Cambridge Antibody Technology Interim Results for the Six Months Ended 31 March 2004
Monday May 17, 2:00 am ET
CAMBRIDGE, England, May 17 /PRNewswire-FirstCall/ -- Cambridge Antibody Technology (LSE: CAT - News; Nasdaq: CATG - News) today announces financial results for the six months ended 31 March 2004 and a business update.
Summary
Developments since the First Quarter results:
* Trial for litigation with Abbott set by London High Court for November
2004
* Library licences granted to Genzyme and Wyeth
* Enrolment in US trial of Trabio(R) to be completed in the third quarter
of 2004
* Wyeth progressing an anti-GDF-8 antibody, licensed from CAT
* Further pre-clinical studies of GC-1008 underway
* Plans for anti-TGFbeta collaboration with Genzyme in development
Previously announced:
* Preliminary results from CAT-192 Phase I/II clinical trial
* Enrolment complete in Phase III pivotal International clinical trial of
Trabio
* Co-development agreement with Amgen restructured on attractive terms
* Co-development agreement with Elan terminated by CAT
* Extension of manufacturing agreement with Lonza
* Second tranche of equity investment by Genzyme
Financial:
* Net cash and liquid resources of 107.6 million pounds at 31 March 2004
(107.8 million pounds at 30 September 2003)
* Net cash outflow before management of liquid resources and financing:
14.2 million pounds for the six months ended 31 March 2004 compared
with 13.2 million pounds for the six months ended 31 March 2003
* Revised financial guidance: net cash outflow before management of
liquid resources and financing for the year to 30 September 2004
expected to be less than 35 million pounds (after Genzyme investment,
net cash outflow after financing less than 21 million pounds)
Paul Nicholson, CAT's Chairman, said "We are pleased to report that CAT has continued to make progress in the first half of the financial year. We are also pleased that the High Court has fixed a trial date in November 2004 to hear our dispute with Abbott in accordance with our wish that the courts resolve the dispute at the earliest opportunity. We look forward to putting our case before the High Court in November."
CAT Product Candidates
In April 2004, three-year follow up results of a Phase II clinical trial of Trabio (lerdelimumab), a human anti-TGFbeta2 monoclonal antibody, in patients undergoing first time phacotrabeculectomy (combined surgery to simultaneously treat glaucoma and a cataract) were presented at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO). The results show that patients treated with Trabio at the time of surgery have lower intraocular pressure (IOP) levels compared to placebo-treated patients. Additionally, the proportion of patients returning to IOP-lowering medication remains lower for Trabio than placebo groups.
In the US clinical trial of Trabio compared to 5-fluorouracil (5FU) in patients undergoing surgery for glaucoma (trabeculectomy) enrolment is ongoing and is now expected to be complete in the third quarter of 2004.
In the Phase II/III European clinical trial of Trabio in 344 patients undergoing first time trabeculectomy, it is expected that preliminary data at one year follow up will be available in the fourth quarter of 2004.
Enrolment is complete in the Phase III pivotal International clinical trial of Trabio in patients undergoing first time trabeculectomy. A total of 393 patients in six European countries and South Africa were randomised in the double-blind trial which compares Trabio with placebo. Data from this trial are expected in early 2005 when all patients will have completed at least one year of follow-up post surgery.
In February, preliminary results from a Phase I/II clinical trial of CAT-192 (metelimumab), a human anti-TGFbeta1 monoclonal antibody, were announced. The double-blind, placebo-controlled trial enrolled 45 patients at 12 medical centres in the US and Europe. Patients were randomised to receive one of three dose levels of CAT-192 (0.5 mg/kg, 5 mg/kg or 10 mg/kg) or matching placebo, given as an intravenous infusion every six weeks for four doses.
The primary objective of the trial was to assess the safety, tolerability and pharmacokinetics of CAT-192 in patients suffering from diffuse systemic sclerosis. Preliminary results show that the primary objective of the trial was met; CAT-192 was generally safe and well-tolerated at each dose level. Elimination half-life was consistently around three weeks. There were no treatment-related serious adverse events observed. The secondary objective was to evaluate the potential clinical outcomes for any future trial in systemic sclerosis, however, no definitive conclusions regarding the efficacy of CAT-192 are able to be drawn at this time.
An Investigational New Drug (IND) application for a Phase I trial in the US in idiopathic pulmonary fibrosis (IPF) of GC-1008, a pan-specific human anti-TGFbeta monoclonal antibody being developed by CAT and Genzyme, has been filed with the US Food and Drug Administration (FDA). Following discussions with the FDA further pre-clinical studies are underway, prior to commencing the Phase I trial.
Utilising the information obtained from the CAT-192 trial and other pre-clinical studies, CAT and Genzyme are working closely to define the most appropriate indications and clinical trial designs to take full advantage of the potentially significant opportunities in anti-TGFbeta antibodies.
CAT-213 (bertilimumab) is a human anti-eotaxin1 monoclonal antibody which CAT has been evaluating as a treatment for severe allergic disorders. Early discussions continue with potential partners to commercialise CAT-213.
