Latest news with #MarioRovirosa
Business Upturn
7 hours ago
- Business
- Business Upturn
Ferrer Receives FDA Fast Track Designation for FNP-223 in Progressive Supranuclear Palsy (PSP)
Barcelona, Spain: Ferrer, a B Corp-certified international pharmaceutical company, has announced that FNP-223, a novel therapy in-licensed from Asceneuron and aimed at slowing the development of progressive supranuclear palsy (PSP), has received Fast Track designation from the US Food & Drug Administration (FDA). FNP-223, a new molecular entity in active development for PSP, is in an ongoing Phase 2 study to evaluate its safety, efficacy, and pharmacokinetics in adult patients with possible or probable PSP-Richardson syndrome (PSP-RS), the most common clinical variant of this neurodegenerative disease1. This press release features multimedia. View the full release here: Ferrer's pharmaceutical production plant in Sant Cugat del Vallés, Barcelona, Spain. 'We are thrilled to receive Fast Track designation from the FDA for FNP-223 in the treatment of PSP. Consistent with our purpose of using business to fight for social justice, we are committed to advancing this promising therapy as quickly as possible to benefit as many patients as possible,' said Mario Rovirosa, Chief Executive Officer of Ferrer. Fast Track designation is a significant milestone in the drug development process. It is a program that offers the possibility of having more frequent meetings with the FDA to discuss the drug's development, eligibility for Accelerated Approval and Priority Review if relevant criteria are met. 'This designation underscores the importance of expediting the development and review of FNP-223 to address critical unmet needs in patients with this rare and devastating disease,' said Marta Parmar, Ferrer's Chief Quality, Regulatory and Pharmacovigilance Officer. Progressive supranuclear palsy manifests in patients with symptoms such as difficulty speaking, imbalance, changes in gait, cognitive problems2-4. PSP has a prevalence of approximately 5 cases per 100,000 people and primarily affects individuals over the age of 603. The disease's etiology is believed to be related to the abnormal accumulation of tau proteins in certain areas of the brain, leading to neurodegeneration3,4. Preclinical models have demonstrated that FNP-223 can prevent the abnormal accumulation of tau proteins in neurons5. Ferrer now aims to show that this molecule is safe and effective in patients with PSP. Oscar Pérez, Chief Scientific Officer of Ferrer, also expressed his enthusiasm: 'Receiving Fast Track designation is a significant milestone in our journey to provide a transformative treatment for PSP. We are excited to advance our research and hopefully offer a new therapeutic option earlier for patients living with this challenging condition.' About FNP-223 FNP-223 is a new orally administered chemical compound that functions as a reversible and substrate-competitive inhibitor of the O-GlcNAcase (OGA) enzyme5. Mechanistically, FNP-223 binds to the active site of OGA enzyme. As a result, the inhibitor prevents the substrate from accessing the catalytic pocket, thereby impeding the removal of O-GlcNAc modifications from natural client proteins such as the tau protein. Inhibiting O-GlcNAcase is expected to cause a rapid increase of O-GlcNAcylated (glycosylated) tau proteins, ultimately leading to a reduction in abnormal aggregated tau as neurofibrillary tangles (NFT) over a certain period5. Bibliography: 1. A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Assess the Efficacy, Safety, and Pharmacokinetics of FNP-223 (Oral Formulation) to Slow the Disease Progression of Progressive Supranuclear Palsy (PSP) (PROSPER). [Internet]. Available from: . 2. Coughlin DG, Litvan I. Progressive supranuclear palsy: Advances in diagnosis and management. Parkinsonism Relat Disord. 2020 Apr;73:105-116. doi: 10.1016/ Epub 2020 May 25. 3. Agarwal S, Gilbert R. Progressive Supranuclear Palsy. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024. Available from: . 4. Rowe JB, Holland N, Rittman T. Progressive supranuclear palsy: diagnosis and management. Pract Neurol. 2021;21(5):376-383. doi: 10.1136/practneurol-2020-002794. 5. Permanne B, Sand A, Ousson S, Nény M, Hantson J, Schubert R, et al. D. O-GlcNAcase Inhibitor ASN90 is a Multimodal Drug Candidate for Tau and α-Synuclein Proteinopathies. ACS Chem Neurosci. 2022 Apr 20;13(8):1296-1314. doi: 10.1021/acschemneuro.2c00057. View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash
