Treeway Announces Orphan Drug Designation For TW001
Rotterdam, 23nd March 2015 – Treeway is pleased to announce that the US Food and Drug Administration (FDA) has granted orphan drug designation for TW001 for the treatment of ALS (Amyotrophic Lateral Sclerosis). ALS is a neurodegenerative disease causing death on average after 3 years of symptoms onset.
Treeway accelerates ALS therapy development by patients involvement and TW001 is the lead compound within Treeway’s pipeline. “Obtaining orphan designation for TW001 from the FDA is an important milestone for Treeway” said Ronald van der Geest, CDO of Treeway. "The orphan drug designation will help us further to align with FDA on the acceptability of a US clinical study program, and to profit from possible financial incentives related to the orphan designation status, such as reduction of clinical trial costs, a waiver of user fee (approx. $2.0 M) for the submission of a future registration file (NDA), and a 7-year Marketing Exclusivity following eventual NDA approval”.
In November 2014 the European Medicines Agency (EMA) already granted an orphan designation for TW001 Treeway.
About ALS
Amyotrophic Lateral Sclerosis, also known as Lou Gehrig’s Disease, is a relentless progressive neurodegenerative disease that causes muscle weakness, disability and eventually death, with a median survival of three years. To date, there is no cure for ALS.
Treeway B.V.
Treeway is a biotechnology company and has been founded by entrepreneurs Bernard Muller and Robbert Jan Stuit, both diagnosed with ALS. Treeway’s strategy is founded on a cohesive combination of approaches, that together should provide the highest likelihood of bringing successful treatments for ALS to the patient in an efficient manner. For further questions about Treeway, please contact info@treeway.nl
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Treeway accelerates ALS therapy development by patients involvement and TW001 is the lead compound within Treeway’s pipeline. “Obtaining orphan designation for TW001 from the FDA is an important milestone for Treeway” said Ronald van der Geest, CDO of Treeway. "The orphan drug designation will help us further to align with FDA on the acceptability of a US clinical study program, and to profit from possible financial incentives related to the orphan designation status, such as reduction of clinical trial costs, a waiver of user fee (approx. $2.0 M) for the submission of a future registration file (NDA), and a 7-year Marketing Exclusivity following eventual NDA approval”.
In November 2014 the European Medicines Agency (EMA) already granted an orphan designation for TW001 Treeway.
About ALS
Amyotrophic Lateral Sclerosis, also known as Lou Gehrig’s Disease, is a relentless progressive neurodegenerative disease that causes muscle weakness, disability and eventually death, with a median survival of three years. To date, there is no cure for ALS.
Treeway B.V.
Treeway is a biotechnology company and has been founded by entrepreneurs Bernard Muller and Robbert Jan Stuit, both diagnosed with ALS. Treeway’s strategy is founded on a cohesive combination of approaches, that together should provide the highest likelihood of bringing successful treatments for ALS to the patient in an efficient manner. For further questions about Treeway, please contact info@treeway.nl
Help employers find you! Check out all the jobs and post your resume.