R+D+i BY DIVISIONS
BIOSCIENCE DIVISION

Grifols’ leadership in the plasma-proteins sector is based on new therapeutic indications for plasmaderived products, the discovery of new proteins and continuous manufacturing innovations that enhance the efficiency and safety of Grifols products.

MAIN MILESTONES AND BREAKTHROUGHS IN 2019
  • Completion of the clinical research phase of 20% subcutaneous immunoglobulin to treat patients with primary immunodeficiencies in Europe to obtain EMA authorization.
  • Development of Gamunex® as maintenance therapy for myasthenia gravis (MG). The company submitted EMA marketing authorization in 2019.
  • Development of the phase III PRECIOSA trial on the potential benefits of albumin to treat liver cirrhosis and phase III APACHE trial to treat acute chronic liver failure (ACLF) with albumin.
  • New Albumin format in flexible packaging for different concentrations. Registration of 25% albumin obtained in May 2019.
  • FDA submission of Gamunex® New process as an Investigational New Drug (IND).
  • Patients admitted in clinical trials to evaluate the efficacy and safety of Grifols’ fibrin sealant to promote hemostasis during liver surgery and soft-tissue surgery.
  • Launch of research phase on intravenous fibrinogen for pediatric use.
  • Establishment of Plasma Protein Replacement Therapies group for the research and development of projects related to plasma-protein replacement applied to different pathologies and modalities, including low-volume plasma exchange.
  • Approvals and launch of new formulations and indications that expands Grifols’ product portfolio and adapt to the needs of patients and healthcare professionals:
    • FDA approval and U.S. market launch of 20% subcutaneous immunoglobulin (Xembify®) to treat primary immunodeficiencies.
    • FDA approval of a new laparoscopic device and applicator tip for Grifols’ fibrin sealant (VistasealTM) and market launch in the U.S.
    • FDA approval of a new high-concentration anti-rabies immunoglobulin (HyperRAB® 900IU) to treat patients exposed to the rabies virus.
    • EMA approval for new indications of the Flebogamma® DIF immunoglobulin, including chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy (MMN).

The following table summarizes the Bioscience Division’s R+D projects over the last three years based on their phase of development


DIAGNOSTIC DIVISION

Grifols strives to deliver diagnostic solutions that enhance the safety of blood and plasma donations in alignment with its corporate mission and the World Health Organization’s integrated strategy. The Diagnostic Division’s R+D+i initiatives focus on developing comprehensive solutions that add value and increase safety throughout the value chain, from donations to transfusion. The development of new systems and technologies, including new reagents and analyzers, are the main focus of their efforts.

In the field of specialty diagnostics – one of the areas with the highest potential for growth – Grifols produces genomic and proteomic tests for in-vitro diagnostics, prognosis assessment, response prediction and biologic drug monitoring. It also develops molecular diagnostic tests and prognosis in oncology, autoimmunity, cardiovascular medicine and the central nervous system.

Main Milestones and Breakthroughs in 2019
  • FDA approval of the blood test to detect the babesiosis parasite, one of the infectious diseases most frequently transmitted via blood transfusions in the U.S. The ongoing development of new trials highlights Grifols’ commitment to safety of the blood supply.
  • Clinical trials on the Procleix® Ultrio Elite line continue in China.
  • Grifols continues to innovate in the area of immunohematology, one of the division’s core diagnostic lines. Noteworthy is the in-house development of a new CD38 recombinant protein that facilitates the identification of suitable blood donors for myeloma and lymphoma patients undergoing monoclonal anti-body immunotherapy (Daratumumab), one of the newest therapies on the market.
  • Launch of new card reader (DG® Reader Net) that mitigates risks of errors in laboratories that use the reader as an auxiliary system and in those whose work volume doesn’t allow for automated transfusion techniques.
  • In-house development of innovative solutions such as the AlphaKitTM (blood test) and AlphaIDTM (bucal swab) to improve the diagnosis rate of alpha-1 antitrypsin deficiency
HOSPITAL DIVISION

The Hospital Division’s research and development efforts focus on expanding the range of hospital logistics systems and compounding processes for hospital pharmacies, as well as providing hospitals with intravenous solutions.

At present, 10% of hospital prescriptions require IV compounding, a process that entails preparing a unique intravenous therapy by modifying the medication’s formulation. Most personalized compounds are prepared manually, a costly process that requires specific cleanroom facilities, equipment and maintenance in a sterile environment. A higher degree of automation in these processes enhances patient safety and reduces hospital costs.

Main Milestones and Breakthroughs in 2019
  • In the Pharmatech line, the bidirectional integration of PharmacyKeeper, a verification intravenous workflow management system, with the healthcare information system Epic® stands out. The interoperability between the workflow management platform and Epic’s health information system increases patient safety and optimizes hospital-pharmacy systems. As an example, this exchange of information facilitates the process of preparing patient-specific doses and batch orders following safe procedures. For its part, PharmacyKeeper’s automatic data exchange functionality enables more accurate financial and inventory management in Epic®.
  • Launch of new PharmacyKeeper software, which improves workflows and safety in all areas, including a better overview of critical pharmacy operations and the capacity to serialize medication batches and identify alternatives by patient and batch. The new software also expands the bidirectional integration with Epic® by admitting rare or unique medications and personalized individual doses.
  • Launch of KIRO Fill®, a next-generation system for automated compounding of sterile preparations that offers greater flexibility in the syringe filling of non-hazardous IV medications. The solution is designed to boost patient safety, optimize operational efficiency and facilitate regulatory compliance.