Company Profile 1 MEDICE, Iserlohn

Company Profile
MEDICE
Arzneimittel Ptter GmbH & Co. KG
Kuhloweg 37
58638 Iserlohn
Germany
www.medice.com
Company Profile 36 MEDICE, Iserlohn
Business Unit
Nephrology
Company Profile 37 MEDICE, Iserlohn
MEDICE - partner of nephrologists for more than 20
years.
MEDICE offers a widespread portfolio in Nephrology.
Nephrology: currently 2 products in development.
Abseamed - the first Epoetin alfa Biosimilar in
Germany.
Business Unit Nephrology
Company Profile 38 MEDICE, Iserlohn
Chronic Renal Insufficiency:
Therapeutic Options
1. Lowering of phosphate level:
Hyperphosphatemia
Along with other substances taken up in the daily diet, phosphate, a vital metabolic
building block, is absorbed by the body from the intestines. In healthy persons, excess
phosphate is eliminated via the kidneys. In patients with restricted kidney function
(especially in dialysis patients), phosphate builds up in the blood.
As a rule, the dialysis procedure and a low-phosphate diet are unable to effectively
reduce phosphate levels in the blood. Therefore, to keep blood phosphate levels under
control it is necessary to take so-called phosphate binders (e.g. calcium carbonate)
additionally.
These bind phosphate from the diet in the intestine to form an insoluble compound (e.g.
calcium phosphate), which cannot be absorbed into the blood and so is eliminated in
the faeces, thus counteracting any detrimental effects on bone metabolism and the
parathyroid.
Company Profile 39 MEDICE, Iserlohn
- Active Ingredient
aluminium chloride-hydroxide
complex (9:8:19) 23 H20
- Pharmaceutical form and
contents
Pack containing 100 hard capsules
Pack containing 200 hard capsules.
PHOSPHONORM

- Mode of action
Phosphonorm Hard Capsules is a medicine for binding phosphate in the intestine
Phosphonorm contains as its active substance the strongly phosphate-binding aluminium
chloride-hydroxide-complex, which is independent of gastric acid.
Compared to simple aluminium hydroxide, a smaller amount of active substance is required with
Phosphonorm to reduce raised blood phosphate levels. Phosphonorm does not neutralize gastric
acid and therefore has unrestricted action even in an environment of reduced gastric acid
production.
As active aluminium chloride-
hydroxide, PHOSPHONORM is
known as the strongest binder of
phosphate!
As active aluminium chloride-
hydroxide, PHOSPHONORM is
known as the strongest binder of
phosphate!
Company Profile 40 MEDICE, Iserlohn
- Active Ingredient
One film coated tablet contains
500/700 mg of calcium acetate
(equivalent to 126.7/177.4 mg
of calcium ions)
- Pharmaceutical form and
contents
Calcium Acetate Nefro 500 and 700 mg is
available in packs of 100 or 200 film coated
tablets
CALCIUMACETAT-NEFRO

