SOURCE: Horizon Pharma plc

Horizon Pharma plc

October 22, 2015 17:38 ET

Horizon Pharma plc Corrects Misinformation in the Marketplace

DUBLIN, IRELAND--(Marketwired - Oct 22, 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 provided the following statement to correct misinformation in the marketplace:

  • Horizon takes seriously its responsibility to ensure patients have access to our medicines. Horizon enhances patients' access through several programs, one of which ensures that patients have a low out-of-pocket cost for Horizon medicines. This has resulted in 96 percent of patients filling prescriptions for Horizon's medicines during the first half of 2015 realizing co-pay amounts of $10 or less. 

  • Horizon's average selling price (ASP) of DUEXIS® (ibuprofen/famotidine), VIMOVO® (naproxen/esomeprazole), PENNSAID® (diclofenac sodium topical solution) 2% and RAYOS (prednisone) averaged $462 in the second quarter of 2015, which is unchanged since the first quarter of 2014. Over this same time period, prescriptions of these products increased 154 percent. [See Figure 1] We believe this strong prescription growth is the result of 1) the clear clinical benefits these products provide and 2) our ability to provide access to important medicines in today's healthcare environment. 

    • Clinical Benefits: Horizon's patented medicines address important unmet needs for patients. For example, both DUEXIS and VIMOVO, which are patented, novel formulations, significantly reduce NSAID-induced ulcers. Every year there are 107,000 hospitalizations and 16,500 deaths related to GI toxicity, including GI bleeding that result from patients taking unprotected NSAIDs. DUEXIS and VIMOVO were not specifically studied to reduce hospitalizations or ulcer complications, however the FDA has recognized that gastrointestinal ulcers are associated with more significant GI toxicity. The number of deaths related to NSAID-induced toxicity is more than that associated with opioid overdoses and certain forms of cancer. By providing the benefits of an NSAID and an agent to reduce NSAID-caused GI ulcers in a single pill, patient compliance is significantly improved. In fact, data indicates that less than 25 percent of physicians co-prescribe an NSAID and an agent to reduce the ulcers they cause. In the few patients that are co-prescribed, data indicates that less than 40 percent of patients are still taking the GI protective after three prescriptions. [See Figures 2 and 3].  

    • Eliminating the burden of access: A majority of all insurers, large and small, cover Horizon medicines in some form. The healthcare system is highly complex and through its access program, Horizon ensures that physicians can prescribe its medicines with a minimal level of administrative steps so that patients can receive them at the lowest level of out of pocket costs possible.

  • In addition, Horizon commented yesterday on its relationship with specialty pharmacies. All pharmacies that distribute Horizon branded medicines are fully independent, including those that are part of Horizon's Prescriptions Made Easy program. Horizon does not own or have an ownership stake in any pharmacy and does not possess an option to purchase any pharmacy. In addition, the relationship with these pharmacies is non-exclusive where each of these pharmacies may also fulfill prescriptions for other drug manufacturers.

  • Horizon will report its third quarter earnings results on November 6, 2015.

DUEXIS Important Safety Information

  • Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, a component of DUEXIS, 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.

  • DUEXIS should not be used before or after a type of heart surgery called coronary artery bypass graft (CABG).

  • NSAID-containing medications like DUEXIS 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.

DUEXIS is not right for everyone. People who have had asthma, hives, or an allergic reaction to aspirin or other NSAIDs should not take DUEXIS. Women in the late stages of pregnancy should not take DUEXIS. People who have had allergic reactions to medications like famotidine (histamine H2‐receptor antagonists) should not take DUEXIS.

Tell your health care provider right away if you have signs of active bleeding (persistent and unexplained) while you are taking DUEXIS.

NSAID‐containing medications like DUEXIS can cause high blood pressure or make existing high blood pressure worse, either of which can increase the chance of a heart attack or stroke. Your health care provider should check your blood pressure while you are taking DUEXIS.

Before you start taking DUEXIS, tell your health care provider if you have heart problems, kidney problems, or liver problems, or if you are taking medications for high blood pressure. DUEXIS can increase the chance of potentially significant liver injury and/or kidney injury, which may be fatal. Stop taking DUEXIS immediately and contact your health care provider if you experience any signs and/or symptoms of liver or kidney injury.

Serious allergic reactions, including skin reactions, can happen without warning and can be life threatening. Stop taking DUEXIS and consult your doctor immediately if you get a skin rash or if you start to have problems breathing or swallowing, or if you develop swelling of your face or throat.

The most common side effects of DUEXIS include nausea, diarrhea, constipation, upper abdominal pain, and headache.

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

VIMOVO 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.

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