• Investigation and research of active ingredients

Investigation and research of active ingredients

Drug Development Seed Research

We collect information globally, and strive for new drug development seed research in cooperation with our international offices.

In regards to active ingredients for new drugs for topical application, we conduct research in cooperation with our international offices in the UK, Germany, and the USA. All information collected is added to a database for visualization and sharing among R&D staff.

Licensing activities

We have been developing in-licensed products from domestic and overseas pharmaceutical companies as well as in-house developed products, which allows us to steadily reduce the lead-time and cost of product commercialization.

In addition to a long-lasting collaboration with European pharmaceutical companies for over half a century, we continuously pursue new licensing activities with pharmaceutical companies in Japan and overseas. We are making every effort to reduce the time to develop new drugs and maintain 10 or more projects in our development pipelines, and as such, we are realizing steady growth in our R&D activities.

Verification of usefulness and optimization for topical use of active ingredient

Assessment of active ingredients

We conduct research for topical drugs by assessing active ingredients with our expertise.

We assess and verify the usefulness of development candidates through various assessment techniques. Researchers with expertise in a variety of different fields are working in collaboration with each other and paying close attention to the opinions of those involved in medical services, and as such, they evaluate the potential of candidates for improvement of the development pipeline.

Optimum design for topical drugs

We develop new topical drugs that offer superior efficacy, safety, quality, productivity and usability.

With regards to the optimization of topical drugs, we rely on the five key concepts of “Improvement to topical formulation”, “Addition of topical formulation", "Addition of indication to topical drugs”, “Topicalization of existent drugs ”, and “Chemical synthesis for topical uses”. We are making efforts to improve patient compliance with the implementation of a variety of different measures, such as developing topical formulations from existing non-topical active ingredients and generating different formulations from ointments to creams, lotions, gels, and other appropriate formulations.

Non-clinical Investigations and Formulation Development

Non-clinical investigations

We are doing our best to estimate the dosage and administration for human clinical trials by accumulating non-clinical data, mainly from animal experiments, to verify efficacy and safety.

We conduct a wide variety of experiments using cells, tissues, and animals for the development of candidates and formulations to ascertain the pharmacological effect, safety threshold, and ADME-behavior. We collect reliable data through experiments in our laboratories in accordance with regulations and guidelines. We are giving our best efforts to setting the accurate dosage and administration for clinical studies, and we support smooth and appropriate clinical investigations.

Formulation development

Equipped with homogenizers ranging from beaker scales to Japan's largest scale for laboratory use, we expedite the development of topical drugs from research to the actual factory production stage.

We are equipped with the same form of homogenizer ranging from 0.3 liters for prescription design to 300 liters for research on industrialization and high-speed tube-filling machines that are capable of handling 3000 tubes per hour. This allows efficient large-scale manufacturing of Phase III investigational drugs and technology transfer to the Production Department. Furthermore, our operations are governed by Good Manufacturing Practices for investigational new drugs in consideration of international GMP enable us to promote clinical trials in cooperation with the Clinical Department.

Clinical Investigations

Clinical investigations

We also conduct clinical investigations not only in Japan but also in Europe and the United States to confirm the efficacy and safety for human use, and to assess the true value of trial drugs as pharmaceuticals.

Clinical investigations are essential in order to ultimately confirm the efficacy, safety, and quality of pharmaceuticals. Based on the data and information obtained from non-clinical investigations, clinical investigations are planned, organized, and executed for the purpose of confirming efficacy and safety in humans. Clinical investigations, which are divided into phases with evaluations conducted in stages from healthy subjects to patients, and from small numbers to large numbers of patients. Clinical investigations must be conducted in compliance with Good Clinical Practice standards. Clinical data must be collected in accordance with the guidelines of ICH. Equipped with offices in three regions, Germany (Leverkusen), the United States (Philadelphia), and Japan, Maruho is talking with global “Key Opinion Leaders” in the dermatology field, and deploying clinical development throughout the world in accordance with regulations overseas. These clinical and non-clinical investigations are managed under the project management system lead by “Project Managers” in each specific region. The reliability of collected data and materials is assured by the “Quality Assurance Unit”, and ultimately compiled as materials for filing the new drug application dossier for approval with the relevant health authorities.

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