enrolment in its two Phase II clinical trials of LymphoStat-B(TM) (belimumab), a human monoclonal antibody which modulates the activities of B- lymphocytes. The first, a double-blind, placebo-controlled multi-centre trial in 283 patients with active rheumatoid arthritis who have failed prior therapy, will evaluate safety, optimal dosing and efficacy of LymphoStat-B. The second is a double-blind, placebo-controlled, multi-centre Phase II clinical trial of LymphoStat-B in 449 patients with active systemic lupus erythematosus (SLE).
In June 2004, HGSI presented interim results of ongoing Phase I clinical trials to evaluate the safety and pharmacology of HGS-ETR1 (previously known as TRAIL-R1 mAb) in patients with advanced solid tumours or non-Hodgkin's lymphoma at the 40th Annual Meeting of the American Society of Clinical Oncology (ASCO) in New Orleans, USA. The interim results demonstrate the safety and tolerability of HGS-ETR1 and support its further evaluation in Phase II trials. HGSI plans to initiate Phase II clinical trials in 2004.
HGSI continues to enrol patients with advanced tumours in two Phase I open-label, dose-escalating clinical trials of HGS-ETR2 (previously known as TRAIL-R2 mAb) and plans to complete enrolment of one of the Phase I trials in 2004.
Wyeth announced in June 2004 that it has filed an Investigational New Drug (IND) application for MYO-029, a human monoclonal antibody discovered by CAT in collaboration with Wyeth and licensed to Wyeth. MYO-029 neutralises the effects of a protein called GDF-8 which is associated with reduced skeletal muscle mass, is being studied as a potential therapy for muscle-wasting diseases, including muscular dystrophy and sarcopenia. Wyeth is now moving forward with a Phase I clinical trial.
People
CAT is delighted to announce the appointment of Professor Christopher Marshall as a Non-Executive Director of CAT. He will take up his position as a Non-Executive Director on 24 September 2004 and is expected to join CAT's Scientific Advisory Board at the same time. Professor Marshall is Director of the Cancer Research UK Centre for Cell and Molecular Biology at the Institute of Cancer Research London, UK and a Fellow of the Royal Society. He brings a new perspective and scientific breadth to the Board of CAT and the Company looks forward to working with him.
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