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As BioQuarter develops, EU pharma bosses take alternating views

Monday 29th June 2009
Model of Edinburgh's BioQuarter life science complex.

As Scottish Enterprise is developing its £1bn Edinburgh BioQuarter life sciences complex, in the 15-year time frame for the life sciences campus, 80 workers at the Intercell factory in Livingston, have helped produce the first side-effect-free vaccine for Japanese encephalitis (JE) for some 30,000 to 50,000 annual sufferers. But Vienna-based Intercell says support offered in Scotland to its manufacturing facility "is on the lower end compared to many other European countries" and the Livingston facility may only have two more years of life. In contrast, Dr Thomas Koestler, executive VP of pharmaceutical giant Schering-Plough, is hopeful of "further investment" and commitment to its operation at Newhouse, Lanarkshire after its merger with Merck is completed later this year.

In a Steven Vass interview  with Thomas Lingelbach,(right)  Intercell MD and COO of the Vienna-based group, it appears the Livingston facility may only have two more years of life.

Lingelbach explains the JE virus is carried by large numbers of the Asian population without attacking them, for reasons that are not well understood. This makes vaccination particularly important for higher-risk groups like indigenous children and foreign travellers, who don't have the necessary antibodies.  However, until now, this has not been an attractive option. The one previous vaccine by Japan-based Beacon, had serious side effects. In many markets, including Europe, it was never even approved.
 
Intercell's answer is Ixiaro, which it has just launched across Europe and the US in a distribution deal with Swiss Novartis to initially focus on expatriots and travellers. This  arrangement,  part of a much wider strategic alliance with Novartis over other trial stage products, is usually the only way that a small company can launch a drug worldwide. Revenues sharing 50-50, Novartis pays for marketing, Intercell pays for manufacturing, all of which will be done in Livingston.

The company also launched the drug in Australia in a deal with a distributor called CSL Biotherapies under the brand name JESPECT, and won a 5-year contract to supply it to the US military. It is also progressing trials in India to launch the drug there and neighbouring markets in a couple of years.

Development of the drug, the first Intercell has brought to market, dates back to its roughly £4m acquisition of the Livingston factory from Excell Biotech in 2004, part of a £150m investment in the vaccine, around £90m of which has been spent in Scotland.

Lingelbach says opening for business in Scotland was not an easy sell to Intercell investors. "First reaction was, 'Why the hell do you want to do that in Scotland?'," he says. "We are still constantly explaining this to analysts worldwide. Scotland's not what I would call a biotech hub. But then you think about Edinburgh University, which belongs to the best scientific universities in Europe. And you think about the industry around it, which is still growing. People who think twice about it, come to this conclusion."

Intercell ran the Livingston site with some 30 to 40 top scientists developing the vaccine. It has now cut back to about 25, developing it for Asia and improving efficiencies, but simultaneously 55 lower-skilled workers have been added for manufacturing work.

Unimpressed by bioscience support
Lingelbach is unimpressed by Scotland economic developers. "There's a lot of room for improvement," he says. "We have made clear to the development agencies and the government that we have put a substantial investment into Scotland, but we have received very, very little in return.

"We have got to get support in order to sustain and develop the business's capacity, talent and management. The support offered in Scotland is on the lower end compared to many other European countries."

Lingelbach, who moves between the plant, Vienna and the US, explains that Ixiaro/JESPECT is to be followed by a number of  Intercell drugs being developed elsewhere and currently in trials. That includes vaccines for pneumonia, diarrhoea and pandemic influenza. The great hope is a vaccine for hospital-acquired infections, including MRSA, co-developed through phase two and three trials with US-based Merck.

"If this becomes a product this would be the very first blockbuster vaccine for us. We think the potential would be 0.5 bn a year," he says.

But while Intercell pursues its goal to be a world's leading pharma company, the future of the Scottish facility is in question. Lingelbach says  Asian generic versions of Ixiaro will be made locally, retail prices being too cheap to justify European manufacture.  A distribution deal with India's Biological E for manufacturing has been reached, if the product gets regulatory approval there next year. At that point, analysts and investors may insist on production switching to a lower-cost economy.

"We will need scientists at Livingston for another two years," Lingelbach says. "After that we will decide whether to put a new product in there or we could do something else."

Significant drug pipeline from Newhouse site
Thomas Koestler, president of Schering-Plough's Research Institute also interviewed by The Herald visiting the Lanarkshire drug discovery operation, would not comment on what Merck plans to do with the former Organon Biosciences plant, but said the £20m investment by Schering-Plough had been committed to the operation and would not be withdrawn.

He said: "I would point out this is truly a centre of scientific excellence in global pharmaceutical research. There is strong scientific culture among the 270 employees. We have world-class scientists here. Our drug Bridion came out of research in Newhouse."

Bridion developed as a safer, faster alternative to older drugs used to reverse anesthesia - was  proclaiimed a "chemical cleaner" that could save the lives of thousands every year.

Koestler added: "I would also point out that we are a global centre of excellence for drug discovery research into psychiatry and pain. Our speciality here is the central nervous system. We're working with compounds that we hope will be used to treat conditions such as Parkinson's and Alzheimer's.

"There is also a significant drug pipeline coming from this site. That's one of the reasons that Schering-Plough acquired it in the first place.

Regenerative medicine & clinical imaging Centres
Meantime Scottish Enterprise, partner in the BioQuarter, with the University of Edinburgh, the National Health Service Lothian, and lab developer Alexandria Real Estate Equities, reports construction in progress on two facilities: the Scottish Centre for Regenerative Medicine, a £60m facility intended to advance research into the uses of adult and embryonic stem cells in treating disease is due to open spring/summer 2011; and the Clinical Research Imaging Centre at Little France, a £10m facility designed to serve the Queen's Medical Research Institute at Little France.

Life sciences comprise a more than £3bn yearly industry, grown by more than 50% over the past six years. Rhona Allison, (right) director of life sciences for Scottish Enterprise, told BioRegion News  that Scotland is home to 625 life-sci organizations that employ 31,500 people, up from the roughly 590 organisations employing 30,000 people recorded by the Young Company Finance Special Report: Life Sciences in Scotland, released two years ago

Future plans for the BioQuarter call for a new hospital for Sick Children, as well as "at least two further significant clinical facilities at BioQuarter, which will add value to our existing impressive translational medicine infrastructure," said Jonathan Wilson, project manager for commercialisation and innovation with Scottish Enterprise.

And Wilson told BRN that BioQuarter will include a venue for startups. "We are developing an opportunity to accelerate the provision of commercial incubation space on site, in spite of the prevailing economic conditions."

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