- Mode of action
Calcium Acetate Nefro 700 mg is a phophate binder.
Calcium Acetate Nefro 700 mg is used to reduce raised blood-phosphate levels in patients with
renal insufficiency undergoing dialysis treatment.
Depending on serum phosphate levels, the daily dose usually lies in the range of 2-3 Calcium
Acetate Nefro 700 mg film coated tablets (equivalent to 1064 - 2129 mg of calcium ions) 3-4
times daily with meals.
In Germany MEDICE is Market Leader in
Calciumacetat preparations!
The advantage of CALCIUMACETAT-
NEFRO is the 700mg dosage!
In Germany MEDICE is Market Leader in
Calciumacetat preparations!
The advantage of CALCIUMACETAT-
NEFRO is the 700mg dosage!
Company Profile 41 MEDICE, Iserlohn
MS Units
20%
6%
2%
14%
15%
4%
5%
6%
7%
14%
1%
2%
4%
MS Value
2%
3%
0%
29%
31%
2%
2%
0%
29%
0%
1%
Market Share Phosphate Binder
Total TC 45.094 (DPM)
MEDICE IS MARKET LEADER IN UNITS IN PHOSPHATBINDERS!
THE WELL ESTABLISHED FAVORABLE ALTERNATIVE TO EXPENSIVE
NON AL/CA THERAPY!
MEDICE IS MARKET LEADER IN UNITS IN PHOSPHATBINDERS!
THE WELL ESTABLISHED FAVORABLE ALTERNATIVE TO EXPENSIVE
NON AL/CA THERAPY!
(MAT 05/2012)
CALCIUMACET.NEFRO PHOSPHONORM (DE-) CC NEFRO
RENAGEL FOSRENOL ANTIPHOSPHAT GRY
OSVAREN CALCIUMACETAT KYR CALCET
RENVELA PHOSPHOSORB CALCI GRY
OTHERS
Company Profile 42 MEDICE, Iserlohn
Chronic Renal Insufficiency:
Therapeutic Options
2. Balancing of acidosis and hyperkalemia
Metabolic acidosis
Hyperkalemia
(potassiumbinders)
Metabolic acidosis is a disturbance in the body's acid-base balance that results in excessive acidity of the
blood. In medicine, metabolic acidosis is a process which if unchecked leads to acidemia (i.e. blood pH is
low (less than 7.35) due to increased production of H+ by the body or the inability of the body to form
bicarbonate (HCO3-) in the kidney.
A high concentration of H+ in the blood serum can be buffered by exchange of H+ into the cell and K+ into
the serum. This can lead to Hyperkalemia (causes 3-5% of death in dialysis patients).
Potassium is a major ion of the body. Nearly 98% of potassium is intracellular. The ratio of intracellular to
extracellular potassium is important in determining the cellular membrane potential. Small changes in the
extracellular potassium level can have profound effects on the function of the cardiovascular and
neuromuscular systems. The physician must be quick to consider hyperkalemia in patients who are at risk
for this disease process. Because hyperkalemia can lead to sudden death from cardiac arrhythmias.
Company Profile 43 MEDICE, Iserlohn
- Active Ingredient
1 enteric coated soft capsule
contains
500mg or 840mg of sodium
hydrogen carbonate
- Pharmaceutical form and
contents
packs containing 100 enteric
coated soft capsules
NEPHROTRANS

- Mode of action
Nephrotrans is used in the treatment of metabolically induced hyperacidity of the blood (metabolic
acidosis) and for maintenance therapy to prevent recurrence of metabolically induced hyperacidity of
the blood in chronic renal insufficiency (mostly in predialysis patients).
The dose always depends on the severity of the metabolically induced hyperacidity of the blood
(metabolic acidosis). The usual dose is 4-6 Nephrotrans 840 mg enteric coated soft capsules per day,
equivalent to 3.4 to 5 g of sodium hydrogen carbonate per day (= 40-65 mg of sodium hydrogen
carbonate per kg of body weight and day). The sodium content (230 mg of sodium = 10 mval per
enteric coated soft capsule) should be taken into consideration, particularly with long-term use. Where
necessary a low salt or strictly low salt diet should be maintained.
Unique galenic formulation!
3 Step Galenic equal to SR Formulation!
1.) Coated Capsule; 2.) Soft Capsule
3.) Active substance embeded in Oil-matrix
Unique galenic formulation!
3 Step Galenic equal to SR Formulation!
1.) Coated Capsule; 2.) Soft Capsule
3.) Active substance embeded in Oil-matrix
Company Profile 44 MEDICE, Iserlohn
- Active Ingredient
1 sachet of granulate (15g)
contains 12 g Poly(styrol-co-
divinyl-benzol) sulfonic acid
(92:8), sodium salt
Sodium concentartion per gram
= 80-88mg
- Pharmaceutical form
and contents
300gr 20 sachets a 15g
ANTI-KALIUM

