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Autism Speaks
Neuropharm has a collaboration agreement with the influential US patient organisation Autism Speaks for the SOFIA multicenter trial of NPL–2008. The agreement gives Neuropharm access to Autism Speaks’ Clinical Trials Network of specialist pediatric centers and key opinion leaders, and will expedite the enrolment of patients into the SOFIA (Study of Fluoxetine in Autism) trial in the US. Neuropharm is funding the trial and, under the terms of the agreement, will fully reimburse Autism Speaks for its services.
To learn more about Autism Speaks, please visit www.autismspeaks.org.
The FRAXA Research Foundation (”FRAXA”)
Neuropharm has a collaboration agreement with FRAXA, the US not-for-profit organisation for patients with Fragile X syndrome. The agreement gives Neuropharm access to FRAXA’s intellectual property rights, data and knowledge relating to the use of NPL–2009 to treat Fragile X syndrome. FRAXA worked with Neuropharm to help secure US Orphan Drug Designation for NPL–2009.
To learn more about FRAXA, please visit www.fraxa.org.
Catalent Pharma Solutions, formerly known as Cardinal Health Pharmaceutical Technologies (”Catalent”)
Catalent is 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 licence agreement with Catalent for collaboration
in respect of the development, licence, manufacture and supply to
Neuropharm of the “Zydis®” formulation of fluoxetine.
Catalent has now developed NPL-2008 in three dosage strengths in
preparation for Neuropharm’s SOFIA trial in the US.
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.
All three completed trials into fluoxetine in autism have been
carried out at Mount Sinai School of Medicine under Professor
Hollander’s direction. Professor Hollander has been retained as a
consultant to Neuropharm.