Keryx Biopharmaceuticals Reports Unsuccessful NCE Designation by FDA

The intellectual property for Zerenex, Keryx Biopharmaceuticals, is expected to give exclusive rights protection until the year 2024. Based on SOTP and DCF analyses, the privilege protection has rechecked Market Outperform value and 2014 closing price target of $22. The recently approved product of Keryx Biopharmaceuticals, Velphoro (PA21), was not provided exclusiveness in the market as an FDA-certified new chemical entity or NCE.

A marketing clannishness of five years is granted along with designation of NCE, which is highly emphasized by the analysts. The standard is established on FDA’s record of approving ferric iron, which is already an active compound in drugs and is found in Velphoro.

Zerenex may encounter the same fate, but the analysts conceived that the designation of NCE may be less significant. This is brought by the fact that the new drug is projected to resist generic competition until the year 2024 in consideration to its surface area, medication substances, and intrinsic dissipation.

An independent and superior statement in relation to Brunauer-Emmette-Teller (BET) surface area that exceeded 16 sq m/g has been defined by the Zerenex patents (U.S. Patent No. 8,338,642 and 8,299,298). The ferric citrate found in Zerenex has a 38 sq m/g surface area and the firm conceives that in order for a competing medication to be effective, it must have a minimum of 25 sq m/g BET surface area. A generic counterpart is usually pushed to utilize numerous bigger pills in order to develop a ferric citrate pill without the use of IP for similar clinical results.

The patents partnered with structure assertions are not process-based. Other than that, in order to make Zerenex adequate for Patent Term Extension (PTE) despite an expiry date of 2017, Keryx utilized a patent for method of use, which is defined as U.S. Patent No. 5,753,706. PTE is fixed by the patent office of United States, whereas FDA administers NCE designation.

Keryx Biopharmaceuticals is highly projected to obtain PTE despite the circulating disputes regarding Zerenex patent. As more investors participate in Keryx Biopharmaceuticals management, investors base will come to a rise as well. The recent reports about the firm simply gave investors hint of acquiring more of the KERX shares. Furthermore, it is fairly certain that long-term exclusiveness of Zerenex can be obtained in the United States since KERX has variety of ways of doing so. When this happens, it can be expected that Zerenex will keep generic competition off the mart for a longer time span.