National Post
9 hours ago
- Health
- National Post
Ferrer Receives FDA Fast Track Designation for FNP-223 in Progressive Supranuclear Palsy (PSP)
Article content BARCELONA, Spain — Ferrer, a B Corp-certified international pharmaceutical company, has announced that FNP-223, a novel therapy in-licensed from Asceneuron and aimed at slowing the development of progressive supranuclear palsy (PSP), has received Fast Track designation from the US Food & Drug Administration (FDA). FNP-223, a new molecular entity in active development for PSP, is in an ongoing Phase 2 study to evaluate its safety, efficacy, and pharmacokinetics in adult patients with possible or probable PSP-Richardson syndrome (PSP-RS), the most common clinical variant of this neurodegenerative disease 1. Article content We are thrilled to receive Fast Track designation from the FDA for FNP-223 in the treatment of PSP. Consistent with our purpose of using business to fight for social justice, we are committed to advancing this promising therapy to patients. Article content 'We are thrilled to receive Fast Track designation from the FDA for FNP-223 in the treatment of PSP. Consistent with our purpose of using business to fight for social justice, we are committed to advancing this promising therapy as quickly as possible to benefit as many patients as possible,' said Mario Rovirosa, Chief Executive Officer of Ferrer. Article content Fast Track designation is a significant milestone in the drug development process. It is a program that offers the possibility of having more frequent meetings with the FDA to discuss the drug's development, eligibility for Accelerated Approval and Priority Review if relevant criteria are met. Article content 'This designation underscores the importance of expediting the development and review of FNP-223 to address critical unmet needs in patients with this rare and devastating disease,' said Marta Parmar, Ferrer's Chief Quality, Regulatory and Pharmacovigilance Officer. Progressive supranuclear palsy manifests in patients with symptoms such as difficulty speaking, imbalance, changes in gait, cognitive problems 2-4. PSP has a prevalence of approximately 5 cases per 100,000 people and primarily affects individuals over the age of 60 3. The disease's etiology is believed to be related to the abnormal accumulation of tau proteins in certain areas of the brain, leading to neurodegeneration 3,4. Preclinical models have demonstrated that FNP-223 can prevent the abnormal accumulation of tau proteins in neurons 5. Ferrer now aims to show that this molecule is safe and effective in patients with PSP. Article content Oscar Pérez Article content , Chief Scientific Officer of Ferrer, also expressed his enthusiasm: 'Receiving Fast Track designation is a significant milestone in our journey to provide a transformative treatment for PSP. We are excited to advance our research and hopefully offer a new therapeutic option earlier for patients living with this challenging condition.' Article content About FNP-223 Article content FNP-223 is a new orally administered chemical compound that functions as a reversible and substrate-competitive inhibitor of the O-GlcNAcase (OGA) enzyme 5. Mechanistically, FNP-223 binds to the active site of OGA enzyme. As a result, the inhibitor prevents the substrate from accessing the catalytic pocket, thereby impeding the removal of O-GlcNAc modifications from natural client proteins such as the tau protein. Inhibiting O-GlcNAcase is expected to cause a rapid increase of O-GlcNAcylated (glycosylated) tau proteins, ultimately leading to a reduction in abnormal aggregated tau as neurofibrillary tangles (NFT) over a certain period 5. Article content Bibliography: Article content 1. A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Assess the Efficacy, Safety, and Pharmacokinetics of FNP-223 (Oral Formulation) to Slow the Disease Progression of Progressive Supranuclear Palsy (PSP) (PROSPER). [Internet]. Available from: Article content 2. Coughlin DG, Litvan I. Progressive supranuclear palsy: Advances in diagnosis and management. Parkinsonism Relat Disord. 2020 Apr;73:105-116. doi: 10.1016/ Epub 2020 May 25. Article content 3. Agarwal S, Gilbert R. Progressive Supranuclear Palsy. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024. Available from: Article content 4. Rowe JB, Holland N, Rittman T. Progressive supranuclear palsy: diagnosis and management. Pract Neurol. 2021;21(5):376-383. doi: 10.1136/practneurol-2020-002794. Article content 5. Permanne B, Sand A, Ousson S, Nény M, Hantson J, Schubert R, et al. D. O-GlcNAcase Inhibitor ASN90 is a Multimodal Drug Candidate for Tau and α-Synuclein Proteinopathies. ACS Chem Neurosci. 2022 Apr 20;13(8):1296-1314. doi: 10.1021/acschemneuro.2c00057. Article content Article content Article content Article content Article content
