UCB and Daiichi Sankyo partner to bring Lacosamide to people living with epilepsy in Japan

Tokyo (Japan), Brussels (Belgium), 28 November 2014 – 7:00am (CET) - regulated information
Daiichi Sankyo Company, Limited ("Daiichi Sankyo"; TSE: 4568) and UCB Biopharma SPRL ("UCB") announced today that the companies entered into an agreement to jointly commercialize Lacosamide for epilepsy patients in Japan. Under this agreement, UCB will manufacture and supply the product for commercialization. Daiichi Sankyo will manage the distribution and book sales, with both Daiichi Sankyo and UCB commercializing Lacosamide in Japan.

"We continue executing on our partnering strategy for Japan to enhance patient access to our core medicines in concert with strong and patient-focused partners," said Jean-Christophe Tellier, CEO-elect of UCB. "We share our partner's passion for people living with epilepsy and for Lacosamide, and believe that Daiichi Sankyo’s excellence and overall market presence, including specialist areas addressing epilepsy such as neurology, neurosurgery and psychiatry, will enhance and broaden patients' access to new treatment options for epilepsy in Japan."

"Daiichi Sankyo expects to contribute to the management of the treatment of epilepsy and provide a new therapeutic option by adding Lacosamide to our product portfolio in the field of CNS in Japan," said George Nakayama, Representative Director, President and CEO.

Based on the agreement and subject to achievement of certain milestones in the future, UCB will receive from Daiichi Sankyo up to a total of approx. €180 million of upfront and milestones payments during the coming years. This agreement does not change UCB's financial outlook for 2014. The impact from this agreement on Daiichi Sankyo’s business results of current fiscal year will be announced at a later date. Further details of the agreement are not disclosed.

Lacosamide is currently not approved in Japan for the treatment of epilepsy. On 28 October 2014, UCB announced that the Phase 3 clinical study evaluating Lacosamide as adjunctive therapy in the treatment of Japanese and Chinese adult patients with partial-onset seizures² met its primary efficacy endpoint. The top-line results demonstrated that Lacosamide (200 and 400 mg/day) significantly reduced partial-onset seizure frequency, when compared to placebo. The adverse event profile in this study was consistent with that known for Lacosamide.¹ Based on the positive results of this study, UCB plans to submit regulatory applications in Japan and China in 2015 for Lacosamide as adjunctive therapy in the treatment of adult patients with partial-onset seizures.

About Epilepsy^3-5

Epilepsy is a disease of the brain affecting approximately 65 million people worldwide. It is defined as either the occurrence of two or more unprovoked seizures >24 hours apart or one unprovoked (or reflex) seizure and a probability of further seizures occurring over the next 10 years that is similar to the general recurrence risk (at least 60%) after two unprovoked seizures or diagnosis of an epilepsy syndrome. Although epilepsy may be linked to factors such as health conditions, race and age, it can develop in anyone at any age, and approximately 1 in 26 people will develop epilepsy in their lifetime.

About UCB in Epilepsy

UCB has a rich heritage in epilepsy with over 20 years of experience in the research and development of novel antiepileptic drugs. Every day, thousands of people use AEDs from our portfolio to help control their seizures. As a company with a long-term commitment to epilepsy research our goal is to address unmet medical needs and to deliver solutions that improve patients’ lives. Our scientists are proud to contribute to advances in the understanding of epilepsy and its treatment. We 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 patients with epilepsy.

About Lacosamide

Lacosamide was first launched in the European Union in September 2008 under the name of Vimpat^®, as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalization in adult and adolescent (16-18 years) patients with epilepsy. Lacosamide is available in 44 countries including the US and in Europe. UCB holds the world-wide rights for development, manufacturing and marketing of Lacosamide. Lacosamide is currently not approved in Japan for the treatment of epilepsy.

