DUBLIN - Horizon Therapeutics plc (Nasdaq: HZNP) announced today that it is increasing the peak U.S. annual net sales expectations for its key growth drivers KRYSTEXXA and teprotumumab, as well as providing several pipeline updates.

'As we enter 2020, Horizon is in its strongest position ever,' said Timothy Walbert, chairman, president and chief executive officer, Horizon. 'We believe KRYSTEXXA and teprotumumab each has the potential for more than $1 billion in peak U.S. annual net sales. In addition, our strong balance sheet allows us to augment our pipeline to bolster long-term growth. Furthermore, we are evaluating ways to help more patients benefit from our medicines, including two new pipeline programs - one that explores more convenient delivery for KRYSTEXXA by significantly reducing infusion time, and the other for an additional indication for teprotumumab, specifically for the rare disease, diffuse cutaneous scleroderma.'

Continued Strong KRYSTEXXA Growth Drives Higher Peak Net Sales Expectation; New Immunomodulation Study Data and Shorter-Infusion Duration Development Program Offer Potential to Benefit More Uncontrolled Gout Patients

Based on current strong performance, the Company is increasing its peak U.S. annual net sales expectation for KRYSTEXXA to more than $1 billion, from the previous expectation of more than $750 million. The Company continues to project KRYSTEXXA full-year 2019 net sales growth of more than 25 percent.

The Company also announced topline results from its MIRROR open-label pilot study, which evaluated the use of the immunomodulator methotrexate with KRYSTEXXA to increase the response rate of KRYSTEXXA. The results of the study demonstrated that 79 percent, or 11 of 14 patients, achieved a complete response, defined as the proportion of serum uric acid (sUA) responders (sUA < 6 mg/dL) at Month 6. The combination was also well tolerated. Detailed results from the study will be presented at a future medical meeting. The 79 percent response rate is significantly higher than the 42 percent response rate in the KRYSTEXXA Phase 3 clinical program, which evaluated KRYSTEXXA alone.

KRYSTEXXA has demonstrated rapid reduction in sUA levels for people with uncontrolled gout; however, treatment with biologic medicines can, in some patients, trigger the body's immune system to develop anti-drug antibodies. These anti-drug antibodies can reduce the effectiveness of the biologic therapy. Immunomodulators such as methotrexate, which is commonly used by rheumatologists, can help reduce this reaction.

The MIRROR open-label pilot study follows other studies that showed an improved response rate when KRYSTEXXA is co-administered with methotrexate. There is a growing body of data supporting the potential of KRYSTEXXA plus immunomodulation to become the standard therapy opposed to KRYSTEXXA therapy alone. This includes an independent case series presented at the Annual European Congress of Rheumatology meeting in June 2019 which demonstrated that the administration of KRYSTEXXA with methotrexate resulted in a 100 percent response (10 of 10 patients) as defined by >80 percent of sUA levels being maintained at goal (

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