Yahoo
9 hours ago
- Health
- Yahoo
Ferrer Receives FDA Fast Track Designation for FNP-223 in Progressive Supranuclear Palsy (PSP)
BARCELONA, Spain, June 17, 2025--(BUSINESS WIRE)--Ferrer, a B Corp-certified international pharmaceutical company, has announced that FNP-223, a novel therapy in-licensed from Asceneuron and aimed at slowing the development of progressive supranuclear palsy (PSP), has received Fast Track designation from the US Food & Drug Administration (FDA). FNP-223, a new molecular entity in active development for PSP, is in an ongoing Phase 2 study to evaluate its safety, efficacy, and pharmacokinetics in adult patients with possible or probable PSP-Richardson syndrome (PSP-RS), the most common clinical variant of this neurodegenerative disease1. "We are thrilled to receive Fast Track designation from the FDA for FNP-223 in the treatment of PSP. Consistent with our purpose of using business to fight for social justice, we are committed to advancing this promising therapy as quickly as possible to benefit as many patients as possible," said Mario Rovirosa, Chief Executive Officer of Ferrer. Fast Track designation is a significant milestone in the drug development process. It is a program that offers the possibility of having more frequent meetings with the FDA to discuss the drug's development, eligibility for Accelerated Approval and Priority Review if relevant criteria are met. "This designation underscores the importance of expediting the development and review of FNP-223 to address critical unmet needs in patients with this rare and devastating disease," said Marta Parmar, Ferrer's Chief Quality, Regulatory and Pharmacovigilance Officer. Progressive supranuclear palsy manifests in patients with symptoms such as difficulty speaking, imbalance, changes in gait, cognitive problems2-4. PSP has a prevalence of approximately 5 cases per 100,000 people and primarily affects individuals over the age of 603. The disease's etiology is believed to be related to the abnormal accumulation of tau proteins in certain areas of the brain, leading to neurodegeneration3,4. Preclinical models have demonstrated that FNP-223 can prevent the abnormal accumulation of tau proteins in neurons5. Ferrer now aims to show that this molecule is safe and effective in patients with PSP. Oscar Pérez, Chief Scientific Officer of Ferrer, also expressed his enthusiasm: "Receiving Fast Track designation is a significant milestone in our journey to provide a transformative treatment for PSP. We are excited to advance our research and hopefully offer a new therapeutic option earlier for patients living with this challenging condition." About FNP-223 FNP-223 is a new orally administered chemical compound that functions as a reversible and substrate-competitive inhibitor of the O-GlcNAcase (OGA) enzyme5. Mechanistically, FNP-223 binds to the active site of OGA enzyme. As a result, the inhibitor prevents the substrate from accessing the catalytic pocket, thereby impeding the removal of O-GlcNAc modifications from natural client proteins such as the tau protein. Inhibiting O-GlcNAcase is expected to cause a rapid increase of O-GlcNAcylated (glycosylated) tau proteins, ultimately leading to a reduction in abnormal aggregated tau as neurofibrillary tangles (NFT) over a certain period5. Bibliography: 1. A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Assess the Efficacy, Safety, and Pharmacokinetics of FNP-223 (Oral Formulation) to Slow the Disease Progression of Progressive Supranuclear Palsy (PSP) (PROSPER). [Internet]. Available from: 2. Coughlin DG, Litvan I. Progressive supranuclear palsy: Advances in diagnosis and management. Parkinsonism Relat Disord. 2020 Apr;73:105-116. doi: 10.1016/ Epub 2020 May 25. 3. Agarwal S, Gilbert R. Progressive Supranuclear Palsy. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024. Available from: 4. Rowe JB, Holland N, Rittman T. Progressive supranuclear palsy: diagnosis and management. Pract Neurol. 2021;21(5):376-383. doi: 10.1136/practneurol-2020-002794. 5. Permanne B, Sand A, Ousson S, Nény M, Hantson J, Schubert R, et al. D. O-GlcNAcase Inhibitor ASN90 is a Multimodal Drug Candidate for Tau and α-Synuclein Proteinopathies. ACS Chem Neurosci. 2022 Apr 20;13(8):1296-1314. doi: 10.1021/acschemneuro.2c00057. View source version on Contacts gortizdez@ +34 936003779 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
