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Agreement with Dr. Reddy’s secures long-term supply to advance the clinical development of SYGNIS’ lead product candidate
HEIDELBERG, Germany and HYDERABAD, India | 26 November 2007 | SYGNIS Pharma AG (Frankfurt: LIO; ISIN DE0005043509; Prime Standard) and the leading Indian pharmaceutical company Dr. Reddy’s Laboratories (NYSE: RDY) today announced the signing of an exclusive 10 year agreement for the supply of the active ingredient AX200, a biological molecule in development by SYG-NIS for the treatment of Stroke and other neurodegenerative disorders. The Agreement secures the supply of AX200 far beyond the clinical development and provides a solid basis for the envisaged marketing of the compound.
SYGNIS successfully completed a Phase IIa clinical trial of AX200 in September, that demonstrated safety and efficacy in patients with acute Stroke. In the second half of 2008, SYGNIS plans to start a Phase IIb efficacy trial in acute Stroke with AX200 supplied by Dr. Reddy’s. Stroke affects over 5 million patients worldwide every year and is the third leading cause of death, presenting a major socio-economic burden.
Dr. Alfred Bach, Chief Executive Officer, SYGNIS Pharma AG, said, "Our collaboration with Dr. Reddy’s represents an important milestone in the development of AX200 which we believe has potential to significantly improve the treatment perspective for millions of patients globally. The long-term access to secure production sources for AX200 is a major step on SYGNIS’ way to becoming a product-focused company. This provides us with the flexibility to optimize our marketing strategy for this product. The fact that Dr. Reddy’s entered into this collaboration also reflects their confidence in the enormous potential of AX200."
Dr. Cartikeya Reddy, Head of Biologics at Dr. Reddy’s, said, "Biopharmaceutical Services is a fast growing business segment globally with a limited number of service providers. Our strategic decision to exclusively produce a biological molecule for a partner is a first in the history of Dr. Reddy’s and fits very well within our Custom Pharmaceutical Services' business model. We are very opti-mistic that AX200 will continue to show real potential in the treatment of Acute Stroke with the potential to be used in the treatment of other degenerative neuro-logical diseases. "
SOURCE: SYGNIS |