Stakes high for R.I. in race to replace statins

CUTTING THE FAT: If Amgen’s AMG 145 drug wins federal approval, it could provide a significant boost for Rhode Island’s stagnant economy. / COURTESY AMGEN
CUTTING THE FAT: If Amgen’s AMG 145 drug wins federal approval, it could provide a significant boost for Rhode Island’s stagnant economy. / COURTESY AMGEN

The financial stakes in Amgen Inc.’s race to develop a new kind of cholesterol-lowering drug are high and, perhaps as much as any other state, Rhode Island is invested in the outcome.
The state’s largest biotechnology employer, Amgen began manufacturing AMG 145, which is currently in the third phase of clinical trials for federal approval, in its West Greenwich plant last year.
The drug is a monoclonal antibody derived from a rare, mutated gene that helps clear cholesterol from the body.
Amgen and their competitors hope the new drug will replace statins, the wildly lucrative anti-cholesterol drugs that gained widespread use to combat heart disease starting in the 1990s.
Lipitor, a statin made by Pfizer Inc., is considered the best-selling drug in pharmaceutical history, with $125 billion in sales, but like most statins its patent recently expired.
If the new class of drugs is proven safe and effective enough for U.S. Food and Drug Administration approval, pharmaceutical companies see potential sales in the billions.
Even if the remaining clinical trials go well, the drug is still likely at least a year or two away from being marketed to the general public, but most of the country’s major drug companies are pursuing it.
Based on the progress of their trials, Amgen is considered a current front-runner, along with a joint effort from Tarrytown, N.Y.-based Regeneron Pharmaceuticals Inc. and Sanofi of France. Pfizer Inc. of New York City is also developing a version of the drug.
Partly based on the potential of drugs in the pipeline, Amgen’s stock in August had risen more than 20 percent since the start of the year.
Based in the Bay Area-city of Mountain View, Calif., Amgen in late 2011 began a $70 million investment in the West Greenwich plant for “pipeline readiness for AMG 145 and other projects,” said Amgen spokeswoman Christine Regan in an email.
It’s unclear whether Amgen would make all of its AMG 145 in West Greenwich if the drug is approved, as the company also has factories in Colorado and Puerto Rico capable of making it.
But if the drug becomes the blockbuster many expect, it could provide a significant boost for Rhode Island’s stagnant economy. Richard Horan, managing director of the Slater Technology Fund and a close observer of the biotech industry, said based on what he has seen from pharmaceutical companies elsewhere, including Bristol Meyers Squibb Co. in Devens, Mass., production of the drug will likely be relatively centralized.
And while the nature of the Amgen manufacturing operation here won’t produce the kind of commercial spinoff and startup energy that a pharmaceutical research facility would, it should provide an employment boost.
“It’s potentially big for Rhode Island,” Horan said. “Not a big story for commercial spinoffs, but big in terms of growth in employment in the bio-manufacturing sector. The design and discovery happens in other facilities, but that doesn’t mean it doesn’t require a very specialized workforce. It is managed by people with chemical-engineering backgrounds and they recruit from the best places in the world for talent.”
Amgen’s investment in Rhode Island comes after several years of scaling back employment in West Greenwich.
In 2005, the company had 1,300 Rhode Island employees and was the fifth-largest manufacturer in the state, according to the PBN Book of Lists.
By 2010, the head count was down to 900 workers, making it the eighth-largest Ocean State manufacturer.
The numbers have already started to inch back up again, as last year Amgen employed 950 people in Rhode Island and was back up to seventh on the manufacturing list.
Amgen’s presence in Rhode Island is the result of a long history of public and private investment.
The plant dates back to the 1980s when the Genetics Institute and Burroughs Wellcome formed WelGen in a state-supported technology park off Interstate 95.
In the 1990s, a series of drug-company mergers and acquisitions led to Seattle-based Immunex’s purchase of the plant in 2001 with plans to make its best-selling drug Enbrel there.
The next year, Amgen bought Immunex and carried forward plans to build a new 250,000-square-foot building next to the existing 200,000 square-foot West Greenwich plant, which was retrofitted. The entire project was estimated to cost $950 million and create what was at the time the largest cell-culture factory in the world.
For the construction project, the R.I. Economic Development Corporation approved two sets of “project status” sales tax exemptions in 1999 and 2002 respectively.
The project was also given expedited permitting and the EDC’s Industrial Recreational Bond Authority issued a $3.4 million bond for a Coventry sewer project necessary to accommodate the plant.
“We have been very supportive of Amgen,” said EDC spokeswoman Melissa Czerwein about the prospect of more growth from the pharmaceutical company.
Of course, the efficacy and benefit of AMG 145 has yet to be proven and there is a group of doctors who question the wisdom of making cholesterol reduction the focus of cardiac health.
Dr. Barbara Roberts, director of the Women’s Cardiac Center at The Miriam Hospital in Providence and an associate clinical professor of medicine at Brown University’s Alpert Medical School, wrote a book called “The Truth About Statins” and has questions about the new anti-cholesterol drugs in the pipeline.
“Cholesterol is a relatively weak risk factor for developing heart disease,” Roberts said. “There’s a very small causative effect that’s outweighed by side effects. I think the push to replace statins is because the patents are about to run out on the last statin, Crestor, and big pharma is looking for other blockbuster drugs.”
Even researchers who support the fight against cholesterol acknowledge that the new class of drugs appear capable of pushing blood cholesterol below levels most doctors are familiar with, something that will need to be watched.
Another concern is the potential cost of a new cholesterol drug, as biologics are more expensive than conventional drugs and have never been made on the scale envisioned by Amgen.
And while most believe success for AMG 145 will result in new jobs for Rhode Island, Amgen isn’t promising anything.
“It is too early to speculate on any type of expansion that may take place as a result,” company spokeswoman Regan said. •

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