BioNona gains FDA approval for Atopis eczema cream, plans to start online US sales
BioNona, which markets skin treatment creams developed by biochemist and chief executive Iona Weir, says it has gained US Food and Drug Administration approval for its Atopis eczema cream treatment, giving it access to a market worth as much as US$6 billion.
It marks the first such FDA approval for a New Zealand-developed over-the-counter (OTC) pharmaceutical skincare cream and is a culmination of more than 30 years of research and pharmaceutical development by Auckland scientist Weir, whose other projects have included the kiwifruit-based Phloe laxative product produced by Vital Foods Processors, where Weir was chief scientific officer until 2014.
Weir said the US market for OTC eczema creams amounts to about US$2 billion, or one-third of the total market. BioNona plans to sell online via Amazon on its eczema treatments page which only allows FDA-approved products. She said in the US about 50 percent of OTC sales now occur online through approved USFDA outlets such as Amazon.
"I suspect it will be our biggest product, though consumers use the eczema cream and then buy the other products," she said. "So it is more of a lead product that draws consumers in."
The Atopis eczema cream is already for sale but to date has been marketed as Dry Itchy Skin Relief Cream. The FDA approval means they can be re-branded as an eczema treatment. BioNona plans to seek FDA approval for its acne-prone skin care next, Weir said.
According to BioNona's website, Atopis contains myriphytase, a patented novel compound "developed for use in the treatment of eczema, psoriasis and acne." Myriphytaseis is created through a patented process called Peptilization, which "fuses together plant, bacterial and insect components."
The work grew out of Weir's Ph.D. in 1997 on programmed cell death in plants known as apoptosis. Her research showed apoptosis in plants was reversible, unlike in animals, and she was able to extract "critical reactions" in plants that could be put in a cream as a topical application for skin conditions in humans, such as eczema and acne. The extract encourages the body's immune response to attack affected areas and repair damaged cells, she told the International Conference on Clinical and Experimental Dermatology in Chicago last year.
The acne cream also contains the myriphytase extract "but it has gone through a different enzymatic fermentation reaction so that it has the bioactive properties required to treat acne," she said today.
Weir has a holding of about 33 percent in Decima Health, which owns the patents and did the research. Decima, in turn, owns 75 percent of BioNona, which was set up to handle manufacturing and distribution.
The company's chair is Paul Dallimore, who also owns about a third of Decima and was the original angel investor in the business, having been given a sample of the cream by Weir which he tried on a grandchild. Dallimore was the founder of National Property Trust and is chair of the Highgate Group.
Weir said the company hopes to have the eczema cream on sale to US consumers from the start of February next year.
Weir won an international award for her original Ph.D. and was able to continue her research with a grant from the Marsden Fund. A grant from Callaghan Innovation helped fund the double blind placebo controlled clinical trial completed by Southern Clinical Trials Group at the end of 2015.
(BusinessDesk receives funding to help cover the commercialisation of innovation from Callaghan Innovation.)