DUBLIN, IRELAND--(Marketwired - May 12, 2016) - Horizon Pharma plc (
Under the settlement and license agreement, Horizon has granted Teligent the non-exclusive right to market a generic diclofenac sodium topical 2% w/w solution in the United States under Teligent's Abbreviated New Drug Application (ANDA) beginning January 10, 2029 or earlier under certain circumstances.
The agreement follows the May 2, 2016, entry of a stipulation of dismissal without prejudice of all lawsuits filed by Horizon in the U.S. District Court for the District of New Jersey relating to the ANDA filed by Teligent with the U.S. Food and Drug Administration for a generic version of PENNSAID 2%.
Details of the settlement are confidential and the agreement is subject to submission to the Federal Trade Commission and the U.S. Department of Justice.
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 nine medicines through its orphan, rheumatology and primary care business units. Horizon's global headquarters are in Dublin, Ireland. 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 anticipated results of or future actions of the parties under the settlement and license agreement for PENNSAID 2%. 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, but are not limited to, risks regarding whether the U.S. Federal Trade Commission or Department of Justice will challenge the enforceability of or seek to enjoin the entry into the settlement and license agreement, whether the U.S. District Court will grant an order dismissing the litigation, whether additional third parties may seek to market generic versions of PENNSAID 2% by filing ANDAs with the FDA and the results of any litigation that Horizon files to defend or assert its patents against such third parties, the occurrence of events under the settlement and license agreement that would allow Teligent to market its generic version of PENNSAID 2% earlier than anticipated, and other 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 does not undertake any obligation to update or revise these statements, except as may be required by law.
Contacts:
Investors:
John Thomas
Executive Vice President, Strategy and Investor Relations
[email protected]
Tina Ventura
Vice President, Investor Relations
[email protected]
U.S. Media:
Geoff Curtis
Senior Vice President, Corporate Communications
[email protected]
Ireland Media:
Ray Gordon
Gordon MRM
[email protected]
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