AdAlta Pty Ltd. Release: Pharma Receives Orphan Designation For Its Lead Drug Candidate Targeting Patients With Idiopathic Pulmonary Disease
MELBOURNE Australia, 18 January, 2017 - AdAlta Limited (ASX: 1AD), today announced it has received Orphan Drug Designation from the United States Food and Drug Administration (FDA) for AD-114, a novel first-in-class drug candidate for the treatment of idiopathic pulmonary fibrosis (IPF).
There is growing global interest in promising new treatments for fibrosis, especially for idiopathic pulmonary fibrosis, which has a 50 to 70 per cent mortality rate and affects 135,000 people in the US every year. Current therapies for the treatment of IPF are sub-optimal and there is a high-unmet medical need. AD-114 has strong pre-clinical results for IPF, demonstrating both anti-fibrotic and anti-inflammatory activity in human lung tissue and indicating greater efficacy than existing approved IPF drugs.
Orphan Drug status allows for significant R&D tax credits, new drug application fee waivers and a seven year period of market exclusivity from the US Food & Drug Administration (FDA) after approval. Companies pursuing orphan treatments are usually granted accelerated development and regulatory timelines as well as premium pricing.
AdAlta Chief Executive Officer Sam Cobb said, "Securing Orphan Designation for our lead program represents an important step in our strategy for the rapid commercial development of AD-114 for the treatment of idiopathic pulmonary disease. We expect this orphan designation, when combined with our pre-clinical package of AD-114, will help accelerate our commercial development path.”
“AdAlta remains on track to meet its stated clinical development milestones and management remains focused on expediting AD-114 into Phase 1 human clinical trials for idiopathic pulmonary fibrosis by early 2018.”
More recently AdAlta also demonstrated broad fibrotic application of AD-114, demonstrating the potential of AD-114 for the treatment of other fibrotic diseases including the liver (NASH) and eye (wet-AMD).
There is growing global interest in promising new treatments for fibrosis, especially for idiopathic pulmonary fibrosis, which has a 50 to 70 per cent mortality rate and affects 135,000 people in the US every year. Current therapies for the treatment of IPF are sub-optimal and there is a high-unmet medical need. AD-114 has strong pre-clinical results for IPF, demonstrating both anti-fibrotic and anti-inflammatory activity in human lung tissue and indicating greater efficacy than existing approved IPF drugs.
Orphan Drug status allows for significant R&D tax credits, new drug application fee waivers and a seven year period of market exclusivity from the US Food & Drug Administration (FDA) after approval. Companies pursuing orphan treatments are usually granted accelerated development and regulatory timelines as well as premium pricing.
AdAlta Chief Executive Officer Sam Cobb said, "Securing Orphan Designation for our lead program represents an important step in our strategy for the rapid commercial development of AD-114 for the treatment of idiopathic pulmonary disease. We expect this orphan designation, when combined with our pre-clinical package of AD-114, will help accelerate our commercial development path.”
“AdAlta remains on track to meet its stated clinical development milestones and management remains focused on expediting AD-114 into Phase 1 human clinical trials for idiopathic pulmonary fibrosis by early 2018.”
More recently AdAlta also demonstrated broad fibrotic application of AD-114, demonstrating the potential of AD-114 for the treatment of other fibrotic diseases including the liver (NASH) and eye (wet-AMD).