9 hours ago
- Health
- Business Wire
Ferrer Receives FDA Fast Track Designation for FNP-223 in Progressive Supranuclear Palsy (PSP)
BARCELONA, Spain--(BUSINESS WIRE)--Ferrer, a B Corp-certified international pharmaceutical company, has announced that FNP-223, a novel therapy in-licensed from Asceneuron and aimed at slowing the development of progressive supranuclear palsy (PSP), has received Fast Track designation from the US Food & Drug Administration (FDA). FNP-223, a new molecular entity in active development for PSP, is in an ongoing Phase 2 study to evaluate its safety, efficacy, and pharmacokinetics in adult patients with possible or probable PSP-Richardson syndrome (PSP-RS), the most common clinical variant of this neurodegenerative disease 1. We are thrilled to receive Fast Track designation from the FDA for FNP-223 in the treatment of PSP. Consistent with our purpose of using business to fight for social justice, we are committed to advancing this promising therapy to patients. Share 'We are thrilled to receive Fast Track designation from the FDA for FNP-223 in the treatment of PSP. Consistent with our purpose of using business to fight for social justice, we are committed to advancing this promising therapy as quickly as possible to benefit as many patients as possible,' said Mario Rovirosa, Chief Executive Officer of Ferrer. Fast Track designation is a significant milestone in the drug development process. It is a program that offers the possibility of having more frequent meetings with the FDA to discuss the drug's development, eligibility for Accelerated Approval and Priority Review if relevant criteria are met. 'This designation underscores the importance of expediting the development and review of FNP-223 to address critical unmet needs in patients with this rare and devastating disease,' said Marta Parmar, Ferrer's Chief Quality, Regulatory and Pharmacovigilance Officer. Progressive supranuclear palsy manifests in patients with symptoms such as difficulty speaking, imbalance, changes in gait, cognitive problems 2-4. PSP has a prevalence of approximately 5 cases per 100,000 people and primarily affects individuals over the age of 60 3. The disease's etiology is believed to be related to the abnormal accumulation of tau proteins in certain areas of the brain, leading to neurodegeneration 3,4. Preclinical models have demonstrated that FNP-223 can prevent the abnormal accumulation of tau proteins in neurons 5. Ferrer now aims to show that this molecule is safe and effective in patients with PSP. Oscar Pérez, Chief Scientific Officer of Ferrer, also expressed his enthusiasm: "Receiving Fast Track designation is a significant milestone in our journey to provide a transformative treatment for PSP. We are excited to advance our research and hopefully offer a new therapeutic option earlier for patients living with this challenging condition." About FNP-223 FNP-223 is a new orally administered chemical compound that functions as a reversible and substrate-competitive inhibitor of the O-GlcNAcase (OGA) enzyme 5. Mechanistically, FNP-223 binds to the active site of OGA enzyme. As a result, the inhibitor prevents the substrate from accessing the catalytic pocket, thereby impeding the removal of O-GlcNAc modifications from natural client proteins such as the tau protein. Inhibiting O-GlcNAcase is expected to cause a rapid increase of O-GlcNAcylated (glycosylated) tau proteins, ultimately leading to a reduction in abnormal aggregated tau as neurofibrillary tangles (NFT) over a certain period 5. Bibliography: 1. A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Assess the Efficacy, Safety, and Pharmacokinetics of FNP-223 (Oral Formulation) to Slow the Disease Progression of Progressive Supranuclear Palsy (PSP) (PROSPER). [Internet]. Available from: 2. Coughlin DG, Litvan I. Progressive supranuclear palsy: Advances in diagnosis and management. Parkinsonism Relat Disord. 