GlaxoSmithKline (GSK) obtained the U.S. rights to Lovaza (omega 3 acid ethyl esters) from Pronova BioPharma in 2007 by acquiring Reliant Pharmaceuticals for $1.65 billion. Since its launch in 2005, Lovaza—formerly branded as Omacor in Europe and Asia—has seen strong growth, raking in $1 billion a year.

 

As an FDA-approved prescription product, Lovaza is designed to lower very high triglycerides at a dose of 4 grams per day. Each 1-gram capsule of Lovaza contains 465 mg of EPA and 375 mg of DHA. In its advertising messages, Lovaza has been careful to qualify that it has not been shown to prevent heart attacks or strokes.

 

From a supplement standpoint, omega 3 EPA and DHA have benefitted from a qualified heart health claim, which states: “Supportive but not conclusive research shows that consumption of omega 3 fatty acids may reduce the risk of coronary heart disease.”

 

Instead of pitting Lovaza against the entire supplement industry, Adam Ismail, executive director of the Global Organization for EPA and DHA Omega-3s (GOED), said the interest of consumers should be top of mind. “I don’t think it’s really a debate about whether or not (Lovaza) will cannibalize the supplement category. The fact of the matter is we want everyone to get more EPA and DHA into their diet because the deficiency problem is so bad. And if you have specific health conditions where a doctor’s care is warranted, there should be pharmaceutical options as well, if they’re effective.”

 

In fact, Mr. Ismail went on to say that Lovaza could be beneficial for the supplement industry, “because it gets the message out in a very visible way about fish oil.”

 

“At the same time, (Lovaza) is leveraging the equity that fish oils already have because they’re talking about how they come from fish oils and things consumers already have a positive opinion about,” he added. “So it’s a very symbiotic relationship.”

 

Several experts in the supplement and functional food space agreed that Lovaza reinforces the positive image of omega 3s. “You can’t go a week or two weeks without seeing a positive story about omega 3 in the news,” said Daniel Fabricant, vice president, Scientific and Regulatory Affairs, Natural Products Association (NPA), Washington, D.C. “If you see it in the news and you hear the same thing echoed by your doctor, I think that’s very persuasive for some people.”

 

While many still see Lovaza as a competitor to the supplement industry, Sam Wright, president and CEO, The Wright Group, Crowley, LA, said the product also represents “a strong proof of concept in using omega 3 fish oil to treat cardiovascular disease, and gives omega 3s more credibility with health professionals and regulatory agencies.”

 

As an FDA-approved pharmaceutical, Lovaza is eligible for insurance coverage, giving it a potential advantage over supplements. “Supplements are much cheaper, but health insurance, in most cases, negates this advantage,” said Mr. Wright. “Maybe insurance companies should consider covering fish oil capsules for customers with high triglycerides who qualify?”

 

While Mr. Fabricant said healthcare reimbursement for Lovaza certainly appeals to consumers, “By and large we’ve seen the (supplement) category grow at retail and we’ll continue to see it grow at retail.”

 

While the long-term impact Lovaza and future prescription omega 3s will have on the supplement industry remains unclear, numerous market research firms continue to predict double-digit sales gains for the omega 3 market overall.

 

Traditionally, products begin in the pharmaceutical space and transition to the over-the-counter (OTC) market. However, Lovaza seems to have taken the reverse route. So now that Lovaza has made a successful transition, will other companies follow its example?
 

Mr. Ismail said there are other pharmaceutical-grade omega 3 products currently in development, at different stages of clinical trials. “Some are for triglyceride reduction,” he noted. “In addition to that, others are trying to get into the generic market by selling generic versions of Lovaza. I think you will see more pharmaceuticals for this condition, as well as others. And there are products being tested for non-heart health related conditions as well.”
 

 

Don’t miss Sean’s full feature article on the Omega 3 Market in Nutraceuticals World’s September issue!