Collaborations

In-Licensing

Neuropharm is seeking to broaden its portfolio of products for the US market through in-licensing and other collaborations.

We would welcome approaches from companies wishing to divest, out-license or otherwise partner specialist neurodevelopmental related products already marketed in, or being developed for, the US market.

Out-Licensing

Neuropharm is seeking to collaborate with partner companies outside of the US; i.e. in Europe, Japan and the rest of the world.

We would welcome approaches from companies wishing to take part in the late stage development, registration and commercialization of our CNS portfolio outside of the US.

Our portfolio of products is aimed at treating or managing neurodevelopmental disorders in children, adolescents and adults with serious unmet medical needs. Our lead candidate NPL-2008 is in Ph III clinical development for the treatment of the core symptoms of Autism, a severe neurodevelopmental disorder. NPL-2510, a follow-on program also directed toward Autism includes the development of a diagnostic screening test for infants, children and adults.

Our portfolio includes three additional compounds in Phase II clinical development as well as a more near-term formulation enhancement of an existing marketed compound commonly prescribed by psychiatrists. Two of the compounds (NPL-2005 and NPL-2009) have completed exploratory Phase II clinical studies for the treatment of Fragile X syndrome, the largest cause of inherited mental retardation. Furthermore, two small Phase II studies using NPL-2003 in pediatric obsessive compulsive disorder (a neuropsychiatric anxiety disorder characterized by repeated intrusive thoughts and associated compulsive, ritualized behaviors), have also been completed with meaningful outcomes.

We would particularly welcome approaches from companies with strong capabilities in the CNS or neurodevelopment space who have established relationships with pediatricians and or pediatric psychiatrists and neurologists. Experience working with orphan drugs would be an advantage.

Alliances

Neuropharm prides itself in the relationships it has fostered and maintained:

  • Autism Speaks – Neuropharm has a collaboration agreement with the US patient organization Autism Speaks which led to the completion of the SOFIA (Study of Fluoxetine in Autism) multicenter trial of NPL–2008 in children and adolescents with Autistic Disorder. Autism Speaks is the world’s largest autism advocacy organization. Autism Speaks runs a Clinical Trials Network (CTN) focusing on translational research, the critical step necessary to transfer findings from the laboratory to clinical application. The SOFIA study was carried out in association with the CTN and is the largest study ever conducted in Autistic Disorder, involving 19 specialist sites across the US.
  • The FRAXA Research Foundation (”FRAXA”) – FRAXA’s mission is to accelerate progress toward effective treatments and ultimately a cure for Fragile X, by directly funding the most promising research. Neuropharm has a collaboration agreement with FRAXA, both working together to develop NPL-2009 for the treatment of Fragile X. FRAXA worked with Neuropharm to help secure US Orphan Drug Designation for NPL–2009, and completed an exploratory Phase II trial in adults with Fragile X syndrome. The results of this trial were published in January 2009 in the peer-reviewed Journal of Medical Genetics. This was the world’s first clinical study using a targeted treatment for Fragile X syndrome.
  • Catalent – The co-development and manufacturing partner for the Zydis® formulation of fluoxetine (NPL–2008) designed specifically for autistic patients. Neuropharm has an exclusive worldwide development and license agreement with Catalent for collaboration with respect to the development, license, manufacture and supply to Neuropharm of the Zydis® formulation of fluoxetine.
  • Mount Sinai School of Medicine – In 2006 Neuropharm acquired the rights to the NPL-2008 program from the Mount Sinai School of Medicine in New York, where Professor Eric Hollander was granted Orphan Drug Designation in 1999 for the use of fluoxetine in autism. Professor Hollander has been retained as a consultant to Neuropharm.

To explore partnering opportunities with Neuropharm, please contact us at partnering@neuropharm.co.uk

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