CAT-354, a human anti-IL13 monoclonal antibody, is being developed as a potential treatment for asthma and possibly other indications. A Phase I single dose clinical trial is expected to begin before the end of 2004.
HUMIRA(TM)
HUMIRATM (adalimumab) is a human anti-TNFalpha monoclonal antibody which was isolated and optimised by CAT in collaboration with Abbott Laboratories. It is the first CAT-derived antibody to receive approval for marketing and is now approved for sale in 41 countries. Abbott has reported that HUMIRA achieved full year sales in 2003 of $280 million and for the first quarter of 2004 of $149 million. Abbott is forecasting sales of HUMIRA of more than $700 million in 2004 and more than $1.2 billion in 2005.
Abbott has also presented new Phase II clinical trial data for HUMIRA that demonstrated that patients with moderate to severe psoriasis receiving 40 mg HUMIRA every other week achieved statistically significant improvement after 12 weeks' treatment. The data also showed that HUMIRA was well tolerated. Additionally, data from clinical trials of HUMIRA in patients with active Crohn's disease will be presented at the Digestive Disease Week conference in New Orleans this month.
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. A trial has now been set by the London High Court to commence in November 2004, with an expected length of three weeks.
Other 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 for a number of autoimmune diseases. Data from a clinical trial of ABT-874 in patients with active Crohn's disease will also be presented at Digestive Disease Week.
In January 2004, Human Genome Sciences, Inc (HGSI) announced that it has begun enrolling and dosing patients in a Phase II clinical trial of LymphoStat-BTM, a human monoclonal antibody which modulates the activities of B-lymphocytes, in patients with rheumatoid arthritis. The double-blind, placebo-controlled multi-centre trial will evaluate safety, optimal dosing and efficacy of LymphoStat-B in approximately 230 patients with active rheumatoid arthritis who have failed prior therapy. Also, HGSI is currently conducting a double-blind, placebo-controlled, multi-centre Phase II clinical trial of LymphoStat-B in patients with active systemic lupus erythematosus (SLE). HGSI plans to complete enrolment of both clinical trials in 2004.
HGSI continues with the 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 and anticipates that the results of two Phase I trials will be available for presentation at the Annual Society of Clinical Oncology (ASCO) meeting in June 2004. HGSI plans to initiate Phase II clinical trials in 2004.
HGSI is currently enrolling patients with advanced tumours into 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.
In March 2004, HGSI presented results from its Phase I placebo-controlled, dose-escalation clinical trial to evaluate the safety, tolerability and pharmacokinetics of ABthrax(TM), a human anti Protective Antigen monoclonal antibody isolated and developed by HGSI from antibody libraries licensed from CAT. The results demonstrate that ABthrax is safe and well tolerated in healthy adult volunteers, and achieved the blood levels predicted in relevant animal models as necessary to afford significant protection from the lethal effects of anthrax toxin. HGSI has stated that further development of ABthrax will depend on the US Government's willingness to commit to the purchase of ABthrax.
Wyeth is moving forward with MYO-029, a human monoclonal antibody discovered by CAT in collaboration with Wyeth and licensed to Wyeth, that neutralises the effects of a protein called GDF-8, which is associated with reduced skeletal muscle mass. MYO-029 is being studied as a potential therapy for muscle-wasting diseases, including muscular dystrophy, an inherited disease that causes degeneration of various muscle groups, and sarcopenia, which is a loss of muscle mass and strength that can result from ageing or from disease such as cancer.
There are four further product candidates at pre-clinical development stage at CAT's collaborators.
Discovery Stage Programmes
There are ongoing research programmes to 13 distinct molecular targets at CAT. Approximately half are funded or co-funded by CAT and half are funded by CAT's licensees.
In December 2003 CAT restructured its agreement with Amgen, with Amgen taking over responsibility for the further development and marketing of the therapeutic antibody candidates isolated by CAT against two targets identified by Amgen and covered by an earlier collaboration agreement between CAT and Immunex. In return, CAT receives from Amgen an initial fee and potential milestone payments and royalties on future sales. This agreement allows CAT to focus its investment on a smaller number of core programmes, while retaining significant interest in the success of these two antibody candidates.
In February 2004, CAT exercised its right to terminate its agreement with Elan. The collaboration involved research on a number of targets in the fields of neurology and pain. Terminating this exclusive agreement allows CAT to collaborate with third parties in these disease areas.
In December, the research collaboration with Pfizer was extended for a further six months to 30 May 2004. Discussions continue on extending this collaboration.
Library Licences
In the last six months CAT has continued to develop its licensing business through the license of its proprietary phage antibody libraries in return for upfront fees and, potentially, option, milestone and royalty payments in the future.
In February 2004, Wyeth exercised an option to license CAT's libraries for in-house use. The libraries will support Wyeth's activities in therapeutic antibody drug discovery and development across a broad range of therapeutic areas. This option was granted to Wyeth as part of the collaboration agreement entered into in March 1999. Wyeth has a number of exclusive therapeutic and diagnostic antibody product options related to its use of the libraries.
