West Coast Editor
Finding the right patients, getting them enrolled in trials and moving the trials along as quickly as possible - that's the name of the game, often summed up in biotechnology as "speed to market." If you can do it cheaply, well, so much the better.
Say hello to Australia, where a relatively untapped patient population awaits, with ethnic and lifestyle characteristics that are similar to those in America. And where the cost of hiring a contract research organizations is about 35 percent less than in the U.S., noted Alek Safarian, CEO of Novotech, Australia's largest independent contract research organization (CRO).
"That's the real clincher," Safarian said, pointing to cultural and language compatibility, as well.
Also powering the trend is the difficulty of luring pharmaceutical partners, he said, along with the scarcity of venture capital.
"Ten years ago you had a situation where pharma would put money in just about anything that had any sort of promise," he recalled, but consolidation since has put "enormous pressures on them to keep the analysts happy. Margins are being squeezed, and biotech [firms are] having to go a bit further on their own."
Novotech, based in Sydney, has worked with more than 15 U.S. biotech firms during the past three years, and about 80 percent of its business comes from North America. Safarian acknowledged that Australia is "a much smaller market in terms of patient population, but not nearly so competitive, so it represents a good venue."
Among the firm's current clients is OSI Pharmaceuticals Inc., of Melville, N.Y.
OSI's Tarceva (erlotinib) gained FDA clearance for non-small-cell lung cancer in November on the basis of a 42.5 percent survival advantage over placebo.
"The pivotal studies had an Australian component, and we are still working with them in a lung study for surviving patients," Safarian told BioWorld Today. Other customers are ICOS Corp., of Bothell, Wash., and Salmedix Inc., of San Diego.
"At the moment we're working on about 25 studies at any one time, across the range of 15 to 20 clients," he said.
Fueling business to some degree are new European Union rules regarding clinical trials.
"The idea is to harmonize regulations across the EU, but each member state has to ratify [the new directive], so it's causing a little bit of ambiguity about who the companies have to go through" for approval of trial plans, Safarian said. "Every country is a sovereign state in its own right."
Upshot: more European red tape.
On the other hand, U.S. regulators' stricter view of the approval process, brought about by recent problems with the likes of Vioxx and Tysabri, probably is not contributing to the quickening trend toward Australian CROs, Safarian said.
"I think there's a general trend in being open and transparent with the data that you have," he said. "In the end, whether you do your study in Australia, the U.S. or Timbuktu, you're still going to have the same requirement to be transparent with the data."
Vioxx (rofecoxib) was taken off the market more than six months ago because of cardiovascular concerns, though two FDA advisory committees voted to allow Merck & Co. Inc., of Whitehouse Station, N.J., to again start selling the painkiller. (See BioWorld Today, Feb. 22, 2005.)
Tysabri (natalizumab) from Cambridge, Mass.-based Biogen Idec Inc. and Elan Corp. plc, of Dublin, Ireland, was withdrawn from the market in February, three months after its approval. So far, three cases of progressive multifocal leukoencephalopathy have turned up in patients given the drug. (See BioWorld Today, April 1, 2005.)
New York-based Pfizer Inc. joined the parade last week when the firm voluntarily quit selling its painkiller Bextra after the FDA cited an increased risk of skin reactions among users. The agency also wants strong warnings about increased risk of heart attack and stroke for those who take non-steroidal anti-inflammatory drugs (NSAIDs).
Verifying the trend of U.S. and European firms toward Australian CROs is not easy.
"I don't know if there's any data at all that would give you that," Safarian said, though the switch makes sense. "I don't think there's any argument, qualitatively, that it is faster.
"It has to be faster," he said.
David Kabakoff, chairman and CEO of Salmedix, said the choice of Novotech was "a no-brainer" for his company, which wanted to identify centers where enrollment would be less encumbered by competition from other trials.
"Certainly, good trial work is done there," he said.
Novotech is helping to conduct Phase II trials with Treanda (bendamustine hydrochloride), a drug that has been marketed and used clinically in Germany for many years in patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, multiple myeloma, metastatic breast cancer and other solid tumors.
In May 2003, Salmedix entered a license agreement with Fujisawa Deutschland GmbH, of Munich, Germany, for exclusive rights in the U.S. and Canada to develop, manufacture and market Treanda as chemotherapy.
First, Salmedix is trying Treanda as a single agent and in combination with Rituxan (rituximab) against indolent non-Hodgkin's lymphoma. Rituxan, approved in 1997 for NHL, is being further developed by Genentech Inc., of South San Francisco, Biogen Idec and F. Hoffmann-La Roche Ltd., of Basel, Switzerland.
"We're running one of our Phase III trials in Canada and Australia," Kabakoff told BioWorld Today, adding that "it's not a major program down there," but four of about 30 sites are located in Australia. "Certainly, for us to do it without a CRO there would be prohibitive."
The cost savings for Salmedix isn't clear yet. "Until the trial is done, we probably won't know the answer," Kabakoff said.