Horizon Receives Notice of Paragraph IV Certification Against Patents for DUEXIS(R)
(firmenpresse) - DEERFIELD, IL -- (Marketwire) -- 02/16/12 -- Horizon Pharma, Inc. (NASDAQ: HZNP), today announced that it had received a Paragraph IV Patent Certification from Par Pharmaceutical, Inc. ("Par") advising that Par has filed an Abbreviated New Drug Application ("ANDA") with the U.S. Food and Drug Administration ("FDA") for a generic version of DUEXIS®, containing 800 mg of ibuprofen and 26.6 mg of famotidine. Par has not advised Horizon as to the timing or status of the FDA's review of its filing, or whether it has complied with FDA requirements for proving bioequivalence.
Horizon is evaluating the Paragraph IV certification and intends to vigorously enforce its intellectual property rights relating to DUEXIS. All of the issued U.S. patents covering DUEXIS are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. Under the FDA's rules and regulations, if Horizon initiates a patent infringement suit to defend the patents identified in the Paragraph IV notice within 45 days after its receipt of the notice, the FDA would be prevented from approving the ANDA until the earlier of 30 months or a decision in the infringement case that each of the patents are not infringed or invalid. In addition to the two issued U.S. patents listed in the Orange Book, Horizon is currently prosecuting additional patent applications that would cover DUEXIS.
Horizon Pharma, Inc. is a biopharmaceutical company that is developing and commercializing innovative medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases. For more information, please visit .
This press release contains forward-looking statements, including statements regarding Horizon's intent to enforce its patents, the possibility of initiating a patent infringement suit and whether the FDA would be prevented from approving Par's ANDA filing. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release, and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include, but are not limited to, whether Horizon would be successful in patent infringement litigation, if initiated. For a further description of these and other risks facing Horizon, please see the risk factors described in Horizon's filings with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in those filings. Forward-looking statements speak only as of the date of this press release, and Horizon undertakes no obligation to update or revise these statements, except as may be required by law.
Robert J. De Vaere
Executive Vice President and Chief Financial Officer
Media
Julie Normart
Invigorate PR
415-946-1087
Investors
Kathy Galante
Burns McClellan, Inc.
212-213-0006
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Datum: 16.02.2012 - 19:13 Uhr
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