PALO ALTO, Calif., Jan. 4 /PRNewswire/ -- Horizon Therapeutics, Inc., a privately held biopharmaceutical company, today announced that it raised an additional $15 million through a Series B financing to advance its lead product HZT-501, a “GI-friendly” prescription NSAID, into pivotal Phase 3 clinical trials in the first half of this year. Scale Venture Partners, formerly known as BA Venture Partners, led the round with Sutter Hill Ventures and Pequot Ventures also participating. The Company completed a $6 million Series A round in October 2005 with the same syndicate of investors.
HZT-501 is a proprietary formulation of the world’s most prescribed non-steroidal anti-inflammatory drug (NSAID) ibuprofen, combined with the most potent H2 receptor antagonist famotidine, in a single pill. HZT-501 is specifically designed to provide pain relief while reducing stomach acidity during the peak time of risk for NSAID-induced ulceration.
The Phase 3 program will include two trials involving a total of 1,200 patients with mild-to-moderate pain, including patients with osteoarthritis. It is designed to demonstrate if HZT-501 prevents or reduces severe NSAID-induced side effects such as gastric and duodenal ulcers compared to patients treated with ibuprofen alone.
HZT-501 targets the widespread product void in the mild-to-moderate pain market left by COX-2 inhibitors such as Vioxx(R), which either have been taken off the market or prescribed less frequently due to elevated cardiovascular risk. In 2005, the NSAID market in the U.S. grew over 20 percent to 73 million prescriptions. Over 26 million ibuprofen prescriptions are now written each year in the U.S. 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 and pain medications has also been shown to be poor.
“Our lead product and pipeline address a major unmet medical need and this financing enables us to rapidly move our Phase 3 program forward,” said George F. Tidmarsh, M.D., Ph.D., co-founder and chief executive officer of Horizon Therapeutics. “HZT-501 combines the proven benefits of ibuprofen together with stomach protection in one medication. The reduced pill burden and convenient oral dosing coupled with on-board GI protection should enhance patient compliance with chronic pain regimens.”
Horizon recently filed an Investigational New Drug (IND) application with the Food and Drug Administration for its second product, HZT-602, a proprietary formulation of the world’s second most prescribed NSAID naproxen combined with famotidine.
“Horizon is very well positioned to capitalize on this extremely large global pain market opportunity,” said Lou Bock, Partner, Managing Director, Scale Venture Partners. “Given the known profiles of the compounds, their product candidates have a relatively low development and safety risk and are moving rapidly toward commercialization. We believe that Horizon’s products have blockbuster potential.”
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, will enter 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 www.horizontherapeutics.com .
About Scale Venture Partners
Scale Venture Partners, formerly known as BA Venture Partners, employs a thesis-based strategy to identify innovative development-stage technology and healthcare investments in emerging markets. Based in Foster City, California, the Scale 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 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.
Horizon Therapeutics, Inc.
CONTACT: E. Blair Schoeb of WeissComm Partners, Inc., +1-917-432-9275, orblair@weisscommpartners.com, for Horizon Therapeutics
