SOURCE: Horizon Pharma plc

Horizon Pharma plc

November 05, 2015 07:00 ET

Horizon Pharma plc Announces Clinical Data to Be Presented at the 2015 ACR/ARHP Annual Meeting

DUBLIN, IRELAND--(Marketwired - Nov 5, 2015) - 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 data from studies related to RAYOS® (prednisone) delayed-release tablets and VIMOVO® (naproxen/esomeprazole magnesium) will be presented during the 2015 ACR/ARHP Annual Meeting, November 6  - 11, 2015 in San Francisco.

Horizon Pharma, in partnership with Corrona, LLC, an independent registry led by academic and clinical rheumatologists, developed the following two studies using the Corrona Rheumatoid Arthritis patient registry consisting of more than 40,000 patients:

Title: The Influence of Patient Reported Morning Stiffness on Patient Global Assessment in Rheumatoid Arthritis Patients Not Achieving ACR/EULAR Boolean Remission in a Large US Registry
Authors: Dimitrios A. Pappas, Robert J. Holt, Ying Shan, Jeffrey D. Kent, John T. Nguyen, Joel M.
Kremer, Jeffrey D. Greenberg
Location: South - Hall B-C (Poster Hall)
Abstract #: 2654
Session Title: Rheumatoid Arthritis - Clinical Aspects Poster Session III
Session Type: ACR Poster Session C
Date: Tuesday, November 10, 2015
Time: 9 - 11 a.m. PST

Title: Persistency of Patient Reported Morning (AM) Stiffness in a Large US Registry Cohort of Rheumatoid Arthritis (RA) Patients Initiating New DMARD Therapy
Authors: Vibeke Strand, Robert J. Holt, Heather J. Litman, Jeffrey D. Kent, Hristina Pashova, John T.
Nguyen, Carol J. Etzel
Location: South - Hall B-C (Poster Hall)
Abstract #: 2669
Session Title: Rheumatoid Arthritis - Clinical Aspects Poster Session III
Session Type: ACR Poster Session C
Date: Tuesday, November 10, 2015
Time: 9 - 11 a.m. PST

In addition, the following two abstracts related to RAYOS will be presented:

Title: Analysis of Morning Stiffness Response in Rheumatoid Arthritis Patients with Low Disease Activity Receiving Delayed-Release Prednisone Plus DMARDs As Compared to Placebo Plus DMARDs
Authors: Rieke Alten, Robert J. Holt, Jeffrey D. Kent, Frank Buttgereit
Location: South - Hall B-C (Poster Hall)
Abstract #: 2656
Session Title: Rheumatoid Arthritis - Clinical Aspects Poster Session III
Session Type: ACR Poster Session C
Date: Tuesday, November 10, 2015
Time: 9 - 11 a.m. PST

Title: Efficacy and Safety of Modified-Release Prednisone in Patients with Polymyalgia Rheumatica: Results of a Multicenter, Randomized, Active-Controlled Phase 3 Study
Authors: Maurizio Cutolo, Michael Hopp, Stefan Liebscher, Bhaskar Dasgupta, Frank Buttgereit
Location: West - 2018 (Oral presentation)
Abstract #: 3145
Session Title: Vasculitis III
Session Type: ACR Concurrent Abstract Session
Date: Tuesday, November 10, 2015
Time: 2:30 - 4 p.m. PST

The following abstract about VIMOVO will be presented:

Title: Reducing Gastric Ulcers in Patients with a History of Gastrointestinal (GI) Ulcers Who Require Long-Term High-Dose Non-Steroidal Anti-Inflammatory Drug (NSAID) Therapy
Authors: John Fort, Robert J. Holt, Jeffrey D. Kent, Alfonso Bello
Location: South - Hall B-C (Poster Hall)
Abstract #: 1439
Session Title: Pain: Basic and Clinical Aspects Poster
Session Type: ACR Poster Session B
Date: Monday, November 9, 2015
Time: 9 - 11 a.m. PST

Abstracts can be accessed on the ACR 2015 annual meeting website at: http://acrabstracts.org/.

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 over 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 for RAYOS/LODOTRA.

Approved Uses for RAYOS
RAYOS, a delayed-release form of prednisone, prevents the release of substances in the body that cause inflammation. RAYOS is approved to treat a broad range of diseases including RA, polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive pulmonary disease (COPD). For a full list of RAYOS indications, please see full prescribing information at www.RAYOSrx.com. RAYOS is contraindicated in patients who have known hypersensitivity to prednisone or to any of the excipients. Rare instances of anaphylaxis have occurred in patients receiving corticosteroids.

