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Keryx Biopharmaceuticals Announces Issuance of A New US Patent

02-Oct-2014 | Source : | Visits : 6060
NEW YORK - Keryx Biopharmaceuticals Inc. announced in a press release that the US Patent and Trademark Office has issued US Patent No. 8,846,976. The patent, which expires in 2024, claims a method of treating hyperphosphatemia comprised of administering a therapeutically effective amount of an orally administrable form of
Ferric Citrate to a subject, wherein the orally administrable form is prepared from a ferric citrate active pharmaceutical ingredient having an intrinsic dissolution rate of at least 1.88/mg/cm2/min. In addition, US Patent No. 8,846,976 contains claims directed to the FDA approved dosing and daily administration of Ferric Citrate.
On September 5, 2014, Ferric Citrate was approved by the US Food and Drug Administration for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.

This newly issued patent further enhances the Company's key patent family, which includes US Patent Nos. 7,767,851, 8,299,298, 8,338,642, 8,609,896, 8,754,257 and 8,754,258, which expire in 2024, and US Patent No. 8,093,423, which expires in 2028, before patent term extension. Each of these patents contains composition and method of use claims covering Ferric Citrate.

Ron Bentsur, Chief Executive Officer of Keryx, commented, "The patent that issued today is significant in that it links orally administrable forms of Ferric Citrate prepared from Keryx's API having an intrinsic dissolution rate of at least 1.88/mg/cm2/min with a method of treatment consistent with the therapeutic claim in the package insert. Moreover, the timing of issuance, which is merely 3 months after the issuance of US Patent Nos. 8,754,257 and 8,754,258 last June, provides substantiating evidence of our rapidly growing patent portfolio."

The Company continues to prosecute additional patent applications for Ferric Citrate, which, if issued, would expand the scope of patent claims covering Ferric Citrate beyond 2030.

In the coming weeks, the Company plans to file for Patent Term Extension, which, if granted, would add up to an additional 5 years to the patent protection for Ferric Citrate. Importantly, following FDA approval, the FDA Substance Registration System adopted tetraferric tricitrate decahydrate as the name of the active ingredient approved for marketing by the FDA, to appropriately describe the Company's proprietary form of ferric citrate.
Bentsur added, "The novelty of our active ingredient is important because Patent Term Extension is granted for a drug if the drug's active ingredient has not been previously approved by the FDA." Bentsur added, "To our knowledge, no other approved drugs contain tetraferric tricitrate decahydrate as the active ingredient."

Keryx Biopharmaceuticals, headquartered in New York, is focused on bringing innovative therapies to market for patients with renal disease. Keryx plans to commercially launch Ferric Citrate in the U.S. in the fourth quarter of 2014. In January 2014, ferric citrate was approved for the treatment of patients with all stages of CKD in Japan, where it is being marketed as Riona® by Keryx's Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd.

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