In April 2004 CAT granted Genzyme a Library licence. Genzyme will use CAT's phage antibody libraries in its research and development of antibody- based treatments across a range of medical areas. Genzyme also received option rights to develop therapeutic and diagnostic products on an exclusive basis.
Operations
In January 2004 CAT and Lonza announced the extension of their November 2001 agreement, confirming that Lonza Biologics will manufacture and supply clinical grade antibody drugs to CAT through to the end of 2006. This enables CAT to plan further ahead with confidence and guarantees that CAT and its collaborators have access to Lonza's world-class manufacturing capability at production scale (up to 2,000L), for both ongoing programmes and future projects, in a cost-effective way.
Financial Results
CAT made a loss after taxation for the six months ended 31 March 2004 of 18.0 million pounds (six months ended 31 March 2003 (H1) 18.8 million pounds; six months ended 30 September 2003 (H2) 20.4 million pounds). Net cash outflow before management of liquid resources and financing for the period was 14.2 million pounds (H1 - 13.2 million pounds outflow; H2 - 20.4 million pounds outflow). Net cash and liquid resources at 31 March 2004 at 107.6 million pounds, were 0.2 million pounds lower than at the start of the period (31 March 2003 - 118.2 million pounds; 30 September 2003 - 107.8 million pounds).
Turnover in the period was 8.5 million pounds (H1- 4.0 million pounds; H2 - 4.7 million pounds). Royalty income of 2.7 million pounds was recognised as revenue in the six month period representing the amount received from Abbott in respect of HUMIRA sales for the year ended 31 December 2003. Payments were received from Abbott in October 2003 and April 2004. Licence fees of 2.2 million pounds were recognised in the period, principally licence fees released from deferred income brought forward at 30 September 2003. Revenues from milestone payments of 2.1 million pounds were recorded during the period. Four technical milestone payments were received from Pfizer in December 2003. A proportion of the clinical milestone received from Abbott in the last financial year was released as revenue, having been offset against the two royalty payments made by Abbott. Revenues of 1.1 million pounds were generated from contract research fees under collaborations with Amgen, Merck & Co., Pfizer and Wyeth Research. Other revenues of 0.4 million pounds were recognised in the period.
Direct costs for the six months ended 31 March 2004 were 1.5 million pounds (H1 - 0.03 million pounds; H2 - 0.7 million pounds), reflecting royalties due to Medical Research Council and other licensors on the royalties CAT receives on product sales under its various licences and collaborations. In addition, the results for the six months ended 31 March 2004 include an amount payable to Medical Research Council following CAT's settlement of litigation with MorphoSys in 2003.
Operating costs for the period amounted to 27.0 million pounds (H1 - 25.3 million pounds; H2 - 28.9 million pounds). Research and development costs for the six months ended 31 March 2004 were 21.5 million pounds (H1 - 21.3 million pounds; H2 - 23.7 million pounds). Research and development costs for the six months ended 31 March 2003 included the one-off cost of a cross-licensing arrangement with Xoma for antibody-related technologies. External development costs were 9.5 million pounds in the six months ended 31 March 2004 (H1 - 5.8 million pounds; H2 - 9.4 million pounds), reflecting increased activity on the Trabio clinical trials and the CAT-354 programme.
General and administration expenses for the period were 5.5 million pounds (H1 - 3.9 million pounds; H2 - 5.3 million pounds). The principal reason for this increase is a non-cash charge of 1.4 million pounds arising from the retranslation of CAT's trading balances with its US subsidiary, Aptein Inc., as since 30 September 2003 there has been a significant depreciation in the value of the US Dollar compared to Sterling. This non-cash charge in the profit and loss account is offset by a 1.3 million pounds non-cash foreign exchange gain arising from the retranslation of the net assets of Aptein reflected in the statement of total recognised gains and losses and, therefore, the net effect on net assets is not significant. The cost of litigation for the six month period was 0.7 million pounds (H1 - 0.1 million pounds; H2 - 0.8 million pounds).
During the period the Group accrued interest receivable on its cash deposits of 2.1 million pounds (H1 - 2.5 million pounds; H2 - 1.9 million pounds) reflecting the reduced level of cash and liquid resources held in interest bearing securities and lower rates of return earned during the period.
The net increase in deferred income balances in the period was 3.3 million pounds following the receipt of licence fees from a number of parties (primarily Amgen and Wyeth Research) which are being recognised over the relevant future period in accordance with CAT's established accounting policy.
In September 2003, Genzyme committed to subscribe 22.9 million pounds in cash for 4.3 million shares in CAT. The subscription was in two tranches, the first of which occurred during the previous financial year and the second of which occurred in October 2004 and was for 2.5 million shares with a value of 13.3 million pounds.
Outlook
In November 2003 CAT gave guidance that net cash outflow, before management of liquid resources and financing, for the current financial year, was expected to be up to 40 million pounds. We now expect external development costs to be lower than anticipated at that time and as a consequence net cash outflow before management of liquid resources and financing is now expected to be less than 35 million pounds. Net of Genzyme subscription monies received in the first half year this would result in net cash outflow after financing of less than 21 million pounds... |
