Horizon Pharma plc
May 15, 2017

Horizon Pharma plc Announces District Court Decision to Uphold PENNSAID® (diclofenac sodium topical solution) 2% w/w Patent

Patent Covering PENNSAID® 2% Infringed by a Proposed Generic Developed by Actavis Laboratories UT, Inc.

DUBLIN, Ireland, May 15, 2017 (GLOBE NEWSWIRE) -- Horizon Pharma plc (NASDAQ:HZNP), a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, today announced that the United States District Court for the District of New Jersey upheld the validity of Horizon Pharma's patent covering PENNSAID® (diclofenac sodium topical solution) 2% w/w, which Actavis Laboratories UT, Inc. (Actavis) has admitted that its proposed generic diclofenac sodium topical solution product would infringe.  

On July 6, 2015, Horizon filed a patent infringement lawsuit in District Court against Actavis related to Abbreviated New Drug Applications filed with the U.S. Food and Drug Administration to market a generic version of PENNSAID 2%.  The lawsuit claims infringement of Horizon's U.S. Patent No. 9,066,913 (‘913 patent) titled "Diclofenac Topical Formulation," which covers PENNSAID 2%.  The District Court's decision was made based on the validity of Horizon Pharma's ‘913 patent for PENNSAID 2% and the Court's judgment will prevent Actavis from launching a generic version of PENNSAID 2% in the United States.

PENNSAID 2% has 18 Orange Book listed patents with terms that extend to 2030.

About PENNSAID 2%
PENNSAID (diclofenac sodium topical solution) 2% w/w is a non-steroidal anti-inflammatory drug (NSAID) indicated for the treatment of pain of osteoarthritis (OA) of the knee(s).  PENNSAID 2% contains diclofenac sodium, an NSAID, and also includes dimethyl sulfoxide (DMSO), a powerful penetrating agent that helps ensure that diclofenac sodium is absorbed through the skin to the site of inflammation and pain.  PENNSAID 2% is an alternative to oral NSAID treatment, reducing systemic exposure to a fraction of that provided by the oral NSAID diclofenac.  The only topical NSAID offered with the convenience of a metered-dose pump, PENNSAID 2% is applied in two pumps, twice daily, to the site of OA knee pain.  For more information, please see www.PENNSAID.com.

IMPORTANT SAFETY INFORMATION

WARNING:  CARDIOVASCULAR AND GASTROINTESTINAL RISK

Heart Risk

Stomach and Intestine Risk

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

USE IN SPECIFIC POPULATIONS

For more information on PENNSAID 2%, please see the Medication Guide and Full Prescribing Information, available at www.PENNSAID.com.

About Horizon Pharma plc
Horizon Pharma plc is a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs.  The Company markets 11 medicines through its orphan, rheumatology and primary care business units.  For more information, please visit www.horizonpharma.com.  Follow @HZNPplc on Twitter or view careers on our LinkedIn page.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the impact of the District Court's ruling on Horizon Pharma's ‘913 patent.  These forward-looking statements are based on management 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 risks regarding whether Actavis appeals the District Court's decision and whether the decision is upheld on such an appeal and other factors described in Horizon Pharma'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 Pharma does not undertake any obligation to update or revise these statements, except as may be required by law.

Contacts:

Tina Ventura

Senior Vice President, Investor Relations

Investor-relations@horizonpharma.com



Ruth Venning

Executive Director, Investor Relations

Investor-relations@horizonpharma.com



U.S. Media Contacts:

Geoff Curtis

Senior Vice President, Corporate Affairs & Chief Communications Officer

media@horizonpharma.com



Ireland Media Contact:

Ray Gordon

Gordon MRM 

ray@gordonmrm.ie

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Source: Horizon Pharma plc

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