A place in pharma’s history of innovation
pharmafile | March 15, 2006 | Feature | Sales and Marketing |Â Â prix galienÂ
Registration has begun for entrants to the 2006 UK Prix Galien, which takes place at the Houses of Parliament this September. The award, which recognises outstanding achievement in research and development, is widely regarded as the industry’s most prestigious prize.
Judged by an independent panel of eminent NHS figures, the Prix Galien celebrates pharma innovation. In 2004, a conjugate vaccine and an anti-retroviral drug shared the award. In fact, the first patient to use Roche’s award-winning HIV treatment, Fuzeon, attended the ceremony, and remarked that the drug had enabled him to look towards the future and have some dreams. Evidence, if any were needed, of the true value of innovation.
Innovation lies at the heart of pharma research and, according to Professor Sir Michael Rawlins, chairman of NICE and head of the Prix Galien judging panel, is achieved when research meets previously unmet clinical need. The Prix Galien recognises the technical, scientific and clinical research skills necessary to develop innovative medicines. What’s more, it provides an opportunity to acknowledge publicly the contributions made by scientists within the pharma industry, and to showcase the good work undertaken by an often much-maligned sector.
The last UK Prix Galien was held in September 2004, when Roche and Wyeth shared the award for innovative and beneficial new medicines. Success was not a new experience for either company, with both having a good history of achievement at the Prix Galien; Wyeth won the award in 2000 with Meningitec, its conjugate vaccine against meningitis C, and a commendation in 2002 for Enbrel, where it was pipped at the post by Roche’s Herceptin and Novartis’ Glivec. So what are the merits of entering the Prix Galien?
“The Prix Galien award is the most prestigious of all pharmaceutical industry awards,” says Simon Harris, business unit director, specialist products, at Roche. “It represents the output of a rigorous review by a prestigious panel that ultimately recognises and rewards true innovation within the industry. It is viewed by many as the pharmaceutical Oscars.”
David Gibbons, corporate affairs project manager at Wyeth agrees, pointing to the motivational impact Prix Galien success can provide to organisations. “A Prix Galien win is a huge boost for a company. Certainly, for everybody involved with a specific product or area, it is a great recognition. Also, from a general company point of view, it is a significant achievement. It is the top pharmaceutical industry award and it makes a big difference.”
The UK Prix Galien has been running since 1990, with the prize being awarded to many of the industrys top pharma companies. So what does it take to win a Prix Galien award? Pharmafocus looks at the current title-holders, Prevenar and Fuzeon, and asks how Roche and Wyeth approached the awards.
Prevenar
The judging panel looks for the highest quality of discovery and development, and the contribution drugs make to patient welfare. Prevenar, the first conjugate vaccine against pneumococcal disease, shared the top award in 2004, with judges highlighting the potential impact the vaccine would have in preventing serious infection in young children and infants, one of the groups at greatest risk.
“Prevenar has been developed to protect infants and babies and young children against invasive pneumococcal diseases,” says Julie Willingham, Wyeth’s group product manager for paediatric vaccines.
“These are serious infections such as pneumococcal meningitis, septicaemia and pneumonia and they are life-threatening. Each year in the UK, around 50 children under the age of five die from these diseases, while many more who survive are left with permanent disabilities, such as brain damage, epilepsy and deafness.”
Prevenar offers protection against seven pneumococcal serotypes, accounting for around 80% of invasive pneumococcal disease in infants and young children in the UK.
“While development of Prevenar involved similar conjugate technology to the Haemophilus influenzae type b (Hib) and meningococcal group C conjugate vaccines, it posed new challenges, since the conjugation process had to be repeated seven times. Reflecting the complexity of development and of manufacture, Prevenar remains the worlds only licensed pneumococcal conjugate vaccine, addressing a major unmet public health need,” says Willingham.
Prevenar has been in routine use in the US since 2001 where it has made an incredible impact. “There has been a huge reduction in the amount of serious pneumococcal infection in children since that time. In addition, a reduction in the amount of disease in unvaccinated adults has also been observed, attributed to the ‘herd’ impact of the immunisation programme. It produces huge health benefits.”
At present, Prevenar is not part of the routine childhood immunisation programme in the UK, but is recommended for infants and children under five years of age who are considered to be at greatest risk of serious pneumococcal diseases. However, at the end of 2004, the Joint Committee on Vaccination and Immunisations (JCVI), an advisory body to the UK Department of Health, recommended in principle that Prevenar should be included on the routine childhood programme. A decision from the Department of Health is currently awaited. For the purposes of its Prix Galien submission, Wyeth provided data to show the potential impact of making Prevenar routinely available as part of the UK childhood immunisation programme, based on the evidence of the vaccines impact in the US since its routine introduction there in 2001.
