SYGNIS Receives Orphan Drug Designation from the European Commission for AX200 in the treatment of Spinal Cord Injury

Heidelberg (ots) -

-Second indication for AX200 given Orphan Drug status

SYGNIS Pharma AG (Frankfurt: LIO; ISIN DE0005043509; Prime
Standard), today announced that it has received Orphan Drug
designation from the European Commission for AX200 in the treatment
of Spinal Cord Injury (SCI). This follows the positive
recommendation that SYGNIS received from the EMEA in September.

Orphan Drug designation can be granted for a product that is
intended for the diagnosis, prevention or treatment of
life-threatening or chronically debilitating conditions that affect
no more than five in 10,000 people in the European Union. During the
development phase certain incentives are given to the developing
company to facilitate the product's registration and market
authorization. These incentives include reductions in fees, an
accelerated registration procedure. Furthermore, for a period of up
to 10 years market exclusivity is granted once the product is
approved.

A spinal cord injury (SCI) is damage or trauma to the spinal cord
which interrupts communication of the brain with body regions below
the site of injury. Spinal cord injuries are predominantly caused by
accidents and, in the majority of cases, result in life-long loss of
control of motor functions and sensation. After the primary injury to
the spinal cord, a cascade of events leads to progressive loss of
tissue which may further deteriorate the patient's prognosis. There
is a large demand for novel therapies in view of the poor treatment
options currently available.

The SYGNIS research team has shown in pre-clinical trials that
AX200 counteracts neuronal cell death. Furthermore, the compound has
demonstrated a profound ability to support neuronal regeneration and
neuronal plasticity which facilitates functional recovery after SCI.

In April 2008, SYGNIS received Orphan Drug Designation from the
European Commission for AX200 in the treatment of Amyotrophic Lateral
Sclerosis (ALS).

Dr. Alfred Bach, CEO of SYGNIS Pharma AG, said: "We are very
pleased to have also obtained the Orphan Drug status for AX200 for
spinal cord injury. It is further validation of the potential of
AX200 as a promising drug candidate in the treatment of diseases of
the central nervous system. We look forward to exploiting this
potential as we currently prepare a further Phase II efficacy study
of AX200 in acute stroke."

About AX200

AX200 is a biological molecule, developed by SYGNIS for the
treatment of neurodegenerative diseases. In the indication of stroke
it is the most advanced drug candidate in SYGNIS' product pipeline.
In summer 2007 the Phase IIa of the clinical development was
successfully completed. AX200 is an endogenous protein. As part of
the body's own protective action the production of AX200 is boosted
after brain damage. If the molecule is given as a medication it
increases the existing endogeneous response to the damage. SYGNIS
pursues a dual neurotherapeutic approach in the development of AX200
or the treatment of neurodegenerative diseases: AX200 stops neuronal
cell death in the acute phase of the disease while at the same time
stimulating the regeneration of the already damaged CNS through the
stimulation of neurogenesis as well as arteriogenesis and the
reorganisation of neuronal networks. Besides stroke, AX200 is
currently in preclinical testing for further neurodegenerative
indications such as Amyotrophic Lateral Sclerosis (ALS) and Spinal
Cord Injuries (SCI).

About SYGNIS Pharma

SYGNIS Pharma AG, headquartered in Heidelberg, is a specialty
pharmaceutical company listed on the Prime Standard of the German
stock exchange. The Company is focused on the research, development
and marketing of innovative therapies for the treatment of disorders
of the Central Nervous System. These include Stroke, Amyotrophic
Lateral Sclerosis and neurological disorders resulting from injuries
to the brain or spinal cord. All these disorders are characterized by
the fact that, as the disease progresses, nerve cells are damaged and
die. Although there is great medical demand, there are currently no
or only inadequate treatment options available.

One of the central elements in this value-creation chain is the
continued development of the existing product pipeline. This is
achieved by testing the Company's proprietary compounds which are
already under development in a number of further CNS indications
("line extension"). By means of specific R&D programs at SYGNIS, new
pre-clinical drug candidates are identified and evaluated and
suitable CNS product candidates are also systematically tested for
the purpose of acquisition or inlicensing.

Disclaimer

Some statements included in this press release, relating neither
to proven financial results nor other historical data, should be
viewed as forward-looking, i.e. not definite. Such statements are
mainly predictions of future results, trends, plans or goals. These
statements should not be considered to be total guarantees since
given their very nature they are subject to known and unknown risks
and imponderability and can be affected by other factors as a
consequence of which the actual results, plans and goals of SYGNIS
Pharma AG may deviate greatly from the established conclusions or
implied predictions contained in such statements. SYGNIS does not
undertake to publicly update or revise these statements in the light
of new information or future results or for any other reason.

Originaltext: SYGNIS Pharma AG
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ISIN: DE0005043509

Pressekontakt:
SYGNIS Pharma AG:
Dr. Franz-Werner Haas
Vice President Operations
+49 (0) 6221 454 812
franz-werner.haas@sygnis.de

Media Contact:
Julia Phillips/Emma Thompson
Financial Dynamics
Tel.: +44 (0) 20 7269 7187