Partnership Opportunities Sought

We aspire to discover, develop and commercialize truly innovative treatments that satisfy unmet medical needs regionally and globally. We have focused our resources on therapeutic areas with a substantial potential for growth and, with you, we will deliver ground-breaking new treatments to patients worldwide.

Type and stage of opportunity

Commercial Licensing

Takeda is seeking pre-registration, registration and in-market late stage opportunities aligned with specific geographic and/or therapeutic areas of focus. While we are focused on opportunities in our core therapeutic areas, our decisions are guided by our in-depth market knowledge, whether that market is a specific country, region or even the globe. Our goal is to identify opportunities that allow us to leverage our global infrastructure to bring products to market that address unmet patient needs. We are interested in opportunities for both ethical and over-the-counter medications. In the United States, our interest is in ethical compounds only.

R&D Partnering

We are seeking multiple and diverse external opportunities including:

• Development collaborations for clinical and preclinical products in core therapeutic areas
• Research alliances involving core therapeutic areas and/or novel technologies
• Pharmaceutical science alliances

Therapeutic areas

Cardiovascular/Metabolic

Takeda has a strong heritage in the cardiovascular and metabolic areas. Our expertise in this area is demonstrated in the early introduction of the alpha glucosidase inhibitor voglibose (BASEN) and the PPAR-γ pioglitazone (ACTOS), followed more recently by the DPP4 inhibitor alogliptin (NESINA). Our current development interests extend into treatments for obesity and metabolic syndrome, as well as innovative treatments that provide A1c lowering benefits for people with type 2 diabetes.

Our commitment to cardiovascular disease is marked by the early introduction of candesartan to the global market. More recently, azilsartan (AZILVA) was introduced to the Japanese market. This is followed by the launch of azilsartan medoxomil (EDARBI), which recently received Marketing Authorization in Europe and is already available in the United States and Mexico. Our focus on the treatment of hypertension continues with the recent approval and launch of azilsartan medoxomil/chlorthalidone (EDARBYCLOR) in the United States. Our development interests extend into cardiovascular disease areas with high unmet need, such as heart failure, critical limb ischemia and atrial fibrillation.

• Areas of interest:

  Obesity

  • Treatments with a 10 percent weight reduction potential

  Cardiovascular Disorders

  • Treatments for acute heart failure with a focus on bioenergetics modulation, calcium kinetics and myocardial regeneration
  • Treatments for atrial fibrillation with a focus on normal sinus conversion and maintenance
  • Treatments for peripheral arterial disease/critical limb ischemia with a focus on angiogenesis, improved endothelial function and inflammation prevention
  • Treatments for regenerative medicine technologies with a focus on acute and chronic disease, including heart failure and peripheral artery disease
  • Treatments for pulmonary arterial hypertension with a focus on improvement over currently available agents and combined therapies

  Diabetes

  • Treatments for type 2 diabetes with a focus on insulin sensitization, significant A1c reduction, cardiovascular protective effects and weight reduction
  • Treatments for type 1 diabetes with a focus on gene therapy, including regenerative medicine; vaccines and anti-inflammatory/immunomodulatory effects
  • Treatments for diabetic neuropathy, excluding foot ulcers, with a focus on immunoglobulin Gs, peptides and oral agents in the clinical stage
  • Diabetic retinopathy with a focus on monoclonal antibodies, peptides and oral agents in the clinical stage

Immunology

We have a strong track record in immunology in the Japanese market and are committed to globalizing that expertise and expanding our portfolio in this area by partnering on oral and injectable mechanisms, biologics and innovative delivery platforms. Currently, we market etanercept (ENBREL) for the treatment of rheumatoid arthritis in Japan and febuxostat (ULORIC) and colchicine (COLCRYS) for the treatment of gout in the US. We are focused on expanding into novel immunology agents, small and large molecule, in both early and late-stage development.

