GLOSSARY

A

AAVLP

Adeno-associated virus-like particle,
AAV-like particle

Acute myeloid leukemia (AML)

Malignant disease of the hematopoietic system

Adoptive T-cell therapy

Means the treatment of patients by transfer of defined T-cells to the patient

AktG

Aktiengesetz
German Stock Corporation Act

AMG

Arzneimittelgesetz
German Medicines Act

Antibody

Protein substance produced by the immune system as a reaction to antigens for reasons of a body’s own defence mechanisms

Antigen

Substance recognised as being foreign by the immune system

Authorised capital

Value or number of shares authorised in advance by the company’s General Meeting for the purpose of a possible capital increase against cash or non-cash contribution

Autoimmune diseases

Diseases caused by an overreaction of the immune system against the body’s own tissues

Autologous

Natural to the body

B

B-cell epitope

Part of the antigen that is recognised by the antibody or B-cell receptor

Biopharmaceutical

Research into and development of drugs and therapies (pharmaceutics), based on biotechnology and molecular biology

Biotechnology

Research into and development of drugs and therapies (pharmaceutics), based on biotechnology and molecular biology

C

CD28 protein, CD80 protein

Proteins on the surface of immune cells, involved in the onset of inflammatory processes
(See also T-cell activation)

CD80 antagonist

Prevents the interaction of the surface protein CD80 with specific receptors

CGU

Cash-generating unit

Combination therapy

The simultaneous treatment of a patient with several therapeutic methods for the same disease

Compassionate use

Prescription of as-yet unapproved drugs in particularly severe cases where there are no treatment alternatives

Conditional capital

Capital resolved by shareholders’ resolution for the issue of stock options or convertible bonds

Controlled trial

Trial with a control group of test persons who do not receive the active ingredient tested but a placebo

D

D&O insurance

Directors and officers insurance
A managers’ liability insurance effected by a company for its board members and executives

DBO

Defined benefit obligation
Value of an obligation arising from company pension scheme

Dendritic cells

Cells of the immune system specialized in antigen uptake and presentation. Dendritic cells are the most potent cells for activating a primary T cell based immune response

Dermatology

Branch of medicine dealing with the treatment of skin conditions and benign and malignant skin tumours

Drug candidate

Drug which is still at the development stage

E

EBITDA

Earnings before interests, depreciation and amortization.
Medigene’s EBITDA is derived from the net profit/loss for the year and  does not include any taxes, financial result, foreign exchange gains or losses, share of result of associates nor amortisation or depreciation

Endothelial cells

Line the interior surface of lymphatic and blood vessels

Exploratory trials

Intended for initial clarification and classification of problem areas. They are often conducted in order to get an over-view, and thus serve as preparation for further studies

F

FDA

Food and Drug Administration
Government agency of the United States Department of Health and Human Services

Formulation

The way in which an active ingredient is combined with suitable carrier substances and excipients and the form in which it is administered

G

Generic drug

Copy of a drug already available on the market, containing the same active ingredient

Genital warts

Benign, but painful and disfiguring skin tumours in the genital and anal areas

GMP

Good Manufacturing Practice
Quality assurance guidelines for production processes and environments in the manufacture of drugs

H

HER2 receptor

Human Epidermal Growth Factor Receptor 2, a protein found on the surface of many human organs
(See also “triple negative breast cancer”)

HGB

Handelsgesetzbuch
German Commercial Code

Human papillomaviruses (HPV)

Viruses that infect the epithelium of the skin and may cause uncontrolled tumour-like growth

I

IAS

International Accounting Standards
Part of the International Financial Reporting Standards

IFRIC

International Financial Reporting Interpretations Committee

IFRS

International Financial Reporting Standards

IIT (Investigator Initiated Trial)

Clinical trial of a drug candidate that is initiated, organised and financed by the medical profession. Such trials focus on enhancing a specific therapy for patients

Immunotherapy

Treatment methods which influence and activate the immune system

Indication

Disease; reason for the execution of a medical examination or treatment

L

Leucocytes

White blood cells

Leukapheresis

Process for collection of white blood cells (leucocytes) from a donors’ blood

Licencing

Sale or acquisition of development and/or marketing rights to a product

Liposomes

Minute, hollow globules, composed of fat molecules

M

Major histocompatibility complex (MHC)

Group of genes and proteins which are relevant in immune recognition

Minimal residual disease

The stage of a tumour in which only very few isolated tumour cells are present in the patient’s body following surgical removal of the primary tumour or chemotherapy or radiotherapy

Monoclonal antibody

Antibodies which are produced from a single cell line and can be traced back to an individual B lymphocyte

Monocytes

Belong to the class of white blood cells and have an important function in the human immune system

N

NK (natural killer) cells

Cells of the immune system which can identify and destroy cancer cells and virally infected cells

O

Oncology

Science of tumours and tumour-related diseases

Orphan drug designation

Drugs developed for the treatment of rare diseases may obtain orphan drug designation from the European Commis-sion or the FDA, allowing benefits in development, approval procedures, and possibly even the commercialisation of the product

P

Paclitaxel

Drug in the treatment of e.g. breast cancer. Paclitaxel prevents cancer cells from dividing

Pancreatic cancer

Malignant tumour of the pancreas

PCT

Patent Cooperation Treaty
International agreement under which a patent application may be filed for currently 146 countries worldwide. For the issue of a patent, this application has to be transferred to a national application at a later date

Peptide

A peptide (short protein) consists of amino acids linked together

Pharmaceutics

Science that deals with the composition, effect, development, testing, production, and dispensing of drugs

Pipeline

All of the drug candidates that are under development

Preclinical

Stages of development of an active substance prior to testing in humans

Primary biliary cirrhosis (PBC)

Chronic liver disease that initially affects the bile ducts. The bile ducts are progressively destroyed by inflammatory processes, causing biliary stasis and build-up of bile in the liver. Liver tissue is destroyed and replaced by connective tissue, liver cirrhosis develops

Proof of Concept

Evidence of the fundamental feasibility of a plan

Proof of Principle

Evidence on the feasibility at an early stage of drug development

Prophylactic vaccine

Administered to prevent a disease, prepares the immune system for the defence against infection

Prostate Cancer

Prostate cancer is a malignant, slow-growing cancer that develops in the prostate

R

R&D

Research and development

Receptor

Protein molecule which can bind different substances

Resistance

Ability of an organism to withstand external influences

Rheumatoid arthritis

Inflammatory disease affecting the joints

T

T-cell activation

Pivotal step in the onset of inflammatory processes

T-cell receptor (TCR)

Receptor by which T-cells recognise antigens bound to other cells of the body

T-cells

T-cells or T lymphocytes belong to a group of white blood cells known as lymphocytes, and play a central role in cell-mediated immunity

TecDAX

Index of the German Stock Exchange listing the thirty major technology equities with respect to market capitalisation and order book turnover

Technology platform

Technology which is the basis for the development of different drug candidates

Therapeutic vaccine

Stimulates the immune system against acute infection or an existing tumour

Triple negative breast cancer

Malignant breast tumours that display neither oestrogen/gestagen nor HER2 receptors on the cell surface are termed “triple negative”

V

Vaccines

Inoculants

W

WpHG

Wertpapierhandelsgesetz
German Securities Trading Act

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