Kowa Pharmaceuticals America, Inc.
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
small (1-50)
Kowa Pharmaceuticals America, Inc.
530 Industrial Park Boulevard, Montgomery, AL 36117, USA
Patents
formulating a 50 mg. dicofenac potassium tablet dosage form for rapid bioavailability, in a formulation comprising water soluble salt of an alkali metal carbonate or bicarbonate, a hygroscopic diluent to absorb water, packaging such tablet dosage in a moisture resistant bottle; pharmacokinetics
US-7700125-B2
View Details
formulating a 50 mg. dicofenac potassium tablet dosage form for rapid bioavailability, in a formulation comprising water soluble salt of an alkali metal carbonate or bicarbonate, a hygroscopic diluent to absorb water, packaging such tablet dosage in a moisture resistant bottle; pharmacokinetics
US-7700125-B2
View DetailsProducts
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
Commercial promotion of cardiovascular and primary care therapies through an internal sales force and formal co-promotion agreements with partner companies.
Provides study drug donations, funding support and operational collaboration for multicenter clinical trials and outcomes research; collaborates with academic networks and NIH-sponsored initiatives.
Provides regulatory submission support, label change facilitation, medical monitoring and medical affairs collaboration to support product approvals and safety communications.
Designs and commissions national patient surveys, develops educational resources and public campaigns to support adherence and patient–physician communication about statin therapy.
Commercial promotion of cardiovascular and primary care therapies through an internal sales force and formal co-promotion agreements with partner companies.
Provides study drug donations, funding support and operational collaboration for multicenter clinical trials and outcomes research; collaborates with academic networks and NIH-sponsored initiatives.
Provides regulatory submission support, label change facilitation, medical monitoring and medical affairs collaboration to support product approvals and safety communications.
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
News & Updates
Provided study drug and funding support for a large randomized, double-blind primary prevention outcomes trial evaluating a statin in HIV‑infected participants.
Entered a U.S. co-promotion agreement to expand promotional reach for an omega-3 prescription product to treat severe hypertriglyceridemia.
Announcement of U.S. FDA approval and subsequent commercial launch activities for an HMG-CoA reductase inhibitor.
Publication of a prospective, randomized, double-blind, active-controlled Phase 4 trial demonstrating superior LDL‑C reduction for one statin versus another in adults with HIV on antiretroviral therapy, with 52‑week safety data reported.
Launched a national public education campaign and clinician resources to encourage patient–physician dialogue about statin therapy and to address medication adherence, supported by a large national survey.
Meta-analysis of 15 randomized controlled studies (4,815 non-diabetic patients) showing no significant differences between the evaluated statin and placebo/other statins for fasting blood glucose, HbA1c or new-onset diabetes across studied doses and follow-up durations.
Provided study drug and funding support for a large randomized, double-blind primary prevention outcomes trial evaluating a statin in HIV‑infected participants.
Entered a U.S. co-promotion agreement to expand promotional reach for an omega-3 prescription product to treat severe hypertriglyceridemia.
Announcement of U.S. FDA approval and subsequent commercial launch activities for an HMG-CoA reductase inhibitor.
Publication of a prospective, randomized, double-blind, active-controlled Phase 4 trial demonstrating superior LDL‑C reduction for one statin versus another in adults with HIV on antiretroviral therapy, with 52‑week safety data reported.
Launched a national public education campaign and clinician resources to encourage patient–physician dialogue about statin therapy and to address medication adherence, supported by a large national survey.
Meta-analysis of 15 randomized controlled studies (4,815 non-diabetic patients) showing no significant differences between the evaluated statin and placebo/other statins for fasting blood glucose, HbA1c or new-onset diabetes across studied doses and follow-up durations.