Keryx Biopharmaceuticals announces NDA for hyperphosphatemia treatment in chronic kidney disease patients
NEW YORK — Keryx Biopharmaceuticals, Inc., today announced the submission of a new drug application to the U.S. Food and Drug Administration seeking approval for the marketing and sale of Zerenex (ferric citrate coordination complex), the company’s drug candidate for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease on dialysis. The company’s NDA submission is based primarily on the data sets derived from its Phase 3 registration program, which was conducted pursuant to a Special Protocol Assessment agreement with the FDA, and is also supported by efficacy and safety data from several additional studies, including four Phase 3 studies conducted in Japan in CKD patients on dialysis.
"The submission of the Zerenex NDA marks a major milestone for the Company. With approximately 1,500 patients exposed to the drug in the clinical development programs conducted by us and our Japanese partner, JT/Torii, we believe that Zerenex is a safe, effective and highly-differentiated drug candidate and today’s submission brings us one step closer to potentially bringing this drug to patients who can benefit from it," said Ron Bentsue the company’s CEO. "We are grateful to Dr. Julia Lewis, the Study Chair for the Zerenex Phase 3 program, and to our highly skilled internal team of clinical, manufacturing and regulatory professionals, for the time and effort they have dedicated towards this tremendous achievement," continued Bentsur.
The company also plans to submit a Marketing Authorization Application to the European Medicines Agency for regulatory approval of Zerenex in the European Union.
Keryx holds a worldwide license (except for certain Asian Pacific countries) to Zerenex from Panion & BF Biotech, Inc. The Japanese rights are sublicensed by Keryx to Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd. On January 7, 2013, JT announced the filing of its NDA with the Japanese Ministry of Health, Labour and Welfare for marketing approval of ferric citrate in Japan for the treatment of hyperphosphatemia in patients with CKD.
Zerenex is also in Phase 2 development in the U.S. for the management of phosphorus and iron deficiency in anemic patients with Stage 3 to 5 non-dialysis dependent CKD.
CVS Caremark’s Accordant Health Services launches new website
WOONSOCKET, R.I. — CVS Caremark has announced that Accordant Health Services has launched an updated website and member portal, which provides new features and services for program members and helps support and improve member engagement and participation for clients.
Accordant.com now provides eligible members with online access to educational materials, videos, communication tools and community resources that encompass 17 conditions such as rheumatoid arthritis, multiple sclerosis, Crohn’s disease and sickle cell disease. In addition, Accordant.com is now integrated with the Accordant Care Management System, which enables personalized and secure on-line communication between Accordant nurses and program members.
The new Accordant.com features offer members the option to choose how, when and where they access the Accordant program. New features include:
- "Let us Know" box on the home page of the website where members can submit questions about their health and their treatment regimen;
- New message center where members receive private messages filled with tips and tools for managing their condition;
- New content where members can find articles, tools and brochures to keep them up-to-date on the latest health information related to their condition; and
- Through the portal, members also can share health information with clinical team members and exchange secure messages with Accordant clinicians at times that are most convenient for them.
"The launch of our member portal marks an important milestone for Accordant," stated Trip Hofer, president of Accordant Health Services. "While most health management organizations position online tools and services as distinct and separate from those provided on the telephone or via mail, we recognize that health care doesn’t happen at a single point in time or through only one channel. The updated member portal at Accordant.com offers a digital experience that further enables Accordant to proactively support and empower individuals with rare conditions to improve their total health and manage their multiple and complex needs."
Access to Accordant.com is included with enrollment in the program. Ongoing enhancements to the website are planned throughout 2013 and 2014, and include expanded health assessments, call scheduling capabilities, online chat with Accordant nurses and advanced educational curricula.
Fred’s pharmacy department posts boost in comp sales, scripts for second-consecutive month
MEMPHIS, Tenn. — Fred’s posted a boost in sales for both the month of July and the second quarter, and noted that pharmacy experienced both comparable sales and scripts increases for the second-consecutive month.
Fred’s total sales for the month increased 4% to $142.2 million from $136.8 million in the year-ago period. Same-store sales for the month increased 2.5% on top of an increase of 1.2% in the same period last year.
Fred’s total sales for the second quarter increased 2% to $482.3 million compared with $470.8 million for the same period last year. On a comparable store basis, second-quarter sales increased 2.2% versus a decline of 1.0% in the same period last year.
For the first six months of fiscal 2013, sales increased 1% to $983.8 million compared with $971.3 million for the same period last year. On a comparable store basis, year-to-date sales increased 0.5% versus a decrease of 0.5% in the same period last year.
"July sales marked a continuation of positive trends in comparable store sales as both general merchandising and the pharmacy departments contributed equally to the month’s increase, a balance we plan to maintain for the remainder of the year. Notably, the pharmacy department experienced both comparable sales and scripts increases for the second consecutive month, while the increase in general merchandising reflected effective promotions to drive traffic,” stated Bruce Efird, CEO. “Our second-quarter sales also underscore the impact of our reconfiguration plan initiatives, most notably with our expanded Hometown Auto & Hardware department – the first phase of our space productivity plan, and our efforts to leverage new opportunities in the pharmacy department. Given our progress during the second quarter, we remain confident that the quarter’s earnings will be in the range previously forecasted."
During the second quarter, Fred’s opened two new store locations, closed 20 stores and opened one new pharmacy location. Fred’s currently operates 697 discount general merchandise stores, including 21 franchised Fred’s stores, in the southeastern United States.