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FUJIFILM Corporation (President and CEO: Shigetaka Komori) announced that it has established FUJIFILM Pharma Corporation (President Kanji Yagi; hereinafter "FFP"), making a full-scale entry into the clinical development and sales of pharmaceutical products. Fujifilm plans to commence business operations of the new company in April 2010. Under a capital and business partnership with Mitsubishi Corporation (hereinafter "Mitsubishi Corp") and Toho Holdings Co., Ltd. (hereinafter "Toho HD"), Fujifilm vies to put the business on track at an early stage to offer a stable supply of quality and reliable pharmaceutical products to medical institutions.
The launch of the new company is aimed at developing a pharmaceutical business arm for Fujiiflm, and building a sales foundation in this market. FFP will undertake the development, manufacturing and marketing of pharmaceutical products, and start with the marketing of generic drugs at the launch of its sales operations. Owing to the fact that generic drugs are more affordable than innovative drugs, the Ministry of Health, Labour and Welfare promotes proliferation of generic drugs to reduce patients' financial burden and mitigate medical spending. In order to promote their use in the future, it is necessary to gain the trust of healthcare professionals concerning the quality, supply stability and information availability of generic drugs. Addressing these market needs, FFP is to define its own quality assurance standards on pharmaceutical products*1 covering "three areas of quality control"; i.e. the "quality control of raw materials", "control of manufacturing processes and design quality" and "post-sale quality control". It will select, evaluate and procure products that meet these standards from Japanese and foreign pharmaceutical partners, and deliver them to medical institutions and prescription pharmacies under the Fujiiflm brand, thereby contributing to the proliferation of highly reliable generic drugs.
In a tie-up with Fujifilm's Drug Discovery Research Laboratories, FFP will use the proprietary FTD technology*2 to develop and market generic drugs of high added value, and aims to evolve into a general pharmaceutical company that also handles innovative drugs to be developed by Fujiiflm. The use of the FTD technology will improve pharmaceutical solubility, enhance chemical stability, add a sustained release property and expand available alteration of dosage forms, reducing physical strains on patients and making them easier to use than conventional products for medical institutions.
In establishing FFP, Fujifilm has formed a partnership with Mitsubishi Corp, which promotes far-reaching life-science businesses in the medical field, and has a powerful network of Japanese and overseas manufacturers of active pharmaceutical ingredients and pharmaceutical products, in order to establish a framework for obtaining high-quality active pharmaceutical ingredients at low costs. The partnership with Toho HD, a major pharmaceutical wholesaler with extensive sales and logistics networks, is designed to establish an infrastructure for the stable supply of pharmaceuticals. The capital and business partnerships with these companies are set to create a new business model in the pharmaceutical industry.
Defining medical systems & life science business as its key growth area, the Fujiiflm Group is seeking to cover "prevention, diagnosis and treatment" comprehensively as a general healthcare company. In the area of "treatment", the Group includes Toyama Chemical, which excels in drug creation, and FUJIFILM RI Pharma, which has extensive track record in the area of radiopharmaceuticals. Other related group companies include Perseus Proteomics, a venture business originated from the University of Tokyo with proprietary antibody development technology, and FUJIFILM Finechemicals, which produces pharmaceutical raw materials. The Drugs Discovery Research Laboratories were also established in June last year to reinforce the Group's ability to explore innovative drug candidates and expand the pharmaceutical business. In the area of "diagnosis", the Group has contributed to the healthcare industry for many years with digital x-ray diagnostic imaging systems, medical image information systems and endoscopes. Tapping into these proprietary technologies and resources, the Fujiiflm Group will draw upon its vast reserve of capacities to conduct R&D of unique pharmaceutical products to be handled in FFP's pharmaceutical business operations.
* *1 FFP's own quality assurance standards on pharmaceutical products: Quality standards for generic drugs based on standards applied to Fujifilm products, which have been compiled in the photographic film business to win customer confidence. They represent the standards for administering "three areas of quality control" as FFP's own way of achieving quality assurance.
* *2 Fujifilm's proprietary technology nurtured in the development of photographic film and other products. It involves formulating desired chemicals and delivering them to targeted sites in appropriate levels and at appropriate times by means of emulsification, dispersion, nanoparticles, nanocapsule formation and porous & multilayer thin films, etc.
