RESULTS -
MELBOURN, England, Nov. 18 /PRNewswire-FirstCall/
Highlights
* Significant pipeline progress
* Humira(TM) filed for approval (Abbott)
* CAT-152 IND filed; Phase III trials underway
* CAT-192 granted US and European Orphan Drug Status
* Encouraging Phase I/II results for CAT-213
* TRAIL-R1 mAb IND filed and approved (HGSI)
* Five exclusive therapeutic licences granted (HGSI, Amgen, Wyeth
Research)
* Research alliance signed with Chugai
* Second agreement with Merck & Co., Inc. (since year end)
* Royalty obligations to DRC bought back
* Net Cash Outflow: 28.3m pounds
* Cash & liquid resources at 30 September 2002: 129.8m pounds
Professor Peter Garland, CAT's Chairman, said, "With significant progress in a number of areas, CAT continues to demonstrate its strength and inherent value. The prospect of the first CAT-derived human monoclonal antibody therapeutic, Humira(TM) (previously known as D2E7), being commercialised in 2003 by Abbott is a strong validation of our technology as a major drug discovery platform.
"Alongside the news of Humira, it is important also to emphasise the growing strength and breadth of CAT's product portfolio, which is underpinned by our leading antibody display technologies and development capabilities. This year we continued to see CAT's product pipeline, which will ultimately drive our commercial success, make good progress."
Peter Chambre, Chief Executive Officer at CAT, said, "Over the past few months we have set ourselves the ambitious goal of completing CAT's transition to a profitable, product based biopharmaceutical company over the next five years. We are also aiming to build a broad portfolio of products that will secure rapid revenue and profit growth beyond that point.
"CAT currently has the largest number of antibodies in clinical development of any company involved in human antibody therapeutics. Despite this success we believe that we need to strengthen further our product pipeline in the coming years. We expect to do this by continuing our internal discovery research, advancing the programmes currently in pre-clinical development, seeking to expand the indications for products already in human clinical trials and through the acquisition and in-licensing of other new products."
Chairman's Statement
With significant progress in a number of areas, CAT continues to demonstrate its strength and inherent value. The prospect of the first CAT-derived human monoclonal antibody therapeutic, Humira(TM) (previously known as D2E7), being commercialised in 2003 by Abbott is a strong validation of our technology as a major drug discovery platform.
Alongside the news of Humira, it is important also to emphasise the growing strength and breadth of CAT's product portfolio, which is underpinned by our leading antibody display technologies and development capabilities. This year we continued to see CAT's product pipeline, which will ultimately drive our commercial success, make good progress. Both CAT-152 (lerdelimumab), an anti-scarring agent to be used as an adjunct to surgery for glaucoma, and CAT-213, our human anti-eotaxin(1) antibody treatment for allergic disorders, have shown promise. With the entry into trials this year of the seventh CAT-derived human monoclonal antibody, TRAIL-R1 mAb, a potential anti-cancer treatment, CAT continues to lead the world in the development of human antibody therapeutics, there being more CAT-derived human antibodies in clinical trials than from any other company.
In a competitive environment for antibody product discovery it is encouraging that a growing number of CAT's partners elected to develop antibody therapeutic drug candidates exclusively with CAT in 2002. CAT issued four exclusive product licences during the year and one after the year end, each of which was the fruit of an existing partnership.
CAT has also entered into new international alliances with well-respected pharma and biotech companies. These collaborations expand the number and breadth of licencees of CAT's proprietary technologies and offer the prospect of CAT deriving significant long-term value from third party development and commercialisation of human monoclonal antibody drugs. Our alliance with Chugai, one of Japan's leading pharma companies, is particularly significant as our first collaboration in one of the world's largest pharmaceutical markets.
Our offer to acquire Drug Royalty Corporation of Canada (DRC) in February of this year, though ultimately unsuccessful, gave us the opportunity to buy back our royalty obligations to DRC. We exercised this right in April.
