June 30, 2010

Making drug names easy to swallow

With slew of new medicines arriving on the market, companies struggle to fulfill own, regulators' requirements

By ALLISON CONNOLLY

Some drug names just roll off the tongue while others are, perhaps, best written and not spoken.

Drug companies can spend hundreds of thousands of dollars on outside legal and marketing services just to develop a name, in addition to the millions they spend developing the actual substance in the lab. Yet half the names they come up with are rejected by regulatory authorities.

And it's only going to become tougher for companies to come up with original names given the expected flood of biosimilars—generic drugs made from living organisms as opposed to chemicals—once the U.S. Food and Drug Administration finalizes the approval process. This is on top of the slew of new drugs, traditional chemical-based generics and over-the-counter drugs that come on the market each year.

Every drug has at least two names in addition to the chemical name based on its chemical structure: the brand name that patients get prescriptions for, and the generic name that is commonly used when the patent expires. Both must pass regulatory muster.

That's why companies outsource the job of naming their drugs to firms such as Miami-based Brand Institute Inc. Brand Institute has coined Sepracor Inc.'s sleep-aid Lunesta, whose generic name is eszopiclone, Pfizer Inc.'s cholesterol drug Lipitor, also known as atorvastatin calcium, and Merck & Co.'s cervical-cancer vaccine Gardasil, generically known as the recombinant vaccine treating types six, 11, 16 and 18 of quadrivalent human papillomavirus.

"There are only 26 letters in the alphabet, and the trademark registries are increasingly becoming cluttered," said Scott Piergrossi, vice president of creative development at Brand Institute. "We have to become more creative with names."

There's a lot to consider: Does the name already exist? Does it suggest it's superior to other drugs on the market? Does it sound like another drug, making it confusing to a pharmacist? Half of medication errors come from prescribing and transcription errors, which could have lethal consequences.

Then there's the question of how the name stacks up against the competition. Take erectile dysfunction. There's Pfizer's Viagra, which was first to the market, and GlaxoSmithKline PLC's and Bayer AG's Levitra, which has the same stem as "levitate."

Eli Lilly & Co.'s Cialis "is the least memorable in the category," said Steve Manning, managing director at branding agency Igor in San Francisco, which also names drugs. "It's difficult to spell and difficult to pronounce and it doesn't have a strong personality."

Companies typically start the naming process when the drug is in Phase II trials, which can be three years before they even apply for approval.

Brand Institute will invent 100 names for a client, but ends up with only about 15 after the screening process. On average, the company charges about $250,000 for a name that passes all the tests.

"We want one global brand name," said Mads Krogsgaard Thomsen, chief scientific officer of Danish pharmaceutical company Novo Nordisk AS. "It's difficult to have a name that's easily pronounced in every language and doesn't mean something untoward."

Novo Nordisk spent $1 billion to develop Victoza, its most recently approved treatment, for Type 2 diabetes. The drug is considered a blockbuster, which means it is expected to earn the company more than $1 billion in peak annual sales in the next few years. So picking the right name was important, Mr. Krogsgaard Thomsen said, and the firm sought help from Brand Institute.

"You want names with a feminine touch, something that connotes caring. Victoza is a soft word," he said. "It's also reminiscent of 'victory' over the disease."

And it checked all the boxes for pronunciation, emotional response and degree of confusion with another drug on the market, he said.

The pharmaceutical company has run into problems with names in the past, however. NovoRapid, a form of insulin, was accepted in Europe, but rejected in the U.S. on the grounds that the name may suggest it acts more quickly than other drugs on the market, he said. So the company settled for NovoLog for the U.S. market.

Zaide Frias, head of regulatory affairs at the European Medicines Agency, who chairs the Name Review Group that approved NovoRapid, said "rapid" was acceptable in this case because it's a rapid or fast-acting insulin, a common term for the therapy.

Only 50% of suggested names make it past Ms. Frias's committee of 15 experts, which is why companies start submitting names 18 months before they intend to file for drug approval. The names are also sent to European Union member countries for review.

About 84% of rejections are due to potential confusion with existing market names, while the rest are rejected because they are deemed promotional or misleading, Ms. Frias said.

Merck & Co. had to go back to the drawing board while coming up with the chemical name for its current best-selling drug Singulair, which treats asthma and allergies.

Marc Labelle, the chemist who discovered the drug in a Merck lab in Montreal, wanted to make Singulair's generic name "realukast"—"luk" for the drug's mechanism of action as a so-called leukotriene receptor antagonist, "ast" for asthma and "real" for the second part of the city's name and his father's first name. At that time, his father had been recently diagnosed with terminal cancer and he thought it would be a nice tribute, Dr. Labelle said.

However, the U.S. Adopted Names Council, which vets generic drug names, said the prefix "real" might give the impression that Merck was claiming the drug was the "real lukast," implying it was superior to competing drugs of the same class. So the name was changed to "montelukast," keeping a Montreal connotation.

While Dr. Labelle said it would have been nice to keep the name, the more important factor was that the drug itself was showing promise in clinical trials at the time. "We were still thrilled," he said.
—Peter Loftus contributed to this article.

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