NORTHBROOK, Ill. and REINACH, Switzerland, April 1 Horizon Therapeutics, Inc. and Nitec Pharma AG, both privately held companies, today announced a definitive agreement in which the two companies have combined in an all-stock transaction. The combined company also completed a concurrent preferred stock financing in conjunction with the transaction.
The combined company will be named Horizon Pharma, Inc., and will be led by Timothy P. Walbert, previously president and chief executive of Horizon Therapeutics. The company will be headquartered in Northbrook, IL, with offices in Reinach, Switzerland (Horizon Pharma AG) and Mannheim, Germany (Horizon Pharma GmbH).
"This combination provides immediate strategic value by strengthening and diversifying our potential product portfolio, as well as providing greater access to the U.S. capital markets," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma, Inc. "With LODOTRA® marketed in Europe and anticipated U.S. new drug application (NDA) submissions for both DUEXA® and LODOTRA in 2010, we are optimistic that we will be able to provide patients and physicians with new treatment options in pain management and chronic inflammatory diseases."
The combined company now has two late-stage U.S. product candidates in development. One of them, LODOTRA, has been approved and is marketed in Europe.
LODOTRA, a novel single-pulse delayed-release (SPDR) low-dose prednisone tablet, was first launched in Germany in April 2009, and is currently being marketed for the reduction in morning stiffness associated with rheumatoid arthritis (RA). A European Phase 3 trial of LODOTRA in rheumatoid arthritis (RA) was completed in 2006 and a marketing authorization application was submitted to 15 Member States of the European Union using the Decentralized Procedure with Germany as Reference Member State. The procedure was completed in December 2008, resulting in the recommendation to grant a national marketing authorization of LODOTRA for the treatment of RA and associated morning stiffness in the Reference Member State and the other 14 Concerned Member States, namely Austria, Belgium, Denmark, Finland, France, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, Sweden, and the United Kingdom.
Merck KGaA holds marketing rights to LODOTRA in Germany and Austria, and Mundipharma holds marketing rights to LODOTRA in the rest of Europe.
The company has completed a Phase 3 trial for LODOTRA in the U.S. for the treatment of the signs and symptoms of RA. In the pivotal U.S. Phase 3 clinical study (CAPRA-2), patients treated with LODOTRA experienced a statistically significant improvement in ACR-20 response when compared with patients in the placebo group (48.5 percent vs. 28.6 percent; p=0.0002). In addition, patients taking LODOTRA experienced a statistically significant improvement in ACR-50 response (22.7 percent vs. 9.2 percent; p=0.0027). Importantly, patients treated with LODOTRA also experienced a statistically significant reduction in morning stiffness when compared with patients in the placebo group (44 percent vs. 21 percent; p=0.0008).
LODOTRA is also being investigated for the treatment of severe asthma and polymyalgia rheumatica (PMR).
DUEXA, formerly HZT-501, is a novel, proprietary tablet formulation containing a fixed-dose combination of ibuprofen, one of the world's most prescribed non-steroidal anti-inflammatory drugs (NSAID), with high-dose famotidine, the most potent H2 antagonist. In two Phase 3 clinical studies (REDUCE-1 and REDUCE-2), DUEXA was shown to significantly reduce the incidence of NSAID-induced upper gastrointestinal (GI) ulcers in patients with mild-to-moderate pain and arthritis. The trials were conducted in the U.S. via a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) and enrolled more than 1,500 patients.
Horizon recently submitted an NDA for DUEXA to the FDA and expects an FDA decision on acceptance for review in the 2nd quarter of 2010. The Company also anticipates it will submit an NDA for LODOTRA to the U.S. FDA in the second half of 2010 and anticipates submitting a marketing authorization application (MAA) for DUEXA in the European Union through the Decentralized Procedure in the second half of 2010.
Other product candidates in the combined company's development pipeline include: HZN-602 (naproxen/famotidine), a combination oral drug consisting of immediate-release naproxen with high-dose famotidine, being investigated for the reduction of the risk of upper gastrointestinal (GI) ulcers in patients with pain and arthritis; and TruNoc(TM) (tarenflurbil), which is under investigation as a potential treatment for pain-related diseases.
The combined company holds worldwide commercialization rights for its products and product candidates, other than the distribution rights granted for LODOTRA in Europe.
About the Transaction
In the completed transaction, Horizon Therapeutics and Nitec Pharma exchanged shares into a new holding company, Horizon Pharma, Inc. Horizon Therapeutics, Inc. is now a subsidiary of Horizon Pharma, Inc. and has been renamed Horizon Pharma USA, Inc. and Nitec Pharma AG is now a subsidiary of Horizon Pharma, Inc. and will be renamed Horizon Pharma AG. Nitec's German subsidiary, Nitec Pharma GmbH will be renamed Horizon Pharma GmbH. Bank of America Merrill Lynch acted as financial advisor and Cooley Godward Kronish LLP was legal counsel to Horizon in the transaction. JMP Securities LLC acted as financial advisor and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. served as legal counsel to Nitec in the transaction.
About Horizon Pharma
Horizon Pharma, Inc. is a late-stage biopharmaceutical company focused on the development and commercialization of innovative medicines for pain-related diseases and chronic inflammation. Horizon Pharma's product portfolio includes innovative therapies in early- and late-stage development that are designed to improve the efficacy, safety and quality of life for patients with chronic pain and inflammation. Horizon's most advanced product is LODOTRA, a circadian cytokine modulator (CCM) for the treatment of rheumatoid arthritis (RA), which has received a recommendation for granting of a national marketing authorization in certain Member States of the European Union. LODOTRA is already launched in Germany. The Company is financed by leading life-science investors Atlas Venture, Deutsche Bank AG, London, Essex Woodlands Healthcare Ventures, FirstMark Capital, Global Life Science Ventures, NGN Capital, Scale Ventures, Sutter Hill Ventures and TVM Capital.
For more information about the company and its products, please visit www.horizon-pharma.com.
Forward Looking Statements
This press release includes forward-looking statements that are subject to risks, uncertainties and other factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, but not limited to, statements regarding the ability of the combined company to realize the anticipated benefits of the combination; any statements regarding the future of any product or product candidate, including the submission of such products or product candidates for approval; and any statements of the plans, strategies and objectives of management for future operations of the combined company. Such statements are only predictions, and actual events or results may differ materially from those projected in such forward-looking statements. Factors that could cause or contribute to the differences include, but are not limited to, risks associated with the ability of the combined company to achieve any benefit resulting from the combination, risks associated with operations conducted in multiple jurisdictions, the inherent risks of product development and approval, clinical outcomes, regulatory risks, risks related to proprietary rights, market acceptance and competition and risks associated with the combined company's ability to obtain additional capital to support its planned operations.
SOURCE Horizon Pharma, Inc.