NattoPharma – First Step Into The Pharmaceutical Market

LYSAKER, NORWAY, Jun 02 (MARKET WIRE) —

This information is subject of the disclosure requirements acc. to
Section 5- 12 vphl (Norwegian Securities Trading Act)

02.June 2010, Lysaker – Today it was agreed that NattoPharma’s natural
vitamin K2, MenaQ7(R), will be used in the VitaVasK study, a placebo-
controlled, double-blind multinational European randomized trial. The
hypothesis that the dietary supplementation of MenaQ7(R) can delay the
progression of vascular and valvular calcification in patients on chronic
hemodialysis will be tested. The study will last for three years and will
measure placebo controlled the effect of high doses of MenaQ7(R) in some
600 kidney patients over one and a half years. VitaVasK is being financed
by a EUR1,8mill grant from the European Renal Association.

Patients on hemodialysis (HD) exhibit an enormous increase in
cardiovascular mortality associated with extensive vascular calcification
(VC). Matrix Gla protein (MGP) is a powerful inhibitor of VC. MGP is
produced by vascular smooth muscle cells and is activated (carboxylated)
by vitamin K. “The proposed VitaVasK study will be the first clinical
trial in HD patients to target the progression of VC using dietary
vitamin K-mediated supplements”, says principle investigator Prof Juergen
Floege, head of the nephrology department at the University Hospital of
the RWTH Aachen University, in Germany.

Studies carried out at Maastricht University, in collaboration with
NattoPharma, indicate that MenaQ7(R) has the potential to prevent or even
reduce vascular calcification. Especially in patients prone to vascular
calcification, such as those with chronic kidney disease, this
calcification reduction may positively influence patient outcome. In a
pilot study, it was shown that hemodialysis patients revealed an extreme
vitamin K deficiency and inactive MGP, indicating that they do not have
the ability to protect against arterial calcification. It was shown that
six weeks of MenaQ7(R) supplementation increased the active MGP levels in
these patients in a dose-dependent manner, suggesting that disturbed
calcification inhibitory activity in the vasculature may be improved by
MenaQ7(R) supplementation, hopefully leading to a better outcome for
dialysis patients.

According to one of the principle investigators of the Vitamin K2 study in
dialysis patients, Dr Leon Schurgers, senior scientist at Maastricht
University and VP of R&D at NattoPharma, “Calcification of the arteries
seen in chronic kidney disease is the same type of calcification which is
found in aging populations. The accumulation of calcium salts in the
arteries results in stiffening and increased fragility. This might be
considered a ‘silent killer’ as hardening of the arteries develops
without any symptoms over time.” Further, he stated that current evidence
now indicates that “the process of calcification is an actively regulated
process and that adequate MenaQ7(R) intake can prevent this process and
eliminate this risk factor.”

Prof Peter Stenvinkel, nephrologist at the Karolinska institute explains,
“Whereas 500.000 people in Europe and the USA suffer from dialysis-
dependent chronic kidney disease, signs of mild to moderate CKD (Chronic
Kidney Disease) are found in more than 10 million patients. Compared to
the general population, patients with advanced chronic kidney disease
experience a 10 – 100x increased risk of cardiovascular complications,
which translates into a mortality risk comparable to the one found in
patients with mestastatic cancer disease. This problematic situation is
further complicated by the fact that many treatment strategies (including
statins, increased dialysis dose and erythropoietin), in randomized
controlled trials have not been shown to improve survival in this patient
group. A major problem in dialysis patients is accelerated vascular
calcification; a process that increases the risk of cardiovascular
complications and premature death. As this deleterious process may be
accelerated by a subclinical deficiency of vitamin K2, MenaQ7(R)
supplementation may be a novel beneficial treatment strategy to slow down
the calcification process and lower the risk of cardiovascular
complications without troublesome side effects in this unfortunate
patient group.”

“We see this as our first step into the pharmaceutical market. Until now,
we have only done trials in healthy subjects. Now, for the first time, we
are part of a large trial in dialysis patients suffering from a disease
with a high mortality. Thus, if this trial is successful, we see a great
potential for MenaQ7(R) as a drug in the future” says Morten Sundsto, CEO
of
NattoPharma.

For further information:

Morten Sundsto
CEO NattoPharma ASA
Phone: +47 950 61860

[HUG#1421003]

NattoPharma – First Step Into The Pharmaceutical
Market: http://hugin.info/137386/R/1421003/370437.pdf

Copyright 2010, Market Wire, All rights reserved.

