Merck & Co.’s leading osteoporosis drug Fosamax illustrates the Hollywood paradigm. Its patent protection ran out earlier this year leaving Merck in a struggle to regain its share of the profitable osteoporosis market – a market that it once led, thanks to Fosamax.

As Hollywood producers acquire licensing rights for their blockbuster movies, so has Merck acquired licensing rights to a substance that appears to promote oral bone growth. Called JTT-305, it is a recombinant parathyroid hormone (PTH) that stimulates bone formation cells. Merck purchased the right to develop and commercialize JTT-305 from Japan Tobacco (JT), the world’s third largest manufacturer of tobacco products according to its own website.

In a statement issued by Japan Tobacco, Alan Ezekowitz, a Merck representative, said that “partnering with JT to develop this novel compound complements Merck’s portfolio of musculoskeletal drug candidates … In the future, we believe that use of antiresorptive and osteoanabolic agents together may provide an effective way to reduce the risk of fractures in patients with osteoporosis.”

Ironically, Fosmax is blamed for a high incidence of bone fractures in patients who have taken the drug for years. Faced with a growing number of lawsuits and a plummet in Fosamax sales and profits, Merck must come up with some new blockbusters to replace its old moneymakers, lest it appear to investors that it is losing money.

SOURCE: Osteonecrosis and Fosamax › Merck developing possible Fosamax replacement

Pharmaceutical companies for 25 years have “imitated the basic business model of Hollywood” and have “focused on creating blockbusters,” which they “hope will appeal to masses” and “promote like mad,” according to the Times. Pharmaceutical companies must spend as much as $1 billion to promote new medications in their first two years on the market to make the products into a “mega-brand” with at least $1 billion in annual sales.

“Only now is it becoming clear that this business model couldn’t work forever,” as the strategy “had a flaw that executives have long ignored” — the approach “required extraordinary amounts of promotion at the expense of scientific creativity,” the Times reports. During the next several years, pharmaceutical companies will lose patent protection on a number of popular and profitable medications — such as the osteoporosis treatment Fosamax, manufactured by Merck, the antipsychotic Risperdal, manufactured by Johnson & Johnson, and the cholesterol medication Lipitor, manufactured by Pfizer — and the “industry’s scientists have hit a dry spell” and are “not discovering enough new drugs to replace the aging standbys,” the Times reports.

“It would be wrong to believe that this is the end of the industry’s wealth and power,” but, as some pharmaceutical companies “struggle, patients will bear the brunt,” with the prices of medications likely to “rise even faster,” according to the Times (Petersen, Los Angeles Times, 1/27).

January 28th, 2008 by Petersen with Los Angeles Times

SOURCE: Osteonecrosis and Fosamax › Pharmaceutical industry focus on ‘blockbuster’ medications