Heidelberg, December 4, 2008 – SYGNIS Pharma AG (Frankfurt: LIO; ISIN DE0005043509; Prime Standard) today announced that the US Patent and Trademark office (USPTO) published a Notice of Allowance for the patent application which protects the treatment of stroke patients with AX200 in the USA. SYGNIS exclusively licensed the respective global rights to this patent application. Following the granting of the corresponding European patent in 2006, AX200 will now also be protected in the USA, the world’s largest pharma market for the treatment of stroke patients.
AX200 is SYGNIS’ product name for G-CSF, an endogenous protein. It is SYGNIS’ lead compound and is being developed for the treatment of neurodegenerative disorders. SYGNIS is currently preparing a Phase II efficacy trial for AX200 in acute stroke and plans to initiate the trial by the end of fiscal year 2008/2009. SYGNIS is also developing AX200 for additional neurological indications. In spring 2008 the company was granted Orphan Drug Designation (ODD) by the European Commission for AX200 in the treatment of Amyotrophic Lateral Sclerosis (ALS) and in early November 2008 in the treatment of spinal cord injury.
Dr. Alfred Bach, CEO of SYGNIS Pharma AG, said: “We are very encouraged to receive this Notice of Allowance from the USPTO. Stroke is the second leading cause of death in the US and novel treatment options are urgently needed. Through the patent position in the USA AX200 is protected in the treatment of stroke in the world’s largest pharma market. This significantly extends the commercial value of AX200 for the treatment of stroke. We continue to extend our IP position around AX200 and to advance the use of the potential of AX200.”
About AX200
AX200 is a biological molecule, developed by SYGNIS for the treatment of neurodegenerative diseases. In the indication 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 endogenous response to the damage. SYGNIS pursues a multiple neurotherapeutic approach in the development of AX200 for 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 pre-clinical testing for further neurodegenerative indications such as Amyotrophic Lateral Sclerosis and Spinal Cord Injuries.
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 in-licensing.
