‘Smart’ cancer drugs share top honours in drug innovation prize
pharmafile | October 21, 2003 | News story | |Â Â prix galienÂ
The innovative science behind two breakthrough cancer drugs, Novartis’ leukaemia treatment Glivec and Roche’s breast cancer drug Herceptin, has been recognised in the prestigious UK Prix Galien awards.
A distinguished panel of judges awarded the products joint honours, with Wyeth’s first-in-class rheumatoid arthritis drug Enbrel also receiving a commendation for the excellence in science demonstrated in its research and development.
The shortlist for the most Innovative Product Award contained eight other products that represent advances in the target therapy area, from malaria to psoriasis and hepatitis C (see below for the full list).
Both Glivec and Herceptin represent the pioneering efforts of the industry to develop ‘smart’ molecules that precisely target disease mechanisms, potentially replacing existing treatments such as older chemotherapy drugs which are far less patient-friendly.
Joint winner Glivec, currently licensed for chronic myeloid leukaemia (CML) and gastrointestinal stromal tumours (GISTs), also won the International Galien prize in October.
The drug targets the Philadelphia chromosome, a genetic mutation detected in 95% of CML patients and responsible for producing an enzyme that promotes the abnormal cell growth and division characteristic of the disease.
The company took the drug through clinical trials to regulatory filing in a record breaking 32 months, halving the typical development time-frame of six years.
European orphan drug status produced marketing approval in July 2001, with the UK license following in November 2001.
“We are delighted that Glivec and Novartis Oncology have been recognised in this way by the Prix Galien judging panel”, said Drummond Paris, Chief Executive Officer and Country President, Novartis UK. “To have our efforts commended by this distinguished independent body of industry experts is a great honour. The results seen with Glivec have been impressive. Glivec is the first drug of its kind to be specifically designed with the disease process in mind and is thus a milestone for future drug development.”
Herceptin is the first drug in breast cancer designed to target and block the function of HER2, a protein found in excessive amounts on the surface of some breast cancer cells.
Women with this advanced form of breast cancer given the treatment can expect significantly improved survival up to 40% increase when combined with another breast cancer agent, paclitaxel.
Women with HER2 positive metastatic breast cancer have the worst survival rates of all sufferers, with an average survival time of less than a year. Approximately one in five women with advanced breast cancer have the HER2 protein, which can be identified by a blood test.
Rebecca Hunt, a spokeswoman for Roche, said: “We are thrilled that the targeted treatment for HER2 positive breast cancer has been given this award, and that technical excellence and innovation has been recognised in the UK”.
The prizes were awarded at a special ceremony by Prof Sir Michael Rawlins, judge panel member and Chairman of NICE an irony for companies behind the shortlisted products, many of which have undergone clinical and cost-effectiveness reviews by the Institute.
Glivec and Herceptin have in particular experienced prolonged and difficult NICE appraisals. A backlog of work and new data emerging mid-appraisal meant NICE only gave Herceptin final approval in March this year, some nine months after its launch in the UK.
Meanwhile, it was only last month that Glivec was formally recommended for use on the NHS, after NICE reversed its preliminary decision to limited prescribing to certain CML patients.
The UK Prix Galien Medal for Innovation and Pharmaceutical Research: shortlisted products
Avandia (rosiglitazone), GlaxoSmithKline
A new insulin re-sensitiser treatment for diabetes to supplement the use of sulphonylurea or metformin when the condition is not controlled by these drugs alone
Dovobet (calcipotriol/betamethasone), Leo Laboratories
An innovative psoriasis vulgaris treatment twinning two hard-to-combine drugs
Enbrel (etanercept), Wyeth Pharmaceuticals
The first in class drug that targets tumour necrosis factor (TNF), a dominant element in rheumatoid arthritis
Glivec (imatinib), Novartis
Keppra (levetiracetam), UCB Pharma
A novel anti-epileptic drug with no known drug interactions, minimal adverse events and optimal pharmacokinetics
Herceptin (trastuzumab), Roche
Malarone (atovaquone/proguanil), GlaxoSmithKline
A prophylactic and therapeutic treatment for malaria, and the first new drug for the condition in 40 years
ViraferonPeg (peginterferon alpha-2b), Schering-Plough
A specially modified interferon for greater viral response in hepatitis C patients
Viread (tenofovir), Gilead
The first nucleotide analogue for HIV patients not responding to treatment
Visudyne (verteporfin), Novartis
Photodynamic therapy for age related macular degeneration
Xeloda (capecitabine), Roche
A tumour-selective and convenient oral treatment for cancers
Zyvox (linezolid), Pharmacia
First in a new antibiotic class for 35 years
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