NattoPharma’s MenaQ7® to significantly reduce bone loss and risk for osteoporosis: Significant commercial opportunities

27th March 2013 Oslo, Norway. NattoPharma announced yesterday the publication of a groundbreaking new study on its proprietary MenaQ7® brand of Natural Vitamin K2 standardized to MK-7 content in the leading journal Osteoporosis International.

MenaQ7 supplementation in the study demonstrated not only a preservation of bone loss, but also a significant improvement in the bone strength impact index – the predictor of risk for osteoporosis – compared to the placebo group. The clinically relevant result has led experts to conclude that the statistical probability of suffering osteoporotic fractures will be moved outside normal life expectation.

These findings are unique amongst dietary supplements and other known treatments. Only MenaQ7 has been shown to provide statistically significant results, and the company is confident of new commercial applications for stand-alone MenaQ7 products, calcium products and bone health products. These findings also provide a basis for novel drug development as previously announced by the company.

“These demonstrated improvements in clinical outcomes are extremely important,” says Dr. Cees Vermeer, Principal Investigator for the study at VitaK laboratory at Maastricht University. “Despite reports on small or insignificant effects on bone health after clinical interventional studies on vitamin K2 – lasting up to one year - we have documented that MenaQ7 supplementation over three years prevents bone loss in postmenopausal women, confirming that bone health benefits of vitamin K2 is best demonstrated over longer periods than previously thought. The dose of 180 mcg of MenaQ7 per day significantly decrease age-related loss in bone mass and thereby improvement in bone strength.”

Impact on bone strength index.

 “These results confirms the importance of the previous communicated negotiated agreement between Nattopharma and VitaSynth, giving NattoPharma access to the pharma-grade vitamin K2, enabling us to enter the pharma segment for bone diseases”, says Executive Chairman of the Board in NattoPharma, Frode Marc Bohan. “In this context I am very pleased to see that earlier experience form the Omega-3 field, where Pronova was able to launch its pharmaceutical product Omacore / Lovaza and generate significant value for the shareholders, is part of the NattoPharma team through CEO Hogne Vik, MD, PhD, MBA. The data from this study points to the potential to build significant shareholder value within the pharma area in NattoPharma.”

“The results from the three-year human study on MenaQ7® show for the first time in history that daily intake of 180 micrograms MenaQ7 may help postmenopausal women to prevent bone loss, and therefore may drastically delay development of osteoporosis,” says CEO of NattoPharma Hogne Vik.

The company initiated the three-year clinical intervention study on the effects of MenaQ7 on bone health and it is now available online in the leading journal Osteoporosis International as an Online First Article (DOI 10.1007/s00198-013-2325-6).

In total 244 women were included in the study and randomly assigned to either a non-treatment group receiving placebo capsules (n=124) or a treatment group receiving capsules containing 180 mcg MenaQ7 (n=120). One capsule was taken daily during a period of 36 months. Participants came to the research site every year (0, 1, 2 and 3 years) for measurements of body weight and height, blood sampling and DXA measurements. The compliance was 91.4% of the randomized participants staying in the study until its completion.

MenaQ7 Benefits

• MenaQ7 demonstrates improved bone strength index (BS) – delaying the likelihood for osteoporotic fractions post normal life expectancy.
• MenaQ7 reduces yearly bone loss with more than 70 % post-menopausal
• MenaQ7 secures Bone Mineral Content (BMC)
• MernaQ7 secures Bone Mineral Density (BMD)
• The MenaQ7 supplementation group significantly increased the circulating active Osteocalcin (cOC), a well-established biomarker for bone- and vitamin K status. The inactive protein, ucOC, in the MenaQ7 group, decreased with 51% +/- 21 % as compared to the placebo group (+4 % +/- 49%).

Osteoporosis

Osteoporosis is a disease that leads to an increased risk of fractures of bones. In osteoporosis the bone mineral density (BMD) is reduced, bone micro architecture deteriorates, and the amount and variety of proteins in the bone is altered. According to the International Osteoporosis Foundation, osteoporosis is estimated to affect 75 million people in Europe, USA and Japan. The results of NattoPharma’s current study show that MenaQ7 plays a positive role in bone health. Both the amount of bone and quality of bone are better conserved in the MenaQ7 group.

About MenaQ7®

MenaQ7® provides natural vitamin K2 as a manufactured fermentation extract. This process generates a highly pure and bio-available form of vitamin K2, menaquinone-7(MK-7). MenaQ7 is the purest and best documented natural vitamin K2 with guaranteed actives and stability, clinical substantiation and several granted patents on cardiovascular health.

About NattoPharma

As a biotechnology-based nutraceutical company, NattoPharma is the worldwide innovator and leader of Vitamin K2 menaquinone-7. Its brand MenaQ7® is supported by a global IPR portfolio and revolutionary research substantiating clear efficacy for bone and cardiovascular health. NattoPharma has since 2007 been in an exclusive research and development collaboration with VitaK, University in Maastricht, The Netherlands, working to substantiate the health benefits of natural vitamin K2.

For more information, please contact:

Hogne Vik
CEO, NattoPharma
Cell phone: +47 97 53 53 26
E-mail: hogne.vik@nattopharma.com