2020 Apr;73:105-116. doi: 10.1016/ Epub 2020 May 25. 3. Agarwal S, Gilbert R. Progressive Supranuclear Palsy. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024. Available from: 4. Rowe JB, Holland N, Rittman T. Progressive supranuclear palsy: diagnosis and management. Pract Neurol. 2021;21(5):376-383. doi: 10.1136/practneurol-2020-002794. 5. Permanne B, Sand A, Ousson S, Nény M, Hantson J, Schubert R, et al. D. O-GlcNAcase Inhibitor ASN90 is a Multimodal Drug Candidate for Tau and α-Synuclein Proteinopathies. ACS Chem Neurosci. 2022 Apr 20;13(8):1296-1314. doi: 10.1021/acschemneuro.2c00057.
National Post
28-04-2025
- Business
- National Post
Ferrer Enters Into a Collaboration and License Agreement With Prilenia for the Commercialization and Co-Development of Pridopidine
Article content BARCELONA, Spain — Ferrer, an international B Corp pharmaceutical company with an increasing focus on rare neurological diseases, and Prilenia Therapeutics B.V., a clinical-stage biotech company, have announced the signing of a strategic co-development and license agreement in which Ferrer obtains the rights to develop, manufacture and commercialize Pridopidine in the European Region, the Middle East and North African Region, the Southern African Region, the Central and South American Region, and the Commonwealth of Independent States Region. Article content Article content Article content Pridopidine, a potent and highly selective, orally administered sigma-1 receptor agonist, designed to regulate key neuroprotective mechanisms that are often impaired in neurodegenerative diseases, is a promising candidate for the treatment of Huntington's Disease (HD), a rare inherited neurodegenerative disease, with a high unmet medical need 1. It has been studied in more than 1,700 people and long-term safety data of up to 7 years duration are available from previous clinical studies 2. These investigational studies demonstrate that at the therapeutic dose, Pridopidine has an observed safety and tolerability profile comparable to placebo 2. Article content Pridopidine is currently being reviewed by the European Medicines Agency, which has accepted the Marketing Authorisation Application submission for the treatment of HD. An opinion from the Committee for Medicinal Products for Human Use is expected in the second half of 2025. Article content The terms of the agreement include an upfront payment and multiple regulatory, development, commercial and sales milestone payments. Prilenia will also receive tiered double-digit royalties on net sales of Pridopidine. Article content 'This agreement with Prilenia means we can continue making our purpose of using business to fight for social justice a reality, while focusing our pipeline development on diseases with high unmet medical need,' stated Mario Rovirosa, CEO of Ferrer. 'The combination of strengths and capabilities of our two companies makes the future brighter for the patients suffering from such underserved conditions.' Article content 'We are proud to partner with Ferrer as we advance our shared mission to bring transformative therapies to people living with neurodegenerative diseases around the world,' said Dr. Michael R. Hayden, CEO of Prilenia. 'Ferrer continues to grow their already significant presence throughout Europe and key international markets with particular focus on innovative products for rare diseases. By combining our unique strengths and shared commitment to these patient communities, we believe that this partnership has the potential to accelerate the delivery of Pridopidine to the thousands of people who are waiting for a new treatment option as well as to broaden its impact through additional indications in the future.' Article content 'Securing rights to this molecule represents a pivotal step in our research strategy in the neurodegeneration arena,' said Oscar Pérez, Chief Scientific and Business Development Officer at Ferrer. 'Given the mechanism of action of Pridopidine, we are fully committed to exploring its potential use across a range of indications.' Article content Article content Article content Article content Contacts Article content Article content
