Adeona : $17.5 Million Corporate Partnership with Meda AB for the Development and Commercialization of Flupirtine for Fibromyalgia

May 7, 2010 - Adeona to Receive Royalties on Potential Billion Dollar indication - Meda to Assume All Future Development Costs - Adeona Pharmaceuticals, Inc., (AMEX: AEN) announced that it has entered into a corporate partnership with Sweden-based Meda AB, to develop flupirtine for the treatment of fibromyalgia syndrome which contemplates the payment to Adeona of up to $17.5 million in upfront and milestone payments, plus royalties.

Under the terms of the agreement, Adeona has granted Meda an exclusive sublicense to all of Adeona’s patents covering the use of flupirtine for fibromyalgia. These patents have issued in the U.S. and are pending in Canada and Japan (the “Territory”).

Meda will assume all future development costs for the commercialization of flupirtine for fibromyalgia. Adeona received an up-front payment of $2.5 million and is entitled to milestone payments of $5 million upon filing of a New Drug Application with the Food and Drug Administration for flupirtine for fibromyalgia and $10 million upon marketing approval. Adeona is also entitled to receive royalties of 7% of net sales of flupirtine approved for the treatment of fibromyalgia covered by issued patent claims in the Territory. Adeona will share such royalties equally with Adeona’s university licensor.

Fibromyalgia is a chronic and debilitating condition characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. Fibromyalgia affects an estimated 2-4% of the population worldwide, including an estimated 4 million patients in the United States... [PDF] Adeona Pharmaceuticals' Press Release - Meda's Press Release -

Pipex Pharmaceuticals : Oral Flupirtine Receives IND with FDA For Phase II Clinical Trial For Fibromyalgia

April 21, 2008 - Pipex Pharmaceuticals, Inc. (AMEX: PP), a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and fibrotic diseases, today announced that the United States FDA has opened an Investigational New Drug Application (IND) to conduct a double-blind, randomized, placebo-controlled Phase II clinical trial of oral flupirtine for the treatment of fibromyalgia, a rheumatic pain disease which affects an estimated 6 million Americans. Lyrica®, the only FDA-approved medication for the treatment of fibromyalgia amongst other indications, recorded $1.8 billion in sales during 2007, with 47 percent annual growth...
...This phase II clinical trial is designed as a double-blind, placebo controlled phase II clinical trial which would evaluate safety and efficacy of oral flupirtine vs. placebo in fibromyalgia patients. This phase II clinical trial is intended to enroll up to 90 subjects and treat subjects for up to 90 days and the primary endpoint will be a reduction in musculoskeletal pain and the overall symptoms of fibromyalgia. Secondary outcomes of the study will be a reduction in the severity of mood, fatigue, cognitive symptoms, and sleep disturbance, as well as improve the overall level of functioning... Pipex Pharmaceuticals' Press Release -