By David Hodges | August 2008
The Medical Post
Manufacturers face many hurdles to secure a catchy handle
MIAMI | There's no hyperbole in saying naming a new drug is a Herculean undertaking.
Scott Piergrossi knows this all too well. As vice-president of creative development for the Brand Institute, a Miami-based brand identity consultancy firm with offices throughout Europe, Asia and North America, it's his job to give pharmaceutical companies' new therapeutics a competitive edge. If crafted effectively, he says, the concept behind a name will be clearly understood or simply explained, "which will help carve that product's space in the marketplace."
Take, for example, the immunoglobulin drug Privigen, recently approved by Health Canada. Its name can be broken down into three parts, each effectively describing the product's major qualities: PRI, indicating it is for patients with PRImary immunodeficiency; IVIG for IntraVenous ImmunoGlobulin; and GEN, a play on its classification as a next GENeration drug.
An even simpler example would be the proton pump inhibitor Prevacid (lansoprazole), which quite clearly spells out PREVent ACID.
A great deal of target audience research goes into the selection of such names, Piergrossi said, all to ensure the ideas embedded into a product name act as a catalyst to the patients using the drugs and the doctors prescribing them.
Getting to this stage, however, and reaping the benefits of a shrewdly calculated name, is no easy feat. Trademark availability-ensuring a brand name is ownable and defendable in all the markets the drug will be sold in-is the first obstacle in a new drug's brand name development.
Typically, a major goal of any pharmaceutical is the trademark registration and approval of a single name that can be used throughout the world. But, as Piergrossi pointed out, "this is becoming an increasingly challenging task as the global trademark landscape is growing exponentially and each trademark registry has distinct (requirements) for that particular region."
No look-alikes or sound-alikes
The regulatory assessment of a new drug name is also critical to its approval. Chiefly, a name can't look like or sound like another drug name already marketed in Canada, said Eric Ormsby of Health Canada's drug policy division, as that may result in nomenclature-related medication errors.
National variations at the assessment level can require a pharmaceutical company to use a different name for its drug in different nations.
Lili Ann Stiver, managing director of Canadian regulatory affairs at the Brand Institute's Ottawa office, used the example of the proton pump inhibitor omeprazole, which is marketed as Losec in Canada and Europe but not in the U.S. Initially, Losec was used in the U.S., but at the FDA's request in 1990 it was changed to Prilosec because Losec was being confused with the diuretic Lasix (furosemide). Unfortunately, the new name has led to confusion between Prilosec and the antidepressant Prozac.
Another consideration for brand name regulatory approval, Stiver said, is the proposed name cannot exaggerate or make inappropriate or misleading claims that aren't substantiated by clinical data. For example, the name Champix was proposed as a global trademark for the smoking cessation drug varenicline. However, that was rejected by the FDA for being overly promotional-too close to "champion"-so a slight variant of the name (Chantix) had to be created for the U.S. market in 2006.
But the tonality of a product's name can play an equally significant role in communicating the big idea behind it.
Consider the prescription sleep aid Lunesta, Piergrossi said: "The name is soft, rhythmic and approachable, conjuring up lunar associations, appropriate for the product's indication. Without any highly descriptive elements, Lunesta still communicates the key concepts associated with the brand simply through how the name sounds."
In Canada, guidelines for the regulatory approval of a drug's chemical or generic name are determined by the international nonproprietary name (INN) system created by the World Health Organization.
Since its inception in 1950, the aim of INNs is to provide health professionals with a unique and universally available name to ensure clear identification, safe prescription and dispensing of medications to patients and for communication and exchange of information worldwide.
Generic names must be distinctive in sound and spelling, and-as with brand names-should not be liable for confusion with other names in common use. This is typically accomplished by using a "stem," a common sequence of letters indicating a substance belongs to a group of substances having similar pharmacological activity: for instance, the nonproprietary name of the drug atorvastatin indicates it is a statin.
H, J, K and W not wanted There are also non-scientific considerations in the development of a nonproprietary name, according to Emily Cukier-Meisner, associate director of chemical research with the Brand Institute's Chicago office.
Just like brand names, nonproprietary names should not be promotional or over-promising, and since they are intended for international use, they should also be easy to translate into a variety of languages.
The use of certain letters, such as H, J, K and W, Cukier-Meisner added, is also strongly discouraged in order to facilitate translation.
Of course, Cukier-Meisner and Pieirgrossi both point out, following all of these considerations for the proprietary and nonproprietary naming of a new drug provides no guarantee that a proposed name will get a green light when submitted for regulatory approval. Often, following several months of research and development, that proverbial light at the end of tunnel turns out to be an oncoming train.
And when that happens, it's back to the drawing board.