寶齡富錦：公告本公司腎臟新藥Nephoxil授權夥伴Keryx在美國時間6月3日於其網站發布Nephoxil(美國產品名稱為Zerenex)新聞稿相關資訊 鉅亨網新聞中心2013-06-04 18:15:11第三十四條第41款1.事實發生日:102/06/03 2.公司名稱:寶齡富錦生技股份有限公司3.與公司關係(請輸入本公司或聯屬公司):本公司4.相互持股比例(若前項為本公司，請填不適用):不適用5.發生緣由:Keryx公司6月2日於2013年世界腎臟醫學會(WCN)中發表討論Zerenex美國第三期臨床試驗數據，並於美國時間6月3日於其網站發佈新聞稿。6.因應措施:進行本次公告。7.其他應敘明事項:(1)本公司腎臟新藥Nephoxil的美國合作夥伴Keryx Biopharmacetical於香港舉辦的2013世界腎臟醫學會(WCN)中，由美國試驗總主持人進行美國第三期長期試驗之學術發表及討論。(2)Keryx於2013.01.28新聞稿己公佈Zerenex美國第三期臨床試驗數據。2013.06.03新聞稿係Keryx於2013年世界腎臟醫學會(WCN)中進行Zerenex學術發表與討論。(3)目前腎臟新藥產品於全球各地均尚未取得新藥的上市許可。本學術發表不屬Keryx應支付本公司里程款的支付要件，因此現階段對本公司財務、業務尚無影響。(4)Keryx為本公司腎臟新藥授權夥伴，為資訊透明及訊息對稱，但基於美國與台灣時差因素，本公司於6月4日發布此一重大訊息。
| Keryx Biopharmaceuticals, Inc. Announces Zerenex™ Phase 3 Data Presented at the 2013 World Congress of Nephrology | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| NEW YORK, June 3, 2013 /PRNewswire/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced the presentation of updated efficacy and safety data from the Phase 3 long-term clinical trial of Zerenex (ferric citrate), the Company's ferric iron-based phosphate binder drug candidate for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis. Dr. Julia Lewis, Professor of Medicine, Department of Nephrology, Vanderbilt University School of Medicine, and member of the Executive Committee of the Collaborative Study Group, and Study Chair of the Zerenex Phase 3 registration program, presented the updated dataset from the study entitled "A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis," in a symposium held earlier today in Hong Kong, during the 2013 World Congress of Nephrology (WCN) and a poster presented yesterday, Sunday, June 2, 2013. Study Design This Phase 3 long-term study was a multicenter, randomized, open-label, safety and efficacy clinical trial in 441 ESRD patients on hemodialysis or peritoneal dialysis. The study consisted of a 2-week washout period followed by a 52-week Safety Assessment Period (SAP) in which subjects were randomized 2:1 to receive either Zerenex or an active control (Renvela® [sevelamer carbonate] and/or Phoslo® [calcium acetate]). The 52-week SAP was followed by a 4-week Efficacy Assessment Period (EAP). During the EAP, only those subjects randomized to treatment with Zerenex during the SAP, and completed the 52-week SAP, were randomized in a 1:1 ratio to either continue treatment with Zerenex or switch to placebo for a 4-week treatment period. Subjects were titrated during the study to achieve normal serum phosphorus levels of 3.5 to 5.5 mg/dL. Zerenex was administered using a 1 gram oral caplet formulation. Oral iron therapy was not permitted during the course of the study. Intravenous (IV) iron therapy was not permitted if a subject's serum ferritin level was greater than 1,000 ng/mL or transferrin saturation (TSAT) was greater than 30%. The use of erythropoiesis-stimulating agents (ESAs) was at the physician's discretion. Study Efficacy Results Dr. Lewis' presentation confirmed that Zerenex met the pre-defined primary and key secondary endpoints, highlighting that Zerenex is an efficacious and safe oral phosphate binder that controls serum phosphorus, increases iron stores as measured by serum ferritin and TSAT, and reduces the use of IV iron and ESAs, while sustaining hemoglobin as compared to the active control group. The following results from the study were presented in the oral presentation given by Dr. Lewis onMonday, June 3, 2013 (Hong Kong time) at the WCN. Table 1 - Primary Endpoint: Zerenex effectively controls serum phosphorus in the EAP.
1 Last observation carried forward was used for missing data.
Table 2: Serum phosphorus was controlled over the 52-week SAP. Subjects were titrated to goal (3.5 to 5.5 mg/dL). There was no statistical or clinical difference between the two groups in managing serum phosphorus over 52 weeks.
1 Last observation carried forward was used for missing data.
Table 3 - Secondary Endpoint: Zerenex increases serum ferritin as compared to Active Control.
1 Last observation carried forward was used for missing data.
Table 4 - Secondary Endpoint: Zerenex increases TSAT as compared to Active Control.
1 Last observation carried forward was used for missing data. Dr. Lewis noted that TSAT and ferritin scores in the Zerenex arm achieved a statistical plateau, in regard to TSAT levels at Week 12 and to ferritin levels at Week 36, compared to Week 52 (end of the SAP).
Table 5 - Secondary Endpoint: Zerenex decreases IV Iron use as compared to Active Control.
1 IV iron intake is calculated as the total IV iron intake during the study divided by the total number of days on study drug during the study.
Table 6: Zerenex reduces the need for IV Iron (p<0.0001) as compared to Active Control.
Table 7 - Secondary Endpoint: Zerenex decreases ESA use as compared to Active Control.
1 ESA intake is calculated as the total ESA intake during the study divided by the total number of days on study drug during the study.
Table 8: Hemoglobin well-maintained with Zerenex in the SAP as compared to Active Controldespite significantly lower IV iron and ESA use.
1 Last observation carried forward was used for missing data. Study Safety Results Dr. Lewis indicated that Zerenex was safe and well-tolerated in the study and provided the below additional safety data.
Table 9: Zerenex arm incurred a lower rate of serious adverse events (SAEs) as compared toActive Control.
1 Subjects may have more than one SAE. Ron Bentsur, the Company's Chief Executive Officer, commented, "The data presented at WCN corroborates the top-line data presented earlier this year and further highlights Zerenex's highly-differentiated product profile. We believe that Zerenex, if approved, can potentially change practice patterns in dialysis and chronic kidney disease and improve patients' lives." Mr. Bentsur added, "We look forward to the presentations of additional data from the study at upcoming medical conferences." About Keryx Biopharmaceuticals, Inc. Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease. Keryx is developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. Keryx has completed a U.S.-based Phase 3 clinical program for Zerenex for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease, conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA, and the New Drug Application filing with the FDA and the Marketing Authorization Application filing with the EMA are pending submission. Zerenex is also in Phase 2 development in the U.S. for the management of phosphorus and iron deficiency in anemic patients with Stages 3 to 5 non-dialysis dependent chronic kidney disease. In addition, Keryx's Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd. has filed its New Drug Application for marketing approval of ferric citrate in Japan for the treatment of hyperphosphatemia in patients with chronic kidney disease. Keryx is headquartered in New York City. |
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