Otsuka Pharmaceutical and UCB focus collaboration in the area of Central Nervous System (CNS) disorders
Tokyo, Japan and Brussels, Belgium, January 13th, 2012 – regulated information – Otsuka Pharmaceutical Co., Ltd. and UCB announced today that the companies have agreed to focus their collaboration on the therapeutic area of Central Nervous System (CNS) disorders and to discontinue their collaboration in immunology.
The companies will end their co-development and co-promotion agreement for certolizumab pegol in Japan followed by an agreed upon transition period.
UCB is preparing to file certolizumab pegol for marketing authorisation with the Japanese Ministry of Health, Labour and Welfare (MHLW) in the first quarter of 2012. Positive Japanese study results, showing that certolizumab pegol was associated with significant inhibition of structural joint damage progression and significant improvements in physical function compared to placebo, were published at the recent American College of Rheumatology’s (ACR) 2011 Annual Scientific Meeting.1
The decision to discontinue its collaboration in immunology is in line with Otsuka Pharmaceutical’s clear priorities to focus in the future on CNS and oncology in its pharmaceutical business.
In December 2011, Otsuka Pharmaceutical filed rotigotine for marketing authorisation in Japan with the MHLW for the treatment of Parkinson’s disease and restless legs syndrome. In 2010, E Keppra® (levetiracetam), was approved and launched in Japan for the adjunctive treatment of partial onset seizures in adults with epilepsy which offers many patients a new option of treatment.
“Otsuka will strengthen the partnership with UCB in Japan while focusing on CNS compounds such as E Keppra®, an anti-epileptic drug, and rotigotine, a dopamine agonist patch,” said Dr. Taro Iwamoto, President and Representative Director of Otsuka Pharmaceutical Co., Ltd. “We remain dedicated to maximising the value of these two compounds while continuing to investigate additional indications. Otsuka and UCB will build a strong sales base so that our compounds can positively contribute to a number of patients in need.”
"We are happy to continue our successful partnership with Otsuka Pharmaceutical in the area of CNS, namely E Keppra® and rotigotine.” said Mark McDade, Executive VP, Chief Operating Officer, UCB. "And in the interest of Japanese patients living with severe immunological disorders, UCB is committed to building on the franchises of the immunology therapeutic area in Japan starting with certolizumab pegol.”
1 For more information about the certolizumab pegol data, please read the press release distributed at the ACR 2011 in Chicago
Cimzia® is the only PEGylated anti-TNF (Tumor Necrosis Factor). 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. The U.S. Food and Drug Administration (FDA) has approved Cimzia® for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy and for the treatment of adults with moderately to severely active rheumatoid arthritis. Cimzia® in combination with MTX, is approved in the EU for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying antirheumatic drugs (DMARDs) including MTX. Cimzia® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. UCB is also developing Cimzia® in other autoimmune disease indications. Cimzia® is a registered trademark of UCB PHARMA S.A.
Cimzia® (certolizumab pegol) in European Union/ EEA important safety information
Cimzia® was studied in 2367 patients with RA in controlled and open label trials for up to 57 months. The commonly reported adverse reactions (1-10%) in clinical trials with Cimzia® and post-marketing were viral infections (includes herpes, papillomavirus, influenza), bacterial infections (including abscess), rash, headache (including migraine), asthenia, leukopaenia (including lymphopaenia, neutropaenia), eosinophilic disorder, pain (any sites), pyrexia, sensory abnormalities, hypertension, pruritis (any sites), hepatitis (including hepatic enzyme increase), injection site reactions. Serious adverse reactions include sepsis, opportunistic infections, tuberculosis, herpes zoster, lymphoma, leukaemia, solid organ tumours, angioneurotic edema, cardiomyopathies (includes heart failure), ischemic coronary artery disorders, pancytopaenia, hypercoagulation (including thrombophlebitis, pulmonary embolism), cerebrovascular accident, vasculitis, hepatitis/hepatopathy (includes cirrhosis), and renal impairment/nephropathy (includes nephritis). In RA controlled clinical trials, 5% of patients discontinued taking Cimzia® due to adverse events vs. 2.5% for placebo.
Cimzia® is contraindicated in patients with hypersensitivity to the active substance or any of the excipients, active tuberculosis or other severe infections such as sepsis or opportunistic infections, moderate to severe heart failure.
Before initiation of therapy with Cimzia®, all patients must be evaluated for both active and inactive (latent) tuberculosis infection. Monitor patients closely for signs and symptoms of infections including tuberculosis before, during and after treatment with Cimzia®. If an infection develops, monitor carefully and stop Cimzia® if infection becomes serious. Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including Cimzia® who are chronic carriers of the virus (i.e. surface antigen positive). Some cases have had a fatal outcome. Patients should be tested for HBV infection before initiating treatment with Cimzia®. For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended. Carriers of HBV who require treatment with Cimzia® should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy. In patients who develop HBV reactivation Cimzia® should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
TNF antagonists including Cimzia® may increase the risk of new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease; of formation of autoantibodies and uncommonly of the development of a lupus-like syndrome; of severe hypersensitivity reactions. If a patient develops any of these adverse reactions, Cimzia® should be discontinued and appropriate therapy instituted.
With the current knowledge, a possible risk for the development of lymphomas, leukaemia or other malignancies in patients treated with a TNF antagonist cannot be excluded. Rare cases of neurological disorders, including seizure disorder, neuritis and peripheral neuropathy, have been reported in patients treated with Cimzia®.
Adverse reactions of the hematologic system, including medically significant cytopenia, have been infrequently reported with Cimzia®. Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on Cimzia®. Consider discontinuation of Cimzia® therapy in patients with confirmed significant haematological abnormalities.
The use of Cimzia® in combination with anakinra or abatacept is not recommended due to a potential increased risk of serious infections. As no data are available, Cimzia® should not be administered concurrently with live vaccines or attenuated vaccines. The 14-day half-life of Cimzia® should be taken into consideration if a surgical procedure is planned. A patient who requires surgery while on Cimzia® should be closely monitored for infections.
Please consult the full prescribing information in relation to other side effects, full safety and prescribing information. European SmPC date of revision November 2011.
For further information Otsuka Pharmaceutical
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About Otsuka Pharmaceutical Co., Ltd.
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 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.
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 8 500 people in about 40 countries, the company generated revenue of EUR 3.2 billion in 2010. UCB is listed on Euronext Brussels (symbol: UCB).
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