Ferrer Advanced Biotherapeutics (FAB) develops products for unmet clinical needs through the extensive use of new technological platforms. A total of eight projects have been incorporated into the Ferrer pipeline. These include:
Cell therapy and regenerative medicine
- FAB-111: Most degenerative diseases of the retina, such as retinitis pigmentosa or Stargardt disease, lack treatment options. FAB-111 is a cellular drug which activates adult stem cells using a proprietary method. FAB-111 promotes regeneration of damaged retinal cells by inducing in vivo reprogramming.
- FAB-112: New cell therapy for ocular surface reconstruction in diseases and injuries that cause vision loss or blindness and present with limbal stem cell deficiency. As an allogeneic approach, FAB-112 can treat bilateral conditions. The drug combines the cellular component with a new generation biomaterial.
- NeuroSave® (FAB-117): Traumatic spinal cord injury can, in many cases, lead to the appearance of paraplegia or quadriplegia, with a huge impact on the quality of life of patients and those around them and a very high social and economic cost. Yet it currently lacks a pharmacological treatment. FAB-117 is a new allogeneic cell therapy for the acute treatment of traumatic spinal cord injuries. FAB-117 reduces neuronal death in the first few days after injury and so aims to improve the patient’s long-term condition, significantly reducing levels of dependence. AB-117 may also be useful in traumatic brain injury and other non-cancer spinal cord conditions.
- FAB-114: For the treatment of non-Hodgkin's lymphoma and chronic lymphocytic leukemia. This drug is already commercialized and widely used in a non-oncological indication, but when administered and formulated in a novel way, it exhibits a potent and selective antitumor action. In addition, FAB-114 exhibits potent synergies when co-administered with other products used in this indication.
Personalized medicine. Epigenetic platform
- EPICUP® (FAB-115): EPICUP is the first multiplexed diagnostic system based on an epigenetic platform on the market. Cancer of unknown primary (CUP) is a very aggressive form of cancer that produces metastases before the primary tumor is apparent. Determining the primary is fundamental to selecting the appropriate treatment. The development of EPICUP has involved the analysis of more than 10,000 clinical samples. EPICUP boasts 97% sensitivity and more than 99% specificity. EPICUP obtained the CE mark in 2015.
- FAB-118: Our second development project in the field of epigenetic multiplex diagnostics, FAB-118 is a product for facilitating certain clinical decisions in the treatment of breast cancer which currently lack adequate tools.
- Ozenoxacin: Non-fluorinated quinolone that has completed clinical development as a treatment for impetigo, in patients two months and older, and potentially other infectious skin conditions. Two successful phase III studies have been completed in patients with impetigo. Documentation is currently being prepared for first registration in the European Union, US and Canada.
- Lorediplon: Long-acting GABA receptor modulator for the treatment of insomnia. Phase I clinical trials have been successfully completed and a proof of concept clinical study in a model of insomnia has demonstrated an excellent safety and hypnotic activity profile as well as clinical superiority in terms of sleep maintenance and quality compared to zolpidem. Currently undergoing phase II clinical development in a multinational European Union trial.
- Arasertaconazole: Fast-acting topical antifungal with a broad spectrum of action against vaginal candidiasis-causing agents, including fluconazole-resistant strains. A phase II study in patients with VVC has been successfully completed. Currently ready for phase III clinical development.
- Cardiovascular polypills: First polypill for the secondary prevention of cardiovascular events in patients already in treatment. It features an innovative technology that ensures the stability and non-interaction of its components. The objective is to improve adherence and reduce the risk of further cardiovascular events. It has been registered in Europe in various fixed dose combinations and further studies are currently being carried out for the registration of other doses and expansion into new territories.
- Inhaled loxapine: Atypical antipsychotic, dopamine D2 and 5-HT2 receptor antagonist registered for in-hospital use in the treatment of agitation in adults with schizophrenia and bipolar I disorder in adults. Observational safety studies and an efficacy study with an active comparator are currently being conducted. Studies are also being designed to expand the use to the domestic setting and pediatric patients.
- Modified release generic products: The majority of projects under development are modified release products, either extended release or delayed release, such as ranolazine XR.
- Complex generic products: Projects currently in development include inhalation drugs and devises and extended-release injectable depot.
- The generic pipeline contains more than a dozen products, aimed mainly at European markets, although many projects that are in development focus on the U.S. market, such as roflumilast.
To access updated information on the Spherium Biomed pipeline, please visit their website.
- DAP: Diagnosis of penicillin allergy. World’s first diagnosis of hypersensitivity to beta-lactam antibiotics. This line of research incorporates progressively more products for the diagnosis of drug allergies into the pipeline.
- VHC-Core: Highly sensitive serodiagnosis to detect antibodies of the hepatitis C virus (HCV). Opens up the possibility of the diagnosis of a greater percentage of patients with HCV infection, providing superior sensitivity in comparison to other currently-available serodiagnostic tests.
- Alt a I: First purified major allergen of the Alternaria alternata fungus which recognizes more than 90% of the immunoglobulin E specific to this fungus. This technology for the purification of native major allergens is in development for application to other allergens. The use of purified native major allergens improves both the sensitivity and specificity of the diagnosis as well as the efficacy and safety of the specific immunotherapy when compared to the fungus allergen extract.
- StrokeChip: Genetic diagnosis for the early detection of a panel of specific biomarkers for stroke. It permits the differentiation of a ischemic stroke from an intracerebral hemorrhage or a hemorrhagic stroke. The development of ‘lab-on-a-chip’ technology as a portable device for use in primary care, ambulances and emergency rooms. A clinical trial has been started that will recruit 1,600 patients to validate the biomarker panel.
To access updated information on the ABAC Therapeutics pipeline, please visit their website
Efficient and scalable biotechnological synthesis of gaxilose: Gaxilose (4-O-β-D- galactopyranosyl-D-xylose) is the active ingredient in the non-invasive diagnostic test for hypolactasia, LacTEST®. Gaxilose is a synthetic disaccharide that is hydrolyzed in the intestine by the lactase enzyme - the same enzyme used to digest lactose, the main sugar in milk and its derivatives - to produce galactose and xylose. Both molecules are absorbed but only xylose is excreted intact in the urine. In people with hypolactasia, a low level of this enzyme, and therefore with lactose intolerance, low levels of xylose in urine are observed after oral administration of gaxilose.
Currently, the industrial production of gaxilose is performed by a transglycosylation reaction with the β-galactosidase enzyme of E. coli. This reaction, which is not specific and has a low yield, has been implemented at the industrial level in Ferrer HealthTech (Interquim S.A.) on a 2.5 kg product scale.
Ferrer HealthTech (Interquim S.A.), in collaboration with IQS and Biópolis S.L., is developing a new process and a new enzyme that improves the specificity and efficiency of the gaxilose synthesis reaction. This new procedure will be implemented at the industrial level in 2018.
This project is co-funded by the European Regional Development Fund (ERDF) of the European Union under the ERDF 2014-2020 Operational Program.