Horizon recently submitted an NDA for HZT-501 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 HZT-501 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™ (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.horizonpharma.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.
Robert J. De Vaere
Executive Vice President, Chief Financial Officer
Horizon Pharma, Inc.