07.23.2007
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 --
PALO ALTO, Calif., July 23, 2007- 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®, 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.