Otsuka and UCB agreed to co-develop and co-promote Keppra® and Cimzia® in Japan
- Otsuka and UCB have agreed to co-promote UCB's anti epileptic drug, Keppra® and its anti-TNF alpha drug, Cimzia® in Japan - the second largest pharmaceutical market in the world. Otsuka will also co-develop new indications.
- Over time, UCB receives upfront and milestone payments of up to €113 million as well as funding for clinical development.
Brussels, Belgium and Tokyo, Japan - June 10, 2008 at 7:00 am CEST - UCB and Otsuka Pharmaceuticals Co., Ltd. announced today that the companies have signed collaboration agreements related to UCB's two important products in Japan. UCB and Otsuka will co-promote the anti-epileptic drug (AED), Keppra® (levetiracetam) for the adjunctive treatment of partial onset seizures and the anti-TNF alpha drug, Cimzia® (certolizumab pegol) for the treatment of Crohn's Disease. UCB and Otsuka will also co-develop and co-promote Keppra® and Cimzia® in other indications. UCB will join Otsuka in co-promoting the anti-platelet agent Pletaal® (cilostazol) to selected accounts for a limited period.
"We are excited to enter into this important strategic relationship with Otsuka, which is one of the top Japanese pharmaceutical companies and which has an excellent reputation in drug development, marketing and sales and an entrepreneurial culture that is consistent with our own," said Roch Doliveux, CEO UCB. "This relationship will ensure that together we can successfully launch and maximize the potential of Keppra® and Cimzia® in Japan and accelerate market access for the benefit of patients in Japan."
"We highly evaluate these compounds and UCB's experience in this area," said Tatsuo Higuchi, president and representative director of Otsuka Pharmaceutical Co., Ltd. "We are delighted to have this opportunity to collaborate with UCB to address the unmet medical needs of patients suffering from these diseases and to develop these innovative products and expand our businesses together."
UCB and Otsuka have agreed on economic terms for Japan under which UCB receives up to €113 million upfront and milestone payments as well as funding for the clinical development of Keppra® and Cimzia®.
The companies plan to submit filing dossiers for Keppra® in epilepsy and Cimzia® in Crohn's disease to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) by early 2009.
Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: 'Otsuka - people creating new products for better health worldwide.' Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and consumer products for the maintenance of everyday health. Otsuka is committed to being a corporation that creates global value, adhering to the high ethical standards required of a company involved in human health and life, maintaining a dynamic corporate culture, and working in harmony with local communities and the natural environment.
The Otsuka Pharmaceutical Group comprises 104 companies and employs approximately 33,000 people in 18 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned JPY928.4 billion in annual revenues in fiscal 2007.
UCB (Brussels, Belgium) (www.ucb-group.com) is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialization of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology. UCB focuses on securing a leading position in severe disease categories. Employing around 12 000 people in over 40 countries, UCB achieved revenue of €3.6 billion in 2007. UCB S.A. is listed on Euronext Brussels.
Keppra® (levetiracetam) is an antiepileptic drug with over two million patient years experience. Keppra® was first approved in 1999 (US) and 2000 (EU) as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. Since this time it has received several supplemental indications as adjunctive therapy across both partial and generalised seizures types in the US and the EU. In Keppra® is also approved as monotherapy in the EU for the treatment of partial onset seizures in adults with epilepsy.
Cimzia® (certolizumab pegol) is the first and only PEGylated anti-TNF (Tumor Necrosis Factor alpha). Cimzia® has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha. Over the past decade, TNF-alpha has emerged as a major target of basic research and clinical investigation. This cytokine plays a key role in mediating pathological inflammation, and excess TNF-alpha production has been directly implicated in a wide variety of diseases. UCB is developing Cimzia® in Crohn's disease, RA and other autoimmune disease indications. For additional information, please refer to the Cimzia® website http://www.cimzia.com
Pletaal®/Pletal® (cilostazole) is an antiplatelet agent that exhibits antiplatelet and vasodilatory effects and improves endothelial cells by selectively inhibiting intracellular PDE3 (cGMP-inhibited phosphodiesterase) activity. The agent improves arterial circulation disorders through the antithrombotic effects from the antiplatelet aggregation, the increase in the cerebral blood flow and the blood flow in the lower extremities from the vasodilatory action, and also through the endothelial cell improvement. The drug therefore improves the subjective symptoms of chronic arterial obstruction and prevents recurrence of cerebral infarction.
Forward looking statement
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.
Otsuka Pharmaceutical Co., Ltd.
Corporate Communication & Investor Relations
Public Relations Department
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