December 22, 2014 10:19 AM ET

Pharmaceuticals

Company Overview of Kowa Pharmaceuticals America, Inc.

Company Overview

Kowa Pharmaceuticals America, Inc., a specialty pharmaceutical company, acquires, develops, licenses, and markets pharmaceutical products. It focuses on delivering customer solutions for cardiovascular conditions. The company provides Lipofen, a prescription medication to manage elevated triglycerides or cholesterol; and LIVALO, a prescription medicine for the treatment of high cholesterol. The company offers its products through pharmacies. Kowa Pharmaceuticals America, Inc. was formerly known as ProEthic Pharmaceuticals, Inc. and changed its name to Kowa Pharmaceuticals America, Inc. as a result of acquisition by Kowa Company, Ltd. The company was founded in 2001 and is headquartered in Mo...

530 Industrial Park Boulevard

Montgomery, AL 36117

United States

Founded in 2001

Phone:

334-288-1288

Fax:

334-288-2788

Key Executives for Kowa Pharmaceuticals America, Inc.

Chief Executive Officer
Age: 52
Chief Financial Officer
Senior Vice President of Operations and Business Development
Senior Vice President of Medical Education and Sales Training
Vice President of Trade & Business Development
Compensation as of Fiscal Year 2014.

Kowa Pharmaceuticals America, Inc. Key Developments

Kowa Pharmaceuticals America, Inc. Announces Results of Pre-Specified Safety Analysis from the Intrepid Trial Evaluating Effect of LIVALO(R) (Pitavastatin) 4 mg Compared with Pravastatin 40 mg in HIV-Infected Adults

Kowa Pharmaceuticals America, Inc. announced results of a pre-specified safety analysis from the INTREPID (HIV-infected patieNts and TREatment with PItavastatin vs. pravastatin for Dyslipidemia) trial evaluating the effect of LIVALO(R) (pitavastatin) 4 mg compared with pravastatin 40 mg in HIV-infected adults with dyslipidemia following completion of the 40-week safety extension. INTREPID was a Phase 4, multicenter, 12-week randomized superiority study demonstrating superior LDL-C reduction for LIVALO 4 mg vs. pravastatin 40 mg at Week 12 and included a 40-week safety extension (NCT01301066) with secondary objectives to compare the safety and lipid profiles at Week 52. Results of the extension showed that, after 52 weeks of therapy, safety profiles were maintained and consistent with 12-week results with an overall incidence of treatment emergent adverse events (TEAEs) of 67.5% for pitavastatin (N=126) and 69.8% for pravastatin (N=126). The most frequently reported TEAEs overall (occurring in >5% of subjects in either group) included upper respiratory infection (19 subjects, 7.5%); diarrhea (16 subjects, 6.3%); sinusitis (14 subjects, 5.6%); nasopharyngitis (13 subjects, 5.2%); bronchitis (11 subjects, 4.4%); nausea (11 subjects, 4.4%); and headache (10 subjects, 4.0%). Eleven subjects discontinued due to TEAE (4.4%) and there were no deaths. In addition, pitavastatin 4 mg maintained significantly greater reductions in LDL-C compared with pravastatin 40 mg at 52 weeks (pitavastatin -47.8 mg/dL and pravastatin -32.6 mg/dL, 30% vs. 20% reduction in LDL-C, respectively; LS mean % change -8.4, p<0.001). The results of the 40-week extension study and the pre-specified safety and efficacy analysis are being presented this week at the National Lipid Association's Scientific Sessions in Orlando, FL.

