Horizon Pharma plc
Jan 12, 2015

Horizon Pharma plc Provides Business Update

Expands Sales Organization, Accelerates Expansion of Prescriptions-Made-Easy(TM) (PME) Program and Launches PENNSAID(R)2% in United States; Secures Agreement With FDA on ACTIMMUNE(R) Phase 3 Clinical Trial Primary Endpoint

SAN FRANCISCO, CA -- (Marketwired) -- 01/12/15 -- Horizon Pharma plc (NASDAQ: HZNP), a specialty biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated products that address unmet medical needs, today announced a business update on its primary care and orphan businesses.

"We have a unique commercial business model where focused representative promotion, PME-program execution and the maximization of the value of the product are all aligned to drive revenue growth," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc. "We are now executing a comprehensive plan to ensure patients maintain access to DUEXIS and VIMOVO when their physicians prescribe them. With the acceleration of our PME program, the creation of an innovative retail-PME program and recent pricing action, we are confident we will grow combined net revenues for DUEXIS and VIMOVO in the first quarter of 2015 versus the first quarter of 2014."

Primary Care Business Update

Orphan Business Update

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 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 is applied in two pumps, twice daily, delivering relief right to the site of OA knee pain. For more information, please see www.PENNSAID.com.

APPROVED USES FOR PENNSAID 2%
PENNSAID® (diclofenac sodium topical solution) 2% w/w is a non-steroidal anti-inflammatory drug (NSAID) used for treating the pain of osteoarthritis of the knee(s).

IMPORTANT SAFETY INFORMATION

WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK

Heart Risk

Stomach and Intestine Risk

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

USE IN SPECIFIC POPULATIONS

For more information on PENNSAID 2%, please see the Medication Guide and Full Prescribing Information, available at www.PENNSAID.com.

About ACTIMMUNE®
ACTIMMUNE (interferon gamma-1b) is currently approved for two rare diseases in the United States. It is approved by the FDA to reduce the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD), a genetic disorder that affects the functioning of a type of white blood cell of the immune system, neutrophils or phagocytes, leading to recurrent severe bacterial and fungal infections and chronic inflammatory conditions. In addition, ACTIMMUNE is approved by the FDA to slow the worsening of severe, malignant osteopetrosis (SMO), another genetic disorder that affects normal bone formation causing the abnormal accumulation of bone material which tends to narrow the space inside bones where bone marrow is formed. This can cause failure of the bone marrow, leading to a decrease in various blood cells such as red blood cells (anemia) and white blood cells (decreased ability to fight infection). For more information, please see www.ACTIMMUNE.com.

APPROVED USES FOR ACTIMMUNE
ACTIMMUNE (Interferon gamma-1b) is indicated:

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

ACTIMMUNE is not indicated for the treatment of Friedreich's ataxia or any indications other than CGD and SMO. This data is not a substitute for FDA approval and should not be interpreted as such.

For more information on ACTIMMUNE, please see the Full Prescribing Information at www.ACTIMMUNE.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. Horizon'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 potential revenue growth, including growth of DUEXIS and VIMOVO net revenue in the first quarter of 2015, the design and timing of the Company's planned Phase 3 clinical trial of ACTIMMUNE in FA, the Company's plans to file an IND application, the potential for ACTIMMUNE as a treatment for FA patients, future collaborative efforts between the Company and FARA and the CCRN in FA, the planned expansion and expected benefits of the Company's PME program and the Company's growth strategy and prospects. 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. These forward-looking statements are based on management's 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, but are not limited to, risks regarding Horizon's ability to commercialize products successfully, including risks relating to availability of coverage and adequate reimbursement and pricing from government and third party payers, Horizon's ability to enforce its intellectual property rights to its products, whether Horizon will be able to realize the anticipated benefits of recent product acquisitions and manage the integration of new products successfully, whether results of subsequent studies will be consistent with results of the Phase 2 clinical trial of ACTIMMINE in FA, the Company's ability to identify and enroll patients in the planned Phase 3 study, potential delays in initiating and completing the planned Phase 3 study, the Company's ability to file the planned IND application within the timeline it expects and whether and when the FDA allows the IND, risks related to regulatory review and approval of product candidates, Horizon's ability to successfully expand its PME program, whether the PME program continues to result in prescription growth and Horizon's ability to execute on its growth strategy. For a further description of these and other risks facing the Company, please see the risk factors described in the Company'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 the Company undertakes no obligation to update or revise these statements, except as may be required by law.

Contacts:

Investors:
Elizabeth M. Higashi, CFA
Vice President, Investor Relations
Email Contact
+1 224 383-3285

Media:
Geoff Curtis
Email Contact
+1 312-233-1253

Source: Horizon Pharma plc

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