Proveca and Tanner Pharma initiate global Managed Access Program for Sialanar®

For Immediate Release

Contact:
Lindsey Stevens
Tanner Pharma Group
704-552-8407
lstevens@tannerpharma.com

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.”

Healthcare professionals can obtain details about the Sialanar® Managed Access Program by calling a Tanner Pharma representative at +44 (0) 1727 884 587 or emailing map@tannerpharma.com.

About Tanner Pharma Group

Tanner Pharma Group partners with biopharmaceutical companies to provide turn-key commercialization solutions to increase patient access to medicines around the world. It believes that access to medicines should have no borders and measures its value as a company based on the lives it helps to improve. With an unparalleled blend of local market knowledge, international supply chain expertise across more than 130 countries, and high regulatory compliance and quality standards, it provides tailored solutions to biopharmaceutical companies outside their core markets of focus.

For more information, please visit www.tannerpharma.com

About Proveca

Proveca Ltd is a specialist UK pharmaceutical company developing and licensing off-patent medicines to improve the lives of children in Europe, many of whom have chronic conditions requiring long term drug treatment.

Proveca is leading the way in licensing children’s medicines using the European regulatory framework, the Pediatric Use Marketing Authorization (PUMA) process. The regulation was specifically designed to increase the number of off-patent medicines being developed and licensed for children.

Proveca seeks to provide children with the medicines they need in an appropriate format and with a valid license throughout Europe. Utilizing the experiences and needs of children, their carers and their doctors, Proveca seeks to tailor the features and benefits of its products to the specific requirements of children.

Learn more by visiting www.proveca.co.uk

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About Tanner Pharma Group

For over 15 years, Tanner’s executive team has provided specialty distribution of pharmaceuticals from markets of availability to markets of need. When healthcare providers in international markets require treatments not currently available in their home market, they rely on Tanner to source and deliver the product from its global network of pharmaceutical manufacturers. Based on its track record of accountability and experience managing regulatory-compliant access programs, top pharmaceutical and biotech companies partner with Tanner to develop and manage their global access programs. By partnering with Tanner, pharma and biotech companies are able to focus on their primary markets while ensuring that patients in international markets of need are receiving their products through a strictly controlled channel.

Tanner’s International Access Division serves providers in 24 of the most challenging countries by developing, implementing and managing global access programs including Named Patient Programs, Expanded Access Programs, Compassionate Use Programs, Government & Private Provider Tender fulfillment and Emergency Supply allocations. Tanner’s Clinical Trials Division procures comparator products for manufacturers, CRO’s and research centers from a broad range of sources. Additionally, the company is able to provide clinical trial logistics and inventory management for trials conducted in the U.S., Europe, Mexico and Brazil.

Headquartered in the U.S., Tanner’s reach includes Europe, Northeast Asia, Southeast Asia, the Middle East, Australia, Canada and Latin America, including Brazil, Mexico, the Caribbean, Central America and all of South America.

For more information about Tanner Pharma Group, please visit www.tannerpharma.com.

For more information about Merz or the Company’s products, please visit www.merzusa.com.

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