1. Outlines of the new company
1. (1) Company name: FUJIFILM Pharma Corporation
(2) Business description: R&D, manufacturing, marketing, exportation and importation of pharmaceutical products
(3) Establishment: November 2, 2009
(4) Capital: 50 million yen
(5) Representative Director: Kanji Yagi
(6) Commencement of business operations: April 2010 (tentative)
(7) Shareholders: FUJIFILM Corporation (80%), Mitsubishi Corp (15%) and Toho HD (5%)
(8) Roles of corporate partners
* Mitsubishi Corp: Assisting in the procurement of quality active pharmaceutical ingredients and pharmaceutical products from within and outside Japan, and the development of overseas sales channels
* Toho HD: Handling the marketing and logistics of FFP products to ensure supply stability to medical institutions, and conducting sales activities for FFP products at medical institutions and prescription pharmacies
2. FFP initiatives for "three areas of quality control"
Fujiiflm has consistently enforced strict quality assurance measures on all processes of photographic film manufacturing from raw material procurement to packaging, with the highest priority placed on product consistency and reliability. In order to ensure that customers can use its generic drug products with absolute peace of mind, FFP will not only work on supply stability through securing sufficient inventories and shortening delivery times, but also establish its own quality assurance standards covering the "three areas of quality control", based on Fujiiflm's stringent quality control system.
(1) Quality control of raw materials
FFP will control the quality of generic drugs' raw materials, encompassing their places of manufacturing, manufacturing management systems and active pharmaceutical ingredients (with a particular emphasis on impurity profiles). This allows the company to provide pharmaceutical products made of raw materials substantiated with solid evidence of good manufacturing practices.
(2) Control of manufacturing processes and design quality
FFP will carry out regular audits on manufacturing contractors to ensure uniform product quality, and manage design quality through the examination of pharmaceutical preparations' physical properties and regular implementation of dissolution tests. Through these measures, the company will build a system for providing pharmaceutical products of absolute quality excellence.
(3) Post-sale quality control
To ensure that consumers can choose its products with confidence, FFP will make use of Fujiiflm Group's medical IT network systems*3 to gather and distribute post-sale pharmaceutical information on drug efficacy, side effects, etc.
* *3 This includes Fujiilm's medical imaging and information management system SYNAPSE, used in the area of "diagnosis", and medical network service "C@Rna" for hospitals and clinics. Fujifilm is working toward linking these systems and services with other medical IT infrastructures to create a Clinical Information System (CIS) integrating all clinical information.
The launch of the new company is aimed at developing a pharmaceutical business arm for Fujiiflm, and building a sales foundation in this market. FFP will undertake the development, manufacturing and marketing of pharmaceutical products, and start with the marketing of generic drugs at the launch of its sales operations. Owing to the fact that generic drugs are more affordable than innovative drugs, the Ministry of Health, Labour and Welfare promotes proliferation of generic drugs to reduce patients' financial burden and mitigate medical spending. In order to promote their use in the future, it is necessary to gain the trust of healthcare professionals concerning the quality, supply stability and information availability of generic drugs. Addressing these market needs, FFP is to define its own quality assurance standards on pharmaceutical products*1 covering "three areas of quality control"; i.e. the "quality control of raw materials", "control of manufacturing processes and design quality" and "post-sale quality control". It will select, evaluate and procure products that meet these standards from Japanese and foreign pharmaceutical partners, and deliver them to medical institutions and prescription pharmacies under the Fujiiflm brand, thereby contributing to the proliferation of highly reliable generic drugs.
In a tie-up with Fujifilm's Drug Discovery Research Laboratories, FFP will use the proprietary FTD technology*2 to develop and market generic drugs of high added value, and aims to evolve into a general pharmaceutical company that also handles innovative drugs to be developed by Fujiiflm. The use of the FTD technology will improve pharmaceutical solubility, enhance chemical stability, add a sustained release property and expand available alteration of dosage forms, reducing physical strains on patients and making them easier to use than conventional products for medical institutions.
In establishing FFP, Fujifilm has formed a partnership with Mitsubishi Corp, which promotes far-reaching life-science businesses in the medical field, and has a powerful network of Japanese and overseas manufacturers of active pharmaceutical ingredients and pharmaceutical products, in order to establish a framework for obtaining high-quality active pharmaceutical ingredients at low costs. The partnership with Toho HD, a major pharmaceutical wholesaler with extensive sales and logistics networks, is designed to establish an infrastructure for the stable supply of pharmaceuticals. The capital and business partnerships with these companies are set to create a new business model in the pharmaceutical industry.
