BioWorld International Correspondent
Nitec Pharma AG in-licensed exclusive worldwide rights to Tarenflurbil in inflammation and pain from PAZ GmbH.
Terms were not disclosed but Nitec CEO Anders Härfstrand told BioWorld International the deal has a "regular structure" and includes a 200-patient proof-of-concept and safety data package. "For us that is highly attractive," he said.
Basel, Switzerland-based Nitec has not yet decided how to take forward the compound. It will undertake pharmacokinetic studies before deciding on a lead indication. A novel inhibitor of the transcription regulator NF-kB and the transcription factor AP-1, both of which are implicated in inflammation, it has potential in osteoarthritis, rheumatoid arthritis and related diseases such as ankylosing spondylitis, Nitec said.
It will be ready to enter Phase II trials in 2009, Härfstrand said.
The company had been in discussions with Frankfurt, Germany-based Paz for three years, Härfstrand said, before concluding the agreement. "It was really time after the Series B financing to roll it in," he said, referring to a CHF32 million (US$28 million) financing round the company completed in the spring. (See BioWorld International, April 4, 2007.).
Tarenflurbil, an R-enantiomer of the nonsteroidal anti-inflammatory drug (NSAID) flurbiprofen, also looms large in the development pipeline of Salt Lake City-based Myriad Genetics Inc.
Myriad is conducting two Phase III clinical trials of the compound in Alzheimer's Disease and, earlier this year, reported that it had failed to demonstrate efficacy in a Phase II trial in prostate cancer.
Nitec, established as a spinout from Darmstadt, Germany-based Merck KGaA in 2004, hopes to gain its first product approval, for Lodotra - a night-time release formulation of the corticosteroid prednisone - by about the middle of next year.
Merck will market the product in Germany. "They will be first out," Härfstrand said.
The company will build its own sales force for smaller markets and will enter partnership deals, including co-promotion agreements, for the larger territories in Europe.
The company also filed an IND for Lodotra with the FDA and plans to commence a Phase III clinical trial in the U.S. next spring, Härfstrand said. It aims to conclude a partnering deal for the U.S. during the trial period.