Cardax bolsters data set for synthetic astaxanthin, pushes forward market entry date

06-Aug-2015 - Last updated on 25-Aug-2016 at 13:57 GMT

After a protracted period of development, Hawaii-based Cardax Inc. is nearing market phase for its forms of bioidentical astaxanthin. The company’s proprietary molecules were first studied more than a decade ago.

Long gestation times in the biotech world are often the norm. Sometimes this is evidence of a company run by scientists who lack a firm grip on how to get a promising drug or dietary ingredient candidate to market and who often run out of money before the finish line is in sight. In other cases, it is a planned process of carefully amassing data to support a robust market entry. The officials at Cardax firmly believe they are charting the latter course.

For one thing, they have had help from some powerful partners in the dietary ingredient game, Capsugel and BASF.

“Our synthetic product has been under development since about 2002. The first candidate was ASTX-1F, which is a single isomer of nature identical astaxanthin that has been formulated with a technology from Capsugel that delivers superior oral bioavailability,” CEO David G Watamull told NutraIngredients-USA.

“We have a second generation compound called CDX-085, which is a proprietary, patented compound that is being produced by BASF. We have composition of matter patents and pharmaceutical use patents on this compound,” he said.

Research backs regulatory filings

Cardax recently announced bioavailability data that shows its compounds outperform astaxanthin from microalgae in a monkey test. More details on dosage levels and test design were unavailable, as the research is still being prepared for publication. But is will be published in a peer reviewed journal, Watamull emphasized.

“We do need to publish it to support our GRAS filing. All of the research cited in a GRAS petition has to be publicly available,” he said.

Which brings up the issue of the compounds’ regulatory status. There has been disagreement in the astaxanthin space about the differences between the nature identical ingredients and those derived from microalgae. The latter producers felt strongly enough about the issue to form the Natural Algae Astaxanthin Association to foster the message about those differences. At least one member of the association, Fuji xxxxxx, has successfully filed a New Dietary Ingredient Notification on its astaxanthin ingredient.

Multiple regulatory paths

But there is more than one path to bring a dietary ingredient to market. DSM has relied on the food additive approval it has received on its bioidentical astaxanthin as a additive to feed for farmed salmon and other fish. The company maintains the rigorous animal studies necessary for this regulatory status that include toxicity tests at dosages that far exceed those that could be expected in a dietary supplement for human use are more than adequate proof of safety.

Another path is to file a GRAS petition on a compound, which is the path that Cardax is pursuing. The recent NDI draft guidance, which has lingered now in limbo for a number of years, included a controversial observation that what FDA terms “synthetic botanical” compounds would not qualify as dietary ingredients. Many in industry have strenuously objected to this wording, saying that it arises from an overly narrow reading of the text of the original statute about what it means to be “found in” a botanical raw material and does not hinge on the safety of the compounds in question. Watamull said synthetic ingredients as a class have a long history of safety and successful use as dietary ingredients in the form of synthetic versions of letter vitamins, and to admit those (which have special regulatory status via the Proxmire Amendment) and to carte blanche exclude others makes little sense.

That being said, the NDI draft guidance also gives a free pass more or less to new ingredients that have already have completed the GRAS status process. Watamull said the company has secured top-shelf consulting help in this effort and is confident that a successful and compliant filing will result.

Boat hasn’t left the dock

Demand for astaxanthin was steadily growing in the years prior to a Dr Oz Show segment in which Dr Joseph Mercola, prior to the launch of his own branded astaxanthin product, hawked the ingredient’s health benefits. Demand went through the roof and stayed there, and Watamull said there is still plenty of room for new players in the market. He said the company has now pushed forward its projected market entry date to mid 2016, and still expects the door to be open at that time because of the difficulty algae producers have in ramping up production and in maintaining high output levels. From his point of view, as much as the astaxanthin market has grown, it has hardly begun to tap its ultimate potential.

“In the current astaxanthin market we are serving a few hundred thousand people at most. If there are 20% increased from that base, or even a doubling, it is going to come nowhere close to address the 10 million people who could benefit from this ingredient. Our partner BASF is the biggest chemical company in the world and we don’t see a supply constraint in the future,” Watamull said.