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3 Apr 2020

Licensing Deal Case Study: Eisai, Seikagaku co-develop & market osteoarthritis drug, SI-613 in China

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Eisai Co Ltd and Seikagaku Corporation, an R&D-oriented pharmaceutical company, announced that the companies have entered into an agreement for the co-development and marketing alliance in China for SI-613 (diclofenac conjugated sodium hyaluronate), a therapeutic agent for osteoarthritis discovered by Seikagaku.

Analysis of licensing deal

  • Eisai Co Ltd and Seikagaku Corporation will jointly develop SI-613 in China for a treatment of knee osteoarthritis.
  • After obtaining approval, Seikagaku will supply products to Eisai, and Eisai will be responsible for distribution.
  • The companies will cover an equal share of the development cost, and Eisai will pay Seikagaku the upfront payment, and development as well as sales milestones.
  • Eisai aims to contribute to patients with knee osteoarthritis that is unmetmedical needs by utilizing the knowledge and networks that Eisai has cultivated through its China business. Seikagaku will seek to maximize the value of SI-613 in China by leveraging Eisai’s businessbase in China.

About diclofenac conjugated sodium hyaluronate

  • SI-613 is diclofenac conjugated sodium hyaluronate created by Seikagaku using their proprietary drug-binding technology to chemically bond hyaluronic acid and diclofenac (an anti-inflammatory drug). This material has the analgesic and anti-inflammatory effects of diclofenac, which is designed to be sustained-released by a drug delivery system, in addition to the joint function improving effect of sodium hyaluronate.
  • Hence, it is expected that SI-613 rapidly and continuously reduces the pain andinflammation associated with osteoarthritis.
  • SI-613 is diclofenac conjugated sodium hyaluronate created by Seikagaku using their proprietary drug binding technology to chemically bond hyaluronic acid and diclofenac (an anti-inflammatory drug).
  • This material has the analgesic and anti-inflammatory effects of diclofenac, which is designed to besustained-released by a drug delivery system, in addition to the joint function improving effects of sodium hyaluronate. It is expected that SI-613 rapidly and continuously reduces the pain and inflammation associated with osteoarthritis (such as knee joint). Also, since this is administered directly into the joint cavity by injection,
  • it is considered that the amount of diclofenac systemic exposure and the risk of eliciting systemic adverse drug reaction are to be low.
  • In Japan, Seikagaku submitted a new drug application (NDA) for manufacturing and marketing approval for SI-613 on January 6, 2020.

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