Mundipharma Medical Company Limited and the independent associated company, Purdue Pharma L.P., announced that, following completion of phase II studies, they have exercised their option and taken over full responsibility from Laboratorios Esteve, S.A.U (ESTEVE) for the clinical, regulatory and commercial development of a potential first-in-class sigma-1 antagonist (S1A or MR309/E-52862).

Mundipharma, Purdue and ESTEVE recognize there are still unmet needs in treating pain and are committed to developing new therapies. The addition of this asset to the Mundipharma and Purdue pain pipelines continues the growth of the global pain franchise, an area of deep heritage and experience for the network of independent associated companies worldwide.

MR309/E-52862 is a potent and highly selective sigma-1 antagonist that may provide a new way to approach the management of neuropathic pain, one of the most challenging pain conditions to manage.

Studies suggest that the novel mechanism of action of MR309/E-52862 will be complementary to those of other drugs used in pain management and may therefore support combination usage with other analgesic compounds.

MR309/E-52862 binds to sigma-1 in the brain and central nervous system. To date, activity has been demonstrated in vitro and in vivo in multiple models of neuropathic pain, including nerve injury and diabetic neuropathy. These studies have also proven that there is a direct relationship between dose, target occupancy of MR309/E-52862 in the brain and pharmacological activity.

The comprehensive phase I program for MR309/E-52862 evaluated the safety, tolerability, pharmacodynamics and pharmacokinetics.

Phase II clinical studies conducted in patients treated with MR309/E-52862 evaluated the efficacy profile in the treatment peripheral neuropathy of different etiologies (including from diabetic and post-surgical origins) as well as in moderate to severe acute post-operative pain. The results of these studies are pending publication. Mundipharma will now take the programme forward into additional clinical studies to support the ongoing development in multiple models of neuropathy and future registration and commercialization.

Antony Mattessich, managing director, Mundipharma International Limited commented on the partnership. “We’re thrilled to expand our partnership with ESTEVE. This strategic collaboration leverages our companies’ individual strengths. Our ability to bring products through the clinical and regulatory process and to successfully commercialize them complements ESTEVE’s focus on discovering novel approaches to the treatment of pain in the laboratory. Mundipharma, Purdue and ESTEVE are equally committed to driving innovation in pain management, so our ongoing collaboration is a natural fit.”

Mark Timney, president and chief executive officer, Purdue Pharma said, “The Sigma-1 antagonism mechanism and MR309/E-52862 specifically hold great promise in treating pain. This acquisition further expands our pain pipeline with another potentially innovative non-opioid, non-NSAID treatment.”

Albert Esteve, chief executive officer, ESTEVE, said: “This partnership with Mundipharma will, we hope, allow patients to have access to a new class of treatment to manage pain. Together, we will foster the development of a first-in-class new molecular entity targeting a novel mechanism of action for pain relief. The alliance with Mundipharma and Purdue strengthens the validation of our innovative first-in-class NME R&D and our mission statement, which is to advance science by establishing novel R&D collaborations and to solve unmet medical needs of diseases with significant social impact.”

Mundipharma and independent associated companies are privately owned companies and joint ventures covering the world’s pharmaceutical markets. These companies are committed to bringing to patients the benefits of significant new treatment options in the core therapy areas of pain, respiratory, oncology and inflammatory conditions.

Purdue Pharma is a privately-held pharmaceutical company and is part of a global network of independent associated companies that is known for pioneering research in chronic pain and opioids with abuse deterrent properties.

ESTEVE is a leading pharmaceutical chemical group based in Barcelona, Spain. Since it was founded in 1929, ESTEVE has been firmly committed to excellence in healthcare, dedicating efforts to innovative R&D of new medicines for unmet medical needs and focusing on high science and evidence-based research.