EFSA opinion strengthens platform for NattoPharma’s MenaQ7™ in Europe

(Lysaker, Norway 17 November 2008) The European Food Safety Authority (EFSA) has published a positive scientific opinion on vitamin K2, MK-7 from natto as a dietary supplement and food ingredient. The positive EFSA-opinion gives NattoPharma ASA a solid platform for wide distribution of MenaQ7™ in Europe.

This is an important milestone for NattoPharma. It concludes the important process of a scientific safety evaluation performed by EFSA, a process that has lasted for nearly three and a half years. We have provided thorough documentation to EU scientific bodies and the EFSA opinion provides us with a strong scientific and legal platform for the distribution of MenaQ7™ in Europe, says Egil Greve, President and Chief Executive Officer of NattoPharma.

The publication of the positive scientific opinion is the go-ahead signal many NattoPharma customers have been waiting for to step up commercial activities, Greve comments.

EFSA provides independent scientific evaluation and advice on existing and emerging risks of a product or an ingredient. NattoPharma’s vitamin K2 product belongs to a group of vitamins known to EFSA. However, NattoPharma has invested in the approval of this specific form of vitamin K to ensure the MenaQ7™product’s uniqueness.  It is one of the first times that EFSA provides a positive opinion on a new vitamin under the new EU legislation for fortified food. - We are extremely happy to learn that the opinion is based upon proprietary data as well as information specific for our product. It is also the first time that an ingredient is to be adopted simultaneously as novel food, as dietary supplement and food ingredient, says Greve.  

NattoPharma`s product has in clinical trials shown to have optimal properties compared to vitamin K1. This ensures adequate supply of vitamin K2 to bones and vasculature. It is well documented that the western population is vitamin K deficient, and that there is correlation between this deficiency and high prevalence of diseases such as osteoporosis and cardiovascular calcification.

MenaQ7™ can prevent vitamin K deficiencies, and we see strong effects on clinical important biomarkers associated with improved bone and cardiovascular health not previously seen. This is exciting and our clinical research shows that MenaQ7™is a powerful form of vitamin K2 that we are proud to continue working with comments Egil Greve.

From the time of publication, EFSA`s opinion represents the official scientific opinion in all EU-countries. When the scientific opinion is adopted by the European Commission, vitamin K2 as Menaquinone-7 from natto will be amended to the annexes in the legislation for food supplements and fortified food.  This will simultaneously give us approval as novel food.

According to the scientific opinion, EFSA concludes that there is no safety concerns related to the proposed use levels of MenaQ7™ in the general population. - We will now study the scientific opinion and examine the various market possibilities that this EFSA opinion gives us.  Simultaneously we are working with MenaQ7 health claims and continue our R&D program, says Egil Greve. This opinion gives us great opportunities in the market place and a strong competitive position, not only in Europe, but also in other parts of the world that is influenced by regulatory decisions taken in EU.

The Norway-based NattoPharma is listed on the Oslo Axess list at the Oslo Stock Exchange and is the exclusive supplier of MenaQ7™. Natural vitamin K2, branded by NattoPharma as MenaQ7™, is produced by J. Oil Mills Japan and the worldwide distribution is assigned to NattoPharma from the Japanese company Sumitomo Corporation.
 
NattoPharma has established an extensive research and development program aimed at documenting the benefits of the K2 vitamin as a dietary supplement and food ingredient. MenaQ7™ is extracted from the Japanese food natto (fermented soy beans). Research shows that our vitamin K2 is essential to develop and maintain strong bones as well as to avoid calcium deposits in the arteries.

FROST & SULLIVAN PRODUCT INNOVATION OF THE YEAR AWARD 2008

The Frost & Sullivan Product Innovation of the Year Award is presented each year to the company that has demonstrated excellence in new products and technologies within its industry.