Important Safety Information about RAYOS
Do not use RAYOS if you are allergic to prednisone. Long-term use of RAYOS can affect how your body responds to stress. Symptoms can include weight gain, severe fatigue, weak muscles and high blood sugar. RAYOS can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. RAYOS can cause high blood pressure, salt and water retention and low blood potassium. There is an increased risk of developing holes in the stomach or intestines if you have certain stomach and intestinal disorders. Behavior and mood changes can occur, including intense excitement or happiness, sleeplessness, mood swings, personality changes or severe depression.

Long-term use of RAYOS can cause decreases in bone density. RAYOS can cause cataracts, eye infections and glaucoma. Do not receive a "live" vaccine while taking RAYOS. The vaccine may not work as well during this time and may not fully protect you from disease. Taking RAYOS during the first trimester of pregnancy can harm an unborn baby. Long-term use of RAYOS can slow growth and development in children.

The most common side effects with RAYOS are water retention, high blood sugar, high blood pressure, unusual behavior and mood changes, increased appetite and weight gain. Please see full prescribing information for RAYOS at www.RAYOSrx.com.

About VIMOVO®
VIMOVO (naproxen/esomeprazole magnesium) is a fixed-dose combination of delayed-release enteric-coated naproxen, a non-steroidal anti-inflammatory drug (NSAID), and immediate-release esomeprazole magnesium, a stomach acid-reducing proton pump inhibitor (PPI), approved for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. VIMOVO is not recommended for use in children younger than 18 years of age. VIMOVO is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. Controlled studies do not extend beyond six months. VIMOVO should be used at the lowest dose and for the shortest amount of time as directed by your health care provider. For Full Prescribing Information please see www.VIMOVO.com.

Important Safety Information

  • Nonsteroidal anti-inflammatory drugs (NSAIDs), including naproxen, a component of VIMOVO, may increase the chance of a heart attack or stroke, which can be fatal. This chance increases with longer use and in people who have heart disease or risk factors for heart disease.
  • VIMOVO should not be used before or after a type of heart surgery called coronary artery bypass graft (CABG).
  • NSAID-containing medications like VIMOVO may increase the chance of stomach and intestinal problems, such as bleeding or an ulcer. These problems can happen without warning and can lead to death. Older patients may have a greater chance of developing these problems.

VIMOVO is not right for everyone, including patients who have had an asthma attack, hives or other allergic reaction with aspirin or any other NSAID medicine, patients who are allergic to any of the ingredients in VIMOVO, or women in late stages of pregnancy.

Serious allergic reactions, including skin reactions, can occur without warning and can be life-threatening; discontinue use of VIMOVO at the first appearance of a skin rash or if you develop sudden wheezing; swelling of the lips, tongue or throat; fainting or problems swallowing.

VIMOVO should be used at the lowest dose and for the shortest amount of time as directed by your health care provider.

Tell your health care provider right away if you develop signs of active bleeding from any source.

VIMOVO can lead to onset of new hypertension or worsening of existing high blood pressure, either of which may contribute to an increased risk of a heart attack or stroke.

Speak with your health care provider before starting VIMOVO if you

  • Have a history of ulcers or bleeding in the stomach or intestines
  • Have heart problems, high blood pressure, or are taking high blood pressure medications
  • Have kidney or liver problems

Tell your doctor about all of the medicines you take, prescription and non-prescription drugs, including clopidogrel, vitamins and herbal supplements. VIMOVO may affect how other medicines work and other medicines may affect how VIMOVO works.

VIMOVO may increase your risk of getting severe diarrhea. Call your doctor right away if you have watery stool, stomach pain and fever that does not go away.

Talk to your health care provider about your risk for bone fractures and developing low levels of magnesium if you take VIMOVO for a long period of time.

Talk to your health care provider about your risk for developing low levels of magnesium if you take VIMOVO for a long period of time.

The most common side effects of VIMOVO include: inflammation of the lining of the stomach, indigestion, diarrhea, stomach ulcers, abdominal pain and nausea.

For more information on VIMOVO, please see the Medication Guide and Full Prescribing Information.

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 seven medicines through its orphan, primary care and specialty 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 Corrona
The Consortium of Rheumatology Researchers of North America, Inc., now Corrona, LLC (Corrona), was founded in 2000 by leading rheumatologists dedicated to advancing and improving the care of patients with rheumatic and other chronic diseases, Corrona's mission is to advance medical research and improve the quality of patient care.

Corrona is an independent registry without any ownership links to the pharmaceutical industry. It is run by a group of experienced academic and clinical rheumatologists throughout the country with a wide range of experience.

Contact Information