2003: Inauguration of business, start of development

■ January - June: Start-up preparation

・Developmental Pharmaceutical Product No. 1 determined: Face-to-face consultation with the Pharmaceuticals and Medical Devices Agency (twice)

- IKH-01 (low-dose pill): exclusively for treating dysmenorrhea with endometriosis

■ June: Inauguration of business

■ July - December: Commencement of clinical development

・Developmental Pharmaceutical Products No. 2 and 3 determined

- NPC-02: Zinc preparation (Wilson's disease)

- NPC-03: Injection-based Phenobarbital (neonatal seizure and status epilepticus )

・Commencement of clinical trials for Developmental Pharmaceutical Product No. 1 (October: Phase III preliminary trials for IKH-01)

2004: Commencement of Phase III clinical trials

■ IKH-01 (Low-dose pill)

・License agreement with Janssen Pharmaceutical K.K. (Johnson & Johnson) (April)

・Conclusion of Phase III preliminary trial (November)

・Commencement of Phase III trial and long-term administration trial (IND filed in November)

・Collaboration formed with Japan Medical Association regarding procurement of clinical trial contracting facilities

■ NPC-02 (Zinc preparation)

・Collaboration formed with Japan Medical Association regarding procurement of clinical trial contracting facilities (March)

・Collaboration formed with Japan Medical Association regarding procurement of clinical trial contracting facilities (March)

・License agreement with Teva Pharmaceuticals USA (April)

・Post PIIb face-to-face consultation with Pharmaceuticals and Medical Devices Agency. (May)

・Commencement of Phase III trial (IND filed in August)

・Orphan drug designation (November)

■ NPC-03 (i.v. Phenobarbital)

・Physician-oriented clinical trials (October: Nattonal project. Full cooperation as investigational new drug supplier)

・Designated as priority face-to-face advice product by the Pharmaceuticals and Medical Devices Agency (November)

2005: Continuation of Phase III clinical trials

■ IKH-01 (Low-dose pill)

・Close of patient entry for Phase III trials and long-term administration test (April)

・Conclusion of Phase III trials (October)

■ NPC-02 (Zinc preparation)

・Close of patient entry for Phase III trials (March)

・Conclusion of Phase III trial (September). Start of long-term administration trial

■ NPC-03 (Injection-based Phenobarbital)

・Post PIIb face-to-face consultation with Pharmaceuticals and Medical Devices Agency: (March)

・Orphan drug designation (March)

・Commencement of Phase III trial (start of Institutional Review Board in May)

・IND filed for Phase III clinical trial (September)

・Discussions to determine the development of Product No. 4 and beyond (in the last half of the year)

2006: Submission and sales preparation, also development of Product No.4 onwards

■ NPC-02 (Zinc preparation)

・Submission (May)

・Choosing a business partner

■ IKH-01 (Low-dose pill)

・License agreement with Fuji Pharma Co. (May)

・Submission (October)

■ NPC-03 (Injection-based Phenobarbital)

・PIII (Physician-oriented clinical trials): In cooperation with the Japanese Medical Association.

・Preparation for submission (July 2007 - provisional)

2007

■ IKH-01 (Lunabell®compound tablets)

・Sales tie-up with Nippon Shinyaku (July)

■ NPC-02(Nobelzin®capsules)

・Sales tie-up with Alfresa Pharma Corporation (April)

・Examined and approved by 1st Committee on New Drug Approval (November)

■ NPC-03 (Intravenous Phenobarbital)

・Submitted (September)

■ NPC-06

・Contracted with Pfizer for development and sale of Fosphenytoin (December)

2008

■ Lunabell® compound tablets (IKH-01)

・Examined and approved by 1st Committee on New Drug Approval (February)

・Received approval for manufacture and sales (April)

・NHI price listed (June)

・Sales launched (July)

・Started Phase III clinical trial for additional indication (functional dysmenorrhea) (July clinical trial report)

■ Nobelzin® capsule (NPC-02)

・Received approval for manufacture and sales (January)

・NHI price listed (April)

・Sales launched (April)

■ Nobelbar®　(NPC-03)

・Received approval for manufacture and sales (October)

・NHI price listed (December)

・Sales launched (December)

■ NPC-06 (Fosphenytoin)

・Started Phase I clinical trial (June clinical trial report)

・Completed Phase I clinical trial (November unblinding)

■ NPC-08 (Gliadel® Wafer (carmustine))

・Entered option contract with Eisai (July)

・Overall structure: face-to-face advice

2009

■ Lunabell® compound tablets (IKH-01)

・Completed Phase III clinical trial for additional indication (functional dysmenorrhea) (September unblinding)

・Applied for additional indication (functional dysmenorrhea) (December)

■ NPC-01 (very low-dose pill)

・Started Phase III long-term dosage clinical trial (March clinical trial report)

■ NPC-05 (talc)　(NPC-03)

・Started Phase II clinical trial in cooperation with the Japanese Medical Association (physician oriented clinical trial)

■ NPC-06 (Fosphenytoin)

・Overall structure: face-to-face advice with Pmda

・Started Phase I & II clinical trial (March clinical trial report)

・Selected as NEDO innovation development expense grant project (August)

■ NPC-08 (Gliadel® Wafer (carmustine))

・Licensed with Eisai for Gliadel® Wafer (July)

・Started Phase I II clinical trials (March clinical trial report)

・Designated as orphan drug (June)

・Overall structure: Safety consultation with Pmda (August)

■ NPC-07 (5-ALA)

・Option contract with SBI ALA Promo(March)

・Overall structure: face-to-face advice with Pmda

■ N-Acetylneuraminic acid

・Selected as NEDO innovation development expense grant project (August), started development as treatment for intractable disease

■ Opened Osaka office (November)

2010

■ Lunabell® compound tablets (IKH-01)

・PMDA: First consultation after application of NDA:additionl indication (February)

・NPC-01( very low dose LEP)

・PMDA: face-to-face consultation (January)

・Started Phase III comparative trial (April clinical trial report)

■ NPC-05 (talc)

・Completed Phase II clinical trial entry (February)

■ NPC-06 (Fosphenytoin)

・NEDO innovation development expense grant project status returned (January)

・Completed Phase III clinical trial entry (February)

・New Drug Application (June)

■ NPC-07 (5-ALA)

・Phase III clinical trial for diagnostic medicine (malignant glioma) started (May clinical trial report)

■ Newly established Eastern Japan marketing headquarters in Marketing Division (January)

■ Marketing organization: 22 MRs (April)

■ Opened new business offices (June)

・Opened Tokyo office, Nagoya office, Fukuoka office

・Marketing organization: 35 Medical Rep (October)

2011

■ NPC-06 (Fosphenytoin)

・ Recommended approvable by (June)

■ Business

・ Marketing organization: 47 Medical Rep (April)

・ Opened Sapporo business office (April)

・ Opened Sendai business office (May)