Important Safety Information about VIMPAT^® in the EU and EEA¹

VIMPAT^® (lacosamide) is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in adult and adolescent (16-18 years) patients with epilepsy. VIMPAT^® therapy can be initiated with either oral or IV administration. A single loading dose may be initiated in patients in situations when the physician determines that rapid attainment of lacosamide steady state plasma concentration and therapeutic effect is warranted. It should be administered under medical supervision with consideration of the potential for increased incidence of CNS adverse reactions. Administration of a loading dose has not been studied in acute conditions such as status epilepticus. Contraindications: Hypersensitivity to the active substance or any of the excipients; known second- or third-degree atrioventricular (AV) block. Special warnings and precautions for use: Treatment with VIMPAT^® has been associated with dizziness which could increase the occurrence of accidental injury or falls. Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicine. Prolongations in PR interval with VIMPAT^® have been observed in clinical studies. Cases with second- and third-degree AV block associated with VIMPAT^® treatment have been reported in post-marketing experience. VIMPAT^® should be used with caution in patients with known conduction problems or severe cardiac disease such as a history of myocardial infarction or heart failure. Caution should especially be exerted when treating elderly patients as they may be at an increased risk of cardiac disorders or when VIMPAT^® is used in combination with products known to be associated with PR prolongation. In the placebo-controlled trials of VIMPAT^® in epilepsy patients, atrial fibrillation or flutter were not reported; however both have been reported in open-label epilepsy trials and in post-marketing experience. Patients should be made aware of the symptoms of second-degree or higher AV block (e.g. slow or irregular pulse, feeling of lightheaded and fainting) and of the symptoms of atrial fibrillation and flutter (e.g. palpitations, rapid or irregular pulse, shortness of breath). Patients should be counseled to seek medical advice should any of these symptoms occur. Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. VIMPAT^® syrup contains sodium methyl parahydroxybenzoate (E219) which may cause allergic reactions (possibly delayed). It contains 3.7 g sorbitol (E420) per dose (200 mg lacosamide), corresponding to a calorific value of 9.7 kcal. Patients with rare hereditary problems of fructose intolerance should not take this medicine. The syrup contains aspartame (E951), a source of phenylalanine, which may be harmful for people with phenylketonuria. VIMPAT^® syrup and the solution for infusion contain sodium, which should be taken into consideration for patients on a controlled sodium diet. Effects on ability to drive and use machines: VIMPAT^® may have minor to moderate influence on the ability to drive and use machines. VIMPAT^® treatment has been associated with dizziness or blurred vision. Accordingly patients should be advised not to drive a car or to operate other potentially hazardous machinery until they are familiar with the effects of VIMPAT^® on their ability to perform such activities. Undesirable effects: The most common adverse reactions (≥10%) are dizziness, headache, diplopia, and nausea. They were usually mild to moderate in intensity. Some were dose-related and could be alleviated by reducing the dose. Incidence and severity of CNS and gastrointestinal (GI) adverse reactions usually decreased over time. Incidence of CNS adverse reactions such as dizziness may be higher after a loading dose. Other common adverse reactions (≥1% - <10%) are depression, confusional state, insomnia, balance disorder, coordination abnormal, memory impairment, cognitive disorder, somnolence, tremor, nystagmus, hypoesthesia, dysarthria, disturbance in attention, paraesthesia, vision blurred, vertigo, tinnitus, vomiting, constipation, flatulence, dyspepsia, dry mouth, diarrhoea, pruritus, rash, muscle spasms, gait disturbance, asthenia, fatigue, irritability, feeling drunk, injection site pain or discomfort (local adverse events associated with intravenous administration), irritation (local adverse events associated with intravenous administration), fall, and skin laceration, contusion. The use of VIMPAT^® is associated with dose-related increase in the PR interval. Adverse reactions associated with PR interval prolongation (e.g. atrioventricular block, syncope, bradycardia) may occur. Laboratory abnormalities: Abnormalities in liver function tests have been observed in controlled trials with VIMPAT^® in adult patients with partial-onset seizures who were taking 1-3 concomitant antiepileptic drugs. Elevations of ALT to ≥3XULN occurred in 0.7% (7/935) of VIMPAT^® patients and 0% (0/356) of placebo patients. Multiorgan Hypersensitivity Reactions: Multiorgan hypersensitivity reactions (also known as Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS) have been reported in patients treated with some antiepileptic agents. These reactions are variable in expression but typically present with fever and rash and can be associated with involvement of different organ systems. If multiorgan hypersensitivity reaction is suspected, VIMPAT^® should be discontinued.

Refer to the European Summary of Product Characteristics for other adverse reactions and full prescribing information. Date of revision: 23 October 2014.

http://www.ema.europa.eu/

For further information

References

1. VIMPAT^® Summary of Product Characteristics. Accessed 23rd November 2014 from http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000863/WC500050338.pdf

2. ClinicalTrials.gov Identifier: NCT01710657: Accessed 23rd November 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01710657?term=NCT01710657&rank = Accessed

3. Fisher, R.S., et al., ILAE Official Report: A practical clinical definition of epilepsy. Epilepsia, 2014. 55(4): 475-82.

4. Institute of Medicine. Epilepsy Across the Spectrum. Promoting Health and Understanding, Washington, DC: The National Academic Press, 2012 brief report. Accessed 23 November 2014 from http://www.iom.edu/~/media/Files/Report%20Files/2012/Epilepsy/epilepsy_rb.pdf

5. The Epilepsy Foundation of America. Who gets epilepsy? Accessed 23 November 2014 from http://www.epilepsy.com/learn/epilepsy-101/who-gets-epilepsy

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 more than 8500 people in approximately 40 countries, the company generated revenue of € 3.4 billion in 2013. 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 the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, dyslipidemia and bacterial infections used by patients around the world, the Group has also launched treatments for thrombotic disorders and is building new product franchises. Furthermore, Daiichi Sankyo research and development is focused on bringing forth novel therapies in oncology and cardiovascular-metabolic diseases, including biologics. The Daiichi Sankyo Group has created a "Hybrid Business Model," to respond to market and customer diversity and optimize growth opportunities across the value chain. For more information, please visit: www.daiichisankyo.com.

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