DAIICHI SANKYO : Anti-epilepsy Drug VIMPAT® Dry syrup 10% Launched in Japan

For Immediate Release

2019.03.11

UCB Japan Co., Ltd.
Daiichi Sankyo Company, Limited

Anti-epilepsy Drug VIMPAT® Dry syrup 10% Launched in Japan

UCB Japan Co., Ltd. (headquarters: Shinjuku-ku, Tokyo; president: Kanako Kikuchi; hereafter referred to as 'UCB Japan'; when referring to the global UCB group, 'UCB') and Daiichi Sankyo Company, Limited (headquarters: Chuo-ku, Tokyo; president: Sunao Manabe; hereafter referred to as 'Daiichi Sankyo') are pleased to announce today that the anti-epilepsy drug VIMPAT^® Dry syrup 10% (generic name: lacosamide) has been launched in Japan.

VIMPAT^® Dry syrup 10% is a new dosage form of VIMPAT^® Tablets 50mg and 100mg indicated for the 'Partial onset seizures of epilepsy patients with or without secondary generalization.' VIMPAT^® Dry syrup 10% is added to water and mixed before administration, and is expected to improve medication adherence in patients who experience difficulty swallowing existing VIMPAT^® Tablets, such as children and elderly patients with impaired swallowing function.

UCB and Daiichi Sankyo aim to make greater contributions to epilepsy patients and healthcare professionals by offering this new VIMPAT^® Dry syrup treatment option in addition to VIMPAT^® Tablets thereby enhancing the VIMPAT^® product lineup in Japan.

Product Outline

Product name	Vimpat® Dry syrup 10%
Generic name (JAN)	Lacosamide
Indications	Partial onset seizures of epilepsy patients with or without secondary generalization
Dosage and administration	Adults： The recommended starting dose of lacosamide is 100 mg/day (dry syrup 1 g/day), which should be increased to an initial therapeutic dose of 200 mg/day (dry syrup 2 g/day) at intervals of at least 1 week, each given orally in two divided doses. Vimpat dry syrup is dispersed before use and administered orally. However, depending on response and tolerability, the maintenance dose can be further increased to a maximum recommended daily dose of 400 mg (dry syrup 4 g/day), and dose increments should be made within doses of 100 mg/day (dry syrup 1 g/day), at an interval of at least 1 week. Children: The recommended starting dose of lacosamide for children aged ≥ 4 years is 2 mg/kg/day (dry syrup 20 mg/kg/day), which should be increased to an initial therapeutic dose of 6 mg/kg/day (dry syrup 60 mg/kg/day) for children weighing less than 30 kg and 4 mg/kg/day (dry syrup 40 mg/kg/day) for children weighing from 30 kg to under 50 kg by 2 mg/kg/day (dry syrup 20 mg/kg/day) at intervals of at least 1 week, each given orally in two divided doses. However, depending on response and tolerability, the maintenance dose can be further increased by 2 mg/kg/day (dry syrup 20 mg/kg/day), every week. In children weighing less than 30 kg, due to an increased clearance compared to adults, a maximum dose of 12 mg/kg/day (dry syrup 120 mg/kg/day) is recommended. In children weighing from 30 to under 50 kg, a maximum dose of 8 mg/kg/day (dry syrup 80 mg/kg/day) is recommended. The dose increments should be made within doses of 2 mg/kg/day (dry syrup 20 mg/kg/day) at an interval of at least 1 week. Dosage in children weighting 50 kg or greater is the same as in adults.
Date of approval	January 8, 2019
Date of listing in the NHI price	February 26, 2019
NHI drug price	Vimpat® Dry syrup 10%: 1g 386.20 yen
Date of initial marketing in Japan	March 11, 2019
Manufacture and marketing:	UCB Japan Co., Ltd.
Marketing	Daiichi Sankyo Co., Ltd.

About VIMPAT^® (generic name: lacosamide)

VIMPAT^® suppresses excessive excitation of neurons by selectively promoting gradual inactivation of potential-dependent Na channels ¹. VIMPAT^® was approved in Japan for use as an adjunctive therapy for partial-onset seizures in adult patients with epilepsy in July 2016. VIMPAT^® was also approved for use as a 'monotherapy for partial-onset seizures in adult patients with epilepsy' in August 2017 and adding a new dosage and administration regimen for pediatric patients (4 years and older) to the indication of the 'partial onset seizures of epilepsy patients with or without secondary generalization' in January 2019. In addition, dry syrup and iv drip infusion formulations were approved in January 2019.

In Japan, UCB and Daiichi Sankyo concluded a licensing agreement in November 2014. Based on that agreement, UCB manufactures and supplies the product, while Daiichi Sankyo manages distribution and books sales. Promotion is carried out jointly by both companies.

About Epilepsy

Epilepsy affects approximately 65 million people around the world with a prevalence of about 1%. It may occur over a wide age range from infancy to old age and its incidence does not vary much across countries, geographies, genders or races. The number of patients with epilepsy is estimated to total about one million in Japan with approximately 57,000 new patients every year ². Epilepsy is a disease with unmet medical needs even today, with a large majority of patients needing long-term pharmacotherapy ³ and over 30% of patients reportedly being unable to adequately control seizures despite treatment with existing antiepileptic drugs ⁴.

Seizures associated with epilepsy are classified into three major groups based on their clinical symptoms: partial-onset seizures (which sometimes progress to secondary generalized seizures), generalized seizures, and unclassified seizures. Partial-onset seizures show the highest incidence among these three types accounting for approximately 60% of the total.

About UCB in Epilepsy

UCB has a longstanding commitment to improving the lives of people with epilepsy around the world. With over 20 years of experience in the research and development of antiepileptic drugs, our goal is to become a preferred partner for the global epilepsy community, improving knowledge about and access to effective solutions to help patients better manage their individual epilepsy journeys. We strive to partner and create super-networks with world-leading scientists and clinicians in academic institutions, pharmaceutical companies and other organizations who share our goals. At UCB, we are inspired by patients, and driven by science in our commitment to support people with epilepsy.

Reference

1. Errington AC. et al. Mol Pharmacol. 2008;73（1）:157-169.

2. The Japan Epilepsy Society: Guidebook for Epileptologists (in Japanese), Shindan to Chiryo Sha Inc., 2014

3. Perucca E. Baillière's Clin Neurol. 1996;5（4）:693-722.

4. Kwan P. et al. N Engl J Med. 2000;342（5）:314-319.

About UCB

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With around 7 500 people in approximately 40 countries, the company generated revenue of € 4.6 billion (approximately 600 billion yen) in 2018. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.

About Daiichi Sankyo

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group's 2025 Vision to become a 'Global Pharma Innovator with Competitive Advantage in Oncology,' Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. For more information, please visit: www.daiichisankyo.com.

UCB Japan Co., Ltd., Communications Dept.

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Daiichi Sankyo Co., Ltd., Corporate Communications Dept.

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