Xceleron grabs a piece of American pie

The firm has signed a long-term lease on a multimillion dollar facility in Germantown, Maryland and ordered a new accelerator mass spectrometer (AMS) - the technology on which Xceleron's microdosing and Phase I services are based - which is expected to be delivered in November.

The company said it has invested around $7.5m (€5.5m) on the acquisition of the new AMS and associated equipment and the 15,000 square foot plant is expected to be up and running by the end of the first quarter of 2008.

Xceleron currently sends all its US contracts over to the UK to conduct the analysis but when the new facility is ready, the US business will be conducted at the new site.

"There is a huge market opportunity in North America," Scott Tarrant, Xceleron's vice president of business development in North America, told Outsourcing-Pharma.com "The market for the types of services Xceleron provides is worth $1bn and a significant part of that is generated in North America."

Tarrant explained that the company had long-term plans to establish a facility in the US in order to accommodate the growing number of US- and Canada-based customers who prefer to conduct business and do the work locally.

"It was a cautious approach; first we had to demonstrate that there is a market, then get the business going that could support a US-based facility and finally invest in a facility," said Tarrant.

At the moment, Xceleron has over 100 clients and around 40 per cent of the company's revenue comes from North American customers, and 60 per cent from Europe, said Jeremy Hague, Tarrant's European counterpart.

"Close to the end of 2008, there will probably be revenue parity between what we do in Europe and what we do in the US," added Tarrant.

He stressed the importance of having the capability and capacity to conduct the actual work on location.

"Especially when you deal with big pharma companies, a lot of them are located on the East Coast, so it will be very easy for them to just come to our facility, conduct an audit for example.

It will also be a strong sales driver," said Tarrant.

Although he would not give an exact figure for the total amount invested in the US expansion, he said that by the end of the year, Xceleron will have an extra 20 new US staff.

The company had 10 employees in January 2005 and currently has 45.

Xceleron conducted the first microdosing study back in 1999 and since then the company has examined 45 different molecules and had Phase I data for 11 of them.

The company found that 90 per cent of them showed a correlation between microdose and pharmacologic dose PK properties.

"We are starting to see a shift in the acceptance of big pharma doing microdosing that was not there a year or two years ago," said Hague.

"For example, we have signed deals with Servier and Sanofi Aventis who are incorporating this type of work into their drug development plans."

Part of that change, he added, is driven by generating data that shows the comparative results of a sub-pharmacologic dose (microdose) to a pharmacologic dose.

"We have done a lot of work that helps put information public

but it's a challenge to get clients to release confidential information about what they are doing."

At the moment it is primarily the small and medium companies that are opting for microdosing for their drug development.

"For the bigger companies, because it takes some redesign of already established development programmes to incorporate microdosing, they are not taking up as quickly as we would like," said Hague.

Asked whether they were seeing a difference in terms of take-up between European pharma companies and US-based ones, both Hague and Tarrant said it is probably higher in Europe first because the concept has been around for longer in Europe and also because EU regulators have released guidance earlier than in the US.

While the US Food and Drug Administration (FDA) published it guidance on microdosing studies in January last year, which it regulates under the banner of an "Exploratory IND" (Investigational New Drug) application, the European regulator, the EMEA, had already published its own document in 2003.

Meanwhile, Xceleron's other major offering involves early exploratory clinical development.

It claims that its technology allows its clients to get much more information within a Phase I setting.

"We are now able to generate very important data in Phase I that would normally not come until later in the clinical drug development.

A lot of companies currently look for that data once they are in Phase II or Phase III.

It costs a lot more to kill a programme in Phase II or Phase III than it is to kill it in Phase I," explained Hague.

"Instead of doing separated studies to understand absolute bioavailability, metabolite profiling and mass balance further down the line, which usually cost hundreds of thousands if not millions in extra money, you can do it within an enhanced Phase I package to get a lot more data earlier."