Key Developments: Dainippon Sumitomo Pharma Co Ltd (DNPUF.PK)
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23 May 2013
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Latest Key Developments (Source: Significant Developments)
Dainippon Sumitomo Pharma Co Ltd Announces BBI608 Phase 1/2 Clinical Study Data
Dainippon Sumitomo Pharma Co Ltd announced that the dose-escalation study results from the Phase 1/2 clinical study on BBI608, an anti-cancer treatment under development, was presented on June 3, 2013 (U.S. time) at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Adverse events for BBI608 were generally mild; the most common being grade 1-2 diarrhea, nausea, anorexia and fatigue with a total of 4 grade 3 events (diarrhea and fatigue), and there were no grade 4 events. MTD was not reached. Hematological toxicity was not observed. The recommended dose for the BBI608 Phase 1/2 clinical study (extension study) was established as 500mg twice daily. For a preliminary efficacy results (RECIST v1.1), the disease control rate (DCR) was found to be 65% (17/26 evaluable patients). In the subset of 18 patients with colorectal cancer (CRC), among those evaluable, DCR was 67%, median progression free survival (PFS) was 14 weeks and median overall survival (OS) was 47 weeks. Median OS for biomarker-positive (nuclear β-catenin and high p-Stat3) CRC patients was 53 weeks and 54 weeks, respectively. Full Article
R&I Affirms Rating on Dainippon Sumitomo Pharma Co., Ltd. at "A"; Rating Outlook Stable
Rating and Investment Information, Inc. (R&I) announced that it has affirmed the rating on Dainippon Sumitomo Pharma Co., Ltd. at "A". The rating outlook is stable. Full Article
Dainippon Sumitomo Pharma Co Ltd Signs License Agreement with Edison Pharmaceuticals for Therapeutic Agents for Mitochondria Disease
Dainippon Sumitomo Pharma Co Ltd announced that it has signed a research, development and commercial license agreement for the territory of Japan with Edison Pharmaceuticals, Inc., for EPI-743 and EPI-589, therapeutic agents under development by Edison for mitochondrial disease. Under the terms of the agreement, the Company obtains exclusive research, development and commercial rights in Japan for EPI-743 and EPI-589. Full Article
Dainippon Sumitomo Pharma Co Ltd Announces Capital Alliance with Retina Institute Japan, K.K.
Dainippon Sumitomo Pharma Co Ltd announced that it has agreed to form a capital alliance with Retina Institute Japan, K.K. for utilization of iPS cell technology. Through the capital alliance, Retina Institute Japan will issue shares worth JPY 1,500 million through private placement to the Company. Full Article
Dainippon Sumitomo Pharma Co Ltd Establishes New Subsidiary in Singapore-Yakuji Nippo
Yakuji Nippo reported that Dainippon Sumitomo Pharma Co Ltd announced that it has established a new wholly owned subsidiary in Singapore, which is engaged in the pharmaceutical business, in January 2013. Full Article
Dainippon Sumitomo Pharma Co Ltd's Subsidiary Files Two Supplemental New Drug Applications Seeking Approval for the use of Latuda® (lurasidone HCl)
Dainippon Sumitomo Pharma Co Ltd announced that its subsidiary, Sunovion Pharmaceuticals Inc., has submitted two supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of LATUDA (lurasidone HCl) as 1) monotherapy and 2) adjunctive therapy to lithium or valproate, both to treat adult patients with depressive episodes associated with bipolar I disorder (bipolar depression). These sNDAs are supported by two 6-week, double-blind, placebo-controlled Phase 3 clinical trials, PREVAIL 1 and PREVAIL 2 (PRogram to EValuate the Antidepressant Impact of Lurasidone), involving 852 patients with bipolar depression. Full Article
Dainippon Sumitomo Pharma Co Ltd's Subsidiary Acquires Elevation Pharmaceuticals, Inc.
Dainippon Sumitomo Pharma Co Ltd announced that its subsidiary has fully acquired Elevation Pharmaceuticals, Inc. on September 5, 2012 (American time). Full Article
Dainippon Sumitomo Pharma Co Ltd's Subsidiary to Acquire Elevation Pharmaceuticals, Inc
Dainippon Sumitomo Pharma Co Ltd announced that its wholly owned subsidiary, Sunovion Pharmaceuticals Inc., based in United States, has signed an agreement to acquire Elevation Pharmaceuticals, Inc. in the second quarter of fiscal year ending March 2013. Full Article
Dainippon Sumitomo Pharma Co., Ltd. Raises Consolidated Mid-year and Full-year Guidance for FY 2013
Dainippon Sumitomo Pharma Co., Ltd. announced that the Company has raised the consolidated mid-year guidance for revenue from JPY 176,000 million to JPY 179,000 million, operating profit from JPY 11,000 million to JPY 17,200 million, ordinary profit from JPY 10,500 million to JPY 17,000 million, net profit from JPY 5,000 million to JPY 8,800 million and earning per share from JPY 12.58 to JPY 22.15 for the fiscal year ending March 31, 2013. The Company has reaffirmed the consolidated full-year guidance for revenue of JPY 348,000 million, and raised the guidance for operating profit from JPY 22,000 million to JPY 25,000 million, ordinary profit from JPY 21,000 million to JPY 24,000 million, net profit from JPY 10,500 million to JPY 12,000 million and earning per share from JPY 26.43 to JPY 30.20 for the fiscal year ending March 31, 2013. The Company raised the consolidated mid-year and full-year outlook due to decreased costs. Full Article
Dainippon Sumitomo Pharma Co., Ltd. Fully Acquires Boston Biomedical Inc.
Dainippon Sumitomo Pharma Co., Ltd. announced that it has fully acquired Boston Biomedical Inc., which is engaged in the development and research of cancer cell related business in America, on April 24, 2012 of the Unite States time. Full Article

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