• Areas of interest:
  • Rheumatoid arthritis
  • Systemic lupus erythematosus
  • Primary Sjogren’s syndrome
  • Psoriasis
  • Solid organ transplantation desensitization
  • Atopic dermatitis
  • Scleroderma
  • Pemphigus
  • Vasculitides with a focus on Behcet’s disease
  • Gout
  • IgA nephropathy
  • Multiple sclerosis
  • Ankylosing spondylitis

Respiratory

In the area of respiratory medicine, our commercial interests encompass asthma, allergic rhinitis and chronic obstructive pulmonary disease (COPD). The respiratory drug roflumilast (DAXAS), for example, a treatment for COPD, is expected to see significant demand in both emerging markets and developed countries. Our current development initiatives extend beyond to include acute lung injury, acute/infant respiratory distress syndrome and idiopathic pulmonary fibrosis. We are interested to investigate novel oral and inhaled mechanisms, biologics and innovative inhaled delivery platforms.

• Areas of interest:
  • Oral, inhaled or injectable agents for COPD with a clinical proof of concept or a compelling biological rationale, including combination therapies
  • Disease-modifying therapies for the treatment of COPD and allergic rhinitis
  • Immune-modulating approaches for the treatment of asthma
  • Oral, inhaled, or injectable agents for asthma, including anti-inflammatory agents with differentiated mechanisms, anti-inflammatory and bronchodilator agents that are additive or differentiated from existing classes, anti-inflammatory agents that are effective in glucocorticoid-resistant asthma and selective glucocorticoid receptor modulators, including combination therapies
  • Inhaled technologies and formulations that provide improved drug delivery and patient compliance or acceptance
  • Biomarker and translational medicine platform technologies

General Medicine

Our General Medicine franchise is built on our foundational products and seeks to exploit our demonstrated scientific and commercial leadership in gastrointestinal (GI) disorders and urology, as well as our expanding interest in renal medicine. In gastroenterology , we have achieved significant success with lansoprazole (PREVACID ), dexlansoprazole (DEXILANT) and pantoprazole (PANTOZOL). In the renal arena, peginesatide (OMONTYS) has recently been launched in the US and ferumoxytol (RIENSO) is soon to launch in the EU. Innovative medicines are being developed for upper GI disorders, inflammatory bowel disease, treatment of anemia in chronic kidney disease and a range of urological conditions.

• Areas of interest:

  Gastroenterology

  • Oral treatments for mild to moderate inflammatory bowel disease (Crohn’s Disease, Ulcerative Colitis)
  • Treatments for irritable bowel syndrome with a focus on diarrhea predominant or mixed types
  • Treatments for non-infectious liver diseases, including fibrosis/cirrhosis and encephalopathy

  Renal/Urological Diseases

  • Treatments for fluid and electrolyte management
  • Treatments for prevention and correction of anemia in chronic kidney disease
  • Treatments for diabetic nephropathy, focal segmental glomerulosclerosis, polycystic kidney disease, IgA Nephropathy or acute kidney injury
  • Treatments for urge urinary incontinence/overactive bladder
  • Medical treatments for stress urinary incontinence
  • Treatments for nocturia

  Other

  • •Treatment of chronic pain, either neuropathic or
  • •osteoarthritic, with a focus on novel mechanisms of action

Central Nervous System

Takeda recently reaffirmed its commitment to CNS disorders: we aim to discover, develop and deliver innovative and truly differentiated medications for patients suffering from psychiatric and neurodegenerative disorders. Our marketed CNS products include the melatonin (MT1/MT2) receptor agonist ramelteon (ROZEREM), available in the US and Japan, and galantamine (REMINYL), co-marketed in Japan with Janssen. We proactively invest in internal and external compounds, technologies, and mutually beneficial research collaborations. Our commitment to productive clinical development partnerships is illustrated by our active collaborations in mood disorders (Lu AA21004, with Lundbeck), schizophrenia (lurasidone [LATUDA], with Dainippon Sumitomo), and Alzheimer’s disease prevention (AD4833/TOMM40 insulin sensitizer/biomarker assay, with Zinfandel Pharmaceuticals).