Defining medical systems & life science business as its key growth area, the Fujiiflm Group is seeking to cover "prevention, diagnosis and treatment" comprehensively as a general healthcare company. In the area of "treatment", the Group includes Toyama Chemical, which excels in drug creation, and FUJIFILM RI Pharma, which has extensive track record in the area of radiopharmaceuticals. Other related group companies include Perseus Proteomics, a venture business originated from the University of Tokyo with proprietary antibody development technology, and FUJIFILM Finechemicals, which produces pharmaceutical raw materials. The Drugs Discovery Research Laboratories were also established in June last year to reinforce the Group's ability to explore innovative drug candidates and expand the pharmaceutical business. In the area of "diagnosis", the Group has contributed to the healthcare industry for many years with digital x-ray diagnostic imaging systems, medical image information systems and endoscopes. Tapping into these proprietary technologies and resources, the Fujiiflm Group will draw upon its vast reserve of capacities to conduct R&D of unique pharmaceutical products to be handled in FFP's pharmaceutical business operations.
* *1 FFP's own quality assurance standards on pharmaceutical products: Quality standards for generic drugs based on standards applied to Fujifilm products, which have been compiled in the photographic film business to win customer confidence. They represent the standards for administering "three areas of quality control" as FFP's own way of achieving quality assurance.
* *2 Fujifilm's proprietary technology nurtured in the development of photographic film and other products. It involves formulating desired chemicals and delivering them to targeted sites in appropriate levels and at appropriate times by means of emulsification, dispersion, nanoparticles, nanocapsule formation and porous & multilayer thin films, etc.
1. Outlines of the new company
1. (1) Company name: FUJIFILM Pharma Corporation
(2) Business description: R&D, manufacturing, marketing, exportation and importation of pharmaceutical products
(3) Establishment: November 2, 2009
(4) Capital: 50 million yen
(5) Representative Director: Kanji Yagi
(6) Commencement of business operations: April 2010 (tentative)
(7) Shareholders: FUJIFILM Corporation (80%), Mitsubishi Corp (15%) and Toho HD (5%)
(8) Roles of corporate partners
* Mitsubishi Corp: Assisting in the procurement of quality active pharmaceutical ingredients and pharmaceutical products from within and outside Japan, and the development of overseas sales channels
* Toho HD: Handling the marketing and logistics of FFP products to ensure supply stability to medical institutions, and conducting sales activities for FFP products at medical institutions and prescription pharmacies
2. FFP initiatives for "three areas of quality control"
Fujiiflm has consistently enforced strict quality assurance measures on all processes of photographic film manufacturing from raw material procurement to packaging, with the highest priority placed on product consistency and reliability. In order to ensure that customers can use its generic drug products with absolute peace of mind, FFP will not only work on supply stability through securing sufficient inventories and shortening delivery times, but also establish its own quality assurance standards covering the "three areas of quality control", based on Fujiiflm's stringent quality control system.
(1) Quality control of raw materials
FFP will control the quality of generic drugs' raw materials, encompassing their places of manufacturing, manufacturing management systems and active pharmaceutical ingredients (with a particular emphasis on impurity profiles). This allows the company to provide pharmaceutical products made of raw materials substantiated with solid evidence of good manufacturing practices.
(2) Control of manufacturing processes and design quality
FFP will carry out regular audits on manufacturing contractors to ensure uniform product quality, and manage design quality through the examination of pharmaceutical preparations' physical properties and regular implementation of dissolution tests. Through these measures, the company will build a system for providing pharmaceutical products of absolute quality excellence.
(3) Post-sale quality control
To ensure that consumers can choose its products with confidence, FFP will make use of Fujiiflm Group's medical IT network systems*3 to gather and distribute post-sale pharmaceutical information on drug efficacy, side effects, etc.
* *3 This includes Fujiilm's medical imaging and information management system SYNAPSE, used in the area of "diagnosis", and medical network service "C@Rna" for hospitals and clinics. Fujifilm is working toward linking these systems and services with other medical IT infrastructures to create a Clinical Information System (CIS) integrating all clinical information.
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