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Keryx Biopharmaceuticals Announces Opening of Boston Office
NEW YORK and BOSTON, May 6, 2014 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical company focused on bringing innovative therapies to market for patients suffering from renal disease, is proud to announce the opening of its office in Boston, Massachusetts. A significant portion of the operations being built by Keryx to support the potential launch of Zerenex in the United States, including commercial, regulatory, medical affairs, legal, public affairs and pharamacovigilance, will be based in Boston.
"Boston is a biopharmaceutical hub with an exceptional pool of talent with relevant experience, which we believe makes it an ideal place to build a top-notch commercial stage organization," said Greg Madison, Chief Operating Officer of Keryx.
For the past few months, as the company prepared its Boston office for occupancy, Keryx's Boston-based staff have been meeting in District Hall, a public innovation space located in the Seaport District of Boston that is run by the Venture Café Foundation. To support District Hall and the important role it plays in facilitating innovation in Boston, the Company is becoming a sponsor of District Hall.
Mr. Madison added, "We would like to thank The Venture Café Foundation and the team at District Hall for hosting us during this very important time. Our sponsorship reflects our appreciation of the critical role a public space like District Hall can play in helping companies of all shapes and sizes through times of transitions and in bringing innovative minds together in a collaborative environment."
Nicole Fichera of District Hall and the Venture Café Foundation said, "We are happy to welcome Keryx to the neighborhood, and thrilled that they have decided to sponsor our space. Partnerships like this one between Keryx and District Hall really demonstrate the supportive nature of Boston's innovation community. When different parts of the ecosystem support each other, we build a stronger network for everyone."
Keryx's Boston office is located at 1 Marina Park Drive, Boston, MA 02210. The Company's headquarters will remain in New York City.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals, headquartered in New York, is focused on bringing innovative therapies to market for patients suffering from chronic kidney disease (CKD). In the United States, ferric citrate coordination complex is currently under review by the Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in dialysis-dependent CKD patients, where, pending approval, it will be marketed as Zerenex™ by Keryx. In January 2014, ferric citrate was approved for the treatment of patients with all stages of CKD in Japan, where it will be marketed as Riona® by Keryx's Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd.
Zerenex™ (ferric citrate coordination complex), is an oral, ferric iron-based phosphate binder. Keryx has completed a U.S.-based phase 3 clinical program for Zerenex for the treatment of hyperphosphatemia (elevated phosphate levels) in dialysis-dependent CKD patients, conducted pursuant to a Special Protocol Assessment (SPA) agreement with the 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. Keryx has filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA), seeking the approval of Zerenex as a treatment of hyperphosphatemia in patients with all stages of CKD and that application is currently under review.
About District Hall
District Hall is Boston's new home for innovation. It is a civic innovation center with a public purpose: the first building of its kind in the world. District Hall is a dedicated space where the innovation community can gather and exchange ideas. The building has open workspace, meeting and assembly space, flexible use 'pods', and writable surfaces everywhere, as well as a full restaurant and coffee shop.
District Hall is the result of a collaborative public-private partnership. The City of Boston's vision for the Innovation District called for a gathering space for innovators to get together and share ideas. The building was privately funded and built by Boston Global Investors, as the first project in their twenty-three acre master plan for Seaport Square. Operations and programming are run by the Venture Cafe´ Foundation. The restaurant and coffee shop, Gather and Brew, are both operated by The Briar Group. The building and the restaurant were designed by Hacin + Associates. The Founding Sponsors of District Hall are John Hancock, Foley Hoag, Microsoft, and In-Kind Sponsors are IdeaPaint, Bose, Digital Sky and Philips Color Kinetics.
Some of the statements included in this press release, particularly the potential FDA approval and subsequent commercialization of 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: 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, and/or EMA ultimately deny approval of the U.S. NDA, and/or MAA, 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 Riona® will be successfully launched and marketed by our Japanese partner, Japan Tobacco, Inc. and Torii Pharmaceutical Co., Ltd.; whether, Zerenex, if approved by the FDA and/or EMA, 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 release and is included for reference purposes only.
Vice President - Corporate Development
and Public Affairs
Keryx Biopharmaceuticals, Inc.
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