What's in a name? At times, danger

It seemed as if the Food and Drug Administration liked everything about Biogen Idec's new drug for multiple sclerosis.

Early this year, the FDA encouraged Biogen Idec and its partner, Elan Pharmaceuticals, to submit an application for approval a year ahead of schedule. The companies sought clearance based on one year of data from a pair of pivotal clinical trials, instead of two years, as originally planned. The agency said it would give the experimental drug priority review, cutting four months off the wait for an answer.

The agency's Nov. 23 ruling gave the companies the go-ahead to sell the drug as a stand-alone therapy or in combination with Avonex, Biogen Idec's big-selling MS drug.

Wall Street analysts called the dual approval a home run.

But there was one thing the regulators didn't like about the new drug: the name.

Biogen Idec and Elan had worked hard all year to build awareness for the experimental drug, which was called Antegren. But when the companies announced the FDA approval, the new treatment was called Tysabri.

The fate of Antegren, the name, illustrates a constant problem in drug marketing. Companies get to pick the trademarked brand name under which they will sell their new treatments. But about a third of the names are rejected by regulators, most often because of fears they will be confused with existing drug names. That could lead a doctor or a pharmacist to accidentally administer the wrong medication, with potentially catastrophic effects.

''The regulators are looking for conflicts that related to the prescribing behavior of the physician and the likely confusion that could arise when a prescription is written in a less than clear fashion," said Clifford Kalb, vice president for the consulting firm Wood MacKenzie.

Kalb pointed to a situation a few years ago when Losec, a treatment for acid reflux, was confused with Lasix, a diuretic which dramatically increases the production of urine. AstraZeneca later changed the name of its drug to Prilosec, which became the blockbuster marketed as the ''purple pill."

Elan acquired Antegren when it purchased a smaller company. The Irish pharmaceutical firm also came up with the name. It suggests an antidote to the Alpha-4 integrin molecule that plays a key role in the inflammatory process that leads to multiple sclerosis. Antegren works by blocking the integrin molecule and preventing immune cells from migrating through blood vessels in the brain to areas of inflammation,

The name also worked for Biogen, which partnered with Elan to develop the drug for MS in 2000. Biogen's other drugs -- Avonex for MS and Amevive for psoriasis -- both begin with the letter ''a." Antegren fit right in.

Just weeks before the approval deadline, the two firms continued to tout trial results under the name Antegren.

Biogen Idec officials won't say exactly when they learned that the name Antegren was a problem. Amy Brockelman, a Biogen Idec spokeswoman, said the name created potential conflicts with Integrilin, a drug marketed by Millennium Pharmaceuticals Inc. of Cambridge for heart attacks and other cardiac woes; Ativan, an anti-anxiety medication; and Edecrin, a diuretic.

But they said they had a list of backup names, and the one they chose was Tysabri.

''Abri is the French word for shelter, and that conveys the notion of protection and that Tysabri offers a new level of of efficacy and new hope for people living with multiple sclerosis," said Brockelman.

James Dettore, president and chief executive of The Brand Institute, a Florida consulting firm that worked with Biogen Idec on the naming of Tysabri, said the drug's powerful benefits outweigh the negatives of having to rename the drug upon launch.

''If this was just another me-too product, from a commercial development perspective it would be hard to reverse the existing brand awareness under the Antegren name," he said. ''But with everyone expecting this to be a billion-dollar-plus drug, there won't be as many hurdles to establishing the new brand."

Jennifer Chao, an analyst with Deutsche Bank, predicted Tysabri would generate $410 million in sales in 2005 and $640 million the following year.

One plus for Biogen Idec and Elan is that the companies didn't print any labels, brochures, or other materials prior to the FDA's approval. That saved millions of dollars that might have been wasted if the ancillary materials had to be scrapped for the Tysabri name.

Biogen Idec officials said the drug, approved Nov. 23, was shipped to doctors the following week. The Tysabri brand name will be used worldwide.

''If a drug is going to be truly successful, a global branding concept is a must," said Kalb, the Wood MacKenzie consultant.

Jeffrey Krasner can be reached at krasner@globe.com.