The receipt of this Award has excelled based on one or more of the following criteria:

• Significance of new product(s) in its industry
• Competitive advantage of new product(s) in its industry
• Product innovation in terms of unique or revolutionary technology
• Product acceptance in the marketplace
• New products value-added services provided to customers
• Number of competitors with similar product(s)

Nattopharma MENAQ7™

NattoPharma proudly announce that NattoPharma’s natural vitamin K2 product, MenaQ7™, has received the prestigious Frost & Sullivan Product Innovation of the Year Award. According to Frost & Sullivan, the award is in recognition of the company’s unique capability to develop natural vitamin K2 as MenaQ7™ with established and proven bone and heart health benefits. Owing to its natural form completed with high bioavailability, MenaQ7™ obtained excellent market acceptance.

MenaQ7™, provides natural Vitamin K2 as an extract of natto, a fermented soy food from Japan. Natto is particularly rich in the highly bio-available form of Vitamin K2 called menaquinone-7 (MK-7) MenaQ7™, provides the only commercially available Natural Vitamin K2 with guaranteed actives and stability, clinical substantiation and international patents awarded and pending.

Newly recognized natural Vitamin K2 is among the most interesting new offerings in the vitamin market in recent years. Its function is unique among other vitamins and its beneficial health effects have been documented. The role of vitamin K2 has for the past decade been linked to two of the most important health issues, osteoporosis and cardiovascular disease.

This link specifically centres of calcium utilization – implying that in the absence of adequate vitamin K, concurrent arterial calcification and osteoporosis may occur. K vitamins are essential to activate proteins involved in calcium metabolism

We are honoured to receive this award from Frost & Sullivan, recognised as a global market analysis and solution leader, commented Egil Greve (CEO, NattoPharma). Vitamin K2 has been consumed in Japan for centuries through the food dish natto, however the beneficial health effects have only recently become known in the western world.

A major challenge is to educate physicians as well as the public about these health benefits and NattoPharma has committed itself to do this in a scientific manner. Greve continued, we are investing heavily in Research & Development and we base all out marketing on the solid scientific documentation of our safe and highly effective natural vitamin K2 product, MenaQ7™,

NattoPharm in a nutshell.
NattoPharma, Norway, is a publicly-traded company and the exclusive international supplier and brand owner of MenaQ7™, natural Vitamin K2. NattoPharma has entered into a multi-year research and development program to substantiate and discover the health benefits on natural vitamin K2 for applications in the marketplace for functional foods and food supplements.

Gee Lawson are the exclusive distributors for NattoPharma’s MenaQ7™

Study Shows Pycnogenol® Reduces Jetlag

Pycnogenol® cut jetlag symptoms in half for passengers taking 7 to 9 hour flights

GENEVA, Switzerland – A new study published in the journal of Minerva Cardioangiologica reveals Pycnogenol®, pine bark extract from the French maritime pine tree, reduces jetlag in passengers by nearly 50 percent. The two-part study, consisting of a brain CT scan and a scoring system, showed Pycnogenol® lowered symptoms of jetlag such as fatigue, headaches, insomnia and brain edema (swelling) in both healthy individuals and hypertensive patients. Passengers also experienced minimal lower leg edema, a common condition associated with long flights.

Jetlag, also called desynchronosis, is a temporary disorder that causes a variety of temporary mental and physical impairments as a result of air travel across time zones – common in flights to Asia and Europe, but also observed in travelers between West and East coast. It is caused due to the body’s inability to immediately adjust to the time in a different zone while travelling. As the body struggles to cope with the new schedule, temporary conditions such as insomnia, fatigue, irritability and an impaired ability to concentrate may set in.

“This study could not have come at a better time for the upcoming holiday travel season,” said Dr. Gianni Belcaro, a lead researcher of the study. Belcaro attributes Pycnogenol's® combined activities for better circulation and antioxidant potency to such remarkable results. “Previous Pycnogenol® flight studies have shown a reduction in jetlag; however this was the first study to solely focus on the condition.”

