Galapagos Release: Orphan Drug Designation In European Union For GLPG1690 In Idiopathic Pulmonary Fibrosis
Mechelen, Belgium; 6 September 2016: Galapagos (Euronext & NASDAQ: GLPG) announces today that the European Commission (EC) has granted GLPG1690 'orphan drug designation' for the treatment of patients with idiopathic pulmonary fibrosis (IPF).
IPF is a chronic progressive fibrotic disorder of the lungs that typically affects adults over the age of 40. The prevalence of IPF is fewer than 30 per 100,000 persons in both Europe and the United States, and as such, IPF is considered a rare disease. Currently, no medical therapies have been found to cure IPF.
In order to stimulate the pharmaceutical industry to develop and market medicines for a small number of patients, the EC offers a range of incentives to encourage the development of these 'orphan' medicines for rare diseases in the European Union. These incentives include protocol assistance, i.e. scientific advice specific for designated orphan medicines, and 10 years of market exclusivity once the medicine is on the market. Orphan designated medicinal products also benefit from regulatory fee reductions and access to the centralized procedure for marketing authorization.[1]
"We are happy to see that the EC recognizes the potential of GLPG1690 as a new treatment for IPF-patients in Europe. Next step will be the application for orphan drug designation with the Food and Drug Administration (FDA) in the US," said Piet Wigerinck, CSO of Galapagos. GLPG1690 is currently being investigated in FLORA, a randomized, double blind, placebo-controlled Phase 2a study for 12 weeks in 24 IPF patients. Galapagos expects to report topline results in Q2 2017. GLPG1690 is a small molecule inhibitor of autotaxin and is fully proprietary to Galapagos.
Today at 16.30 CET hours, Galapagos is presenting 'Strong reversal of the lung fibrosis disease signature by autotaxin inhibitor GLPG1690 in a mouse model for IPF' at the European Respiratory Society Congress in London.
About IPF
IPF is a chronic, relentlessly progressive fibrotic disorder of the lungs that typically affects adults over the age of 40. According to an April 2013 GlobalData EpiCast report, the prevalence of IPF is <30 per 100,000 persons in both Europe and the United States, and as such, IPF is considered a rare disease. The clinical prognosis of patients with IPF is poor, as the median survival at diagnosis is 2-5 years. Currently, no medical therapies have been found to cure IPF. The medical treatment strategy aims to slow disease progression and improve the quality of life. Lung transplantation may be an option for appropriate patients with progressive disease and minimal comorbidities.
Regulatory agencies have approved Esbriet®[2] (pirfenidone) and Ofev®[3] (nintedanib) for the treatment of IPF. Both pirfenidone and nintedanib have been shown to slow the rate of lung function decline in IPF and are likely to become the standard of care worldwide. These regulatory approvals represent a major breakthrough for IPF patients; yet neither drug improves lung function, and the disease continues to progress in the majority of patients, despite treatment. Moreover, the adverse effects associated with these therapies include diarrhea, liver function test abnormalities with nintedanib, nausea, and rash with pirfenidone. Therefore, there is still a large unmet medical need, as IPF remains a major cause of morbidity and mortality.
About Galapagos
Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action. Our pipeline comprises Phase 3, 2, 1, pre-clinical and discovery studies in cystic fibrosis, inflammation, fibrosis, osteoarthritis and other indications. We have discovered and developed filgotinib: in collaboration with Gilead we aim to bring this JAK1-selective inhibitor for inflammatory indications to patients all over the world. Galapagos is focused on the development and commercialization of novel medicines that will improve people's lives. The Galapagos group, including fee-for-service subsidiary Fidelta, has approximately 460 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia. More information at www.glpg.com.
Contacts
Investors:
Elizabeth Goodwin
VP IR & Corporate
Communications
+1 781 460 1784
Media:
Evelyn Fox
Director Communications
+31 6 53 591 999
communications@glpg.com
Paul van der Horst
Director IR & Business
Development
+31 6 53 725 199
ir@glpg.com
IPF is a chronic progressive fibrotic disorder of the lungs that typically affects adults over the age of 40. The prevalence of IPF is fewer than 30 per 100,000 persons in both Europe and the United States, and as such, IPF is considered a rare disease. Currently, no medical therapies have been found to cure IPF.
In order to stimulate the pharmaceutical industry to develop and market medicines for a small number of patients, the EC offers a range of incentives to encourage the development of these 'orphan' medicines for rare diseases in the European Union. These incentives include protocol assistance, i.e. scientific advice specific for designated orphan medicines, and 10 years of market exclusivity once the medicine is on the market. Orphan designated medicinal products also benefit from regulatory fee reductions and access to the centralized procedure for marketing authorization.[1]
"We are happy to see that the EC recognizes the potential of GLPG1690 as a new treatment for IPF-patients in Europe. Next step will be the application for orphan drug designation with the Food and Drug Administration (FDA) in the US," said Piet Wigerinck, CSO of Galapagos. GLPG1690 is currently being investigated in FLORA, a randomized, double blind, placebo-controlled Phase 2a study for 12 weeks in 24 IPF patients. Galapagos expects to report topline results in Q2 2017. GLPG1690 is a small molecule inhibitor of autotaxin and is fully proprietary to Galapagos.
Today at 16.30 CET hours, Galapagos is presenting 'Strong reversal of the lung fibrosis disease signature by autotaxin inhibitor GLPG1690 in a mouse model for IPF' at the European Respiratory Society Congress in London.
About IPF
IPF is a chronic, relentlessly progressive fibrotic disorder of the lungs that typically affects adults over the age of 40. According to an April 2013 GlobalData EpiCast report, the prevalence of IPF is <30 per 100,000 persons in both Europe and the United States, and as such, IPF is considered a rare disease. The clinical prognosis of patients with IPF is poor, as the median survival at diagnosis is 2-5 years. Currently, no medical therapies have been found to cure IPF. The medical treatment strategy aims to slow disease progression and improve the quality of life. Lung transplantation may be an option for appropriate patients with progressive disease and minimal comorbidities.
Regulatory agencies have approved Esbriet®[2] (pirfenidone) and Ofev®[3] (nintedanib) for the treatment of IPF. Both pirfenidone and nintedanib have been shown to slow the rate of lung function decline in IPF and are likely to become the standard of care worldwide. These regulatory approvals represent a major breakthrough for IPF patients; yet neither drug improves lung function, and the disease continues to progress in the majority of patients, despite treatment. Moreover, the adverse effects associated with these therapies include diarrhea, liver function test abnormalities with nintedanib, nausea, and rash with pirfenidone. Therefore, there is still a large unmet medical need, as IPF remains a major cause of morbidity and mortality.
About Galapagos
Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action. Our pipeline comprises Phase 3, 2, 1, pre-clinical and discovery studies in cystic fibrosis, inflammation, fibrosis, osteoarthritis and other indications. We have discovered and developed filgotinib: in collaboration with Gilead we aim to bring this JAK1-selective inhibitor for inflammatory indications to patients all over the world. Galapagos is focused on the development and commercialization of novel medicines that will improve people's lives. The Galapagos group, including fee-for-service subsidiary Fidelta, has approximately 460 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia. More information at www.glpg.com.
Contacts
Investors:
Elizabeth Goodwin
VP IR & Corporate
Communications
+1 781 460 1784
Media:
Evelyn Fox
Director Communications
+31 6 53 591 999
communications@glpg.com
Paul van der Horst
Director IR & Business
Development
+31 6 53 725 199
ir@glpg.com