ALL FOR LOVAZA

In the year since it was officially introduced in the United States, Lovaza is on target to top $1 billion in sales this year. The success of this prescription-only omega-3 fish oil capsule from GlaxoSmithKline opens a whole new door for Big Pharma, which has a deepening interest in natural substances to prevent and treat health conditions.

“The pharmaceutical industry is opening itself up to considering natural substances and their clinical benefits,” said Bernardette King, a GSK spokesperson. “I think Lovaza is a perfect example of that.”

The drug is approved by the Food and Drug Administration to treat high triglyceride levels, which are known to contribute to heart disease, stroke and diabetes.

To differentiate its fish oil from mass-market supplements, GSK conducted extensive efficacy and safety tests. For those efforts, Lovaza was granted FDA approval for prescription-only availability, at a cost of roughly $160 for a month's supply.

“There was a lot more rigor around having this approved, keeping it approved and having it manufactured,” continued King.

Lovaza's success is a challenge to the OTC supplement industry, which itself manufactures high-quality omega-3. Kurt Cameron, a marketing specialist in the product development department at Swanson Health Products, wrote in the company's blog that the GSK seems to be taking an “if you can't beat 'em, join 'em” approach.

“If Lovaza is a medicine, where does that put the supplement you've been taking?” he asks readers. “It that medicine too?”

Cameron points out that pursuing FDA approval allowed GSK to label Lovaza as a “prescription medication.” Everything else — the omega-3 caplets lining the shelves of supermarkets and mass merchandisers — is a “supplement.” The only difference between them is price, Cameron said.

“Depending on your co-pay [Lovaza] may cost you less, but your insurance company is picking up the rest of the tab and GSK is making millions,” he wrote.

The success of Lovaza has only whetted the appetite of drug makers. Another prescription heart medication on the market is simply a version of niacin, or vitamin B3.

“There are competitors that are potentially coming down the pike, so this is an attractive area for pharmaceuticals to consider,” said King.