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Aker BioMarine and Swisse collaborate to launch a ground-breaking product under Australia’s Listed Assessed medicine category

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Aker BioMarine’s Superba™ Boost Krill oil, used by the Swisse brand in Australia, is now included in the Australian Register of Therapeutic Goods (ARTG) as an ‘assessed listed’ medicine.

 

Oslo, September 5, 2023: Swisse Ultiboost High Strength Krill Oil, which uses Aker BioMarine’s Superba Boost Krill oil, has been included on the Australia Register of Therapeutic Goods (ARTG) with an AUST L(A) 417392 with two specific indications, those being:

  1. Decrease/reduce/relieve knee pain and stiffness in mild to moderate osteoarthritis
  2. Increase knee physical function in mild to moderate osteoarthritis

All medicines supplied to the Australian market must be included in the ARTG. The ‘assessed listed’ medicine status of Swisse’s Ultiboost High Strength Krill Oil containing Superba Boost, means that it has been reviewed to assess the efficacy of its health claims, prior to being officially added to the country’s register for medicines.

With its newly secured Listing ARTGL (A) 417392, Swisse Ultiboost High Strength Krill Oil can now add information about the health benefits of the Superba Boost Krill Oil to its label and include these messages in consumer advertising. The specific indications are exclusive to Swisse for the next five years.

“With this milestone, the Swisse Superba Boost Krill oil product will carry the unique identifier on the label, giving consumers clear indication that the product claims have been evaluated against the evidence provided and considered fit for purpose. “This study came after decade’s worth of scientific research focused on uncovering the full potential of krill and is a testimony to the unique nature and effectiveness of Aker BioMarine’s Antarctic krill oil ingredient.”, says Line Johnsen, SVP Human Health & Nutrition R&D, Aker BioMarine.

“Aker BioMarine has continually invested in research in many countries and at different times and this research consistently shows that this powerful omega-3 source is both safe to consume and can lead to improvements in knee pain, stiffness, and physical function in adults, in addition to heart and brain benefits,” Johnsen adds.

"It is great to see companies like Swisse Wellness securing access to this regulatory pathway. It is a recognition of their ongoing commitment to research to enable new innovative products. It means more specific evidence-based information for consumers and highlights the benefits of complementary medicines. It also demonstrates that Australia is a world leader in the research and development of complementary medicines,” says John O’Doherty, Chief Executive Officer | Complementary Medicines Australia.

Recent CSIRO trial concludes Superba Boost can help to reduce knee pain in adults with mild to moderate osteoarthritis
A clinical trial was recently executed under the guidance of Australia's national science agency, CSIRO, to evaluate the impact of krill oil on osteoarthritis of the knee. The study, which was sponsored by Swisse's H&H Research, the research arm of global health and nutrition company, H&H Group, was conducted across three clinical trial sites in Australia and evaluated 235 adults between 40 to 65 years of age who had been clinically diagnosed with mild to moderate knee pain. The results showed that not only did Superba Boost significantly reduce the pain, but it also helped improve stiffness and physical function in the participant’s knees.

"This study demonstrates our commitment to contributing to the body of research focusing on complementary medicines and in turn displays our dedication to delivering innovative and efficacious products to our consumers," said Nick Mann, the Australian CEO of Swisse.

The efficacy of an ‘assessed listed’ medicine is evaluated pre-market, which is a prerequisite for the use of the “TGA assessed” claim on the label. More information on how the Australian government regulates medicines can be found here: How we regulate medicines | Therapeutic Goods Administration (TGA).

 

About Superba Krill Oil
SuperbaTM Krill is a pure and natural source of the health-promoting EPA & DHA omega-3 essential fatty acids and the naturally occurring antioxidant, astaxanthin. The uniqueness of SuperbaTM Krill is that the omega-3 fatty acids are provided in phospholipid form. In vitro, in vivo, and human clinical research has demonstrated the safety and efficacy of SuperbaTM Krill.

About Aker BioMarine
Aker BioMarine is a biotech innovator and Antarctic krill-harvesting company, dedicated to improving human and planetary health. Listed on Oslo Stock Exchange, the company develops krill-based ingredients for pharmaceutical, nutraceutical (Superba®, NKO® and K·REAL®), aquaculture (QRILL™ Aqua), and animal feed applications (QRILL™ Pet), including Understory™, Aker BioMarine's new high-quality single source protein brand, and LYSOVETA™, a targeted transporter of EPA and DHA from krill. Aker BioMarine’s fully transparent value chain stretches from sustainable krill harvesting in pristine Antarctic waters through its Montevideo logistics hub, Houston production plant, and to customers around the world. The company’s strong focus on sustainability inspired the launch of AION by Aker BioMarine, a circularity company dedicated to helping companies to recycle and reuse waste. Read more: www.akerbiomarine.com.