DGAP-News: Keryx Biopharmaceuticals Provides Update From Ongoing Zerenex(TM) (ferric citrate coordination complex) Long-Term Safety Extension Study in Patients With Hyperphosphatemia on Dialysis
(firmenpresse) - Keryx Biopharmaceuticals, Inc.
08.11.2013 14:30
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Data to Date Support Results From Long-Term Phase 3 Study
NEW YORK, 2013-11-08 14:30 CET (GLOBE NEWSWIRE) --
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) today announced preliminary,
unaudited data from an ongoing 48-week safety extension study of Zerenex(tm)
(ferric citrate coordination complex) the Company's drug candidate for the
treatment of hyperphosphatemia in patients with chronic kidney disease on
dialysis. Only patients who had participated in, and successfully completed the
58-week, long-term Phase 3 study were eligible for enrollment into this safety
extension study. This 48-week, open-label extension (OLE) study, which is not a
regulatory requirement, is being conducted in 35 sites in the United States.
The study commenced enrollment in August 2012 and is anticipated to be
completed in the first half of 2014.
Patients in the OLE study are titrated to achieve and maintain normal serum
phosphorus levels (3.5 to 5.5 mg/dL) for a period of 48 weeks. This study,
together with the 58-week, long-term Phase 3 safety and efficacy study,
represents potential cumulative exposure to Zerenex of up to 2 years.
Enrollment in the OLE study included 168 patients, of which 166 patients were
dosed with Zerenex, consisting of 114 and 52 patients from the Zerenex and
Active Control arms of the completed long-term Phase 3 study, respectively.
The data presented is through October 31, 2013, and appear to corroborate the
data observed in the completed long-term Phase 3 study. Key highlights from
this preliminary data include:
-- Effective control of serum phosphorus within the normal range of 3.5 to 5.5
mg/dL;
-- Increase and plateau of transferrin saturation (TSAT) and ferritin at weeks
12 and 24, respectively, with ferritins decreasing after week 36;
-- Extremely limited use of intravenous (IV) iron in the study, with 69% of
patients not receiving any IV iron throughout the study; and
-- Substantially lower use of IV iron and erythropoiesis stimulating agents
(ESAs) in the OLE study, as compared to national averages, by 85% and 62%,
respectively, while maintaining hemoglobin.
Mean Laboratory Measurements:
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Baselin Week Week Week Week
e 12 24 36 48
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Number of subjects at timepoint as of 166 154 135 108 59
October 31, 2013
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Serum phosphorus (mg/dL) 5.7 5.3 5.3 5.2 5.5
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TSAT (%) 32 38 36 38 38
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Ferritin (ng/mL)700 804 848 846 717
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Note: Missing values were not imputed.
IV Iron Use in the OLE Study:
Based on these preliminary data through October 31, 2013, the observed uses of
IV iron and ESAs in the OLE study are substantially lower than the national
averages, as referenced in the most recent U.S. Dialysis Outcomes and Practice
Patterns (DOPPS) database, as of April 2013.
Per the OLE protocol, the use of IV iron is prohibited if the patient's
ferritin is>500 ng/mL or TSAT is>30%. The use of IV iron in this study has
been extremely limited to date, with 69% of the OLE patients receiving no IV
iron at all in the study.
Moreover, as of October 31, the mean monthly administered IV iron dose per
patient, for all treated patients in the OLE, is only 32mg/month, or 380mg/year
(median dose = 0), compared to the national mean monthly administered IV iron
dose per the current DOPPS report of approximately 210 mg/month, or
2500mg/year. This represents an 85% reduction in IV use as compared to the
current national average, thereby supporting the Company's belief that
treatment with Zerenex could substantially eliminate the need for IV iron in
the overwhelming majority of patients on Zerenex.
ESA Use in the OLE Study:
There are no study protocol limitations on the use of ESAs in the OLE study and
ESAs are administered at the physician's discretion. To date, the weekly
average administered dose of ESAs per patient, for all treated patients in the
OLE, is 4,500 units/week, compared to the national mean weekly administered ESA
dose per the current DOPPS report of 11,800 units/week, representing a
reduction of 62% compared to the national average. Also of interest, the
current DOPPS report also provides the national median weekly administered ESA
dose of 6,800 units/week per patient. In the OLE study to date, the median
weekly administered ESA dose is 2,200 units/week per patient, representing a
reduction of 68% compared to the national median weekly dose.
Moreover, the preliminary data suggests that hemoglobin appears stable
throughout the study, with the baseline hemoglobin level at 11.1 g/dL, and
subsequent measurements between 11.1 and 11.6 g/dL (11.5 g/dL at week 48).