NA
- Mode of action
Treatment of raised potassium concentration in the serum (Hyperkalemia). The synthetic
substance leads to an exchange of NA against K.
Oral dose is 1-4 times 1 sachet (15g) per day
Rectal dose is 1-2 times 2 sachet (30g) per day
In contrast to the competition,
MEDICE's ANTI-KALIUM NA is packed in
patient convenient sachets!
VANILLA FLAVOUR!
In contrast to the competition,
MEDICE's ANTI-KALIUM NA is packed in
patient convenient sachets!
VANILLA FLAVOUR!
Company Profile 45 MEDICE, Iserlohn
Market Shares Balancing of
acidosis and hyperkalemia
Market Share NA-Hydrogencarbonate
Total TC 6.947 (DPM)
Market Share Potassium regulators
Total TC 3.475 (DPM)
Acetolyt
2%
Nephrotrans
36%
Bicanorm
62%
Resonium
A
28%
Anti-
Kalium
26%
Other
3%
CPS
37%
Elutit
NA/CA
6%
MAT 05/2012
Company Profile 46 MEDICE, Iserlohn
Chronic Renal Insufficiency:
Therapeutic Options
3. Balancing deficiency symptoms:
Carnitine deficiency
Carnitine is a quaternary ammonium compound biosynthesized from the amino acids lysine and
methionine or is ingested with the aliment. In living cells, it is required for the transport of fatty
acids from the cytosol into the mitochondria for the generation of metabolic energy. Carnitine exists
in two stereoisomers: its biologically active form is L-carnitine.
The daily consumption differs between 35-50mg L-Carnitin.10-60% are biosynthesided in the body
Liver, Kidney, Cerebric but not in the heart and skeletal muscles. The latter needs nutrion from
outside.
Patients with DCD (dialysis-related carnitine disorder) needs the treatment of levocarnitine
deficiency
Company Profile 47 MEDICE, Iserlohn
- Active Ingredient
levocarnitine
- Pharmaceutical form and
contents
Nefrocarnit Oral Solution is
available in bottles of 50 ml of
Nefrocarnit Oral Solution and 150
(3 x 50) ml of Nefrocarnit Oral
Solution
Nefrocarnit Injection Solution is
available in original packs of 10 or
25 ampoules, each containing 5 ml
of injection solution
NEFROCARNIT

- Mode of action
Nefrocarnit Injection/Oral Solution is used in the treatment of levocarnitine deficiency in
patients with DCD (dialysis-related carnitine disorder)
1 g of levocarnitine (3.3 ml of Nefrocarnit

Oral Solution = 1 measuring beaker) per day. On

days with haemodialysis treatment, Nefrocarnit

Oral Solution should be taken after dialysis.

For intravenous administration: At the end of each haemodialysis treatment, 20 mg of
levocarnitine per kg bw are administered by slow intravenous injection via the inserted reflux
canula. As a rule, 1 to 2 ampoules are required
In Germany
only 2 Products
are in the
market
reimbursed!
In Germany
only 2 Products
are in the
market
reimbursed!
Company Profile 48 MEDICE, Iserlohn
14%
86%
Nefrocarnit
68%
L-Carn
32%
PARENTERAL ORAL
Market Share L-CARNITIN
Total TC 980 (DPM)
Nefrocarnit L-Carn
48%
52%
MAT 05/2012
MAT 05/2012
Company Profile 49 MEDICE, Iserlohn
- Mode of action
Iron sucrose injection is a form of the mineral iron. Iron is important for many functions in the
body, especially for the transport of oxygen in the blood.
Iron sucrose injection is used to treat iron deficiencies and iron deficiency anemia in patients
with kidney disease.
A sterile aqueous complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use.
Following intravenous administration, iron sucrose is dissociated by the reticuloendothelial
system into iron and sucrose; the sucrose component is eliminated mainly by urinary excretion.
Iron sucrose can be administered with or without erythropoietin to raise hemoglobin levels and
may be used in cases of oral iron therapy intolerance or ineffectiveness. Hypersensitivity
reactions are less common with iron sucrose compared to other parenteral iron products, such
as iron dextran
- Active Ingredient
Iron sucrose 20mg/ml
- Pharmaceutical form
and contents
5ml ampoules
Pack with 5 ampoules
FERMED

Company Profile 50 MEDICE, Iserlohn

Mercaptopurin-Medice

Active Compound:
Mercaptopurine
Indication:
For induction therapy and maintenance therapy
for acute lymphoblastic leukemia in children and
adults.
With Mercaptopurin-Medice 10 mg a definitely
improved adjustment of patients is possible.
The medicine is used in the UK since 2004 as part
of a large ALL therapy study with more than
14.000 packages and where it has proven best.
Business Unit Oncology
Company Profile 51 MEDICE, Iserlohn
Thank you very much
for your attention !
MEDICE Arzneimittel Ptter GmbH & Co. KG
C/o Mr. Manuel Martins
Cc.
Kuhloweg 37
58638 Iserlohn
Germany
m.martins@medice.de
www.medice.com
Contact: