Amgen Exhibits Bone Drug
The financial community finally got a look at Amgen Inc.’s highly touted bone drug on Sunday, and in general it liked what it saw.
The Thousand Oaks company presented data at a medical meeting here that showed the drug was as good at increasing bone density as Merck & Co.’s Fosamax, the leading osteoporosis treatment.
Wall Street analysts said the Amgen drug could become a big product, provided a large clinical trial now underway showed the drug could prevent bone fractures -- the aim of all osteoporosis treatments.
Called AMG 162, the drug is the most promising in Amgen’s product development pipeline because its sales potential is so large. Amgen believes the drug could one day have annual sales of $2 billion, half to treat osteoporosis and half for cancer patients whose disease has spread to their bones.
Amgen plugged AMG 162 at a high-profile meeting on Wall Street in March, and since then analysts have been eager for evidence of the drug’s potential. AMG 162 is an early fruit growing out of an overhaul of Amgen’s drug development program, led by Chief Executive Kevin Sharer and his handpicked R&D; boss, Roger Perlmutter, who joined the company in 2001.
AMG 162 is important because Amgen needs to add several billion dollars to its revenue each year to maintain annual earnings growth of 20%. Amgen’s total revenue was $8.36 billion in 2003, mostly from sales of specialized drugs that cause blood cells to grow. AMG 162 would be the company’s first drug for osteoporosis.
The results of the Amgen-sponsored clinical trial presented Sunday showed that after one year, patients taking AMG 162 increased bone density in the spine by 4% to 7% and in the hip by 2% to 4%. The results were as good as or better than what was seen in a group of patients who took Fosamax, Amgen said.
Amgen’s drug also increased the density of cortical bone, the type found in the wrist. Fosamax hasn’t been shown to prevent wrist fractures, analysts said.
Two patients who received AMG 162 in the clinical trial suffered broken bones, but the fractures resulted from injuries and not osteoporosis, the company said.
The trial was a Phase 2 study of 411 post-menopausal women with low bone density, the second of three rounds of tests required for Food and Drug Administration approval.
Michael McClung, director of the Oregon Osteoporosis Center and an investigator in the Amgen-sponsored trial, said AMG 162 had all the signs of becoming “an attractive therapy.” The twice-yearly injection, he said, would be more convenient for patients than the once-weekly Merck pill. Patients tend to stop taking the pills after six months to a year, he added.
What’s more, McClung said, the Amgen drug did not appear to cause indigestion, a common side effect of Fosamax.
“There is a lot of excitement about the data,” said Geoffrey Porges of Sanford C. Bernstein & Co.
“On a number of measures it does not look materially different from Fosamax. But it has clear marketing advantages, and there is the possibility it may lower the risk of wrist fractures.”
However, some doctors attending the annual meeting of the American Society for Bone and Mineral Research said bone density changes shouldn’t be used to compare drugs.
“The magnitude of the gain in bone density tells you little or nothing about protection from bone fracture,” said Nelson Watts, director of the University of Cincinnati’s Osteoporosis and Bone Health Center. Although the Amgen drug looked promising, Watts said, “what doctors really want to see is strong evidence of protection against a variety of fractures.”
Tim Sleeth, vice president of Merck’s U.S. Fosamax business, said it was too early to evaluate AMG 162.
With expected sales of more than $3 billion this year, Fosamax is one of Merck’s most important drugs -- particularly in wake of the demise of Vioxx, an arthritis drug that Merck pulled off the market last week, citing patients’ risk of heart attacks.
“We have seen many drugs come along in Phase 2 and then disappear from the horizon,” Sleeth said.
In fact, about half of all drugs in Phase 2 studies fail to reach the market.
Osteoporosis is a bone-thinning condition associated with aging that affects an estimated 10 million Americans. Women account for 80% of the cases.
Frost & Sullivan, a market research firm, said annual sales of osteoporosis drugs in the U.S. could reach $9 billion by 2010, up from $5 billion today, thanks to an aging population.
But Amgen’s drug won’t reach the market before 2007, and by then it will face heavy competition. GlaxoSmithKline, Novartis and NPS Pharmaceuticals are all preparing osteoporosis treatments that could beat AMG 162 to market.
Fosamax could lose patent protection in 2007, analysts said, and cheap, generic versions of the drug might also be available soon afterward.
“The marketplace will be very crowded,” said Carilee Berg, an analyst with Decision Resources, a market research firm. Berg said doctors were “pretty satisfied” with Fosamax and Procter & Gamble Co.’s Actonel, which, like AMG 162, block bone-thinning cells called osteoclasts.
Amgen, she said, “will have to find a niche, perhaps convenience or fewer side effects, to make headway.”
