Proveca Signs Exclusive Licensing Agreement with LinDo K.K. for the Development and Commercialisation of Sialanar® in Japan

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Proveca Signs Exclusive Licensing Agreement with LinDo K.K. for the Development and Commercialisation of Sialanar® in Japan

Partnership expands access to a licensed paediatric treatment for severe sialorrhoea and supports delivery of innovative medicines to children in Japan

MANCHESTER, UK and TOKYO, JAPAN, July 15th, 2026 – Proveca Ltd. (“Proveca”; Manchester, UK; CEO: Dr. Simon Bryson) and LinDo K.K. (“LinDo”; Tokyo, Japan; President: Jun Katsura) today announced that they have entered into an exclusive licensing agreement for the development and commercialisation of Sialanar® (glycopyrronium bromide oral solution) in Japan for the symptomatic treatment of severe sialorrhoea in paediatric patients aged 3 years and older with chronic neurological disorders.

Under the terms of the agreement, LinDo has obtained exclusive rights to develop, register and commercialise Sialanar® in Japan. The partnership represents an important additional step in Proveca’s strategy to expand global access to its paediatric medicines by partnering with organisations that share its commitment to addressing unmet medical needs in children globally.

Sialanar® was the first licensed oral glycopyrronium formulation specifically developed for children and adolescents with chronic neurological disorders associated with severe sialorrhoea. Since receiving European approval in 2016, the product has been launched in multiple international markets and is now available to patients in more than 20 countries worldwide, providing clinicians and families with an evidence-based treatment option supported by a dedicated paediatric dosing and administration profile.

Severe sialorrhoea is an often challenging complication associated with a range of chronic neurological conditions, including cerebral palsy and rare neurological disorders. The condition can significantly affect quality of life, social interaction and daily functioning, while also increasing the burden on families and caregivers. In some patients, aspiration of saliva may contribute to serious respiratory complications, including aspiration pneumonia.

Despite the recognised clinical need, approved treatment options for paediatric sialorrhoea remain limited in Japan. Through this agreement, Proveca and LinDo aim to make Sialanar® available to Japanese patients and healthcare professionals, bringing an established paediatric therapy to a market where it is currently unavailable.

The collaboration aligns with Proveca’s mission of developing and delivering medicines specifically designed to meet the needs of children, while reinforcing the Company’s commitment to expanding access to innovative paediatric treatments through strategic international partnerships.

Dr. Simon Bryson, co-founder and Chief Executive Officer of Proveca, commented:

“We are delighted to partner with LinDo to advance the development and commercialisation of Sialanar® in Japan. LinDo’s commitment to addressing unmet medical needs and improving access to important therapies for patients in Japan aligns closely with Proveca’s mission to deliver better medicines for children around the world.”

“Sialanar® has already provided a valuable treatment option for children and families across numerous international markets, and we are excited by the opportunity to work with LinDo to make this therapy available to patients in Japan. This agreement represents another important milestone in our strategy to expand global access to our specialised paediatric medicines through strong regional partnerships.”

Quote from LinDo

Jun Katsura, President of LinDo, commented:

“We are deeply honoured to enter into this partnership with Proveca, which allows us to contribute to improving the quality of life for patients and alleviating the daily caregiving burden on their families and caregivers. While medical innovation continues to advance globally, the value generated by these innovations does not always reach everyone in need. Our vision is a society where medical choices are not limited by country or disease. Medical value is only truly realized when it reaches the hands of those who need it most. We are fully committed to driving the development of this therapy in Japan, striving for early regulatory approval to bring it to patients and their families as swiftly as possible.”

About Sialanar®

Sialanar® (320mcg/ml glycopyrronium) is a medicinal product licensed for the symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders. Glycopyrronium use is well established, with a known and predictable anticholinergic side effect profile. Adverse reactions are common with glycopyrronium due to its known pharmacodynamic anticholinergic effects. The most common adverse reactions are dry mouth (11%), constipation (20%), diarrhoea (18%), urinary retention (15%), flushing (11%) and nasal congestion (11%). Adverse reactions are more common with higher doses and prolonged use.

Full product information on Sialanar® (Prescription Only Medicine) can be found here: https://www.ema.europa.eu/en/medicines/human/EPAR/sialanar

About Proveca Ltd.

Proveca Ltd. is a speciality pharmaceutical company focused on the development, licensing and commercialisation of evidence-based medicines that address unmet medical needs in children. The Company develops age-appropriate formulations and paediatric-specific medicines designed to improve treatment outcomes, adherence and quality of care. Proveca’s growing portfolio spans multiple therapeutic areas, including neurology and cardiology, and is supported through a global network of regulatory, commercial and development partners.

For more information, visit: www.proveca.com

About LinDo K.K.

At LinDo, we address vital medical needs that extend beyond mere patient numbers or market size, striving to realize a society where medical choices are not limited by country or disease. Our mission is to address “drug loss” by in-
licensing, developing, and commercialising therapies that are approved globally but remain unavailable in Japan. Through strategic partnerships both locally and worldwide, we advance our unique “New Business Model to Overcome Drug Loss,” enhancing healthcare access to ensure that essential medical value reaches the people who need it most.

For more information, visit: https://lindosi.com/

References:

1. Sialanar® 320 micrograms/ml oral solution. Summary of Product Characteristics. Proveca Pharma Limited. Available at:
https://www.ema.europa.eu/en/documents/product-information/sialanar-epar-
product-information_en.pdf. Accessed July 2026.

2. European Medicines Agency. Sialanar®: European public assessment report (EPAR). Available at:
https://www.ema.europa.eu/en/medicines/human/EPAR/sialanar®. Accessed July 2026.

3. Mier RJ, Bachrach SJ, Lakin RC, Barker T, Childs J, Moran M. Treatment of Sialorrhea with Glycopyrrolate: A Double-blind, Dose-Ranging Study. Arch Pediatr Adolesc Med. 2000;154(12):1214-1218.
doi:10.1001/archpedi.154.12.1214.

4. Hockstein NG, Samadi DS, Gendron K, Handler SD. Sialorrhea: A management challenge. Am Fam Physician. 2004;69(11):2628-2634.
Sialanar® is a registered trademark of Proveca Limited.

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Proveca Ltd., WeWork, One St Peter’s Square, Manchester, M2 3DE, UK

Please contact us on +44 (0) 161 468 2627 or email at info@proveca.com

 

INT-SIA-26-0008 July 2026

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