DUBLIN, IRELAND--(Marketwired - Apr 17, 2015) - Horizon Pharma plc (
"This Notice of Allowance furthers our goal of strengthening the PENNSAID 2% patent estate and supports the innovation behind this important medicine for patients in need of treatment," said Timothy P. Walbert, chairman, president and chief executive office, Horizon Pharma plc.
This Notice of Allowance concludes the substantive examination of the patent application and will result in the issuance of a U.S. patent after administrative processes are completed. The U.S. patent scheduled to issue from this application will expire in 2027. After issuance, Horizon plans to list the patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book. This will be the eighth U.S. patent to be listed in the Orange Book for PENNSAID 2%.
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 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
- Non-steroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious heart clotting events, heart attack and stroke, which can kill you. This risk may increase with longer use. Patients with heart disease or risk factors for heart disease may be at greater risk.
- PENNSAID 2% should not be used if you are in the hospital for certain heart surgeries.
Stomach and Intestine Risk
- NSAIDs cause an increased risk of serious stomach and intestine events including bleeding, ulcers and holes in the stomach or intestines, which can kill you. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious stomach and intestine events.
CONTRAINDICATIONS
- DO NOT USE PENNSAID 2% if you:
- are in the hospital for certain heart surgeries.
- know you are allergic to diclofenac sodium or any other ingredient of PENNSAID 2%.
- have experienced asthma, hives, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, allergic reactions, that will rarely kill you, to NSAIDs have been reported in such patients.
WARNINGS AND PRECAUTIONS
- To minimize the potential for increased risk of serious heart events while being treated with an NSAID, use the lowest effective dose for the shortest duration possible.
- Elevation of one or more liver tests may occur during therapy with NSAIDs. PENNSAID 2% should be discontinued immediately if abnormal liver tests persist or worsen.
- Use with caution in patients with fluid retention or heart failure.
- Hypertension can occur with NSAID treatment. Monitor blood pressure closely with PENNSAID 2% treatment.
- Long-term use of NSAIDs can result in severe kidney injury. Use PENNSAID 2% with caution in patients at greatest risk of this reaction, including the elderly, those with impaired kidney function, heart failure, liver dysfunction and those taking diuretics and ACE-inhibitors (certain blood pressure medicines).
- Severe allergic reactions may occur without prior use of PENNSAID 2%. NSAIDs can cause serious skin reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN), which can kill you.
- Wash and dry hands before and after use. Avoid contact of PENNSAID 2% with the eyes, nose and mouth.
- PENNSAID was not studied under the conditions of heat application, complete covering bandages or exercise; therefore, concurrent use of PENNSAID 2% under these conditions is not recommended.
- Do not:
- Apply PENNSAID to open wounds.
- Shower for at least 30 minutes after applying PENNSAID 2%.
- Wear clothing over the PENNSAID 2% treated knee until the treated knee is dry.
- Protect treated knee(s) from natural or artificial sunlight.
- Protect treated knee(s) from sunlight (real and tanning booths).
- Topicals, such as sunscreen and bug repellent, should not be used until after PENNSAID 2% treated knee(s) are completely dry.
- Do not use with oral NSAIDs unless your doctor says it is OK and you have lab tests to check your progress.
- There is no consistent evidence that regular use of aspirin lessens the increased risk of serious heart events, such as heart clotting, heart attack and stroke associated with NSAID use. As with all NSAIDs, regular administration of PENNSAID 2% and aspirin is not generally recommended because of the potential of increased risks.
ADVERSE REACTIONS
- The most common adverse events in a phase 2 clinical trial of PENNSAID 2% were application site reactions, such as dryness (22%), peeling (7%), redness (4%), itching (2%), pain (2%), skin hardening (2%), rash (2%) and scabbing ( < 1%). Other adverse reactions occurring in > 1% of patients receiving PENNSAID 2% included bladder infection (3%), bruising (2%), sinus congestion (2%) and nausea (2%).
- The most common treatment-related adverse events in patients receiving PENNSAID 1.5% were application site skin reactions including dry skin (32%), skin reaction characterized by redness and hardening (9%), skin reaction with blisters (2%) and itching (4%). In a long term safety study, skin reactions occurred in 13% and skin reactions with blisters in 10% of patients, generally within the first 6 months of exposure, leading to a withdrawal rate for an application site event of 14%. Other common adverse events greater than placebo include: stomach upset (9%), stomach pain (6%), gas (4%), diarrhea (4%) and nausea (4%).
USE IN SPECIFIC POPULATIONS
- PENNSAID 2% should not be used in pregnant woman or in women who are breastfeeding and is not approved for use in children.
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 specialty biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated products that address unmet medical needs. The company markets a portfolio of products in arthritis, inflammation and orphan diseases. The company's U.S. marketed products are ACTIMMUNE® (interferon gamma-1b), DUEXIS® (ibuprofen/famotidine), PENNSAID® (diclofenac sodium topical solution) 2% w/w, RAYOS® (prednisone) delayed-release tablets and VIMOVO® (naproxen/esomeprazole magnesium). Horizon's global headquarters are in Dublin, Ireland. For more information, please visit www.horizonpharma.com .
Forward-Looking Statements This press release contains forward-looking statements, including statements regarding the issuance of a patent based on the Notices of Allowance from the U.S. Patent and Trademark Office, the expected term of the patent, if issued, the ability to protect the innovation and commercial potential of PENNSAID 2% and plans to list newly issued patents in the FDA's Orange Book. 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 the administrative processes required for the issuance of a patent as indicated in the Notice of Allowance will be completed in a timely matter or at all, whether the patent, if issued as indicated in the Notice of Allowance, will provide sufficient protection and market exclusivity for PENNSAID 2%, whether any patents covering PENNSAID 2% may be challenged, invalidated, infringed or circumvented by third parties and other 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.
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