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Horizon Pharma - Nitec Pharma and Horizon Therapeutics combine businesses

Nitec Pharma AG, a spin-off from Merck (Darmstadt, Germany) and Horizon Therapeutics, Inc. (USA) have announced the combination of their businesses to become Horizon Pharma, Inc. and the filing of a registration statement for a proposed initial public offering. The company’s Mannheim-based subsidiary, which is focused on the development and commercialisation of drugs for the treatment of pain and chronic inflammatory diseases, has been named Horizon Pharma GmbH.

The two privately owned biopharmaceutical companies Nitec Pharma AG with headquarters in Switzerland and a subsidiary in Mannheim, and Horizon Therapeutics, Inc. with headquarters in Northbrook, IL, USA combined their businesses in April 2010. Nitec Pharma was spun off from Merck KGaA, a member of the BioRegion Rhein-Neckar-Dreieck association, in 2004. The Mannheim subsidiary now operates as Horizon Pharma GmbH.

Lodotra package © Merck

"The combination of the businesses of Nitec Pharma and Horizon Therapeutics provides immediate strategic value by strengthening and diversifying the company's 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 of Horizon Pharma, Inc. "With LODOTRA® marketed in Europe and anticipated approval of a U.S. new drug application (NDA) 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."

Company portfolio

Nitec brings into the combined company LODOTRA®, which is the company’s most important product and novel single-pulse delayed-release (SPDR) low-dose prednisone tablet. It has been approved for sale in 15 EU member states since 2009 for the treatment of rheumatoid arthritis and for the reduction in painful morning stiffness associated with the disease.

Merck KGaA holds marketing rights to LODOTRA in Germany and Austria, and the pharmaceutical company Mundipharma (Limburg/Lahn) holds the rights to LODOTRA in the rest of Europe (Belgium, Denmark, Finland, France, Italy, Luxemburg, the Netherlands, Norway, Poland, Portugal, Spain, Sweden and the UK). The company has completed a Phase 3 trial for LODOTRA in the USA for the treatment of the signs and symptoms of rheumatoid arthritis. Horizon intends to file an NDA submission with the American FDA in the second half of 2010 and is also investigating the use of LODOTRA for the treatment of severe asthma and polymyalgia rheumatica (PMR).

In addition to LODOTRA, Horizon Pharma has another US product candidate in advanced clinical testing. 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, DUEXA was shown to significantly reduce the incidence of NSAID-induced upper gastrointestinal 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 and involved 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 and that it will submit a marketing authorisation application (MAA) for DUEXA in the European Union through the Decentralised Procedure in the second half of 2010.

Other product candidates in the development pipeline of the combined company 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 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 commercialisation rights for its products and product candidates, other than the distribution rights granted for LODOTRA in Europe.

Financial information

The new company is financed by leading life sciences investors, including NGN Capital in Heidelberg and Atlas Venture, Deutsche Bank AG, London, Essex Woodlands Healthcare Ventures, FirstMark Capital, Global Life Science Ventures, Scale Ventures, Sutter Hill Ventures and TVM Capital. At the beginning of August, Horizon Pharma announced that it has filed a registration statement with the NASDAQ, which is expected to achieve revenues of US$ 86.3 million, which will be used for the development, approval and U.S. sale of LODOTRA and HZN-602.

About Horizon Pharma

Horizon Pharma, Inc. is a late-stage biopharmaceutical company focused on the development and commercialisation of innovative medicines for the treatment of 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 for the treatment of rheumatoid arthritis. The drug has received recommendation for the granting of national marketing authorisation in certain EU Member states. LODOTRA has already been launched in Germany.

Website address: https://www.gesundheitsindustrie-bw.de/en/article/press-release/horizon-pharma-nitec-pharma-and-horizon-therapeutics-combine-businesses