• Areas of interest:
  • Treatments that slow progression in Alzheimer’s disease (AD), with a preference for non-amyloid mode of action (MOA)
  • Treatments having MOAs consistent with the ability to slow disease progression across multiple neurodegenerative disorders (e.g. Huntington’s disease, ALS, Parkinson’s disease, Dementia with Lewy Bodies, and Frontotemporal Dementia)
  • Agents providing significant symptomatic improvement for AD and other neurodegenerative disorders (unusual benefit as monotherapy and/or adjunctive therapy)
  • Disease-modifying therapies that aim to change the natural history of schizophrenia
  • Treatments for schizophrenia symptoms not addressed by antipsychotic medications, such as cognitive impairment and negative symptoms
  • Disease-modifying treatments for other psychotic or neurodevelopmental disorders (e.g. Bipolar Disorder, Autism, Fragile X Syndrome, Rett Syndrome), with a focus on therapies that can be applied across multiple disorders
  • Symptomatic treatments for psychotic and neurodevelopmental disorders that meaningfully differentiate from available treatments (monotherapy and/ or adjunctive therapies)
  • Novel technologies, including:
    • Biomarkers to identify populations at risk for prioritized CNS disorders
    • Technologies to assess and support patient compliance with treatments for prioritized CNS disorders
    • Translational biomarkers with proof of concept in animal models
    • Technologies to improve blood-brain barrier penetration
    • Technologies to assess dynamics of neural circuits/ networks and to assess neuroinflammatory/neurodegenerative changes in vivo
    • Novel animal models and technology platforms for Alzheimer’s disease, schizophrenia and related disorders
  • Vasculitides with a focus on Behcet’s disease
  • Gout
  • Multiple sclerosis
  • Ankylosing spondylitis

Oncology

When it comes to oncology, our goals are ambitious. Millennium, the Takeda Oncology Company, aspires to cure cancer. We have established a world-class research and development organization that is building on our existing blockbuster drugs , such as bortezomib (VELCADE) and leuprorelin (LUPRON), and is advancing our commitment to treat orphan disease. We engage the full spectrum of academic, venture capital and industry partners to supplement our extensive internal activities in the oncology arena. Millennium has an exciting pipeline in hematologic and solid tumors. Late stage assets are in development for multiple myeloma, prostate cancer and lymphoma. In the drug discovery area, we have a unique focus on all aspects of protein homeostasis, building on the knowledge developed from bortezomib, the first proteasome inhibitor to be marketed and to achieve blockbuster status worldwide. We are committed to the development of both small molecule drugs and biologics.

• Areas of interest include:
  • Protein homeostasis
  • Targeted therapeutics
  • Companion diagnostics for patient selection
  • Reformulation technologies for enhanced PD and DMPK properties
  • Assets that have achieved proof-of-concept stage

Vaccines

We aspire to become a global leader in vaccines. To achieve this goal, we will build on our heritage as a major supplier of pediatric vaccines in Japan for the past 60 years. We are particularly interested in identifying and working with partners to develop prophylactic vaccines for unmet disease states. Vaccines currently under development by Takeda for the Japanese market include pediatric combination vaccines and a haemophilus influenza type b vaccine, which is currently in Phase 3 trials.

• Areas of interest:
  • Monoclonal antibody approaches
  • Nanoparticle adjuvant and micro needle patch
  • Nanoparticle adjuvant and micro needle patch
  • Respiratory Syncytial virus
  • Dengue/Chikungunya
  • Cytomegalovirus
  • Norovirus

Chemistry Manufacturing and Controls Center (CMCC)

Takeda CMCC is the corporate division responsible for supplying clinical trial materials to support Takeda development projects. CMCC has three important areas of focus: 1) timely supply of clinical trial materials; 2) improvement of drug products through the application of novel technologies to enhance value to patients; and 3) optimization of manufacturing processes for drug substance and drug product to improve efficiency, environmental impact and cost. External partnerships are vital to the successful achievement of our objectives, and Takeda CMCC is seeking collaborations on a wide variety of novelpharmaceutical science technologies and outsourcing opportunities that can add to, or create, new pipeline value.

