Facing dwindling product pipelines and looming patent cliffs, nearly all of the world’s major drug makers have recently overhauled their research and development activities. Brendan Borrell asks what difference these efforts have made.
Cheryl Barton, a biochemist who runs the consultancy PharmaVision in West Sussex, UK, says this outsourcing represents a sea change from the old way of doing things. "When I worked at Merck years ago, it was one of those companies that didn't outsource anything at all,” she says. "It took great pride in being able to do everything internally, and it was frowned upon if you had to go outside to do anything at all."
Trying to keep track of all the changes afoot in the industry is daunting. And, as yet, no single strategy has emerged as a clear winner. So, in the meantime, companies continue to pursue the approach that best seems to fit their business models. "No one has found a solution to the patent cliff," notes Sanofi's Bonnefoi. "No one has written the book. We need to write it ourselves."
"The market is demanding controlled release technology," says Cheryl Barton, director of the Chichester, UK - based biomedical consultancy Pharmavision. She notes that patients like the convenience of once-a-day pills as opposed to having to remember to take multiple doses morning, noon and night.
According to a 2009 Pharmavision report, medications using controlled release technology generate annual sales in excess of $20 billion. And although the majority of such sales currently derive from pill formulations, injectables are on the rise, Barton says.
From a market research point of view, Pharmavision's Barton sees increasing dialogue between companies that develop drugs and those that develop time-release technology. The chemical engineers behind these technologies are taking greater initiative in thinking up new applications. "They're actually talking to the drug development guys much earlier," she says. Proponents of this type of sustained release technology advocate that it extends both the drug's effect and the patient's life.
In many parts of the world, price has proven to be another major deterrent to long-acting drugs. "There's a price to be paid for the convenience of those products," says Barton. This, she notes, has resulted in uneven adoption of time-release medications from country to country. "One of the biggest markets for this has been the US," she explains, but European countries with nationalized health systems seem less keen to pay for such medications."
SOURCE: PHARMAVISION Companies are racing to produce treatments that exploit RNA interference (RNAi), a natural process that silences gene expression in cells. PharmaVision, a biomedical consultancy based in Chichester, UK, estimates that the market for RNAi therapies could be worth more than US$2.9 billion by 2020. But no RNAi therapy has yet completed phase III clinical trials.
With concern growing over the side effects of RNAi-based treatments, firms must now "conclusively prove the mechanism of action of their products", says PharmaVision consultant Cheryl Barton.
Locking up the IP Dendritic Nanotechnologies' Donald Tomalia is one of the pioneers of the dendrimer field. Together with the University of Michigan's James Baker, he controls most of the IP behind dendrimers.
In 1992, Tomalia left Dow Chemical to found Midland, Michigan - based Dendritech. Nine years later, when Dendritech folded, Dow granted Tomalia global licensing rights to dendrimer applications in return for waiving future royalty rights; this created the basis for another Tomalia startup, Dendritic Sciences of Mount Pleasant, Michigan. Two years later, Starpharma got together with Tomalia to form a joint venture, Dendritic Nanotechnologies, headquartered in Melbourne, Australia with production and laboratories in Central Michigan University's Center for Applied Research and Technology in Mount Pleasant.
From 1985 to 1995, Dow Chemical and Stamford, Connecticut - based Xerox were dominant dendrimer patent holders, the latter patenting the use of dendrimers in toner and ink dispersion; Bayer and DSM of Heerlen, The Netherlands, also were granted patents for the use of dendrimers in plastics manufacturing and other nano-based products. In 2005, Dow Chemical assigned its entire dendrimer IP to Dendritic Nanotechnologies in exchange for an equity stake in the firm. Then, a year later, Starpharma acquired Dendritic Nanotechnologies for $6.97 million in shares. Thus, Starpharma is currently the dominant dendrimer patent holder.
"I believe they have up to 90% of the patents," says analyst/consultant Cheryl Barton. With a total of 224 patents and applications, StarPharma is also the only company with a dendrimer in clinical trials. "As far as I know they are still out in front, nobody else is close to bringing its dendrimer along as far as they have," says Steven Rutt, IP attorney at Foley & Lardner in Washington, DC. But he still sees room to patent, stating "in an area like dendrimers, where there are so many things to tinker with, it allows you to come up with new improvements." Another dendrimer researcher, Harald Pielartzik, formerly of Bayer, agrees with Rutt: "When industry finds an application, then it's completely normal to license a technology, talk to each other, cooperate. I don't see that as a barrier."
Interest in personalized medicine hasn't been lost on incumbent biotech giants, like Roche, Abbott Laboratories [ABT] and Siemens AG [SI]. Many of them are launching initiatives that combine in vitro diagnostics with therapeutic solutions in one procedure, according to Dr Cheryl Barton, founder of U.K. consultant firm PharmaVision.
Targeted carrier systems represented about half of the $6.5 billion market for advanced drug delivery in 2006, reported Barton. By 2015, the sector could see nearly thirty new commercial therapies focusing on treatment for cancer, cardiovascular and infectious disease.