Adeona Pharmaceuticals, Inc., 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 US 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. There are presently three products approved for this indication in the US –Lyrica, Cymbalta and Savella. Flupirtine is differentiated from these products in that it employs a unique mode of action. Meda estimates the US market for fibromyalgia to be near $1 billion at the time of potential launch of flupirtine.
Flupirtine is a first-in-class, novel type of central nervous system agent known as a selective neuronal potassium channel opener that also has NMDA receptor antagonist properties. Flupirtine is currently approved and marketed by Meda for the treatment of pain in various countries outside of the US.
“We are very pleased to collaborate with Adeona in the development of flupirtine for fibromyalgia, a therapeutic area with a large unmet medical need. Flupirtine has the potential to have better efficacy and safety than current treatments. Additionally, flupirtine has displayed good tolerability during all the years it has been used for the treatment of acute and chronic pain,” stated Anders Lonner, CEO Meda.
James S. Kuo, M.D., M.B.A., Adeona’s Chief Executive Officer, stated, “We believe that our flupirtine program, combined with Meda’s substantial resources and experience with flupirtine will greatly accelerate the time to which this potential new class of treatment can be made available to the millions of people that suffer from fibromyalgia.”