Key Developments: Eisai Co Ltd (ESALF.PK)
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23 May 2013
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Latest Key Developments (Source: Significant Developments)
Eisai Co Ltd to Sell Treasury Stock
Eisai Co Ltd announced that it has decided to distribute 105,400 shares of its treasury stock, at the price of JPY 4,525 per share, or for JPY 477,989,000 in total, through a private placement to Mitsubishi UFJ Trust and Banking Corporation, on May 30, 2013. The Company will be using the total proceeds as research and development capital. Full Article
EU Regulatory Authorities Grant Orphan Status To Eisai Co Ltd's Lenvatinib For Treatment Of Radioiodine-Refractory Differentiated Thyroid Cancer
Eisai Co Ltd announced that the investigational multi-tyrosine kinase inhibitor (TKI), lenvatinib (development code: E7080), has been granted orphan drug designation (ODD) for the treatment of follicular and papillary thyroid cancer by the European Commission. ODD is for medicines developed for the diagnosis, prevention or treatment of rare diseases that are life-threatening or very serious. In the European Union (EU), a disease is defined as rare if it affects fewer than five in 10,000 people across the EU. Lenvatinib received ODD from the Swiss agency for therapeutic products, Swissmedic, on March 13, 2013 for the treatment of follicular (FTC), medullary (MTC) and anaplastic (ATC) thyroid cancer. Orphan drug status was granted in February 2013 by the US Food and Drug Administration (FDA) in the treatment of FTC, MTC and ATC thyroid cancer. Japan's Ministry of Labour, Health and Welfare also granted ODD for thyroid cancer in August 2012. Full Article
Koninklijke DSM NV's DSM Pharmaceutical Products Signs Master Supply Agreement With Eisai Co Ltd's Eisai Inc
Koninklijke DSM NV's DSM Pharmaceutical Products, the custom manufacturing and technology business announced the signing of a three year master supply agreement with Eisai Inc., based in Woodcliff Lake, NJ, USA, for the production of sterile products. The agreement covers the production of eribulin mesylate as well as other developmental drugs. DSM will be a supplier for eribulin mesylate to the US market. Commercial production is anticipated to start in early 2013. No financial details were disclosed. Full Article
Valeant Pharmaceuticals Acquires U.S. Rights To Targretin From Eisai Co Ltd's Eisai Inc
Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., and Valeant Pharmaceuticals International, Inc. announced that Valeant has acquired U.S. rights for Targretin (bexarotene) capsules and Targretin (bexarotene) gel 1% from Eisai for $65 million upfront, plus potential contingent payments based on certain milestones. As part of the transaction, which takes effect immediately, Eisai has transferred the New Drug Application (NDA) for Targretin to Valeant, with Valeant assuming responsibilities for all regulatory obligations associated with the product in the United States. Eisai will retain its rights to Targretin outside of the United States and continue to meet the needs of its distribution partners outside of the United States. Full Article
Eisai Co Ltd Announces Results of Phase III Study of Anticancer Agent Farletuzumab in Patients with Relapsed Platinum-Sensitive Ovarian Cancer
Eisai Co Ltd announced the preliminary results of its phase III study of farletuzumab, an investigational compound under development at its U.S. subsidiary, Morphotek, Inc., in patients with platinum-sensitive epithelial ovarian cancer in first relapse. The patients received standard-of-care therapy (carboplatin and a taxane) in combination with doses of either 1.25 mg/kg of farletuzumab, 2.5 mg/kg of farletuzumab, or placebo. Preliminary results showed that the trial did not meet the pre-specified statistical criteria for progression-free survival (PFS). The post hoc exploratory analysis showed, however, a trend toward improved PFS in some patient subsets and further analysis is ongoing. The preliminary safety analysis indicated that the most commonly reported adverse events were those known to be associated with the study chemotherapy agents. Additionally, some immune-mediated events were observed with farletuzumab. Full Article
Eisai Co Ltd to Dissolve Subsidiary-Yakuji Nippo
Yakuji Nippo reported that Eisai Co Ltd announced that it has decided to dissolve an Ibaraki-based subsidiary, which is engaged in the research and development of diagnosis agent, on March 31, 2013. Full Article
Eisai Co Ltd Receives Approval for Halaven in South Korea and Australia – Yakuji Nippo
Yakuji Nippo reported that Eisai Co Ltd has received an approval for its anticancer agent Halaven (Eribulin Mesylate), in South Korea and Australia. Full Article
Eisai Co Ltd Issues FY 2012 Guidance; Operating Profit Guidance Above Analysts' Estimates-Conference Call
Eisai Co Ltd announced that for fiscal 2012, it expects JPY610 billion in sales and JPY87 billion in operating profit. According to I/B/E/S Estimates, analysts on average were expecting the Company to report revenues of JPY610 billion and operating profit of JPY85 billion for fiscal 2012. Full Article
Eisai Co Ltd Announces Final Pivotal Phase III Fycompa (perampanel) Study Results Published Ahead of First European Launch
Eisai Co Ltd announced results from the final pivotal Phase III study and long term Phase III extension study Fycompa (perampanel), were published online in Epilepsia. Findings from Study 305, one of three pivotal global studies, and the extension study for perampanel add further weight to the growing body of clinical evidence supporting the efficacy and safety of the new treatment. The 305 study demonstrated that once-daily, adjunctive perampanel improved seizure control and was acceptably-tolerated in subjects 12 years and older with refractory partial-onset seizures. Study 305 is one of three pivotal Phase III studies in the EXPLORE (EXamining PerampaneL Observations from Research Experience) clinical trial programme. Showing consistency with other results from the Phase III clinical trial programmes, the 307 interim results showed that perampanel had an acceptable tolerability profile in patients with refractory partial-onset seizures over the longer term. Furthermore, reduced seizure frequency and improved responder rates were consistent and maintained during 1 - 2 years of continued perampanel therapy.[2] Study 307 is an open-label extension study for people with epilepsy completing the double-blind phase of three pivotal Phase III trials (studies 304, 305, and 306). Full Article
Eisai Co., Ltd. Announces Preliminary Results of Phase III Study (Study 301) of Anticancer Agent Halaven
Eisai Co., Ltd. announced preliminary results from a Phase III study (Study 301) of its in-house discovered and developed anticancer agent Halaven® (eribulin mesylate) versus capecitabine in women with locally advanced or metastatic breast cancer for whom prior treatment with both an anthracycline and taxane has failed. The study was conducted with a view to expanding the current indication to allow such patients to receive benefits from Halaven from an even earlier stage in the treatment of their disease. Data showed that the safety profile of Halaven was consistent with that reported in previous clinical studies. Full Article
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