Pain specialists Horizon Therapeutics Inc. and Nitec Pharma AG are merging, creating a new company with one approved product in Europe and two late-stage candidates in the U.S.

The surviving company will be called Horizon Pharma Inc., headed by Timothy P. Walbert, president and CEO of Horizon Therapeutics. It will be based in the original Horizon hometown of Northbrook, Ill., with offices in Reinach, Switzerland (Nitec's base, where it will be called Horizon Pharma AG) and Mannheim, Germany (where Nitec's subsidiary, Nitec Pharma GmbH, will be based and named Horizon Pharma GmbH). Financial terms of the merger of the two private companies were not disclosed, but it was called an all-stock transaction conducted in conjunction with an unspecified preferred stock financing.

Nitec's contribution to the deal includes Lodotra, a single-pulse delayed-release low-dose prednisone tablet that was first launched in Germany in April 2009 for the reduction in morning stiffness associated with rheumatoid arthritis. A European Phase III trial of Lodotra in RA was completed in 2006, and a marketing authorization application was submitted to 15 European Union member states.

Merck KGaA, of Darmstadt, Germany, from which Nitec was spun out in 2004, holds marketing rights to Lodotra in Germany and Austria, and Mundipharma, of Cambridge, UK, holds marketing rights in the rest of Europe.

Nitec completed a Phase III trial for Lodotra the U.S. for the treatment of the signs and symptoms of RA. In the pivotal U.S. 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). Also, patients taking Lodotra experienced a statistically significant improvement in ACR-50 response (22.7 percent vs. 9.2 percent; p = 0.0027). Patients in the Lodotra arm 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).

Horizon brings to the new party Duexa, formerly HZT-501, a tablet formulation containing a fixed-dose combination of ibuprofen with high-dose famotidine. In two Phase III studies (REDUCE-1 and REDUCE-2), Duexa significantly reduced the incidence of NSAID-induced upper gastrointestinal ulcers in patients with mild-to-moderate pain and arthritis. The trials, of more than 1,500 patients, were conducted under a special protocol assessment with the FDA.

Horizon has submitted a new drug application for Duexa and expects an FDA decision in the second quarter. It also said it expected to submit an NDA for Lodotra to the FDA in the second half of this year, and anticipates submitting a marketing authorization application in the EU for Duexa in that same time period.

Other product candidates in the combined company's development pipeline include: Horizon's 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 Nitec's TruNoc (tarenflurbil), which is under investigation as a potential treatment for pain-related diseases.