R & D

R&D Strategy

ESTEVE’s R&D strategy rests on three key pillars:

  • Maintaining a risk-balanced, sustainable portfolio.

    Our portfolio presently includes:

    New Chemical Entities in Analgesia

    New Biological Entities / Advanced therapies in different therapeutic areas

    New formulations for innovative concepts in different therapeutic areas

    High added-value projects with generic drugs in different therapeutic areas

    Lifecycle management projects to secure the positioning of our already marketed products

    Development of new processes for the manufacturing of new pharmaceutical active ingredients

    Our portfolio and our bet on R&D, together with our manufacturing capacity, have been given an Excellent rating by the Proforma Plan uninterruptedly since the year 1986.

  • Strengthening our focus on pain.

    ESTEVE programs in the field of pain are designed to understand the mechanisms of pain and their impact on physical and emotional well-being. Our research is closely related to unmet medical needs in this field and, consequently, contributes to enhance the quality of life of patients.

    As a key component of ESTEVE’s R&D portfolio, we are currently developing innovative treatments against pain. We believe that these treatments will give hope to patients who suffer from severe, hard-to-control pain, thus significantly enhancing their quality of life.

  • Expanding our network of excellence

    We currently enter into two types of collaboration:
    Collaborations with Centers of Excellence
    External R&D projects

    Because collaborations with Centers of Excellence allow us to access knowledge, talent and cutting-edge technologies, we become part of an open innovation ecosystem.
    On the other hand, as part of the diversification strategies of our R&D portfolio to other therapeutic areas besides analgesia, ESTEVE builds R&D alliances of varying nature to access highly innovative projects that deliver real added value to the patient.

Capacities

We promote internal synergies through integrated collaboration between groups with complementary capacities, ranging from drug discovery to marketing.

  • NCE/NBE R&D&i

    Directed at product development

    • Design of in silico drugs
    • Cell & molecular biology
    • Medicinal chemistry
    • Pharmacology
    • Preclinical development
    • Clinical development
    • Pharmaceutical development
    • Quality assurance
    • Regulatory affairs
    • Industrial property
    • Safety pharmacology and
      pharmacovigilance
    • R&D Strategy
  • R&D&i Pharmaceutical Innovation

    Directed at formulation development

    • Oral formulations
      • • Capsules, tablets, multilayer, mups
      • • Enteric coatings
      • • Pellets
    • New technologies
    • New formulations
    • Pilot plant
    • Clinical samples
    • Registration batches
  • R&D&i in active ingredient manufacturing processes

    Focused on active ingredient development

    • New manufacturing processes
    • In-house and third parties developments
    • Use of new technologies
  • Collaboration between groups with complementary skills

  • Directed at product development

    • Design of in silico drugs
    • Cell & molecular biology
    • Medicinal chemistry
    • Pharmacology
    • Preclinical development
    • Clinical development
    • Pharmaceutical development
    • Quality assurance
    • Regulatory affairs
    • Industrial property
    • Safety pharmacology and
      pharmacovigilance
    • R&D Strategy
  • Directed at formulation development

    • Oral formulations
      • • Capsules, tablets, multilayer, mups
      • • Enteric coatings
      • • Pellets
    • New technologies
    • New formulations
    • Pilot plant
    • Clinical samples
    • Registration batches
  • Focused on active ingredient development

    • New manufacturing processes
    • In-house and third parties developments
    • Use of new technologies

R&D Partnerships

R&D has been present in ESTEVE’s DNA since the very beginning. We have a long tradition of collaboration in R&D, mainly in two fields:

R&D strategic alliances and collaborations

ESTEVE’s goal is to develop innovative models of collaboration in R&D with companies and academic centers in order to accelerate the transference of science to a possible new medicine. Our wide range of collaborations in R&D includes Joint Strategic Units, Public-Private Partnerships (PPP) and Research Consortia (FP7 and IMI). Particularly:

  • Institut Català d’Investigacions Químiques, Tarragona (ICIQ): Esteve-ICIQ mixed unit
  • University of Santiago de Compostela (USC): Esteve-USC mixed unit
  • Parc Científic de Barcelona (PCB): Esteve-PCB mixed unit
  • Universitat Pompeu Fabra, Barcelona (UPF): Esteve-UPF mixed unit
  • University of Granada
  • Universidad Miguel Hernández, Alicante
  • University of Girona
  • Instituto Ramón and Cajal, CSIC, Madrid
  • Universidad Rey Juan Carlos, Alcorcón
  • Universitat Autónoma de Barcelona (UAB): Esteve-UAB Public-Private Partnership
  • Companies: Enantia, Galchimia, etc...
Esteve lliances and collaborations in R&D
Esteve partnering R&D

Partnering in R&D projects

Our objective is to select the best partners for the codevelopment (particularly in the final stages of development) and further marketing of our in-house R&D programs.

