Kaydence Pharma – Successful completion of Pre-IND meeting with FDA

Oslo, Norway (15 January 2019) — Kaydence Pharma AS, the development stage pharmaceutical company spun-out of NattoPharma in 2017, reports today that it has successfully completed a pre-IND (Investigational New Drug) meeting with the US Food and Drug Administration (FDA). At the meeting, the FDA addressed questions regarding key components of the planned IND application and the clinical/regulatory pathway for MQ7, Kaydence Pharma’s novel drug candidate for the treatment of arterial stiffness in stable renal transplant recipients with subclinical vitamin K deficiency.

“The continued positive momentum in the Kaydence Pharma development plan is very encouraging and validates the strategic decision to spin the activity out of NattoPharma’s ordinary supplement business in 2017. This decision ensures that Kaydence continues to have both the correct focus and attention from competent people to succeed. NattoPharma is very enthusiastic about this project and has great faith in the future potential for a pharmaceutical drug based on the extensive clinical understanding that NattoPharma has developed over the last 10 years of working with MK-7." said Kjetil Ramsøy, CEO of NattoPharma.

The press release issued by Kaydence Pharma is attached to this announcement for further reading.

X X X


About NattoPharma and MenaQ7®

NattoPharma ASA, based in Norway, is the exclusive international supplier of MenaQ7® Vitamin K2 as MK-7, the best documented, vitamin K2 as menaquinone-7 (MK-7) with guaranteed actives and stability, clinical substantiation, and international patents granted and pending; and now the new MenaQ7® Full Spectrum, which delivers menaquinones 6, 7 and 9. The company has a multi-year research and development program to substantiate and discover the health benefits of Vitamin K2 for applications in the marketplace for functional food and dietary supplements. With a global presence, the company has a North American subsidiary, NattoPharma USA, Inc., in Edison, NJ, and NattoPharma R&D Ltd. in Cyprus. For more information, visit www.nattopharma.com or www.menaq7.com.

For more information, please contact:

Kjetil Ramsøy, NattoPharma Chief Executive Officer

E-mail: kjetil.ramsoy@nattopharma.com

Tags:

About Us

NattoPharma, the world leader in Vitamin K2 Research and Development, has invested millions of dollars in in-vitro, in-vivo, and clinical studies to document the effects of MenaQ7® Vitamin K2 as MK-7. This commitment has created the only patented and clinically validated K2 on the market. After establishing the first commercial Vitamin K2 with its flagship brand, MenaQ7®, NattoPharma has consistently answered and met market needs through the development of new production technologies:• In 2012, the company introduced MenaQ7® Crystals, which represented an important breakthrough in the new generation of Vitamin K2 products, producing the purest natural MK-7 available.• In 2014, NattoPharma introduced the only all-trans nature-identical synthesized Vitamin K2, MenaQ7® PURE. Not only did the company succeed in changing the market with MenaQ7® PURE – offering a high-quality, competitively priced ingredient – but its efforts were rewarded with the NutrAward for Best Functional Ingredient at Natural Products West/engredea 2015. Vitamin K2 is essential for the body to utilize calcium to build healthy, strong bones and to inhibit calcium deposits in the arteries. Published clinical studies have demonstrated the high bioavailability and proof of efficacy for Nattopharma’s all-trans MK-7 products in healthy and diseased populations, for bone and cardiovascular health. NattoPharma continues to build its competitive advantage through focuson IPR and has patents both granted and pending related to relevant healthbenefits and market segments, creating extra value for its customers. And NattoPharma staff consists of professionals people with longstanding experience in medical and biochemical research as well as pharmaceutical and food supplement development. By understanding and controlling the chemistry, NattoPharma provides the market all-trans MK-7 products, while our sales and marketing team has extensive knowledge of international market demands with which it supports our partners.