Fuzeon
Fuzeon is the first of a new class of anti-retroviral drugs, called fusion inhibitors. Its victory at the 2004 Prix Galien was attributed not only to its health benefits but also to the sophistication of its manufacturing process.
“We were impressed not only with the results of the clinical trials of the product,” says Professor Sir Michael Rawlins, “but also the extraordinarily complex manufacturing issues that had to be solved.”
According to Harris, Fuzeon is the most complex and challenging molecule ever developed via a synthetic process by the pharmaceutical industry. It has a 36 amino acid chain, which involves more than 100 production steps in order to manufacture the product, he says.
Fuzeon has a unique mode of action that is completely different to other conventional anti-HIV drugs. Whereas all other drugs work inside infected immune cells, Fuzeon blocks the HIV virus before entering the human immune cells. This has led to staggering results in the pre-treated HIV patient population.
“Patients taking Fuzeon were twice as likely to achieve undetectable levels of HIV and gained twice the increase in CD4 count when compared to patients who did not receive Fuzeon in the control groups,” says Harris.
And not only is Fuzeon cost-effective, with a cost per QALY of 23,000, but more importantly it has demonstrated a significant increase in the quality of life for HIV patients. This increase is best reflected by the words of the first patient to receive the treatment, who spoke after Fuzeon received the coveted Prix Galien award.
“A year ago I was half the man I am today, so 50% has been a huge increase within a year. It has enabled me to do things Ive never done before and also to contemplate returning to the workplace full-time. Ive only been on the trial for 56 weeks. Now Im starting to prepare myself to look towards the future and have some dreams.”
The impact of winning
The benefits of winning a Prix Galien award are huge, and both Roche and Wyeth have exploited their victories in a marketing sense.
“Upon winning the Prix Galien we had a broad internal communication programme to highlight the success of Fuzeon gaining this award,” says Harris. “There was considerable interest and excitement around the fact that we had yet again won this prestigious award. Our employees certainly recognised that they were working for a truly innovative pharmaceutical company that ultimately made a significant impact on patients lives.”
From an external perspective, the Prix Galien can not only help raise awareness of individual drug companies, but it can also help repair the current reputation of the sector as a whole.
“We seem to be struggling along the bottom of the curve with regards our reputation at the moment. The Prix Galien can be used to demonstrate to a wider, public audience the achievements of the pharmaceutical industry,” says Gibbons.
In the case of Enbrel and Prevenar, Wyeth has already communicated its Prix Galien achievements to various patient groups in those disease areas. It also makes reference to its success on detail aids and product information, which supports the prestige of the brands. Likewise, Roche has noted that Fuzeon’s victory stimulated much excitement and debate among its customers who had recognised the innovation behind the product’s development and how it could support them with the management of HIV patients.
Entering the Prix Galien
The Prix Galien is open to all pharma companies in the UK. The Advisory Board will consider entries for the 2006 Prix Galien for products launched or granted a new indication in the UK market between January 2004 and March 2006. Products granted marketing authorisation through EU centralised procedure, in the UK or available under the mutual recognition process, are also admissible.
The Advisory Board will be looking for the most significant overall contribution to patient care in the UK in terms of efficacy, safety, benefits and innovation. A number of entries may be short-listed by the Advisory Board for commendation with the overall winning entry receiving the UK Prix Galien medal.
This year’s judging panel includes a wide array of health technology appraisal experts, their involvement emphasising the credibility of the Prix Galien and underlining the significance of winning.
These judges scrutinise data in the most rigorous manner. To be given an award by such a tough audience is a tremendous achievement, says Karen Westaway, joint chief executive at WG Consulting, who own the UK `franchise and have successfully managed the awards for almost a decade.
Entering the Prix Galien is clearly a time-consuming exercise, but its benefits make the effort worthwhile. Roche set up a small internal project team to scope out and define its approach for the submission of Fuzeon.
“We felt that it was important that the submission was generated internally as this was where the expertise for the product lay,” says Harris. “Obviously this approach took some internal time and resource. However, we considered this was a sensible investment given the prestigious nature of the Prix Galien Award.”
Gibbons concedes that putting a submission together is hard work, but believes it is important for the industry to take part.
“It involves a number of people from different areas of the company, and with everybody being incredibly busy, getting everyone together is no mean feat.
“However, ultimately its worthwhile finding the time and motivating people to take part. Prix Galien is an opportunity to stand up and show what the industry can achieve. It is certainly an important thing to put in for, and its up to us as an industry to shout a little bit more about it.”
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