Research & Development Pipeline

Product pipeline of currently disclosed themes

<Pharmaceuticals>

Development code

/ Product name, etc.

Lead indication Target market Stage

In-house

In-license

SI-6603(HERNICORE)
Condoliase
Lumbar disk herniation

 

Japan

 

Market

Approval

March 23, 2018

In-house

 

U.S.

 

 

Phase III

 

SI-613

Diclofenac Etalhyaluronate

Sodium

 

Osteoarthritis Japan

 

Phase III

 

 

In-house

 

Knee

osteoarthritis

U.S.

 

Phase II

 

SI-613-ETP

Diclofenac Etalhyaluronate

Sodium

Enthesopathy Japan

Late-Stage

Phase II

SI-614
Modified Hyaluronate

Dry eye U.S.

 

Phase II / III

 

In-house

<Medical Device>

Development code

Product name, etc.

Pipe of product Target market Stage

In-house

In-license

SI-449
Cross-linked Chondroitin Sulfate

Adhesion barrier Japan

 

Pilot study

 

In-house

(As of May 21, 2018)

Outline of development theme

SI-6603 (treatment for lumbar disc herniation - developed in the U.S.) ※Japan : Market approval

SI-6603 is  a treatment option for lumbar disc herniation with the active pharmaceutical ingredient of condoliase. This is therapeutic agent with intradiscal administration. It does not require a general anesthesia and is less invasive to the patient than surgical treatment. As this agent specifically degrades GAGs in the nucleus pulposus, resulting in decrease in the pressure on the nerve root by a single administration of the agent, Seikagaku believes that this new treatment option is able to contribute to quality of life of the patient.

The Japanese Ministry of Health, Labour and Welfare “MHLW” has approved the New Drug Application “NDA” of HERNICORE 1.25 units for intradiscal injection in Japan, indicated for the treatment of lumbar disc herniation on March 23, 2018.

SI-613 (treatment of osteoarthritis - developed in Japan and the U.S.)

SI-613-ETP (treatment of enthesopathy - developed in Japan)

SI-613 is a formulation in which hyaluronic acid and a diclofenac (anti-inflammatory drug)

are chemically bound using Seikagaku’s own proprietary technology. SI-613 was designed to provide pain relief and anti-inflammatory effect by sustained release of diclofenac, and the joint function improving effect by hyaluronic acid. It is expected to provide prompt and sustained relief of the severe pain and inflammation associated with osteoarthritis and enthesopathy. Since SI-613 is administered directly into the joint cavity or near the tendon or ligament enthesis as an injectable treatment, the transfer of the NSAID into the systemic blood is extremely low, and it is expected to mitigate the risk of side effects reported in oral or transdermal administration of NSAID.

SI-614 (treatment of dry eye - developed in the U.S.)

SI-614 is a modified hyaluronate that is produced using the Company’s proprietary technology. Ocular instillation of SI-614 in patients with dry eye is expected to protect
the ocular surface and promote corneal wound healing.

SI-449 (adhesion barrier - developed in Japan)

SI-449 is a powdered adhesion barrier whose main ingredient is cross-linked chondroitin sulfate developed using Seikagaku’s own glycosaminoglycan cross-linking technology. SI-449, which has the property of absorbing moisture and swelling, is expected to prevent or mitigate post-operative adhesion formation by forming a barrier between the surgical wound site and surrounding tissues after application.

Seikagaku is considering introducing SI-449 not only in Japan, but in global.