Two programs are currently in Phase II (E-52862 and E-58425).

Pipeline - Portfolio

ESTEVE developed several programs in the field of pain that are currently in preclinical phase. ESTEVE’s portfolio also includes a set of R&D projects themselves(Bioequivalence Projects, Technology formulation, line extensions) with high added value, which are in various stages of development in different therapeutic areas.

A portafolio of novel therapeutic solutions targeting unmet medical needs

  • In-house R&D programs

    • Research / Preclinical

    • Phase I

    • Phase II

    • Phase III

    • Registration

  • neuropathic pain

    E-52862: First-in-class NEQ

    Selective Sigma-1 receptor antagonist

    Primary indication:

    Neuropathic pain.

    Development goals:

    Improving the efficacy of the response rate.

    Increasing the magnitude of the effect.

    Improving safety and tolerability.

    Achieving a better risk-benefit ratio.

    Targeted positioning:

    New first-in-class therapeutic standard for the treatment of neuropathic pain.

    Additional indications:

    Acute and chronic pain treatment in patients treated with opiates.

    Partnering Status:

    Worldwide Development Rights Mundipharma-Purdue.

  • (Moderate to severe) ACUTE AND CHRONIC PAIN

    E-58425: First-in-class co-cristal. Multimodal mechanism of action.

    USA development: Esteve / Ex-USA development: Mundipharma

    Primary indication:

    Moderate to severe acute and chronic pain.

    Development goals:

    Increasing the magnitude of efficacy without increasing adverse effects.

    Targeted positioning:

    Therapeutic standard for the treatment of moderate to severe pain.

    Partnering Status:

    USA development: Esteve / Ex-USA development: Mundipharma.

  • PAIN

    MUMO1: First-in-class NCE. Multimodal

    mechanism of action, including Sigma-1 act.

    Primary indication:

    Pain.

    Development goals:

    Same efficacy as standard treatment.

    Reduction of side effects as compared to standard treatment.

    Partnering Status:

    Worldwide option to license by Mundipharma-Purdue.

  • PAIN

    Other projects

  • R&D collaborative programs research

    • Research / Preclinical

    • Phase I

    • Phase II

    • Phase III

    • Registration

  • MUCOPOLISACARIDOSIS TYPE III A

    EGT-101: First-in-class AT

    Gene therapy for Sanfilippo A syndrome

    Primary indication:

    Development of gene therapies for the treatment of mucopolysaccharidosis.

    The most advanced project is a novel gene therapy for the treatment of Sanfilippo type A Syndrome.

    Currently there is no cure for Sanfilippo type A Syndrome.

    Currently available treatments do not stop the progression of the disease.

    Development goals:

    Developing a safe, effective gene therapy to stop the progression of the disease and potentially reverse the effects of Sanfilippo type A Syndrome.

    Orphan Drug Designation by both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA).

  • MUCOPOLISACARIDOSIS TYPE III B

    EGT-201: First-in-class AT

    Gene Therapy for Sanfilippo type B Syndrome

  • MUCOPOLISACARIDOSIS TYPE II

    EGT-301: First-in-class AT

    Gene Therapy for Hunter Syndrome

  • Gene Therapy

    Other projects

NCE: New Chemical Entities

AT: Advanced Therapy

ESTEVE developed several programs in the field of pain that are currently in preclinical phase. ESTEVE’s portfolio also includes a set of R&D projects themselves (Bioequivalence Projects, Technology formulation, line extensions) with high added value, which are in various stages of development in different therapeutic areas.


Projects of new molecular entities have been the subject of aid by the Ministry of Economy and Competitiveness, through the Center for Industrial Technological Development CDTI (E-52862, mumo projects) and INNPACTO (HIVACAT, Sanfilippo) and CHALLENGES (Phenopain) programs, all financed by the European Regional Development Fund, ERDF. As well we have received aid from the European Commission through the 7th Framework Programme (Neuropain) and the Agency for Competitiveness Company, ACC1ó, Generalitat de Catalunya (E-58425).


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