Key development projects
Ferrer Early Development Center
- Ozenoxacin: Non-fluorinated quinolone in development for the treatment of impetigo and other infectious skin conditions with a broad spectrum of action even against resistant strains (such as MRSA). A successful absorption, tolerability and safety study has been completed in patients with impetigo (2 months to 65 years old) together with a phase II clinical study in infected traumatic skin lesions. A phase III study in children and adults with impetigo is currently being finalized.
- 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.
- 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 ready for phase II clinical development.
- Orexin modulator program: Search for new orexinergic modulators. The agonism of this receptor will lead to treatments for various conditions, such as narcolepsy. The antagonism is applicable in the treatment of sleep disorders.
- Personalized antibacterials program: Identification and development of new antibacterials with selective activity against specific pathogens of clinical relevance, hospital infections and infections causing considerable mortality and morbidity worldwide.
Collaborative & Open Innovation Unit
A total of eight projects from external sources have been incorporated into Ferrer’s pipeline. Examples classified by technology platform include:
- FIB-112: New therapy for ocular surface reconstruction in diseases and injuries that cause vision loss or blindness and present with limbal stem cell deficiency. There is currently no satisfactory medium- or long-term treatment when the disease presents with such a deficiency.
- FIB-117: New therapy for the treatment of traumatic spinal cord lesions that can lead to the onset of paraplegia or quadriplegia. The indication of traumatic brain injury is also being considered.
- FIB-114: Drug for the treatment of non-Hodgkin's lymphoma and chronic lymphocytic leukemia. This product is already commercialized and widely used in other non-oncological indications, but when administered and formulated in a novel way, it exhibits a potent and selective antitumor action.
- FIB-115: New diagnostic system based on an epigenetic platform to determine the primary site in cancers of unknown origin.
- TTC ELA: Demonstrate the technical viability and efficacy of a new biological drug for the treatment of amyotrophic lateral sclerosis, based on the extreme C-terminal of the tetanus toxin and, should it prove possible, proceed to an advanced stage of pre-clinical development.
Lifecycle Management Unit
Eight projects are being developed in the fields of dermatology, gastroenterology, cardiology and the central nervous system. They include line extensions of products already on the market, providing new formulations and indications, and research into new products to expand Ferrer’s therapeutic arsenal.
Corporate Product 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. This project is being undertaken together with the Spanish National Center for Cardiovascular Research and the endorsement of the World Heart Federation.
- Modified release generic products: Various projects in development, such as Pramipexole XR and Ranolazine XR.
- Complex generic products: Projects currently in development include transdermal patches and extended-release injectable depot, such as Paliperidone Palmitate.
The generic pipeline contains more than a dozen products, aimed mainly at European markets, although six projects that are in development focus on the U.S. market, such as Celecoxib.
- DAP: Diagnosis of penicillin allergy. World’s first diagnosis of sensitivity to beta-lactam antibiotics. This line of research incorporates progressively more products for the diagnosis of drug allergies into the pipeline.
- VHC-Core: In vitro diagnosis of hidden hepatitis C. Opens up the possibility of the diagnosis of a greater percentage of patients with HCV infection, providing a higher sensitivity in comparison to currently-available diagnostic tests.
- Alt a I: Allergen of the fungus Alternaria alternata with a high degree of purification. This purification technology is being tested for application in other allergens. Having a highly purified protein improves both the diagnostic capacity and safety when compared to the efficacy obtained with the full 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.
- FibroChip: Genetic diagnosis for predicting the risk of developing liver fibrosis in patients with the hepatitis C virus. The genotyping data which has been obtained is currently being processed to confirm the genetic signature and to start developing the technology.