Breaking Merck's Bones
Robert Langreth, 10.04.04, 2:55 PM ET
[Some more information on the osteoporosis market and AMG 162. Evidently the drug has alredy been promoted to blockbuster status, four to five years before it has reached the market - if it ever will. No mention of Preos in the article, by the way].
NEW YORK - Merck suffered a huge blow last week when it had to pull its blockbuster painkiller Vioxx from the market after a big study showed that it doubled the risk of heart attacks and strokes. And in 2006, it will lose patent protection for its $5 billion cholesterol drug Zocor.
If that is not enough, competitors are now taking aim at the company's popular osteoporosis drug Fosamax, which had $2.7 billion in sales last year. Roche Holding (otc: RHHBY - news - people )is expected to release results of a big study showing that its experimental osteoporosis drug Boniva, which works by the same mechanism as Fosamax, can protect bones when given only once a month. That would be more convenient for patients than Fosamax's once weekly regimen. A once-daily version of Boniva is already approved, but the Swiss drugmaker has held off marketing the drug until it gets approval of the once-a-month pill, which could happen early next year.
But the most intriguing potential threat to Merck's (nyse: MRK - news - people ) dominance comes from biotech stalwart Amgen (nasdaq: AMGN - news - people ). Late Sunday, the company released data from a second-stage trial of 411 patients showing its experimental drug AMG-162 was at least as effective at boosting bone density as Fosamax and only has to be given as little as once every six months. AMG-162 is still years from the market, as definitive trials aiming to show the drug can actually prevent fractures have only recently begun.
Nonetheless, top Amgen officials are hopeful this drug will have many advantages because it works by a totally new mechanism to prevent bone from being broken down. The drug is a bioengineered antibody to a crucial natural protein called Rank-ligand that appears to play a central role in initiating the bone breakdown process.
Amgen has begun a massive final-stage trial program on over 9,000 patients aiming to show that AMG-162 is more powerful and convenient than existing osteoporosis drugs. The studies include trials aiming to show that can prevent fractures in women with osteoporosis or at risk for it, as well as studies to prove the drug help prevent bone problems in patients with prostate and breast cancer.
"This is the largest clinical trial program ever undertaken at Amgen," says Amgen R&D chief Dr. Roger Perlmutter. "It is very clear that [this drug] really has dramatic effects" on bone loss.
Dr. Perlmutter says that AMG-162 may have a faster onset of action than so-called bisphosphonates, such as Fosamax and Actonel, which is sold by Procter & Gamble (nyse: PG - news - people ) and Sanofi-Aventis (nyse: SNY - news - people ); AMG-162 may also be good at building bone density in parts of the body such as the wrist that existing drugs aren't so good at targeting, he says. One potential disadvantage for Amgen is that AMG-162, like most biotech drugs, must be injected. Amgen also has less experience targeting the big primary care physician market than Merck and other big drug makers.
Merck dismisses the threat to Fosamax, noting that its drug has long-term data proving that its drug can prevent hip and spine fractures, and is safe for up to ten years of use. "Years of market research show that efficacy is what is important to physicians and patients...and we have unparalleled efficacy data," says Merck spokesman Tony Plohoros.
Merck fought back last week against Procter & Gamble's Actonel by releasing a study showing that Fosamax does a better job at increasing bone density in the hip than Actonel. Other Merck competitors in the osteoporosis market are, Eli Lilly (nyse: LLY - news - people ), which markets Evista, and Wyeth (nyse: WYE - news - people ), which markets the hormone therapies Premarin and Prempro.
Amgen's drug AMG-162 has significance beyond just the osteoporosis market. It is one of the first drugs to enter final stage trials whose discovery stems from computerized gene-hunting methods dubbed genomics. In the 1990s, drug and biotech firms spent hundreds upon hundreds of millions of dollars on such techniques, with little to show for it to date. If AMG-162 is successful, it could be a sign that the huge sums the drug industry spent on genomics weren't completely wasted. Analyst Geoffrey Porges from Bernstein Research estimated in a report today that AMG-162 could be approved in 2008 and garner annual worldwide sales of $1.4 billion in 2012.
forbes.com |
