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Toyota Tsusho Makes New Entry into Biomedicine Business
- Agreement for Exclusive Agency in Japan Signed with Spanish Biomedicine Manufacturing Company -

2011-05-26

Toyota Tsusho Corporation (hereinafter referred to as “Toyota Tsusho”; Headquarters: Nagoya City; President: Junzo Shimizu) signed an agreement to be the exclusive agency in Japan for the Spanish biomedicine manufacturing company, Genhelix S.A. (Headquarters: Leon, Spain; President: David Marcos Martinez).

 

The drugs that Toyota Tsusho and Genhelix will collaborate on are called Biosimilars, branded generic drugs manufactured and sold as medications with an equivalent potency and effectiveness as the preceding drugs, following the patent expiration period for biomedicines created through the application of genetic engineering.

 

The current biomedicine market in Japan is estimated to be about JPY400 million but it is anticipated to become a market of about JPY1.2 trillion by the year 2020, due to the fact that the drugs have little side effects for cancer and rheumatism patients, and the growth of the overall biomedicine market, as well as full scale expiration of the patents for preceding drugs from the year 2012, which will lead to the moderation of prices.

 

Toyota Tsusho entered into the biosimilar market, where future growth can be expected and will provide agency services to deliver biosimilar products manufactured by Genhelix to pharmaceutical manufacturers in Japan, as well as the commissioned manufacturing of new biodrugs.

 

Both companies will be enhancing their pharmaceutical businesses in the future by utilizing the various products and service know-how of Genhelix, as well as the worldwide network of Toyota Tsusho.

< Features of this project >

(1) Features of biomedicines Medications are created by converting antibodies that exhibit immune effects through a combination with specific antigens (foreign matter, such as causal organisms or cancer cells), as well as other in vivo proteins. They are used as curative medicines for cancer and rheumatism and their features include the presentation of few side effects.
(2) Market scale The biomedicine market in Japan is anticipated to triple from the current JPY400 million to JPY1.2 trillion in ten years. (3) Background to market expansion ・ Few side effects. ・ Since the patents of many precedent biomedicines expire by the year 2015, the need for more economical biosimilars is expected to increase.
(4) Significance of entry into this business Approval for biosimilars requires clinical tests to verify the equivalencies with preceding drugs. Barriers for entry are high and we are able to enter into the biosimilar market rapidly as a trading company by allying early with Genhelix, which has the sophisticated technologies and know-how necessary for the manufacture of biomedicines.

< Corporate Summary of Genhelix >

* A pharmaceutical company with a state of the art production system for the development and manufacture of biomedicines intended for intractable diseases, such as autoimmune disorders.

* The manufacturing plant (in Spain) for biosimilars is scheduled for completion by the end of 2011.

* Genhelix has a research and development center, a GMP (for the manufacture of medications), an industrial production plant and a training center, aiming to establish a position in the development of biosimilars and a new biodrug manufacturing market by taking advantage of the high quality levels and the state of the art technologies.

 

[ Corporate Summary ]

Company name GH Genhelix, S.A.
Headquarters location Leon, Spain
Establishment date 2006
Representative Officer David Marcos Martinez
Main business lines Manufacture and sale of biosimilars, as well as the commissioned manufacturing of biodrugs
Number of employees

25 persons(approximately 60 by the manufacture launch phase in 2012)

 

[ Location ]

 

[ Reference (features of Genhelix) ]

(1) The company owns a GMP manufacturing plant with six units of 2,000 liter single use animal cell cultivation tank, potentially producing 500 to 750 kilograms of refined protein antibodies annually.

(2) Dedicated cultivation tanks available for use at all times using disposable bags, makes it possible to completely prevent secondary contamination between lots and eliminate the time for cleaning the cultivation tank, thereby potentially reducing the fixed costs in comparison with existing manufacturing methods.

(3) Experimental laboratory for manufacturing process development and scaling up work, a corporate organization for research and development, which includes a pilot production facility, as well as their own training center.
(4) Executive officers have ample experience in both management and technology aspects, with careers including employment at noteworthy companies in the European biomedicine industry such as Genetech, Lonza, Glaxo SmithKline (GSK).

 

< Global Market Scale of Biosimilars >

 

[ Reference ]

Medication development support businesses

participated in by Toyota Tsusho thus far

Entry into businesses in the pharmaceutical field  

Agreement for Exclusive Agency in Japan Signed with ChemRoutes Corporation (Canada) (press release dated April 9, 2009)

* Business alliance with ChemRoutes Corporation (Province of Alberta), a new drug research company in Canada. 

* ChemRoutes Corporation is a recipient of a public subsidy issued by the Province of Alberta in Canada, which is enthusiastic about supporting nanotechnologies and biotechnologies. It has also received numerous awards from the Province of Alberta.

* The desire of ChemRoutes Corporation to further expand the company’s business by entering into the Japanese market, slated as their new Asian market, as well as the desire of Toyota Tsusho to enhance the pharmaceutical field as a part of an effort to expand business in fields other than the automotive field, struck an accord which resulted in the signing of an exclusive agency agreement for Japan.

* Smooth progress made for increasing the number of new customers and business is currently continuing.

* Sales of products started in April 2010. Scale of sales: Approx. JPY100 million.

 

Enhancement of business in pharmaceutical field  

Agreement for Exclusive Agency in Japan Signed with Respiratorius AB (Sweden) (press release dated May 17, 2010)

* Agreement for an exclusive agency in Japan signed with Respiratorius AB (Sweden).

* Respiratorius is a drug development company that conducts development of new drugs and consigned evaluations of chemical compound candidates, and specializes in pulmonary diseases. In Sweden, the company promotes research and development through collaborations between industry and academia, specifically in collaboration with Lund University.

* Toyota Tsusho will provide new drug candidate chemical compounds of Respiratorius and services for accepting consignments for evaluations on candidate chemical compounds to and from pharmaceutical manufacturers in Japan, as a part of the efforts to expand the drug creation support business in the pharmaceutical business field.

* At the present time strong expressions of interest have been received from companies, and activities for commercialization of the business are under way.

 

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