About Horizon
Corporate Profile
Horizon Therapeutics is a late stage biopharmaceutical company focused on the development of prescription drugs for mild to moderate pain relief. We are creating novel therapies through innovative combinations of existing pharmaceutical products. The Company is building a portfolio of proprietary formulations that seek to improve safety, efficacy, and patient compliance.
A Significant Patient Need: Pain Relief and GI Side Effects
The elevated cardiovascular risk associated with Cox-2 Inhibitor drugs has created a huge product void for pain relief. The fallout from these safety issues has led directly to a recent shift in physician and patient demand back to traditional pain management treatments. As a result, the U.S. market for traditional non-steroidal anti-inflammatory drugs ("NSAIDs") grew by over 20% in 2005 to more than 73 million total prescriptions. Over 26 million ibuprofen prescriptions are now written annually in the U.S. alone.
However, serious GI ulcer side effects afflict from 10-25% of all chronic arthritis patients treated with these drugs. NSAID induced toxicity causes over 16,500 related deaths and over 100,000 hospitalizations for GI complications each year. In addition, at least 10-20% of patients are estimated to suffer from dyspepsia (upset stomach) or other nuisance side effects while taking an NSAID. Yet, despite being one of the most prevalent drug toxicities in the U.S., studies indicate that preventative GI medications are not commonly co-prescribed to high-risk patients.
Lead Product HZT-501: "GI Friendly" NSAID
Horizon's lead product candidate HZT-501 is a proprietary fixed dose combination formulation of the world's most prescribed NSAID, ibuprofen, with the most potent H2 antagonist, famotidine, in a single pill. HZT-501 is expected to provide safe and effective pain relief while reducing stomach acidity during the peak time of risk for ulceration. HZT-501 offers a potential near term solution to a widespread need in the mild to moderate pain market:
- Safe, effective pain relief
- Prevention of severe (ulcer) NSAID induced GI side effects
- Treatment of chronic and acute pain indications
- Ensured patient compliance: an optimal dosing regimen of pain relief + stomach protection in a single pill
- Convenience and reduced pill burden
Phase 3 Study Clinical Results Expected in Fall 2008: SPA in Place
An end-of-phase 2 meeting in May 2006 resulted in acceptance from FDA on material aspects of Phase 3 trial design. The Company has begun initiating Phase 3 clinical trials under Special Protocol Assessment (SPA) from FDA, with first patient dosed in March 2007. Enrollment is now closed in both studies. Clinical results are expected in Fall of 2008.
Demonstrated Efficacy in Proof-of-Concept Trials
Clinical trials have demonstrated that famotidine is effective in preventing NSAID-induced GI ulcerations. In a randomized placebo controlled study published in the New England Journal of Medicine (Taha, et al, 1996), famotidine and an NSAID were administered in combination to 285 patients and compared to administration of the NSAID alone. The cumulative incidence of gastric ulcers was 20% in the NSAID-alone group and 8% in the 40-mg BID famotidine plus NSAID group (p = 0.03). The cumulative incidence of duodenal ulcers was 13% in the NSAID-alone group and 2% in the 40-mg BID famotidine plus NSAID group (p = 0.01). There also were significantly lower rates of gastric and duodenal ulceration combined (28% for the NSAID-alone group vs. 11% for the 40-mg BID famotidine plus NSAID group; p = 0.003).
Well-Known Trusted Compounds with Long Term Safety History
Both ibuprofen and famotidine have well documented and excellent long-term safety profiles, and both compounds have been demonstrated effective when administered individually. Both products are approved over-the-counter, and have been used for years by millions of patients worldwide.
Pipeline - Second Product HZT-602 IND Filed
Horizon Therapeutics is developing additional follow-on products to HZT-501 for the treatment of mild to moderate pain relief. The Company filed an IND for its second product candidate HZT-602 - a proprietary formulation of naproxen and famotidine - in October 2006. Together with HZT-501, the Company's first two products address an unmet need in the ibuprofen and naproxen Rx markets, which together represent over 40 million annual combined prescriptions in the U.S. alone (approximately 50% of total traditional NSAID prescriptions).
Broad Intellectual Property Portfolio
Horizon Therapeutics has engaged a team of leading biotech patent attorneys and legal advisors to build a strong intellectual property position. The Company has filed a portfolio of patents with multiple claims based on clinical and PK/PD modeling discoveries, in addition to its proprietary formulations. Horizon will continue to aggressively file future patent claims to protect its intellectual property as it generates formulation refinements, new methods of manufacturing, and clinical trial results.
Proven Track Record
The Horizon team is made up of highly successful entrepreneurs, senior managers, advisors, and key opinion leaders with extensive experience in the areas of biotechnology, pharmaceuticals, and consumer products. The Company is backed by leading life science venture investors including Scale Venture Partners (formerly BA Venture Partners), Essex Woodlands Health Ventures, Pequot Ventures, and Sutter Hill Ventures.