Ken Kam's Best Ideas Blog

Elan took over development of Prialt when it acquired Neurex Inc., of Menlo Park, CA., in 1998. Prialt went through a far lengthier and costlier development process than originally expected. The drug was first developed in the mid 1990s, and Elan filed for FDA approval in the fall of 2000. But unlike the case of Tysabri, the FDA did not feel there was a large unmet medical need and so did not grant Prialt a priority review. When the FDA feels that a drug does not address an unmet medical need, they generally focus more attention on its risk profile. In Prialt’s case, in order to satisfy the FDA’s safety concerns, Elan had to do a second Phase III trial.

Four years after the original submission, Prialt finally received FDA approval on December 28, 2004 -- but only for patients with severe pain who cannot tolerate morphine. This is not a blockbuster size market. At the start of 2005, Elan estimated that over the next few years the market could grow from $150 million to $250 million per year in peak sales. So far, in the first 9 months of 2005, Prialt generated a disappointing $4.3 million in revenues.

Prialt is interesting because it relieves pain in a completely new way. The drug, based on a compound found in the poison of the South Pacific Cone Snail, blocks a calcium channel found at the end of nerve fibers that transmits the pain signal up the spinal cord to the brain. Prialt is 1,000 times more powerful than morphine, but shows no signs of being addictive. Because it is so potent, tiny amounts of the drug could be dangerous to the heart and possibly other organs so it has to be delivered directly to the fluid surrounding the spinal cord via an implanted catheter and pump. As a result, it is a last resort, rather than a first-line pain medication.

Elan says there are as many as 100,000 people in the U.S. that might be helped by the drug. About 50,000 patients already have implanted or external devices that pump morphine directly into the spinal column. If some of them switch to Prialt to avoid the downside of morphine, Prialt could become a moderate success. But after 9 months of marketing efforts, the results are not encouraging.

It may be that Elan simply does not have the right sales force for this drug. The doctors that prescribe Maxipime and Azactam are different than the ones that would prescribe Prialt. Elan’s sales force came with their acquisition of Dura Pharmaceuticals so it makes sense that they are more comfortable selling Maxipime and Azactam because these were the products they were originally hired to sell.

Selling Prialt will require a sales force that has relationships with a completely different set of doctors. I don’t think it’s worth the expense to build a sales force for a product that does not have the potential to be a blockbuster. Instead, it makes more sense for Elan to sell this drug to a company that already has a sales force that calls on doctors who treat chronic pain.

The Bottom Line: This may be a bust. Unless there is a lot more than we can see, Elan should sell this drug to another company.