NattoPharma: NattoPharma – First Step Into The Pharmaceutical Market

This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian
Securities Trading Act)

02.June 2010, Lysaker – Today it was agreed that NattoPharma’s natural vitamin K2,
MenaQ7®, will be used in the VitaVasK study, a placebo-controlled, double-blind
multinational European randomized trial. The hypothesis that the dietary supplementation
of MenaQ7® can delay the progression of vascular and valvular calcification in patients
on chronic hemodialysis will be tested. The study will last for three years and will
measure placebo controlled the effect of high doses of MenaQ7® in some 600 kidney
patients over one and a half years. VitaVasK is being financed by a €1,8mill grant from
the European Renal Association.

Patients on hemodialysis (HD) exhibit an enormous increase in cardiovascular mortality
associated with extensive vascular calcification (VC). Matrix Gla protein (MGP) is a
powerful inhibitor of VC. MGP is produced by vascular smooth muscle cells and is
activated (carboxylated) by vitamin K. “The proposed VitaVasK study will be the first
clinical trial in HD patients to target the progression of VC using dietary vitamin
K-mediated supplements”, says principle investigator Prof Jürgen Floege, head of the
nephrology department at the University Hospital of the RWTH Aachen University, in
Germany.

Studies carried out at Maastricht University, in collaboration with NattoPharma,
indicate that MenaQ7® has the potential to prevent or even reduce vascular
calcification. Especially in patients prone to vascular calcification, such as those
with chronic kidney disease, this calcification reduction may positively influence
patient outcome. In a pilot study, it was shown that hemodialysis patients revealed an
extreme vitamin K deficiency and inactive MGP, indicating that they do not have the
ability to protect against arterial calcification. It was shown that six weeks of
MenaQ7® supplementation increased the active MGP levels in these patients in a
dose-dependent manner, suggesting that disturbed calcification inhibitory activity in
the vasculature may be improved by MenaQ7® supplementation, hopefully leading to a
better outcome for dialysis patients.

According to one of the principle investigators of the Vitamin K2 study in dialysis
patients, Dr Leon Schurgers, senior scientist at Maastricht University and VP of R&D at
NattoPharma, “Calcification of the arteries seen in chronic kidney disease is the same
type of calcification which is found in aging populations. The accumulation of calcium
salts in the arteries results in stiffening and increased fragility. This might be
considered a ‘silent killer’ as hardening of the arteries develops without any symptoms
over time.” Further, he stated that current evidence now indicates that “the process of
calcification is an actively regulated process and that adequate MenaQ7® intake can
prevent this process and eliminate this risk factor.”

Prof Peter Stenvinkel, nephrologist at the Karolinska institute explains, “Whereas
500.000 people in Europe and the USA suffer from dialysis-dependent chronic kidney
disease, signs of mild to moderate CKD (Chronic Kidney Disease) are found in more than
10 million patients. Compared to the general population, patients with advanced chronic
kidney disease experience a 10 – 100x increased risk of cardiovascular complications,
which translates into a mortality risk comparable to the one found in patients with
mestastatic cancer disease. This problematic situation is further complicated by the
fact that many treatment strategies (including statins, increased dialysis dose and
erythropoietin), in randomized controlled trials have not been shown to improve survival
in this patient group. A major problem in dialysis patients is accelerated vascular
calcification; a process that increases the risk of cardiovascular complications and
premature death. As this deleterious process may be accelerated by a subclinical
deficiency of vitamin K2, MenaQ7® supplementation may be a novel beneficial treatment
strategy to slow down the calcification process and lower the risk of cardiovascular
complications without troublesome side effects in this unfortunate patient group.”

“We see this as our first step into the pharmaceutical market. Until now, we have only
done trials in healthy subjects. Now, for the first time, we are part of a large trial
in dialysis patients suffering from a disease with a high mortality. Thus, if this trial
is successful, we see a great potential for MenaQ7® as a drug in the future” says Morten
Sundstø, CEO of NattoPharma.

For further information:

Morten Sundstø

CEO NattoPharma ASA

Phone: +47 950 61860

HUG#1421003

NattoPharma – First Step Into The Pharmaceutical Market

http://hugin.info/137386/R/1421003/370437.pdf

Post-transplant patients off steroids have fewer cardiovascular events

Washington, May 8 (ANI): Post-transplant patients, who have given up corticosteroid regimen, have fewer cardiovascular events than those on steroids, increasing their graft survival rates and reducing early mortality, University of Cincinnati (UC) transplantation researchers have found.

Corticosteroids are commonly given to post-transplant patients as part of an immunosuppressive regime to promote graft survival.

But the steroids also cause harmful cardiovascular side effects such as increased blood pressure, cholesterol and weight gain, said Dr Rita Alloway.

