Will The Rising Tide Of Rx Omega-3s Float The Fish Oil Supplement Market?
This article was originally published in The Tan Sheet
|
Omega-3 fish oils, once exclusive to the realm of dietary supplements, increasingly are swimming upstream into prescription drugs – a trend with both positive and negative implications for supplements. Nutritional industry stakeholders say the jury is still out on how omega-3 pharmaceuticals will affect the supplement space long-term, but supplement marketers should do everything they can to step up their game. Though several drug firms are developing products derived from fish oil, GlaxoSmithKline's Lovaza for reducing very high triglyceride levels remains the only FDA-approved omega-3-based pharmaceutical.
GlaxoSmithKline's Lovaza (omega-3-acid ethyl esters)
GSK acquired Lovaza (omega-3-acid ethyl esters) along with Reliant Pharmaceuticals in 2007, and the drug tallied about $716 million worth of U.S. prescriptions in 2009, plus $588 million through the first three quarters of 2010, the firm reported. By contrast, omega-3 supplements – comprising mainly fish oil concentrate products – generated $359.3 million in U.S. sales during the 52 weeks ended Nov. 27, according to data from market research firm SPINS Inc. GSK Sees No Point Of Comparison With Glaxo's marketing muscle driving Lovaza to blockbuster status, consumer awareness of omega-3s in general is growing, too, according to Harry Rice of the Global Organization for EPA and DHA Omega-3. "We've always considered that there's plenty of room for both dietary supplements and prescription drugs, omega-3-based," said Rice, GOED's director of regulatory and scientific affairs. GSK's marketing material for Lovaza plays up its natural ingredient, but the company strives to distance it from supplements. "There are no head-to-head studies with supplements and Lovaza, so we're not really in a position to actively or directly compare ourselves to supplements," GSK spokeswoman Bernadette King said. Lovaza's prescribing information says a 1-gram capsule contains "at least" 900 mg of omega-3 ethyl esters – predominantly eicosapentaenoic acid (465 mg) and docosahexaenoic acid (375 mg) – significantly more potent than a standard fish oil supplement.
As the drug's website makes clear, "You can't get it at a health food store." In an interview, King also emphasized the FDA-approved refinement process behind Lovaza, which helps assure purity and consistency, as well as the drug's established efficacy. "What we know is how we reduce very high triglycerides and have the data to prove that," King added. One Of These Pills Is Not Like The Others Rice noted that with FDA's good manufacturing practices regulation in place for dietary supplements, compliant supplement firms make products as rigorously as their pharma counterparts. GOED touts the quality standards followed by all its member companies, one of which is Watsonville, Calif.-based Nordic Naturals. Joar Opheim, CEO of the fish oil supplement firm, said big pharma sits in an enviable position given the high barriers to entry for drugs and a health insurance model that covers Rx medication but not nutritionals. For many patients with prescription drug coverage, out-of-pocket costs for Lovaza likely are less than the retail price of a bottle of fish oil supplements. "I would love to have a business model where I sold something to a consumer and somebody else had to pay for it. It would be fantastic," Opheim said. "But we are not in a position to do that because it's, on average, $240 million to get a drug on the market." Opheim highlighted Nordic Naturals' track record for product purity and quality – aspects that kept the company out of a lawsuit filed by environmental activists in 2010 against several makers of fish oil products allegedly containing contaminants (Also see "Fish Oil Firms Float Toxicology Work, Plot Media Blitz To Fight PCB Suit" - Pink Sheet, 22 Mar, 2010.). He also cited research showing omega-3s in re-esterified triglyceride form, as Nordic Naturals uses, are more stable and 70% more bioavailable than in the ethyl ester form found in Lovaza. The manufacturing process that reattaches fatty acids to their glycerol backbone – re-esterification – is about three times more expensive than leaving them in ethyl ester form, Opheim said. "I believe we have a better product than Lovaza," he said. Staking Claims To Health Benefits As the list of health benefits attributed to omega-3 EPA and DHA grows, so does a degree of frustration among supplement marketers. "It's a supplement that is too good to be true, and that's the problem," Opheim said. "We cannot talk about anything." As with any supplement, no claims can be made about fish oil's effects on disease states. FDA allows a qualified health claim, approved in 2004, citing "supportive but not conclusive research" that shows consumption of EPA and DHA "may reduce the risk of coronary heart disease" (Also see "Solae, Cargill Swim Against Tide Of Fish Oil With Vegetarian Omega-3s" - Pink Sheet, 9 Aug, 2010.).