The study, conducted at the G. D’Annunzio University in Pescara, Italy, consisted of 133 passengers who took flights that were seven to nine hours in length. Fifty mg of oral Pycnogenol® was administered three times daily, for seven days, starting two days prior to the flight.

Patients in the first part of the study were evaluated with a rating scale consisting of a scoring system. Thirty-eight Pycnogenol®-treated and 30 control patients were rated on the most common complaints of jetlag: dehydration and loss of appetite; headaches and/or sinus irritation; fatigue; disorientation and/or grogginess; nausea and/or upset stomach; insomnia and/or highly irregular sleep patterns; irritability; irrational behavior; alternation in mental performance (easy crossword); alternations in general wellbeing; hours of duration of any signs/symptoms; and nights of altered/disturbed sleep. Observations were measured and taken within 48 hours after the end of the flights. Results showed a significantly lower score (56 percent) in the Pycnogenol® group for all items rated, amounting in a significant reduction of all jetlag signs and symptoms. Moreover, symptoms lasted only for an average of 18.2 hours in the Pycnogenol® group as compared to 39.3 hours in the control group.

In a second group of flight passengers, a brain CT scan was performed after the flight in order to assess brain alterations after flights. The study consisted of 34 Pycnogenol®-treated patients and 31 controlled patients. Jetlag symptoms were evaluated using a rating scale providing scores according to the severity. The first observation was performed within 28 hours from the end of the flight. Sleep alterations, short-term memory alterations, disorientation, neurological signs/symptoms of instability, anxiety, minor cardiac alterations (heart rate, blood pressure), lower limb swelling, fatigue and other, a-specific signs/symptoms (cramps, joints/muscular pain, blurred vision, vertigo, mild sickness, increase in body temperature, appetite loss, headache, mild tongue swelling) were all significantly lower by in average 61.5% in the Pycnogenol® group compared to the untreated control group.

“This is the first study describing diffuse subliminal swellings of the brain after long haul flights, which we found to be reduced to less than half in the Pycnogenol® group,” said Dr. Belcaro

“I'm encouraged by the results of the study as Pycnogenol® was effective in preventing jetlag related effects without any side-effects,” said Dr. Belcaro. While more research needs to be conducted on this topic, Pycnogenol® is emerging as natural, yet safe option for long distance travelers.

Pycnogenol® has been shown to be beneficial for flight travel in previous studies pertaining to edema, deep vein thrombosis (DVT) and blood circulation improvement. A study published in Clinical Applied Thrombosis/Hemostasis recorded passengers supplementing with Pycnogenol® on long distance flights lasting 7-12 hours were significantly protected from thrombotic events, complications resulting from deep vein thrombosis (DVT) and superficial vein thrombosis (SVT). In 2005, a study published in Clinical and Applied Thrombosis/Hemostasis showed Pycnogenol® to be effective in reducing leg and ankle swelling (edema) during long airplane flights lasting seven to 12 hours.

Gee Lawson are the exclusive distributors for Horphag’s Pycnogenol®

Gee Lawson at Hi Europe 2008

If you didn't get to see us at this year's Health Ingredients Europe exhibition in Paris and need information about the range of products we are able to supply, please contact us today.

Pycnogenol® is a natural plant extract originating from the bark of the maritime pine that grows along the coast of southwest France and is found to contain a unique combination of procyanidins, bioflavonoids and organic acids, which offer extensive natural health benefits. The extract has been widely studied for the past 35 years and has more than 220 published studies and review articles ensuring safety and efficacy as an ingredient. Today, Pycnogenol® is available in more than 600 dietary supplements, multi-vitamins and health products worldwide. For more information, visit www.geelawson.co.uk.

MenaQ7™ provides Natural Vitamin K2 as an extract of natto, a fermented soy food from Japan. Natto is particularly rich in the highly bio-available form of vitamin K2, menaquinone-7 (MK-7). MenaQ7 is the commercially available Natural Vitamin K2 with guaranteed actives and stability, clinical substantiation and international patents awarded and pending.

For more information, visit www.geelawson.co.uk.