Amarin Corporation plc and Kowa Pharmaceuticals America, Inc. Announce U.S. Co-Promotion Agreement for Vascepa(R) (Icosapent Ethyl) Capsules

Amarin Corporation plc and Kowa Pharmaceuticals America, Inc. announced an agreement to co-promote Amarin's product, Vascepa(R) (icosapent ethyl) capsules, in the United States. Vascepa is approved for use in the United States as an adjunct to diet to reduce triglyceride levels in adult patients with severe (>= 500 mg/dL) hypertriglyceridemia. In bringing together two companies focused on the primary care and cardiovascular health communities, the agreement is designed to benefit a greater number of patients. The agreement provides for the near-term expansion of Vascepa promotional efforts through use of Kowa Pharmaceuticals America's sales force to substantially increase both the number of sales targets reached and the frequency of sales calls on existing sales targets. Under the agreement, Kowa Pharmaceuticals America will employ its sales force of approximately 250 sales representatives to co-promote Vascepa in the United States augmenting Amarin's approximately 130 sales representatives and more than doubling Amarin's current sales detail frequency through primary and secondary details. Kowa Pharmaceuticals America's sales force is expected to begin its Vascepa promotional efforts in May 2014 to its existing target audience of primary care physicians and cardiologists. Under the agreement, Kowa Pharmaceuticals America will pay for certain incremental costs associated with the use of its sales force that are associated with the commercialization of Vascepa, such as sample costs and costs for promotional and marketing materials. Each party has agreed to deliver specified minimal primary detail equivalents and spend specified minimal amounts on sample, promotional and marketing costs. Amarin's commitments under the agreement are within its commercialization plans prior to the agreement. Amarin will continue to control marketing of the product and recognize all revenue from sales of Vascepa. Amarin will compensate Kowa Pharmaceuticals America with a co-promotion fee based on a percentage of Vascepa gross margins that increase during the agreement's term, from the high single digits in 2014 to the low 20% levels in 2018, subject to certain adjustments. The initial term of the agreement extends through 2018.

Kowa Pharmaceuticals America, Inc. and Eli Lilly and Company Announce Results of Pre-Specified Safety Analysis from the INTREPID Trial

Kowa Pharmaceuticals America, Inc. and Eli Lilly and Company announced results of a pre-specified safety analysis from the INTREPID (HIV-infected patieNts and TREatment with PItavastatin vs. pravastatin for Dyslipidemia) trial evaluating the effect of LIVALO (pitavastatin) 4 mg compared with pravastatin 40 mg on changes in levels of blood glucose and glycated hemoglobin (HbA(1c)) in HIV-infected adults with dyslipidemia. INTREPID was a Phase 4, multicenter, 12-week randomized superiority study followed by a 40-week safety extension study (NCT01301066) comparing the lipid-lowering effects of pitavastatin 4 mg and pravastatin 40 mg in adults with HIV infection and dyslipidemia. The results of this pre-specified safety analysis, presented at the Endocrine Society's 95th Annual Meeting & Expo in San Francisco, CA, showed neutral effects of pitavastatin 4 mg and pravastatin 40 mg on fasting serum glucose (FSG) and HbA(1c) levels over 12 weeks. By week 12, the mean change in FSG for pitavastatin (n=109) was -0.1mg/dL and pravastatin (n=112) was 0.6 mg/dL, and the adjusted (least squares mean) change in FSG was 0.6 mg/dL for pitavastatin and 2.5 mg/dL for pravastatin with no significant differences in each treatment group (p=0.68 and 0.09, respectively). There was no significant difference between treatment groups (p=0.20). The mean change in HbA(1c) was -0.02% for pitavastatin (n=110) and -0.01% for pravastatin (n=113), and the adjusted (least squares mean) change in HbA(1c) was 0.04% for pitavastatin and 0.05% for pravastatin with no significant differences in each treatment group (p=0.27 and 0.09, respectively). There was no significant difference between treatment groups (p=0.58). A significantly greater decrease in LDL-C over 12 weeks was noted with pitavastatin 4 mg compared with pravastatin 40 mg where the primary endpoint of mean percent change was -31.1% and -20.9%, respectively (p<0.001), with a mean change in LDL-C of -49.4 mg/dL for pitavastatin 4 mg vs. -33.6 mg/dL for pravastatin 40 mg.

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