But omega-3 boosters tout the fatty acids' ability to alleviate arthritis pain, improve skin and eye health, aid brain development and reduce inflammation. Nutritional consultant Gretchen Vannice notes health organizations including the American Heart Association and American Dietetic Association recommend high levels of omega-3 consumption, which she says could help assuage many widespread health problems. Vannice, managing director of Omega-3 RD in Portland, Ore., says a dietary reference intake for omega-3, which stakeholders have asked the Institute of Medicine to issue, would go even further to validate fish oil supplements ("Groups request DRI for omega-3s," "The Tan Sheet" Nov. 23, 2009, In Brief). Additionally, Rice says GOED and the fish oil industry plan to seek FDA approval for a health claim meeting significant scientific agreement regarding omega-3 and heart disease. "We believe we have the research now to support a full health claim," Rice said. "It takes a little bit of time to pull that dossier together, but we're excited about that." With around 8,000 clinical studies completed on fish oil – more than twice than on any drug – Opheim says he is optimistic that a liberalized health claim paradigm eventually will emerge. "I believe that we, at some point, will be able to tell the world what our products can do," he said, adding, "Right now, the only people who are losing out are the consumers." Amarin Looks To Surface With New Drug Rice notes that the Rx indication for Lovaza may serve as a helpful proxy for fish oil supplement claims in consumers' minds. "That's where the Rx side helps us out, because they say things that we can't say and then they're generalized to dietary supplements," he said. If the hypothesis is true, supplements may benefit further in the coming decade as more omega-3-based drugs wend their way through development pipelines and eventually to market. Amarin Corp. seems a strong candidate to gain FDA approval for its AMR101 molecule; positive results from a phase III trial have Amarin on track to submit a new drug application in 2011, a year earlier than originally planned (Also see "Amarin Accelerates Timeline For NDA Filing Of AMR101" - Pink Sheet, 1 Dec, 2010.). AMR101 (ethyl-EPA) seeks an indication for lowering high or very high triglycerides, but unlike Lovaza, data suggest AMR101 does not increase LDL cholesterol, which could appeal to patients already on a statin regimen. Since November 2010, Ireland-based Amarin has been led by Joseph Zakrzewski, former chief operating officer of Lovaza originator Reliant. In an interview, the CEO said Amarin plans to seek out a marketing partner for AMR101, contingent on the success of its current research.
The firm wants to position its drug as highly differentiated from Lovaza, rather than a direct competitor. Zakrzewski added Amarin has no plans to run a head-to-head trial comparing AMR101 and Lovaza. Much like GSK, Amarin looks to draw a heavy line between its drug and supplements. "AMR101 is not a dietary supplement/fish oil," but rather "a semi-synthetic, ultra-pure ethyl icosapentate, a single-active moiety, and its composition is highly regulated with no variations or deviations," a company spokeswoman said in an e-mail. Other Pipelines Flooded With Omega-3s Elsewhere in the Rx arena, Catabasis Pharmaceuticals, of Cambridge, Mass., announced in December it secured additional financing to help advance an omega-3-based compound toward human clinical trials studying its effect on type 2 diabetes. Catabasis says it intends to test whether the drug can affect diabetes by targeting inflammation triggered by obesity; human studies are expected to commence in the second half of 2011. Another Cambridge start-up, Resolvyx Pharmaceuticals, hopes to begin phase III trials in 2011 for RX-10045, a treatment for dry eye syndrome based on resolvins – lipid mediators generated by the omega-3 oxidation process – according to the firm's website. Nordic Naturals has long marketed fish oil supplements to help alleviate eye dryness, Opheim said, and it's no surprise a drug developer would try to up the ante. "I guess we are creating the trends and when it's big enough, the drug companies are jumping on and then it's time for us to find something new," he said. Clock Ticking For Lovaza Exclusivity With competition on the horizon, Lovaza's days as a blockbuster may be numbered. A recent study published in the Journal of the American Medical Association showed Lovaza did not reduce the recurrence of symptomatic atrial fibrillation – an indication for which the company would have explored had the study succeeded, spokeswoman King said. She added Glaxo is not actively pursuing other indications for Lovaza. But omega-3 industry observers say GSK likely is pursuing other indications for Lovaza, especially with generics firms eagerly awaiting a shot at launching equivalents. The drug's current period of market exclusivity runs through Sept. 16, 2012, and the last of its lipid management patents expires April 10, 2017, according to FDA's Orange Book. Vannice suggested that pursuing depression and other mental health indications could be the next course of action for GSK and other pharmas with omega-3 molecules. "I wonder if people just ate more omega-3 in their diet, would we have less incidence of depression?" she said. "Research suggests that's the case." Some see Lovaza as an Rx-to-OTC switch candidate at some point, though Rice says he wonders whether it could command a high enough price as an OTC to make economic sense for Glaxo (Also see "New GSK Global Switch/Strategy Position Supports Firm’s OTC Commitment" - Pink Sheet, 26 May, 2008.). Supplements Need Clarity To Compete Fish oil supplement makers can reap the rewards of greater omega-3 awareness through pharmaceuticals, but many of them will need to raise the bar on product quality and labeling. "Unfortunately, a lot of the products that are out there are basically [using] label dressing, as we call it," Opheim said, citing supplements that tout their EPA and DHA but contain suboptimal levels. "If it does anything to you, I would be surprised. It's not enough, it's just so you can put omega-3 on your label," he added. Supplement giant NBTY recently settled with the Federal Trade Commission after advertising the brain and eye benefits of 100 mg of DHA in children's multivitamins, when some of the products actually contained a thousandth of that amount per serving (Also see "NBTY Agrees To $2.1M Settlement With FTC For False DHA Claims" - Pink Sheet, 20 Dec, 2010.). With Lovaza offering such a high dose of omega-3s, consumers need more effective information to help them get comparably beneficial levels from supplements, Vannice said. "I think where dietary supplement companies could step up is better labeling – being more clear in their dose, being more clear in what they're offering per capsule," she said. |