CAT would like to thank Jim Foght, who has recently announced his intention to retire from CAT's Board of Directors after the AGM in February 2003. Jim has been a Non-Executive Director since 1996, prior to CAT's flotation, and we have benefited greatly from his experience of the biotechnology and investment industries. We are grateful to him for his valuable contribution.
CAT is pleased to announce the appointment of Ake Stavling as a new Non-Executive Director. Ake has extensive senior management experience, covering finance and the pharmaceutical industry, and most recently held the post of Executive Director at AstraZeneca PLC, with responsibility for business development, incorporating corporate strategy and mergers & acquisitions. Previously, he was Chief Financial Officer at Astra AB. Ake takes up his position on 2 December 2002 and will succeed Jim Foght as chairman of the Audit Committee.
This year's achievements demonstrate that CAT is fundamentally a strong company underpinned by a talented organisation and exceptional science. However, the progress made during the year has not been reflected in the share price, which has fallen considerably over the period. We recognise that CAT has been as affected as other companies in the sector by the current lack of investor appetite for biotechnology stocks. This notwithstanding, we remain committed to developing therapeutic antibodies as the best way of creating value for shareholders from our capabilities and technologies.
Chief Executive Officer's Statement
Over the past few months we have set ourselves the ambitious goal of completing CAT's transition to a profitable, product based biopharmaceutical company over the next five years. We are also aiming to build a broad portfolio of products that will secure rapid revenue and profit growth beyond that point.
CAT will focus on the exploitation of its leadership position in the antibody field in two ways: through the development of products in a selected number of areas of disease, and through the licensing of our capabilities and technology for the discovery and development of therapeutic antibodies outside those specific target areas.
For some time, CAT has been developing the application of industrialised microarray technology for use in personalised medicine. We see this as a very exciting opportunity. As a result of our focus on therapeutic antibodies CAT will be seeking independent financing for this business, which Kevin Johnson, our Chief Technology Officer, will lead.
CAT currently has the largest number of antibodies in clinical development of any company involved in human antibody therapeutics. Despite this success we believe that we need to strengthen further our product pipeline in the coming years. We expect to do this by continuing our internal discovery research, advancing the programmes currently in pre-clinical development, seeking to expand the indications for products already in human clinical trials and through the acquisition and in-licensing of other new products.
As we plan the management of our resources for the future, we anticipate further growth in expenditure during the next year due principally to the growth in our clinical trials programme. After a period of rapid growth in capability and resource level, however, we do not expect further significant growth in headcount next year. There will be some increase in development and commercialisation resources.
Review of the Year
Product Development
Humira(TM)
Humira(TM) (D2E7, adalimumab), a human monoclonal antibody that neutralises TNF alpha, is being developed by Abbott as a treatment for rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA) and Crohn's disease.
* April 2002 Abbott simultaneously filed Humira with the US Food and
Administration (FDA) and European Agency for the Evaluation of
Medicinal Products (EMEA) for marketing approval. Humira remains under
review and results of both filings are expected in the first half of
2003. If approved, Humira will be the first human monoclonal antibody
therapy on the market. RA is a condition which affects an estimated
five million patients in Europe and the US, of whom around one million
of the most severely affected could potentially benefit from treatment
with Humira.
* June 2002 Encouraging Phase III data were presented at the European
League Against Rheumatology (EULAR) meeting. The trial results showed
Humira improved signs and symptoms of RA in up to 50 per cent of
patients and was safe and well tolerated at the doses used.
* September 2002 Abbott began enrolling patients into a Phase III
clinical trial to assess the efficacy of Humira to treat patients with
JRA. JRA causes swollen and tender joints and can lead to permanent
joint damage. It affects around 90,000 children in Europe and North
America.
* September 2002 Abbott started recruiting patients to a Phase II/III
clinical trial to evaluate the safety and effectiveness of Humira as a
treatment for Crohn's disease, a chronic inflammatory disorder of the
gastrointestinal tract. Crohn's disease affects around half a million
patients in Europe and North America.
* October 2002 Further promising Phase III data were presented at the
American College of Rheumatology (ACR) meeting, particularly the
slowing of progression of joint disease (as evidenced by X-rays).
