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Proveca and Tanner Pharma Initiate Global Managed Access Program for Sialanar®

13 June 2017

Proveca and Tanner Pharma Initiate Global Managed Access Program for Sialanar®

CHARLOTTE, N.C.--()--Tanner Pharma Group’s Managed Access Programs (MAP) division and Proveca have agreed to launch a Managed Access Program for an oral formulation of glycopyrronium (Sialanar®) outside Europe and the USA. Sialanar is for the treatment of sialorrhea, or chronic drooling, in pediatric patients.

Sialorrhea results in the unintentional loss of saliva from the mouth and is considered abnormal in children older than three years. It is most significantly observed in patients with cerebral palsy and other neurodevelopmental disabilities.

Glycopyrronium bromide is a high affinity muscarinic receptor antagonist used to suppress salivation in children. Sialanar received a European Medicines Agency pediatric-use marketing authorization in September 2016 due to the current unavailability of a licensed oral formulation of glycopyrronium for the treatment of sialorrhea in pediatric patients.

The program allows physicians to request Sialanar for individual patients for whom alternative treatment options are not currently available. This enables patients outside of Europe to benefit from Sialanar ahead of a potential marketing approval in their country.

Rob Keel, Global Director of Managed Access Programs, of Tanner Pharma said:

“There is a large unmet need for providing treatment options to children with sialorrhea as the pediatric population has thus far been underserved. Tanner Pharma and Proveca share a common view of wanting to enable patients in need with access to available medicines, regardless of where they live or whether a medicine is licensed in their market. Tanner Pharma provides patients access to unlicensed medicines in over 130 countries where no other treatment options are available, and the needs of patients and Proveca align well with the capabilities and mission at Tanner Pharma.”

Simon Bryson, Managing Director of Proveca said:

“We are pleased to be working with Tanner on this strategically important partnership. The collaboration strengthens Proveca’s objective in leading the way in the development and supply of medicines for children, and provides us with a significant opportunity to expand our business globally.”