PREDICTIVE GENETIC TEST FOR BOWEL CANCER TREATMENT IS INTRODUCED IN THE UK

Amgen and Lab21 in Partnership Agreement for New Cancer Therapy Test

CAMBRIDGE, England (March 17 2008) Amgen Limited UK and Lab21 have announced their partnership to introduce a new genetic therapy test for advanced bowel cancer treatment in the UK.

Under the terms of the agreement, leading diagnostics company Lab21 will provide a screening test to indicate which patients are likely to benefit from Amgen’s new drug for advanced bowel cancer Vectibix® (panitumumab). It is the first time that the European Commission has licensed a bowel cancer product with the stipulation that a predictive test should be carried out. The Lab 21 test was developed by DxS Ltd, a developer of biomarker assays and companion diagnostics for targeted cancer therapies.

Introduced to the UK earlier this year, Vectibix is currently licensed for patients with metastatic bowel cancer for whom standard chemotherapy has failed in patients with a specific gene mutation1. In a biomarker analysis of the pivotal clinical trial, the drug doubled median progression-free survival in patients with non-mutated (wild type) KRAS (Kirsten Rat Sarcoma 2 viral oncogene homologue) compared with patients receiving best supportive care alone.

Amgen scientists had discovered that only those patients with the non-mutated (wild type) KRAS would respond to Vectibix. Patients with metastatic bowel cancer will be tested for the presence of the wild type KRAS gene before they are prescribed the drug.

Approximately 60 per cent of patients with advanced bowel cancer have wild type KRAS. Of these, up to 60 per cent would be expected to respond to Vectibix.2 Over 36,000 people in Britain develop bowel cancer every year and about 21,000 have metastatic cancer at any one time.3

Dr Berwyn Clarke, chief scientific officer at Lab21, said, “We are delighted to complete this partnership with Amgen, a global biotechnology leader. We are committed to providing a fully comprehensive service for cancer patients and believe that the KRAS test is an important component. Being able to select which patients are more likely to respond to therapy is an important step forward in the treatment of cancer.”

“As new technologies develop to assist in cost-effective and efficient use of drugs, the need for prospective analysis of patient samples in high quality reference laboratories will become increasingly more important. The successful conclusion of this agreement further demonstrates Lab21 as a recognised provider of top quality clinical diagnostic services to facilitate improved healthcare in Europe. We are especially pleased to secure this partnership and we hope to support Amgen with other clinical services in the future,” Clarke said.

“We are very pleased to work with Lab21,” said Dr Charles Brigden, medical director of Amgen Limited UK. “We are proud that for the first time we will be able to treat advanced bowel cancer patients with a targeted agent based on a predictive biomarker. This is a big step forward towards individualized care in bowel cancer. We now know that Vectibix will only be effective in those patients whose cancers are positive for non-mutated (wild type) KRAS. Conversely, it also means that we can exclude those patients in whom the agent will not be beneficial,” Bridgen said.

"It is particularly useful that Vectibix is being launched with a screening test for KRAS, which will help clinicians to target those patients, most likely to benefit,” said Dr Maurice Slevin, consultant medical oncologist at the London Oncology Clinic. “This means that patients unlikely to benefit will not receive a treatment which could expose them to unnecessary side-effects. Targeting cancer treatments is critical for the future if society is going to afford the ever increasing cost of innovative drugs,” said Slevin.

“This predictive test is an important advance,” said Ian Beaumont, director of Public Affairs at the charity Bowel Cancer UK. “Launching a new drug for advanced bowel cancer with a predictive screening test brings us closer to personalised care.”

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Notes to Editors

About Amgen

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realise the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics has changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.co.uk

About Lab21

Lab21 is a global provider of state-of-the-art diagnostic products and services, supporting drug discovery, healthcare and environmental monitoring. Its customers include healthcare providers, pharmaceutical and biotechnology companies, in addition to organisations that need to monitor their impact on the environment.

The Company has a growing test portfolio providing companion diagnostics and high technology assays for the growing integration of personalised medicine into healthcare. These services and products are currently in infectious diseases, oncology and pharmacogenetic areas with emerging interests in cardiovascular and metabolic disease.

Lab21’s environmental monitoring business specialises in the detection of heavy metal contamination in soil and water. Its products provide information to help organisations take action to reduce pollution and to protect the water supply of millions of people globally. Lab21’s clinical reference laboratory and corporate office is based in Cambridge and employs 48 people. The Company’s investors include Merlin Biosciences and Kreos Capital. Website: www.lab21.com 

About DxS

DxS is a personalised medicine company providing molecular diagnostics to aid doctors and drug companies in selecting therapies for patients. TheraScreen® is the range of cancer mutation diagnostic products, which includes kits that detect mutations in the EGFR gene. Tumour mutation products are available for research use for EGFR, RAS, RAF and other genes associated with cancer drug responses. DxS also offers a tumour mutation assay service.

About Vectibix

In the EU, Vectibix (panitumumab) is indicated as monotherapy for the treatment of patients with metastatic colorectal carcinoma expressing EGFR with tumours with non-mutated KRAS and after failure of fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy regimens. The effectiveness of panitumumab as a single agent for the treatment of EGFR-expressing, metastatic colorectal carcinoma is based on progression-free survival. Currently, no data are available that demonstrate an
improvement in disease-related symptoms or increased overall survival with panitumumab.

Vectibix (panitumumab), the first fully human IgG2 monoclonal antibody, targets the Epidermal Growth Factor Receptor (EGFr), a protein that plays an important role in cancer cell signaling.

With its demonstrated efficacy, low rate of infusion reactions, low risk of immunogenicity and convenient fortnightly dosing schedule Vectibix provides an important option in the management of metastatic colorectal cancer (mCRC) patients.

Important Product Safety Information EU

Dermatologic related reactions, a pharmacologic effect observed with epidermal growth factor receptor (EGFR) inhibitors, are experienced with nearly all patients (approximately 90 percent) treated with panitumumab. The majority of dermatological reactions are mild to moderate in nature. In clinical studies, subsequent to the development of severe dermatological reactions (including sore mouth), infectious complications including sepsis, in rare cases leading to death, and local abscesses requiring incisions and drainage were reported. Patients who have severe dermatologic reactions or who develop worsening reactions whilst receiving panitumumab should be monitored for the development of inflammatory or infectious sequelae, and appropriate treatment promptly initiated.1

Severe infusion reactions occurred with panitumumab in approximately one per cent of patients. Severe infusion reactions were identified as anaphylactic reactions, bronchospasm, fever, chills and hypotension. Although fatal infusion reactions have not been reported with panitumumab, they have occurred with other monoclonal antibody products. Severe infusion reactions require stopping the infusion and possibly permanently discontinuing panitumumab, depending on the severity and/or persistence of the reaction.1

References

1. Vectibix Summary of Product Characteristics 2007.

2. Cancer Research UK: UK Bowel Cancer Statistics http://www.cancerresearchuk.org  and search for bowel cancer.

3. Esteller M, et al. J Clin Oncol. 2001; 19(2): 299-304.


CONTACTS

Amgen, United Kingdom

Annette Condon, 01223 436313

Lab21

Helen Marriott, 01223 395454