Biotech Values

[DewDiligence]

Inspra Success Is Too Late to Help Pfizer

[See #msg-32523077 for a related piece. PFE’s own PR on the successful study is at http://finance.yahoo.com/news/Pfizer-Announces-EMPHASISHF-prnews-1990404553.html?x=0&.v=1 .]

http://blogs.forbes.com/sciencebiz/2010/05/inspra-study-wont-help-pfizer

›by Matthew Herper
May 27, 2010 - 1:24 pm

This morning, Pfizer announced what sounded like fantastic news: a study of its heart failure drug, Inspra, had been stopped early because patients who got the drug did better than those who received placebo.

But on closer inspection, this result is unlikely to make a difference in Pfizer's bottom line, because cost issues will keep doctors from prescribing Inspra. Instead, the Inspra story illustrates why companies are abandoning heart drug research: the studies needed to prove the drugs work take so long that medicines are close to being generic by the time positive results emerge.

"It's sort of like winning the battle and losing the war," says William Boden, a cardiologist at the University of Buffalo. "They've got an important result and they may not benefit commercially."

Inspra was launched in 2003 by Pharmacia, with high hopes that it would become a big drug in helping to control the blood pressure of heart failure patients. Pharmacia chief executive Fred Hassan called it "a significant advance."

Pfizer bought Pharmacia later that year, barely marketed Inspra and it flopped. Most doctors believe that spironolactone, a very old drug that costs $4 a month, does the same thing. Inspra, by contrast, costs $130 a month.

"We use a truckload of spironolactone," says James Stein of the University of Wisconsin-Madison. "It's hard to beat a drug that costs four bucks at Wal-Mart and has been around for fifty years." He says he mainly switches patients to Inspra when men had breast growth or tenderness, a side effect he says is rare.

This new study showed patients who would not get spironolactone benefited from Inspra use, too. That would be an opportunity to market Inspra if a generic version were not already available. But in 2008, Novartis' Sandoz unit launched a generic version of Inspra that costs $100 a month, 30% less than the brand. That still won't cause anybody to use Inspra over spironolactone, but it will cause patients to choose the generic over the brand name. Because Inspra is still protected by lots of patents [i.e. patents on the formulation rather than the active ingredient per se], there is only one generic version so the price has not come down further.

Pfizer and most other drugmakers are spending less than they used to on heart drugs, and the length of time required for heart studies is one big reason. A patent on a new drug molecule lasts 20 years, but different kinds of drugs require different amounts of time to develop. Increasingly, cardiovascular medicines require very big trials that last many years, with the effect that if something goes wrong with a patent, a good result might not come in until generics are already on sale. That is what appears to have happened here.‹