SOURCE: Horizon Pharma

Horizon Pharma

November 08, 2010 17:17 ET

Horizon Pharma Awarded Therapeutic Discovery Grant

NORTHBROOK, IL--(Marketwire - November 8, 2010) -  Horizon Pharma, Inc., today announced it has been awarded a non-taxable federal grant under the Qualifying Therapeutic Discovery Project (QTDP) program in the amount of $244,479 for research and development of its lead product candidate, HZT-501, a novel fixed-dose combination of ibuprofen and high-dose famotidine. The grant was awarded through The Patient Protection and Affordable Health Care Act. Horizon Pharma was one of nearly 60 Illinois companies to receive a grant.

The project recipients, jointly selected by the Treasury Department and the Department of Health and Human Services (HHS), were required to demonstrate preclinical or clinical research costs incurred in 2009 or 2010 expended on projects which have potential to result in new therapies for the treatment or prevention of diseases with an unmet medical need, and potential for long-term healthcare cost reduction and increased high-quality U.S. job creation.

About HZT-501
HZT-501 is a novel single tablet formulation containing a fixed-dose combination of ibuprofen, one of the most widely prescribed NSAIDs, and high-dose famotidine, a well-established GI agent used to treat dyspepsia, gastroesophageal reflux disease (GERD) and active ulcers and to reduce the risk of NSAID-induced upper GI ulcers. Ibuprofen has proven anti-inflammatory and analgesic properties, and famotidine reduces the stomach acid secretion that can cause upper GI ulcers. Both ibuprofen and famotidine have well-documented and excellent long-term safety profiles, and both products have been used for many years by millions of patients worldwide.

HZT-501 is currently under review by the U.S. FDA with a PDUFA goal date of January 21, 2011. The Company also plans to submit a marketing authorization application (MAA) for HZT-501 in the European Union through the Decentralized Procedure in the fourth quarter of 2010.

About the Arthritis, Pain and Inflammation Market
Some of the most common and debilitating chronic inflammation and pain-related diseases are osteoarthritis, or OA and rheumatoid arthritis, or RA, and acute and chronic pain.

Arthritis is a large and growing public health problem in the United States and continues to be the most common cause of disability. According the CDC, arthritis costs the U.S. economy nearly $128 billion annually in medical care and indirect expenses, including lost wages and productivity. From 2007-2009, approximately one in five (49.9 million) adults age 18 or older in the United States had self-reported doctor-diagnosed and 21.1 million adults (42.4% of those with arthritis) had self-reported arthritis-attributable activity limitation (AAAL). The CDC estimates that 67 million people in the U.S. will be affected by arthritis by 2030. Additionally, chronic pain affects an estimated 86 million American adults.

NSAIDs are very effective at providing pain relief, including pain associated with arthritis; however there are significant upper GI complications that can result from the use of NSAIDs, including ulcers. NSAID-induced GI toxicity causes an estimated 16,500 deaths and more than 107,000 hospitalizations annually in the U.S. alone. Recently published data also indicates that physicians only co-prescribe GI protective agents to NSAID users 24 percent of the time, and studies show sub-optimal patient compliance with the prescribed GI co-therapy.

About Horizon Pharma
Horizon Pharma, Inc. is a biopharmaceutical company that is developing and commercializing innovative medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases. For more information, please visit www.horizonpharma.com.

Forward Looking Statements
This press release contains forward-looking statements regarding the company's plans to submit marketing applications for HZT-501, regulatory review of HZT-501, the potential for HZT-501 as a treatment to reduce the risk of developing NSAID-induced upper gastrointestinal ulcers in patients with mild to moderate pain and arthritis, and the arthritis and pain markets. Actual results may differ materially from those in these forward-looking statements as a result of various factors, including, but not limited to, risks regarding the company's ability to submit marketing applications for HZT-501 in the timeframe it expects, regulatory review and approval of its product candidates, the company's ability to commercialize products successfully, and competition in the markets for HZT-501. For a further description of these and other risks facing the company, please see the risk factors described in the company's Registration Statement on Form S-1 that was originally filed with the United States Securities and Exchange Commission on August 3, 2010, and the amendments thereto, 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.

Contact Information

  • Contacts
    Robert J. De Vaere
    Executive Vice President and Chief Financial Officer
    Email Contact

    Molly Rabinovitz
    WCG
    312-646-6294
    Email Contact