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Gene-Signal Vallentech Agreement

December 15, 2016 - Gene-Signal Vallentech Agreement
Gene Signal and Vallentech enter into an exclusive supply and distribution agreement relating to GS-101 (aganirsen) eye-drops, under development for the treatment of several ophthalmological conditions.

Under the agreement, Vallentech gets the exclusive rights to GS-101 in Columbia and Brazil up until regulatory approval, and will be responsible for the distribution, provision and sale of the product in that territory.

Gene-Signal Medical Need Agreement

Gene Signal and Medical Need enter into an exclusive supply and distribution agreement relating to GS-101 (aganirsen) eye-drops, under development for the treatment of several ophthalmological conditions. 

Under the agreement, Medical Need gets the exclusive rights to GS-101 in Denmark, Finland, Iceland, Norway and Sweden, and will be responsible for the distribution, provision and sale of the product in that territory. Up until regulatory approval, the product will on request be provided on a named patient basis, through special license prescription by a specialist physician.

• http://medicalneed.com/gs-101-aganirsen-in-the-nordic-countries/

BioEurope Spring 2016 in Stockholm

Gene Signal attends BioEurope Spring 2016 in Stockholm

BioEurope 2015

Gene Signal attends BioEurope 2015 in Munich and presents in the innovative therapies track

Gene Signal- Stragen Pharma Agreement

Gene Signal announces its distribution agreement for France with Stragen’s Lyon office, at 2 Rue de la République, 69002 Lyon, France

Positive pre-IND Meeting with the US Food and Drug Administration (FDA)

Gene Signal is pleased to report the positive outcome of Pre-IND Meeting with the US Food and Drug Administration (FDA).

The purpose of this meeting was to present the current data on aganirsen 0.86 mg/mL eye drops and to confirm that the design of the pivotal trial agreed upon with the European Medicines Agency earlier this year would be acceptable to the FDA. Following the positive feedback from the FDA, Gene Signal will finalize the protocol of the pivotal trial that will meet both the US and the EU Regulatory Authorities’ recommendations.

15th Annual BioEquity Europe meeting 2015

Gene Signal to attend the 15th BioEquity Europe meeting taking place in Amsterdam

BioEurope Spring 2015 

Gene Signal attends BioEurope Spring 2015 in Paris and presents in the regenerative therapies track

Positive Scientific Advice Meeting at European Medicines Agency (EMA)

Gene Signal is pleased to report the positive outcome of a Follow-up Scientific Advice with European Medicines Agency (EMA).

The purpose of this meeting was to discuss the design of the upcoming Phase III pivotal trial of aganirsen 0.86 mg/mL eye drops in a corneal indication.

During this meeting, Gene Signal has agreed with the Agency on a trial that will demonstrate the efficacy and safety of aganirsen using a scientifically and clinically meaningful endpoint, and within a reasonable timeframe.

EuroStars Innovation funding award

Gene Signal announces that its EuroStars application for Aganirsen in AMD was ranked #6 of 233 eligible applicants (the AWAIRE study). Eurostars is a European commission programme co-funded by Eureka member countries and the European union. It supports innovative product development

European Cornea Experts Survey

Gene Signal has conducted a survey among members of the European Society of Ocular and Surface Disease Specialists (EUCORNEA) and of the European Eye Bank Association (EEBA). Topics included indications for keratoplasty, surgical techniques and management of patients with pre-graft corneal neovascularization.

Gene Signal has collected responses from 34 major European centres, corresponding to approximately 15 to 25% of the 20,000 keratoplasty procedures performed in the EU annually.

The outcome of this survey has provided a clear picture of the current medical practice in the EU, and will be instrumental in the design of the upcoming Phase III pivotal clinical trial with aganirsen 0.86 mg/mL eye drops. This survey also showed the continued interest of the EU cornea experts in aganirsen.

BioEurope 2014

Gene Signal attends BioEurope 2014 in Frankfurt and presents in the regenerative therapies track

BioPharma America 2014 

Gene Signal attends BioEurope 2014 in Frankfurt and presents in the regenerative therapies track

European Eye Bank Association (EEBA) Annual Meeting 

Gene Signal holds Cornea Expert Roundtable at the 2014 EEBA meeting held at the Hotel Beau Rivage in Lausanne, Switzerland

JP Morgan's 32nd Annual Healthcare Conference

Gene Signal's CEO, Eric Viaud to attend JP Morgan's 32nd Annual Healthcare Conference to be held January 13-16th in San Francisco, California