Kowa Pharmaceuticals
Specialty pharmaceutical company focused on acquisition, clinical development, licensing, commercialization and co-promotion of cardiometabolic and cardiovascular therapies in the United States. Operates clinical development activities through a research institute, conducts and sponsors randomized clinical trials and drug–drug interaction studies, supports large multicenter outcomes research, and deploys a field sales force to support product commercialization and partner co-promotion agreements.
Industries
Nr. of Employees
large (251-1000)
Kowa Pharmaceuticals
Products
Pitavastatin (HMG-CoA reductase inhibitor)
An HMG-CoA reductase inhibitor indicated as an adjunct to diet to reduce elevated LDL-C, total cholesterol, apolipoprotein B and triglycerides and to increase HDL-C in adults with primary hyperlipidemia or mixed dyslipidemia; subject of regulatory approval and clinical development programs in the U.S.
Omega-3 prescription therapy (co-promotion)
Commercial co-promotion of an omega-3 prescription product indicated as an adjunct to diet to reduce triglyceride levels in patients with severe hypertriglyceridemia.
Diclofenac-based oral analgesic formulation (historical asset)
Diclofenac formulations combined with buffering agent designed for rapid absorption; historically licensed and later divested as a strategic portfolio decision.
Pitavastatin (HMG-CoA reductase inhibitor)
An HMG-CoA reductase inhibitor indicated as an adjunct to diet to reduce elevated LDL-C, total cholesterol, apolipoprotein B and triglycerides and to increase HDL-C in adults with primary hyperlipidemia or mixed dyslipidemia; subject of regulatory approval and clinical development programs in the U.S.
Omega-3 prescription therapy (co-promotion)
Commercial co-promotion of an omega-3 prescription product indicated as an adjunct to diet to reduce triglyceride levels in patients with severe hypertriglyceridemia.
Diclofenac-based oral analgesic formulation (historical asset)
Diclofenac formulations combined with buffering agent designed for rapid absorption; historically licensed and later divested as a strategic portfolio decision.
Services
Product commercialization and co-promotion
Commercial promotion of cardiovascular and primary care therapies through an internal sales force and formal co-promotion agreements with partner companies.
Clinical trial support and investigational product provision
Provides study drug donations, funding support and operational collaboration for multicenter clinical trials and outcomes research; collaborates with academic networks and NIH-sponsored initiatives.
Regulatory and medical affairs support
Provides regulatory submission support, label change facilitation, medical monitoring and medical affairs collaboration to support product approvals and safety communications.
Patient survey research and public education campaigns
Designs and commissions national patient surveys, develops educational resources and public campaigns to support adherence and patient–physician communication about statin therapy.
Product commercialization and co-promotion
Commercial promotion of cardiovascular and primary care therapies through an internal sales force and formal co-promotion agreements with partner companies.
Clinical trial support and investigational product provision
Provides study drug donations, funding support and operational collaboration for multicenter clinical trials and outcomes research; collaborates with academic networks and NIH-sponsored initiatives.
Regulatory and medical affairs support
Provides regulatory submission support, label change facilitation, medical monitoring and medical affairs collaboration to support product approvals and safety communications.
Patient survey research and public education campaigns
Designs and commissions national patient surveys, develops educational resources and public campaigns to support adherence and patient–physician communication about statin therapy.
Expertise Areas
- Clinical trial management and multicenter outcomes research
- Pharmacokinetic/pharmacodynamic and drug–drug interaction studies
- Regulatory submissions and post-approval safety
- Clinical evidence generation and meta-analysis
Key Technologies
- Randomized controlled trials (Phase III/IV and head-to-head designs)
- Pharmacokinetic and pharmacodynamic assessment
- Meta-analysis and pooled trial synthesis
- Nuclear magnetic resonance (NMR) spectroscopy for lipoprotein analysis