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AnorMED sold the global patent rights for Fosrenol — a drug used to reduce phosphate levels in the blood of patients undergoing dialysis — to Shire Pharmaceuticals Group plc (Basingstoke, U.K.) in March 2004, the second recent deal the company has signed to lighten the load of products the founding researchers brought with them from a former workplace.
Breaking Off
AnorMED was not the creation of one founding scientist, or a spinoff from a local university — as is often the case in British Columbia — but rather a breakaway from a larger U.S. metal products company.
Started by a group of researchers who worked together since the late 1980s at Johnson Matthey plc’s (London, U.K.) Philadelphia, Pa.-area laboratory, AnorMED was established in Canada, and specifically in B.C., for a tried-and-true reason — money.
“Our roots are completely outside of B.C., but this is where the money was,” says president and CEO Michael Abrams, PhD. “So we raised close to $20 million, and we moved seven people here and established the company.”
Johnson Matthey, which focuses on the refinement of platinum and gold, had initially started a research group to develop cancer drugs that use platinum as well as other metallic-based compounds to be licensed out to larger drug companies, Abrams explains.
After working together for approximately 12 years, the group faced the end of its collaboration when Johnson Matthey decided not to pursue this area of research any further.
Abrams says the desire to see their work continued and fulfilled is what pushed the group to start a new company.
“We had a number of compounds in development and we thought we could raise money to develop these further. And that was the beginning of AnorMED,” he says.
“It was a desire to see what these drug candidates will come to, what more can we build. It was really the motivation to want to see the end of the story.”
Hand in hand with this desire was an outright challenge, Abrams says.
“There were plenty of voices within Johnson Matthey who said we could never do it,” he says. “And there’s nothing like being told you can never do something to motivate you.”
Despite the challenges that lay ahead, Abrams decided to leap into the lead role at AnorMED with both feet.
With a scientific background that includes a PhD in chemistry from the Massachusetts Institute of Technology (MIT) (Cambridge, MA), and having conducted research that led to the development of DuPont™’s (Wilmington, DE) Cardiolite® kit, Abrams has had to learn the business skills needed to be president and CEO as he goes.
“That is the fact,” he laughs. “I hesitate to say this: I have never had a business course in my life.”
But trial by fire isn’t all bad. In fact, the transition from researcher to business leader has had both good and bad sides, Abrams says.
“I think being a CEO, you are ultimately accountable to everybody, including your employees, and shareholders, and the board, and everything. Whereas, what I really loved about being a scientist was being able to discover things and to invent things. And I miss that, I miss the hands-on aspect of that,” he says.
“But what you end up doing, or what I have strived to do, is try to make the ability to do that, the opportunity to do that, available to other people and to provide an environment where that can happen. And when you do that, there’s a satisfaction involved with that as well.”
Financial Drivers
The environment Abrams has built at AnorMED has proven to be a fruitful one.
Over the past year, two of the main compounds that were brought to AnorMED by the original Johnson Matthey group have been sold off. Shire bought Fosrenol, whose FDA approval initiated an $18-million US payment to AnorMED. The deal also outlined payments of $6 million US to be paid upon Japanese approvals, and $7 million upon European approvals — $1 million of which AnorMED has already received following approval in Sweden last March.
Additionally, AnorMED licensed its platinum anti-cancer agent, AMD473, early last year to NeoRx Corp. (Seattle, WA), receiving a one-time upfront milestone payment of $1 million US, and $1 million US in NeoRx stock.
Moving out of the platinum drug areas, and selling off these older drugs from the Johnson Matthey days, has provided the company with significant resources to further its current pipeline.
The company’s lead product, AMD3100, is a stem cell mobilizer that works by blocking a receptor molecule, called CXCR4, that is found on stem cells. Blocking CXCR4 prevents the stem cells from adhering to bone marrow, which causes the stem cells to be released into the blood stream, making it easier to harvest these cells as compared to traditional procedures for bone marrow collection.
“Most people probably haven’t heard of a stem cell transplant, but they have heard of bone marrow transplant, which is the same idea,” Abrams explains. “Which is, you collect stem cells to give back to cancer patients once they’ve had high doses of chemotherapy.”
Preliminary results have been positive for AMD3100 in Phase II trials. Additionally, in early December 2004, AnorMED received Special Protocol Assessment (SPA) from the FDA for a Phase III trial, and expects patient enrolment for this trial to commence early this year.
Receiving the SPA requires more work at the beginning of trials, but it proves advantageous at the end, Abrams says.
“It’s probably an advantage in the sense that it takes some of the regulatory risk out,” he says. “You have an extra review period at the beginning, which slows you down, but I think it’s ultimately worth it.”
Other researchers are currently investigating the use of stem cells to repair tissue damage caused by heart disease, an area of research that opens up AMD3100 to larger markets for indications other than cancer.
“Obviously, what we’re hoping is that that field advances, and then we’re going to be in a good position to say, OK, if you want stem cells, we’ve got a good way to get them,” he says.
Another of the company’s drugs, AMD070, is an HIV-entry inhibitor that has completed Phase I trials, and is about to start a Phase II trial. Like AMD3100, AMD070 also blocks the CXCR4 receptor.
HIV comes in two variants that use different receptors, Abrams explains, with up to 40 per cent of HIV patients having both strains. Abrams says that AnorMED is the only company he knows of that has CXCR4 in clinical trials, and that while it does have a program for the other receptor, CCR5, it is in early stages. Combining the strains is an ideal situation the company is looking into, however.
“One of the things we’re very much open to is a potential partnership with one of these companies that has a CCR5 inhibitor,” he says. “Because, ideally, I think we’d want to combine both inhibitors to block both strains of the virus.”
Time for a Change
The transition AnorMED is currently undergoing not only highlights a move out of the platinum drug areas of its past and a focus on its new pipeline, but also its progress toward becoming a more hands-on company where it can.
Though the deals AnorMED struck last year with NeoRx and Shire were significant, Abrams says the company itself would like to sell AMD3100, at least in North America.
“One of the things about stem cell transplant is it’s a highly specialized thing. It’s not done in that many hospitals in North America — there’s only about 120 major transplant centres — and we think that a sales force of around 20 people could effectively sell this in North America,” he says.
“I think there’s a transition in the works here from being just an R&D company to actually being a business that sells something,” Abrams says. “As we make that transition, we’re obviously going to be much more interested in not only driving the business through our own internal efforts, but also bringing things in, and I think that’s something that we’re gearing up to do more of.”
