Rx suppliers prepare for patent-protection storm

BOSTON —Drug companies stand to lose a lot of money in the coming years, as the worldwide value of drugs losing patent protection between 2009 and 2012 totals nearly $100 billion. This places the companies under continued pressure to ramp up the pace of drug development, according to the Tufts University Center for the Study of Drug Development.

On average, 3-in-10 new drugs that reach the market make enough money to sustain research and development, putting drug companies under more pressure to bring more drugs to market, according to the CSDD. Drugs worth more than $88 billion in worldwide sales will have come off patent during the 2009-2012 period, but bringing a new drug onto the market usually costs more than $1 billion and takes more than seven years from the time clinical trials begin.

“The simple fact is that product launches are not keeping pace with patent expirations,” CSDD director Kenneth Kaitin said in a statement.

Recently, the industry experienced a wave of large-scale acquisitions by companies facing the colliding problems of huge profit losses from patent expirations and anemic pipelines, including Pfizer’s purchase of Wyeth and Merck’s move to buy Schering-Plough. Both companies spent considerable sums for their purchases, but they got a lot of return.

In particular, Pfizer aims to become a top-tier biotherapeutics company by 2015 and now has 30 drugs in development for cancer, 11 for Alzheimer’s disease, 11 for inflammatory diseases and eight for pain. The market analysis firm Decision Resources predicted that by 2015, Wyeth’s pneumococcal disease vaccine Prevnar 13 will generate sales of $3.1 billion. Merck’s acquisition of Schering-Plough brought the number of drugs in its pipeline in late-stage clinical development to 18, including cardiovascular and psychiatric drugs. All in all, Merck’s pipeline shows the most promise.

“It looks like Merck’s going to be able to weather their patent expiration problems better with some of their pipeline projects,” Decision Resources corporate analyst Michael Latwis told Drug Store News. “Pfizer has a much bigger gap to fill.”

Another company with some big patent expirations approaching that hasn’t received as much attention is Eli Lilly. Instead of following the lead of Pfizer and Merck, the Indianapolis-based drug maker decided to pump money into its own research and development efforts. Lilly has a number of drugs for such diseases as Alzheimer’s and autoimmune disorders, but most of them remain in earlier stages of development, so Latwis said it was too soon to make a call on Lilly’s approach.

“Lilly has a deep pipeline; it’s just earlier-stage,” Latwis said, adding that Lilly would not likely contribute much in the near term, but that it was “something to keep an eye on.”