The researchers have largely focused on reducing patient exposure to corticosteroids during post-transplantation treatment.

“Ten years ago, almost 80 percent of post-transplant kidney patients were discharged from the hospital on steroids. Now, according to United Network for Organ Sharing (UNOS) reports, less than 20 percent are discharged from the hospital on steroids. We’ve effectively removed chronic steroids from the immunosuppressive regimen while maintaining similar graft survival outcomes,” said Alloway.

In the study, led by Dr. Adele Rike Shields, researchers are now able to show patients removed from a steroid treatment have decreased cardiovascular events after transplant, in addition to their lowered side effects.

Shields evaluated acute graft rejection and graft loss in 630 kidney transplant patients withdrawn from corticosteroids.

She found the risk factors in the corticosteroid-withdrawn kidney transplant population are similar to those traditionally defined under conventional immunosuppression with steroids.

“With the summation of 10 years of work, we’ve been able to show that patients off corticosteroids have the same graft-function outcomes as patients on corticosteroids. In addition, the patients off corticosteroids benefit from fewer cardiovascular events,” said Alloway.

The researchers are presenting the study at the American Transplant Congress (ATC), the annual meeting of the American Society of Transplantation. (ANI)

Kidney patients walk ramp at fashion event in New Delhi

New Delhi, Mar 14 (ANI): Dazzling lights, reverberating music and an atmosphere filled with triumph when patients with kidney disorders walked the ramp in traditional Indian ensembles here last evening.

Organised by Fortis at New Delhi, the show was part of celebrations to commemorate the World Kidney Week that Fortis is observing.

The show was an attempt to provide a platform to the patients to showcase their will to live and fight against kidney disorders.

It was also an attempt to break the myth that kidney disorders can put an end to a person’s normal life.

“Many people believe that patients with kidney failure have no real life and that probably is the end of life. This fashion show demonstrates that patients with kidney failure and kidney transplantation can lead a normal life just like any other person,” said Vijay Kher, Director, Nephrology and Renal Transplant Services, Fortis Hospital.

Walking the ramp in exquisite and dazzling outfits, these patients were radiant with joy as they exuded self-confidence on ramp.

They said they wanted to show that a kidney ailment does no cripple you for life.

“I just walked down the ramp just to show that after transplant life does not end. You have certain restrictions, but accordingly you can do whatever you want to do,” said Rajat, a kidney transplant patient.

There has been a tremendous increase in the kidney related disorders and a large number of youngsters are also reporting chronic renal failures.

According to reports, million of people die prematurely every year of kidney failure or heart attacks and strokes linked to chronic kidney disease. (ANI)

Food labels conceal kidney-harming phosphorus content

Washington, Feb 11 (ANI): A large number of processed and fast foods hide information about phosphorus additives, which can be dangerous for kidney patients, according to researchers from MetroHealth Medical Center and Case Western Reserve University School of Medicine in Cleveland.

High blood levels of phosphorus can lead to heart disease, bone disease, and even death among patients with advanced kidney disease.

Thus, patients must avoid foods with naturally high levels of phosphorus – such as certain meats, dairy products, whole grains, and nuts.

However, the researchers found that it has become an increasingly common practice by food manufacturers to include phosphorus additives, such as sodium phosphate or pyrophosphate, to processed foods.

The additives are used to enhance flavour and shelf life -particularly in meats, cheeses, baked goods, and beverages – and thus it gets difficult for consumers to know whether or not these additives are present in products.

“Calories, fat, and sodium content are required to be listed on nutrition labels, but phosphorus is not. This makes it impossible for kidney disease patients to know how much phosphorus they are eating. For example, we discovered that while chicken is often on dialysis patients’ ‘Safe List’ of foods to eat, chicken from fast food and sit down restaurants often contains this phosphorus additive,” said Catherine Sullivan, M.S., R.D., lead researcher from the Center for Reducing Health Disparities.

It was found that the researchers could significantly lower phosphorus levels among advanced kidney disease patients after teaching them how to avoid foods containing phosphorus additives.

Then 279 advanced kidney disease patients receiving dialysis treatment were assigned to a control group that received usual care or to an intervention group that was taught to avoid additive-containing foods when purchasing groceries or eating at fast food restaurants.

After three months, phosphorus levels declined two and a half times more in the intervention group than in the control group.

However, the researchers found that these additives may even affect people with normal kidney function.

Previous research has found that high phosphorus diets appear to lower bone density and increase fracture risk as well.

The study is published in the latest issue of the Journal of the American Medical Association (JAMA). (ANI)