CAT development programmes
Encouraging clinical data on CAT-152 (lerdelimumab), a human anti-TGF beta2 monoclonal antibody being developed by CAT as a treatment to prevent post-operative scarring in patients undergoing surgery for glaucoma (trabeculectomy), were presented this year. CAT estimates up to 250,000 patients per year undergoing an operation for glaucoma in the US and Western Europe could potentially benefit from treatment with CAT-152.
* November 2001 Six month follow-up results from a Phase II clinical
trial using CAT-152 in patients undergoing combined surgery for
glaucoma and cataract (phakotrabeculectomy) presented at an American
Academy of Ophthalmology meeting.
* February 2002 Phase II/III clinical trial commenced in six European
countries to investigate CAT-152 in conjunction with first time
trabeculectomy.
* May 2002 Encouraging twelve month follow-up results of the Phase II
phakotrabeculectomy trial of CAT-152 were presented at the Association
for Research in Vision and Ophthalmology (ARVO) meeting. The results
support findings from the earlier clinical trial of CAT-152 in
trabeculectomy, and demonstrate that the benefits of CAT-152 treatment
have become more apparent with longer term follow-up: patients treated
with CAT-152 achieved lower intraocular pressure (IOP) and fewer
needed to return to topical medication.
* October 2002 Enrolment commenced for an International Phase III trial
of CAT-152 in Europe and South Africa in patients undergoing first
time trabeculectomy.
* November 2002 Investigational new drug (IND) application submitted to
the FDA to start clinical trials in the US.
Recruitment of patients for the European Phase II/III and International Phase III clinical studies of CAT-152 continues, with enrolment in the European trial expected to be complete in the first half of 2003.
Data from these clinical trials is expected to be available towards the end of 2004. CAT has commenced discussions with a number of potential partners, with a view to the partner marketing and selling CAT-152. The timetable for future product licence applications of CAT-152 remains on schedule.
CAT-192 (metelimumab), a human anti-TGF beta1 monoclonal antibody being jointly developed by CAT and Genzyme as a potential treatment for scarring and fibrotic conditions, including scleroderma, continues its progress in trials. CAT and Genzyme estimate that around 300,000 patients worldwide suffer from diffuse progressive scleroderma, a chronic, life-threatening autoimmune disease that causes inflammation and pain in the muscles, joints and connective tissue.
* November 2001 CAT-192 commenced European Phase I/II clinical trials in
patients with scleroderma to assess safety and efficacy.
* December 2001 Pre-clinical data for CAT-192 in pulmonary fibrosis were
presented at the British Pharmacological Society (BPS).
* January 2002 Orphan Drug Status in the US was awarded to CAT-192 as a
treatment for scleroderma.
* February 2002 Orphan Drug Status in Europe was awarded to CAT-192 as a
treatment for scleroderma.
* June 2002 Successful IND application for CAT-192 to start Phase I/II
clinical trials of CAT-192 as a treatment for scleroderma. Patient
recruitment is now underway.
Results of the Phase I/II clinical trials are expected to be available in late 2003.
Good progress was also shown this year in trials of CAT-213, a human anti-eotaxin(1) monoclonal antibody being developed as a treatment for allergic disorders.
* December 2001 Data from a Phase I clinical trial of CAT-213 in healthy
volunteers were presented at the BPS.
* April 2002 Recruitment to a single-dose Phase I/II allergic rhinitis
challenge study completed.
* August 2002 Preliminary results of the challenge study released,
showing that CAT-213 has a significant positive effect upon nasal
patency and reduces the numbers of tissue eosinophils and mast cells
associated with allergen challenge. The data also show that CAT-213 by
nasal aerosol generally produced greater effects than by intravenous
injection.
* November 2002 CAT began recruiting patients for a Phase I/II challenge
study of CAT-213 in allergic conjunctivitis.
The results of the allergic rhinitis challenge study have been submitted for presentation at the American Academy of Allergy, Asthma and Immunology (AAAAI) meeting in March 2003. Data from the allergic conjunctivitis challenge study are expected to be available in the third quarter of 2003....
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