May 22, 2018
SEIKAGAKU CORPORATION(Securities Code: TSE 4548)
Kaken Pharmaceutical Co., Ltd.
(Securities Code: TSE 4521)

Seikagaku and Kaken Announce the Listing in the National Health
Insurance Drug Price List and Launch Date of HERNICORE® 1.25
Units for Intradiscal Injection in Japan, Indicated for Treatment ofLumbar Disc Herniation
Seikagaku Corporation (Tokyo, Japan; “Seikagaku”) and Kaken Pharmaceutical Co. Ltd.
(Tokyo, Japan; “Kaken”) announced today that HERNICORE® 1.25 units for intradiscal injection(generic name: condoliase) has been listed in the National Health Insurance drug price list. The
planned launch date is August 2018.
HERNICORE® 1.25 units for intradiscal injection ("the Agent") is a new treatment option for
lumbar disc herniation whose active pharmaceutical ingredient is condoliase. This is the firsttherapeutic Agent in Japan with intradiscal administration. It does not require a generalanesthesia and is less invasive to the patient than surgical treatment. Seikagaku obtained New
Drug Application (“NDA”) approval for the Agent in Japan on March 23, 2018, and Kaken will
distribute it in Japan. As improvement effects to the symptoms of lumbar disc herniation byprolapse of the posterior longitudinal ligament* are expected by a single administration of theAgent, Seikagaku and Kaken believe that this new treatment option is able to contribute toquality of life of patients.
The Agent is a pharmaceutical with a novel mechanism of action, and from the standpoint ofsafety assurance, the special Warnings and Precautions for Use in the package insert reads,“This Agent should be administered under the supervision of a physician with sufficientknowledge and experience in the diagnosis and treatment of lumbar disc herniation. It should
be administered by a physician with proficiency in performing lumbar puncture.”
Accordingly, at this time specific physician requirements and facilities requirements are being
considered. Kaken will commence sales of the Agent after these requirements have been
determined and strive for a phased rollout while promoting appropriate use.
*Herniation by prolapse of the posterior longitudinal ligament: a type of herniation and its
structure is that it is covered by the posterior longitudinal ligament, although the hernia extends
beyond the outermost layer of the annulus fibrosus<Overview of the Agent>
Product name: HERNICORE® 1.25 Units for Intradiscal Injection
1Generic name: condoliase
Efficacy and effects: Lumbar disc herniation by prolapse of the posterior longitudinal ligament
for which sufficient improvement cannot be obtained through conservative
treatment Usage and dosage: For adults, 1.25 units of condoliase areadministered by a single injection in the intervertebral disc that is thesource of the symptoms.
NHI drug price: 81,676 yen (1 bottle containing 1.25 units)
New Drug Application approval date: March 23, 2018
Date of listing in the National Health Insurance drug price list: May 22, 2018
Launch date: August 2018 (planned)
Marketing authorization holder: Seikagaku Corporation
Distributor: Kaken Pharmaceutical Co. Ltd.
Mechanism of action: It is expected that condoliase degrades chondroitin sulfate, chondroitin,and hyaluronic acid and also improves the clinical manifestations ofherniation by lowering the internal pressure of the intervertebral disc due
to dissolving the glycosaminoglycans* within the nucleus pulposus of theintervertebral disc, and lowering the water-holding capacity of the nucleus
pulposus.
* Glycosaminoglycans (GAG): A major component of complex carbohydrates. Chondroitin
sulfate and hyaluronic acid etc.

<Regarding lumbar disc herniation and therapies>
Lumbar disc herniation is the partial protrusion of the nucleus pulposus at the core ofeach intervertebral disc or the annulus fibrosus, the disc’s outer layer. The resulting
pressure on the spinal nerve root causes pain and numbness.
Current treatments are generally categorized into conservative treatments for temporalpain relief (rest and pharmaceutical methods such as NSAIDs) and surgical treatments.
As this Agent specifically degrades GAGs in the nucleus pulposus, resulting in decreasein the pressure on the nerve root, it is positioned as an innovative treatment of lumbar
disc herniation.
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