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.
PBN is now accepting applications for its newest award program and event for RI & Bristol County to celebrate the Manufacturing Renaissance that is evolving regionally and across the country. The deadline for applications is March 20th.
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