Operations and Business Environment - Fresenius Medical Care

02. 3
Our Fiscal year
88
Renal Drug Initiative – Growth Through
Dialysis Drugs
As mentioned in the “Growth Paths” section from
page 50
onwards, we plan to expand our portfolio beyond
patient care and dialysis products to open up
new growth possibilities. In our view, the area of
dialysis drugs (or renal drugs) has a particularly high
growth potential for Fresenius Medical Care. We
estimate the market volume for dialysis drugs at
nearly $1.5 billion. Therefore, under the slogan “renal
drug initiative” we have become more involved in
some areas of dialysis medication and will continue
to do so in the future.
In 2006, we concentrated on drugs which regulate
patients’ mineral and blood levels and improve the
control of bone mineralization. These include iron and
vitamin D supplements as well as phosphate binders.
Excess phosphate consumed with food is normally
removed by the kidneys in a process that can only
partially be replaced by dialysis in patients with chronic
kidney failure. Too much phosphate in the blood can
result in a number of adverse effects including bone
disease, thyroid problems and vascular calcification.
The risk of such damage in end-stage renal disease
patients can be lowered by administering phosphate
binders regularly.
Iron and vitamin D supplements are also important for
dialysis patients. The human body needs vitamin D,
which is further processed in the kidneys, to be able to
absorb sufficient calcium from food. When the kidneys
are diseased, not enough vitamin D can be created to
enable adequate calcium absorption. The consequence
is that the body does not absorb enough calcium from
food. In order to compensate, the body obtains the
lacking vital mineral from its largest calcium depot, the
bones. This results in bone decalcification, i.e. bone
mineralization is critically disrupted. Administering
vitamin D can counteract this effect. Iron preparations
support blood formation in people with kidney disease,
a task normally performed by the kidneys.
With the acquisition of Nabi Biopharmaceutical’s phosphate
binder business (PhosLo), we were able to add a
safe and proven drug to our range of clinical therapy
offerings. PhosLo is a calcium acetate phosphate binder
for oral application in end-stage renal disease patients
that has total product line revenues in the U.S.
of approximately $ 40 million in 2006. The total consideration
paid in the transaction will be $ 65 million cash
at closing, plus royalties on a new product formulation
plus milestone payments. The milestone payments
consist of $10 million expected to be paid in 2007 and
$10 million to be paid over the next two to three years,
contingent upon the achievement of certain performance
milestones.
We investigated the efficacy of PhosLo in the CARE-2
(Calcium Acetate Renagel Evaluation) study. The CARE-2
study was a randomized, controlled head-to-head
comparison between PhosLo and the rival product
Renagel (sevelamer hydrochloride). In the study, one
patient group was treated with PhosLo and the other
with Renagel; lipid levels were kept constant in the
two groups. The patients in both groups additionally
received, depending on their lab results, the cholesterol-lowering
drug Lipitor (atorvastatin calcium) to
control LDL (low-density cholesterol levels). The study
found no statistically significant difference in the progression
in cardiovascular calcification (CAC) between
the two treatment groups after twelve months of
treatment. Patients treated with PhosLo and Renagel
achieved comparable reductions in serum-phosphorus
and calcium-phosphorus product. The data refute the
hypothesis that the calcium in Phoslo contributes to
cardiovascular calcification. What is even more important,
however, is that K/DOQI (Kidney Disease Outcomes
Quality Initiative) target levels were reached
faster with PhosLo.
The findings were presented by Dr. Wajeh Qunibi, of
the University of Texas Health Science Center, San Antonio,
at the American Society of Nephrology’s Renal
Week 2006 Conference in San Diego, California.
Fresenius Medical Care 2006