2003-2007News & Press Release

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 Committeeon New Drug Approval (November)
NPC-03(Intravenous Phenobarbital)
  • Submitted (September)
NPC-06
  • Contracted with Pfizer for development and sale of Fosphenytoin (December)

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)

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)

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)

2003 : Inauguration of business, start of development

January - JuneStart-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
JuneInauguration of business
July - DecemberCommencement 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)
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