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  CMCC is looking for opportunities for manufacturing and service partnerships in the following areas:

  • API and intermediate synthesis
  • API isotope labelling
  • Process and formulation development
  • Master cell bank (MCB) creation and testing
  • GLP and GMP manufacturing, including sterile fill
  • Packaging
  • Dissolution testing for BE
  • Registration stability studies

  CMCC works on four drug modalities: small molecules, biologics (monoclonal antibody and protein), synthetic polymer drugs (oligonucleotide, peptide and oligosaccharide) and vaccines. Our areas of interest for novel pharmaceutical science technologies are as follows:

  Formulation

  • High concentration/stabilizing formulation for biologics (including mAB, ADC, proteins)
  • High loading SR formulation (including oral and injectable)
  • Nano sizing/crystallization for solubility enhancement
  • Vaccine stabilization (including cold-chain free systems)

  Delivery

  • Depot systems (such as biomarker sensitive polymer)
  • Vaccine delivery systems (such as microneedle, intelligent transdermal systems, nasal delivery systems)
  • DDS technology (including polymer materials and conjugation)
  • Active targeting technology
  • Oral delivery enhancement for peptides
  • Nanoparticle systems

  Devices

  • IT technologies for compliance enhancement
  • IT and electronics-based delivery technologies
  • Smart packaging
  • Non-sharps injection systems

  Analytical technologies

  • IVIVC: in vivo release prediction and characterization
  • Polymorph screening
  • Non-destructive analysis (including imaging such as near-infrared spectroscopy and X-ray-CT)
  • Rapid microbiological method
  • Biologics and vaccine characterization
  • Counterfeit drug detection

  Drug substance process and manufacturing

  • Biologics: Cell line construction (including host-vector systems and transfection methods), purification process, conjugation (including antibody-drug, peptide and PEGylation), production process for antibody and antibody fragments, computational fluid dynamics of cell culture
  • Synthetic polymer drug: Liquid phase synthesis
  • Small molecule: Continuous processing, flow micro chemistry, crystallization, asymmetric catalysis, enzyme catalysis, particle size control
  • Process optimization: High throughput screening technologies

New Frontier Science

New Frontier Science (NFS) was established to support scientists who are conceiving ground-breaking life science technologies and nurture translation of their ideas from concept to reality. Our goal is to work closely with innovators and provide guidance, resources and financing to advance their vision from conception through key proof of concept experiments. We will act as the point of entry for innovation into Takeda by brokering connections between NFS-supported groups and researchers, investors and development partners within Takeda. We are focused on academic medical centers, research institutions, incubators and nascent companies around the world. In addition to Takeda’s traditional business focus of novel pharmaceutical agents, we are interested in adjacent technologies such as diagnostics, devices or business practices that would influence pharmaceutical development, as well as patients and their use of pharmaceutical products. We will consider any disease that can be treated with prescription pharmaceuticals to realize true and substantial clinical benefit.

Takeda Ventures

Takeda Ventures, Inc. (TVI) is our corporate venture arm. Our mission is to support the development of external therapeutic innovation that is strategically aligned with Takeda’s R&D imperatives and that offers the potential to realize new, advanced healthcare options for patients worldwide. We do this by investing in pharmaceutical technology and product concepts and by fostering highly effective management teams that can turn ideas into reality.

As a strategic investor, we aim to encourage and support therapeutic innovation in the biopharmaceutical sector, as well as academic centers of excellence, through early stage capital investment and access to the resources of a multinational pharmaceutical company. The geographic scope of investments includes North America, Europe and the Pacific Rim territories, including Japan. While we will consider product, target and technology opportunities at any stage, our focus is on start-up/ seed rounds through mid-stage financing. We will consider follow-on rounds of investment where the strategic intent remains true and further funding is required to drive projects to fruition.

We maintain a diverse investment portfolio with a concentration on drugs and biotherapeutics to treat cancer, metabolic disorders (obesity, diabetes and dyslipidemias), cardiovascular disorders, chronic inflammatory and immune disorders (gastrointestinal and bone and joint disorders) and diseases of the central nervous system (Alzheimer’s disease and schizophrenia). Additional areas of strategic importance include regenerative medicines, RNA and DNA modulation, protein and peptide drug delivery systems, novel vaccine technologies and innovative protein and peptide biotherapeutics.