Status of Clinical Development
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1 Status of Clinical Development May 10, 2005 Toshiaki Nishihata, Ph.D. Senior Corporate Officer Head of Research and Development Division 1
2 Progress of the Medium-term Management Plan - In the last fiscal year of the Medium-term Management Plan (1) - Increase R&D capabilities and development speed Successfully shortened period and improved efficiency of clinical and non-clinical studies 1. From P1 to NDA submission: 5 Yrs. e.g. DE-085: P2b submission of clinical trials to P3 LPO Achieve in less than 3 Yrs. DE-092: P2a submission of clinical trials to P2b LPO DE-089: P2a submission of clinical trials to P2b LPO Both DE-092 and DE-089: Achieve in 2.5 Yrs. At present it takes 5 to 5.5 Yrs. from P1 to NDA submission 2. Non-clinical development: 1.5 Yrs. e.g. Two projects in progress in Glaucoma and Cornea treatments Aiming to start clinical trial in one year 3. Utilize the clinical data from overseas Implemented in DE-085, DE-092 projects 2
3 Progress of the Medium-term Management Plan - In the last fiscal year of the Medium-term Management Plan (2) - Focused resource allocation Focus resources on promising research themes Concentrate resources in high priority therapeutic areas Discovery of candidate compounds Integrate our know-how of rheumatic and osteoarthritic research and a part of ophthalmic research Implemented in two projects (FY03, 04) Set up several projects mainly in treatment for ophthalmic disorder from FY05 Expand opportunities through alliances Entered into agreement with Argenes Inc. on R&D of anti-apo-1 antibody in Japan 3
4 Progress of the Medium-term Management Plan -Progress in domestic clinical trials - P3 DE-076 DE-085 DE-085 DE-085 P2b DE-092 DE-092 DE-085 DE-085 DE-089 DE-089 DE-092 P2a P1 DE-089 DE-092 DE-092 DE-090 DE-090 DE-089 DE-089 * DE-081 DE-090 DE-090 DE-090 (Retina) DE-099 DE-099 May, 2003 Nov., 2003 May, 2004 Nov., 2004 May, 2005 : Preparation for P2a (Retina) DE-076: NDA filed in August, 2003 DE-081: Discontinued study in November, 2003 : Glaucoma 4
5 Product Pipeline: Glaucoma, Retina Glaucoma (Development code) /Licensor Tafluprost (DE-085) Glaucoma and ocular hypertension Prostanoid FP-receptor agonist. Promotes uveoscleral outflow (codevelopment with Asahi Glass) Japan: P3 US/Europe: P3 Olmesartan (DE-092) Glaucoma and ocular hypertension Angiotensin II AT1 receptor antagonist. Promotes uvescleral outflow (Sankyo) Japan: P2b US/Europe: P2 Lomerizine hydrochloride (DE-090) Glaucoma Calcium channel blocker. Improves ocular bloodflow circulation (Nippon Organon) Japan: P2a Retina (Development code) Undetermined () Diabetes Mellitus Edema An oral TNF-alpha inhibitor Inhibits production of TNF-alpha Underlined part in red shows changes from announcement of 2004/11/05 /Licensor In preparation for P2a 5
6 Product Pipeline: Anti-inflammatory, Cornea and Anti-infective (Development code/ brand name) / Licensor Levofloxacin 1.5% (IQUIX) Bacterial corneal ulcer DNA gyrase inhibitor. Anti-intefcive action (Daiichi) US: approved Ciclosporin (DE-076) Vernal keratoconjunctivitis Calicyneurin inhibitor. Immunosuppressant (Novartis) Japan: NDA Diquafosol tetrasodium (DE-089) Corneal & conjunctival epithelial disorder associated with dry eye, etc. P2Y 2 receptor agonist. Stimulates tear secretion (Inspire) Japan: P2b Levofloxacin + Prednisolone (DE-094) Infectious keratitis Fluoroquinolone + steroid. Anti-infective + antiinflammatory action (Daiichi) US: P2 Gefarnate DE-099 Corneal & conjunctival epithelial disorder associated with dry eye, etc. Muco-membranous protective agent. Stimulates mucin secretion Japan: P1 6
7 Product Pipeline: Bones and Joints (Development code/brand name) / Licensor Undetermined () Rheumatoid Arthritis TNF-alpha inhibitor. Inhibits production of TNF-alpha Japan: P1 P2a Bucillamine (Rimatil) Osteoarthritis DMOAD. Protects cartilage and modifies edema Japan: preparing for clinical trials License out (Development code/ brand name) Licensee Undetermined (DE-098) Rheumatoid Arthritis Anti-APO-1 antibody. Induces apoptosis in synovial cells Argenes Japan: preparing for clinical trials Underlined parts in red show changes from announcement of 2005/11/05 7
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