SAN FRANSISCO - Amgen Inc., the world’s largest biotechnology company, is developing a new anti-cholesterol medicine by 2015 that it sees as its best shot to offset reduced sales when its popular anemia drugs lose exclusivity.
Amgen, which has a facility in West Greenwich has traded at a record high by resorting to share buybacks and dividend payments, investor benefits that aren’t normally linked to biotech companies. By 2015, though, the anemia drugs Aranesp and Epogen, with a combined $4 billion in estimated sales this year, will face competition from rivals introducing cheaper follow-on versions, necessitating growth from new products.
The drug AMG-145 is one of several that companies are developing to target a cholesterol-regulating gene in the liver, a new approach to current therapies that generate $39 billion in annual sales. Some of the world’s biggest drugmakers, Pfizer Inc., Roche Holding AG and Sanofi are testing versions. Data to be presented next week at the American Heart Association meeting in Los Angeles will show how AMG-145 stacks up.
“It’s clear that the drug has blockbuster potential,” Michael Yee, an analyst with RBC Capital Markets in San Francisco, said in an interview. “AMG-145 could be a $500 million-plus opportunity for Amgen, and could be bigger depending on what parts of the market they capture.”
The market for drugs targeting the liver cholesterol gene may be at least $10 billion, said Adnan Butt, an analyst with RBC Capital Markets in San Francisco, in an e-mail. In the U.S. alone about 11 million patients aren’t keeping their cholesterol low enough with standard pills called statins, which include Pfizer’s Lipitor, and another 1 million can’t take them because of side effects such as muscle soreness, he said.
That leaves an opening for Amgen’s AMG-145, which may head to pharmacies as soon as 2015 if study results confirm its efficacy, according to Yee. That may not be soon enough. New York-based Pfizer, the world’s biggest pharmaceutical company, Basel, Switzerland-based Roche, Sanofi, based in Paris, and its development partner on the drug, Tarrytown, New York-based Regeneron Pharmaceuticals Inc. are all racing to be first to sell their own inhibitors of the gene, called PCSK9, a status that can lead to market dominance.
Sanofi and Regeneron are testing their drug in the third of three clinical trials typically required for U.S. regulatory approval. Amgen said it will start its Phase 3 testing sometime next year.
Amgen fell less than 1 percent to $86.99 at 9:46 a.m. New York time. The company’s shares had gained 36 percent this year through yesterday.
“Neck and neck”
Amgen, Sanofi and Regeneron are running “neck and neck” to get Food and Drug Administration approval, said Steven Nissen, head of cardiology at Cleveland Clinic in Ohio. The class is eagerly awaited by physicians, he said.
“These drugs produce very substantial reductions in LDL cholesterol levels,” said Nissen, an unpaid consultant to Amgen on its PCSK9 inhibitor program, in a telephone interview. “It’s a big step in the right direction.”
For Amgen, winning the race is crucial. The medicine could become the first new blockbuster approved for the company since it unveiled its bone-strengthening drug, Xgeva, in November 2010. Another potentially top-selling product, the bone-growth therapy romosozumab, remains a few years away from approval as well, Christopher Raymond, an analyst with Robert Baird wrote in a September note that downgraded shares to neutral.