Horizon Therapeutics Completes $30 Million Equity Financing to Advance Pipeline of 'GI-Friendly' NSAIDs for Mild-to-Moderate Pain

- Phase 3 Trials Ongoing for Lead Investigational Product Candidate HZT-501

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    PALO ALTO, Calif., July 23 /PRNewswire/ -- Horizon Therapeutics, Inc.,
 a privately held biopharmaceutical company, today announced that it has
 closed a $30 million Series C financing to advance the development of its
 lead investigational product candidate HZT-501 and pipeline of other
 "GI-friendly" prescription non-steroidal anti-inflammatory drugs (NSAID).
 Essex Woodlands Health Ventures (EWHV) led the round with participation
 from existing investors Scale Venture Partners, Sutter Hill Ventures and
 Pequot Ventures. Horizon has previously raised $21 million in equity
 funding.
     "This financing will take us through to clinical data and, if
 successful, the new drug application filing of HZT-501, while also enabling
 us to advance our second product candidate HZT-602 into Phase 3 trials,"
 said George F. Tidmarsh, M.D., Ph.D., co-founder and chief executive
 officer of Horizon Therapeutics. "We initiated our pivotal studies for
 HZT-501 earlier this year and are on track to complete enrollment in 2008."
     HZT-501 is a proprietary formulation of ibuprofen, the most prescribed
 NSAID in the United States, combined with famotidine, the most potent H2
 receptor antagonist, in a single pill. HZT-501 is specifically designed to
 provide pain relief while reducing stomach acidity during the peak time of
 risk for gastric ulceration. In a randomized pilot clinical study published
 in The New England Journal of Medicine (Taha, et. al May 1996), famotidine
 was demonstrated to significantly reduce the incidence of gastric and
 duodenal ulcers vs. placebo when administered together with NSAIDs.
     Horizon recently filed an Investigational New Drug (IND) application
 with the U.S. Food and Drug Administration for the next product in its
 pipeline, HZT-602, a proprietary formulation of naproxen, the second most
 prescribed NSAID in the United States, combined with famotidine.
     "We are extremely excited about Horizon and their approach in
 developing new pain medications to address this unmet worldwide need," said
 Jeff Himawan, PhD., managing director, EWHV. "We believe Horizon's product
 candidates offer a potential near-term solution to a widespread problem
 associated with current pain therapies and their GI side effects."
     About HZT-501 Phase 3 Clinical Program
     The phase 3 clinical program for HZT-501 is comprised of two trials
 involving a total of 1,200 patients with mild-to-moderate pain, including
 patients with osteoarthritis. Horizon protocols HZ-CA-301 and HZ-CA-303
 will evaluate the efficacy and safety of HZT-501 with the primary endpoint
 being reduction in the risk of development of ibuprofen-associated upper
 gastrointestinal ulcers in patients who require the use of ibuprofen.
     The clinical trials are multi-center, randomized, and include an active
 control treatment. Trial participants will receive study medication for up
 to 24 weeks. Both studies are being conducted in the United States.
     About the Pain Market
     HZT-501 targets the widespread medication void in the mild-to-moderate
 pain market left by COX-2 inhibitors such as Vioxx(R), which have either
 been taken off the market or are being prescribed less frequently due to
 elevated cardiovascular risk. From 2004 to 2006, the U.S. NSAID market grew
 over 20 percent to 73 million prescriptions. Over 26 million ibuprofen
 prescriptions are now written annually in the United States alone.
     However, while commonly prescribed to treat pain, NSAIDs have been
 linked to serious gastrointestinal (GI) side effects in up to 25 percent of
 all chronic arthritis patients. NSAID-induced GI toxicity causes an
 estimated 16,000 deaths and more than 100,000 hospitalizations annually in
 the United States. Despite this, studies have shown that as low as 30% of
 high-risk patients are commonly co-prescribed a gastro-protective agent in
 combination with their NSAID to prevent or relieve side effects. In
 addition, patient adherence to a regimen of separate GI protective and pain
 medications has also been shown to be poor.
     About Horizon Therapeutics
     Horizon Therapeutics, Inc. is a late stage biopharmaceutical company
 focused on the rapid development and commercialization of therapeutic
 treatments for mild-to-moderate pain management. The Company is building a
 novel portfolio of therapies through innovative combinations of approved
 pharmaceutical products that seek to improve safety, efficacy, and patient
 compliance. Its lead product candidate, HZT-501, entered Phase 3 trials in
 2007. In addition to HZT-501, Horizon has a pipeline of follow-on pain
 combination products in earlier stages of development. For more information
 visit http://www.horizontherapeutics.com.
     About Essex Woodlands Health Ventures
     Essex Woodlands Health Ventures (with roughly $1.6 billion under
 management) is one of the world's premier venture capital firms focused
 exclusively on the healthcare industry. Essex Woodlands recently raised
 their seventh fund of $600 million. The firm has offices in California,
 Texas, New York and London. The Essex Woodlands team has been involved in
 the founding, investing, and/or management of over 100 healthcare companies
 ranging across all sectors, stages and geography. For more information,
 visit http://www.ewhv.com.
     About Scale Venture Partners
     Scale Venture Partners employs a thesis-based strategy to identify
 innovative development-stage technology and healthcare investments. The
 ScaleVP team works with technology and healthcare companies to accelerate
 their growth and become more valuable to entrepreneurs, investors and
 consumers. Based in Foster City, California, the ScaleVP team collectively
 offers decades of technology and venture industry experience to
 development- stage companies in hardware, software, healthcare and medical
 devices. Representative portfolio companies include Alimera, Frontbridge,
 Glu Mobile, Good Technology, Monolithic Power Systems, Omniture, Orexigen,
 Placeware, ScanSafe, Seattle Genetics, Somaxon, Wayport and Xceive. For
 more information, visit http://www.scalevp.com.
     About Sutter Hill Ventures
     Sutter Hill Ventures is a venture capital firm that finances
 technology- based start-up and early stage companies pioneering products or
 services in growth markets, especially those in information technology and
 health care. Founded in 1962, it is one of Silicon Valley's original
 venture capital firms. Companies backed by Sutter Hill include nVidia,
 Amylin Pharmaceuticals, COR Therapeutics, Corixa, Portola Pharmaceuticals,
 Threshold Pharmaceuticals, and Lifescan.
     About Pequot Ventures
     With more than $1.8 billion in capital commitments, Pequot Ventures is
 the venture investing arm of Pequot Capital Management, one of the oldest
 and largest, multi-billion dollar alternative asset management companies
 worldwide. Life sciences companies backed by Pequot include Threshold
 Pharmaceuticals, Sequenom, Prestwick, Insulet, Embolic Protection and
 Cryovascular Systems, among others.
 
 

SOURCE Horizon Therapeutics, Inc.