Horizon Pharma plc Announces the U.S. Patent and Trademark Office Issuance of an Additional Notice of Allowance With Claims Covering RAYOS® (prednisone) Delayed-Release Tablets

DUBLIN, Ireland, Aug. 18, 2016 (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 Patent and Trademark Office (USPTO) has granted a Notice of Allowance for U.S. patent application number 14/563,000 (U.S. publication number 2015-0141388), entitled “Delayed-Release Glucocorticoid Treatment of Rheumatoid Disease” that covers Horizon’s U.S. approved medicine RAYOS (prednisone) delayed-release tablets.

The 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 August 3, 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 RAYOS.
About RAYOS
RAYOS, known as LODOTRA^® in Europe, is a proprietary delayed-release formulation of low-dose prednisone.  The pharmacokinetic profile of RAYOS is different with an approximately four-hour lag time from that of immediate-release prednisone formulations.  In clinical trials studying use of RAYOS in rheumatoid arthritis (RA), patients were administered RAYOS at 10 p.m. with food.  The delayed-release profile of RAYOS helps to achieve therapeutic prednisone blood levels at a time point when cytokine levels start rising during the middle of the night.  While the pharmacokinetic profile of RAYOS differs in terms of lag time from immediate-release prednisone, its absorption, distribution and elimination processes are comparable.  For more information, please visit www.RAYOSrx.com.
RAYOS utilizes Skyepharma’s proprietary Geoclock™ technology.
Outside the United States, LODOTRA is approved for the treatment of moderate to severe active RA when accompanied by morning stiffness in more than thirty-five countries.  Horizon has granted commercialization rights for LODOTRA in Europe, Asia (excluding Japan) and Latin America to its distribution partner Mundipharma International Corporation Limited.  Horizon has an exclusive license from Skyepharma (a division of Vectura) for RAYOS/LODOTRA.
Important Safety Information
RAYOS is a corticosteroid indicated:

• As an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation
• For the treatment of certain endocrine conditions
• For palliation of certain neoplastic conditions

CONTRAINDICATIONS

• Known hypersensitivity to prednisone or any excipients in the formulation

WARNINGS AND PRECAUTIONS

• Corticosteroids can cause hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome and hyperglycemia. Monitor patients for these conditions with chronic use. Taper doses gradually for withdrawal after chronic use.
• RAYOS may increase susceptibility to new infection and increase risk of exacerbation, dissemination or reactivation of latent infection. RAYOS may mask signs and symptoms of infection. The rate of infectious complications increases with increasing doses of corticosteroids.
• Corticosteroids can cause elevated blood pressure, salt and water retention and hypokalemia. Monitor blood pressure and sodium, potassium serum levels. RAYOS should be used with caution in patients with a history of recent myocardial infarction, congestive heart failure, hypertension or renal insufficiency.
• There is an increased risk of gastrointestinal (GI) perforation in patients with certain GI disorders. RAYOS may mask signs and symptoms of GI perforation.
• Corticosteroid use may be associated with behavioral and mood disturbances, including euphoria, insomnia, mood swings, personality changes, severe depression and psychosis. Existing conditions may be aggravated.
• Corticosteroid use may lead to inhibition of bone growth in children and adolescents and the development of osteoporosis at any age. Give special consideration to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating corticosteroid therapy, and bone density should be monitored in patients on long-term corticosteroid therapy.
• Prolonged use of corticosteroids may result in cataracts, infections and glaucoma. Monitor intraocular pressure if corticosteroid therapy is continued for more
  than 6 weeks.
• Do not administer live or attenuated vaccines to patients receiving immunosuppressive doses of corticosteroids.
• Long‐term use of corticosteroids can have negative effects on growth and development in children. Monitor pediatric patients on long‐term corticosteroid therapy.
• Fetal harm can occur with first trimester use of corticosteroids. Apprise women of potential harm to the fetus.

ADVERSE REACTIONS

• Common adverse reactions for corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain.

For further information on RAYOS, including a complete list of indications, please see the full Prescribing Information at www.RAYOSrx.com/PI.
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.
About Vectura
Vectura, a FTSE250 company listed on the London Stock Exchange (LSE:VEC), is an industry-leading inhaled airways disease focused business with proprietary formulation and devices across DPI, pMDI and smart nebulisation platforms.  With our extensive range of technologies, capabilities and collaborations, we believe we can become a leader in the development of inhalation products, increasing our ability to help patients suffering from respiratory diseases.  In June 2016 Vectura completed a merger with Skyepharma PLC.
Vectura has seven inhaled, four non-inhaled and ten oral products marketed by partners with growing global royalty streams, and a portfolio of drugs in clinical development, a number of which have licence agreements with several global pharmaceutical and biotechnology companies including Hikma, Novartis, Sandoz, Mundipharma, Kyorin, Baxter, GSK, UCB, Ablynx, Grifols, Chiesi, Almirall, Janssen, and Tianjin KingYork.
For further information, please visit Vectura’s website at www.vectura.com.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the issuance of a patent based on a Notice of Allowance from the U.S. Patent and Trademark Office, the expected term of the patent, if issued, 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 RAYOS, whether any patents covering RAYOS 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.

Investors:
John Thomas
Executive Vice President, Strategy and Investor Relations
Investor-relations@horizonpharma.com
Tina Ventura
Vice President, Investor Relations
Investor-relations@horizonpharma.com
U.S. Media:
Geoff Curtis
Senior Vice President, Corporate Communications
media@horizonpharma.com
Ireland Media:
Ray Gordon
Gordon MRM
ray@gordonmrm.ie