R&D Pipeline (November 2006)

Transcription

1 R&D Pipeline (November 2006) 1Japan (1)Filed Code No Generic Name (Filing Date ) Therapeutic Target Classification YM177 celecoxib (Dec 2002) Rheumatoid arthritis, osteoarthritis, low back pain, etc Cyclooxygenase-II inhibitor Oral Pfizer YM060 (Oct 2005) ramosetron (Jan 2006) Lupus nephritis Immunosuppressant Oral In-house Irritable bowel syndrome (IBS) 5-HT 3 antagonist Oral In-house 9 YM026 nateglinide (Jan 2006) Type II diabetes (concomitant treatment with biganides) Rapid onset insulin secretion enhancer Oral Ajinomoto FK463 T-3811 micafungin (Jan 2006) (May 2006) garenoxacin (May 2006) Deep-seated fungal infection (prophylaxis of Aspergillus and Candida infections in patients undergoing hematopoietic stem cell transplantation) Suppression of organ rejection in organ transplant (modified release) Respiratory infections and otolaryngologic infections Candin antifungal agent Injection In-house Immunosuppressant Oral In-house Quinolone antibiotic Oral Toyama YM086 (BIBR277) telmisartan (June 2006) Type 2 diabetic nephropathy Angiotensin II receptor blocker Oral Boehringer Ingelheim YM529 minodronate (July 2006) Osteoporosis Bisphosphonate Oral In-house

2 (2)Phase-III YM617 tamsulosin Lower urinary tract syndrome Alpha-1 receptor antagonist Oral In-house YM026 nateglinide Type II diabetes (concomitant treatment with insulin sensitizers) Rapid onset insulin secretion enhancer Oral Ajinomoto YM177 celecoxib Post surgical pain, post traumatic pain, tooth extraction pain Cyclooxygenase-II inhibitor Oral Pfizer Ulcerative colitis Immunosuppressant Oral In-house YM1170 famotidine Symptomatic-gastro-esophageal reflux disease (S-GERD) H 2 receptor antagonist Oral In-house Myasthenia gravis (all) Immunosuppressant Oral In-house FK199B zolpidem Insomnia (modified release) Omega-1 receptor agonist Oral Sanofi Aventis 10 (3)Phase-II YM974 valdecoxib Rheumatoid arthritis, osteoarthritis, low back pain, etc Cyclooxygenase-II inhibitor Oral Pfizer YM978 parecoxib Acute pain Cyclooxygenase-II inhibitor Injection Pfizer YM533 YM150(*) beraprost * Joint Japan and Asia trials are planned Chronic renal failure (primary / nephrosclerosis) Prevention of venous thromboembolism (VTE) after major orthopedic surgery Prostacyclin receptor stimulator Oral Toray Factor Xa inhibitor Oral In-house

3 2USA (1)Filed Code No YM087(*) Generic Name (Filing Date) conivaptan (Jan2004) (Dec 2005) Therapeutic Target Classification Hypervolemic hyponatremia Vasopressin receptor antagonist Injection In-house Suppression of organ rejection in organ transplant (modified release) * YM087:Received approvable letter from FDA in December, 2005 Immunosuppressant Oral In-house (2)Preparation for Filing RSD1235(*) vernakalant Atrial fibrillation Antiarrhythmic agent Injection Cardiome 11 *Received a refusal to file letter from FDA in May 2006 NDA will be re-submitted (3)Phase-III Atopic dermatitis Immunosuppressant Cream In-house CVT-3146 regadenoson Pharmacologic stress agent in cardiac perfusion imaging studies Adenosine A 2 a agonist Injection CV Therapeutics Psoriasis Immunosuppressant Cream In-house telavancin Complicated skin and skin structure infections (csssi), hospital-acquired pneumonia (HAP) Lipoglycopeptide antibiotic Injection Theravance YM617 tamsulosin Pediatric neurogenic bladder Alpha-1 receptor antagonist Oral In-house

4 (4)Phase-II YM443 Functional dyspepsia Acetylcholine level enhancer Oral Zeria YM155 YM672 (IPD-1151T) carperitide Acute heart failure Hormone refractory prostate cancer, non small cell lung cancer, metastatic melanoma, etc Alfa-human atrial natriuretic peptide Injection Daiichi Asbio Survivin expression inhibitor Injection In-house suplatast tosilate Interstitial cystitis anti-allergy agent Oral Taiho YM758 Atrial fibrillation Cardiac I f channel inhibitor Oral In-house 3Europe 12 (1)Filed Code No FK463 YM617 Generic Name (Filing Date) (Jan 2006) micafungin (April 2006) tamsulosin (May 2006) Therapeutic Target Classification Suppression of organ rejection in organ transplant Immunosuppressant Oral In-house (modified release) Deep-seated fungal infection Candin antifungal agent Injection In-house Functional symptoms with benign prostatic hyperplasia Alpha-1 receptor antagonist Oral In-house Orally disintegrating tablet

5 (2)Phase-III telavancin Complicated skin and skin structure infections (csssi), hospital-acquired pneumonia (HAP) Lipoglycopeptide antibiotic Injection Theravance 13 (3)Phase-II Urinary frequency, urinary YM178 incontinence or urgency associated Beta 3 receptor agonist Oral In-house with overactive bladder Prevention of venous thromboembolism (VTE) after major orthopedic surgery, YM150 prophylaxis of thromboembolic Factor Xa inhibitor Oral In-house complications associated with atrial fibrillation (AF) YM060 ramosetron Irritable bowel syndrome (IBS) 5-HT 3 antagonist Oral In-house Hormone refractory prostate cancer, YM155 non small cell lung cancer, Survivin expression inhibitor Injection In-house metastatic melanoma, etc YM672 (IPD-1151T) suplatast tosilate Interstitial cystitis anti-allergy agent Oral Taiho YM311 (FG-2216) Renal anemia, chemotherapy-induced anemia HIF stabilizer Oral FibroGen YM758 Stable angina Cardiac I f channel inhibitor Oral In-house

6 4Projects at Early Stage (Phase-I/Pre-clinical): 25 5Project Discontinued Code No Stage Therapeutic Target Reason YM643 (interferon alfacon-1) P-III(Japan) Chronic hepatitis C virus infection (concomitant use with ribavirin) We judged that an additional clinical study will be required to obtain a marketing authorization () P-II (Europe/USA) Asthma Expected efficacy was not achieved in the P-II study Changes from the previous announcement (Financial results announcement for 1Q of FY2006 in August 2006) 14 - Development status of YM150 for the treatment of prevention of venous thromboembolism (VTE) after major orthopedic surgery is Phase-II in Japan - Development of YM643 for the treatment of chronic hepatitis C virus infection (Phase-III in Japan) was discontinued - Ketek(telithromycin), additional indication for pediatric use(p-ii in Japan) was removed from the pipeline as a results of discontinuation of marketing alliance between Sanofi-aventis KK - Development of for the treatment of asthma (Phase-II in Europe and USA) was discontinued