These preliminary data on IV iron and ESA use in the OLE study appear to
corroborate the long-term Phase 3 data by demonstrating Zerenex's ability to
significantly reduce the need for IV iron and ESAs, while maintaining
hemoglobin in dialysis patients.
Safety and Tolerability:
To date, Zerenex appears to be safe and well-tolerated in the study.
Importantly, there are no clinically meaningful changes in serum calcium levels
and liver enzymes as measured by alanine transaminase (ALT) and aspartate
transaminase (AST). The discontinuation rate in the study, to date, is
approximately 17%.
Ron Bentsur, the Company's Chief Executive Officer, commented, 'While
preliminary, I believe that the data from this OLE study to date reinforces the
data observed in the long-term Phase 3 study. Importantly, it is encouraging to
see that Zerenex appears to be safe and well tolerated for up to two years of
cumulative exposure in clinical studies.' Mr. Bentsur continued, 'Also of note
is the extremely limited use of IV iron and the considerably lower use of ESAs
observed in the OLE study to date, as compared to the national averages, while
maintaining stable hemoglobin levels. With approximately $2.5 billion of annual
spending on ESAs and IV iron in the U.S. dialysis setting, the OLE study could
further highlight the potential profound pharmaco-economic benefits that we
believe Zerenex can bring forth in dialysis.'
The Company's New Drug Application (NDA) for the use of Zerenex for the
treatment of hyperphosphatemia in chronic kidney disease patients on dialysis
is currently under review by the FDA with an assigned Prescription Drug User
Fee Act (PDUFA) goal date of June 7, 2014.
Keryx holds a worldwide license (except for certain Asian Pacificcountries) to
Zerenex (ferric citrate coordination complex) from Panion&BF Biotech, Inc.
The Japanese rights are sublicensed by Keryx to Japan Tobacco Inc. and Torii
Pharmaceutical Co., Ltd.
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
coordination complex), 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 chronic
kidney disease on dialysis, conducted pursuant to a Special Protocol Assessment
(SPA) agreement with the Food and Drug Administration (FDA). The Company's New
Drug Application (NDA) is currently under review by the FDA with an assigned
Prescription Drug User Fee Act (PDUFA) goal date of June 7, 2014. The Marketing
Authorization Application filing with the European Medicines Agency (EMA) is
pending submission. The Company is also developing Zerenex in the U.S. for the
management of elevated phosphorus and iron deficiency anemia in 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.
Forward-Looking Statements
Some of the statements included in this press release, particularly those
relating to the results of clinical trials, the clinical benefits to be derived
from Zerenex (ferric citrate coordination complex), regulatory submissions and
the timing of any such review, approvals, the commercial opportunity and
competitive positioning, and any business prospects for Zerenex, may be
forward-looking statements that involve a number of risks and uncertainties.
For those statements, we claim the protection of the safe harbor for
forward-looking statements contained in the Private Securities Litigation
Reform Act of 1995. Among the factors that could cause our actual results to
differ materially are the following: safety and efficacy data from the ongoing
48-week, open-label extension (OLE) study presented herein are preliminary and
unaudited in nature and there is the risk that the data and our interpretation
of the data and its findings and conclusions could change following a more
comprehensive review of the data or upon the completion of the study;
acceptance of the NDA filing represents only a preliminary evaluation of the
application and is not indicative of deficiencies that may be identified during
the FDA's review; a PDUFA goal date is subject to change and does not guarantee
that the review of the NDA will be completed on a timely basis; the risk that
the FDA, EMA, and/or the Japanese Ministry of Health, Labour and Welfare
ultimately deny approval of the U.S. NDA, MAA and/or Japanese NDA,
respectively; the risk that SPAs are not a guarantee that the FDA will
ultimately approve a product candidate following filing acceptance; whether the
FDA and EMA will concur with our interpretation of our Phase 3 study results,
supportive data, or the conduct of the studies; whether, Zerenex, if approved,
will be successfully launched and marketed; and other risk factors identified
from time to time in our reports filed with the Securities and Exchange
Commission. Any forward-looking statements set forth in this press release
speak only as of the date of this press release. We do not undertake to update
any of these forward-looking statements to reflect events or circumstances that
occur after the date hereof. This press release and prior releases are
available at http://www.keryx.com. The information found on our website is not
incorporated by reference into this press releaseand is included for reference
purposes only.
CONTACT: KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer(at)keryx.com
News Source: NASDAQ OMX
08.11.2013 Dissemination of a Corporate News, transmitted by DGAP -
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Company: Keryx Biopharmaceuticals, Inc.
United States
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term-safety-extension-study-in-patients-with-hyperphosphatemia-on-dialysis
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Datum: 08.11.2013 - 14:30 Uhr
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