Key Developments: Torii Pharmaceutical Co Ltd (TRXPF.PK)
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15 Apr 2013
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Latest Key Developments (Source: Significant Developments)
Torii Pharmaceutical Co Ltd Announces Officer Change
Torii Pharmaceutical Co Ltd announced that it has appointed Shoichiro Takagi as President and Representative Director, and Norihiko Matsuo as Chairman of the Board of the Company, effective June 20, 2013. Full Article
JAPAN TOBACCO INC and Torii Pharmaceutical Co., Ltd. File for New Drug Application for Marketing Approval of Hyperphosphatemia Remedy JTT-751 in Japan
JAPAN TOBACCO INC announced that it has filed a new drug application (NDA) for marketing approval of a hyperphosphatemia remedy JTT-751 in Japan. If the application is approved, Torii Pharmaceutical Co., Ltd. will be in charge of the sale of the new drug. Full Article
JAPAN TOBACCO INC Signs Exclusive Sales Contract with TORII PHARMACEUTICAL CO., LTD.
JAPAN TOBACCO INC announced that it has signed an exclusive sales contract with TORII PHARMACEUTICAL CO., LTD. The contract allows TORII PHARMACEUTICAL to sell the new HIV receptor antagonist with JTK-303(elvitegravir) in the domestic market. TORII PHARMACEUTICAL will pay JPY 2.7 billion to JAPAN TOBACCO. Full Article
Alk Abello A/S's Partner Torii Pharmaceutical Co., Ltd. Initiates Clinical Phase II/III Development Program for MITIZAX in Japan
Alk Abello A/S (ALK) announced that its partner Torii Pharmaceutical Co., Ltd. is advancing the clinical development program for MITIZAX by initiating two parallel Phase II/III trials in Japan. MITIZAX is ALK' new allergy immunotherapy tablet (AIT) against house dust mite induced hay fever and asthma. The two trials will include approximately 1,800 subjects and will investigate safety and efficacy of MITIZAX in the treatment of house dust mite induced allergic rhinitis and asthma in a Japanese population. In Europe, ALK is conducting two similar clinical Phase III trials which will complete in 2013. In North America, MITIZAX has been licensed to Merck (known as MSD outside the United States and Canada) and is in Phase II clinical development. Initiation of patient dosing in the Phase II/III trials in Japan entitles ALK to an undisclosed payment from Torii. This payment has already been included in ALK's financial outlook for 2012 and consequently, this announcement does not lead ALK to change its financial outlook for the year. Full Article
Keryx Biopharmaceuticals Announces Positive Top-line Results From Phase Three Study Of Ferric Citrate (Zerenex) In Japan By Partner, Japan Tobacco Inc And Torii Pharmaceutical
Keryx Biopharmaceuticals announced that its Japanese partner, Japan Tobacco Inc. (JT) and Torii Pharmaceutical Co., Ltd. (Torii), has announced positive top-line results from a Phase Three study of ferric citrate in Japan for the treatment of hyperphosphatemia in end-stage renal disease patients on hemodialysis. This study is part of an ongoing Phase Three program for ferric citrate in Japan for the treatment of hyperphosphatemia. The Phase three study, conducted in Japan, was an open-label, randomized study evaluating the efficacy and safety of ferric citrate against an active control, sevelamer hydrochloride, over 12 weeks in hemodialysis patients with hyperphosphatemia. In the top-line results, which evaluated the change of serum phosphorus from baseline, the primary endpoint of efficacy met non-inferiority to sevelamer hydrochloride. Furthermore, there were no clinically significant findings on safety and tolerability of ferric citrate within the treatment period. Zerenex (ferric citrate), a ferric iron-based phosphate binder, is also in a Phase Three clinical program in the United States for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease on dialysis, which is being conducted pursuant to a Special Protocol Assessment agreement with the FDA. Full Article
Torii Pharmaceutical Co., Ltd. Cancels Co-development Alliance with JAPAN TOBACCO INC. and Toray Industries, Inc.; Amends FY 2012 Outlook
Torii Pharmaceutical Co., Ltd. announced that it has canceled the co-development alliance signed with JAPAN TOBACCO INC. and Toray Industries, Inc., for nalfurafine hydrochloride ("TRK-820"). The Company also reaffirmed its consolidated full-year outlook for revenue of JPY 48,800 million, and raised its consolidated full-year outlook for operating profit from JPY 3,400 million to JPY 3,700 million, ordinary profit from JPY 3,500 million to JPY 3,800 million, net profit from JPY 2,100 million to JPY 2,800 million and earning per share from JPY 74.20 to JPY 98.93 for the fiscal year ending March 31, 2012. This is due to the recording of terminal bonus of joint development expense. Full Article
Torii Pharmaceutical Co., Ltd. Amends FY 2012 Outlook
Torii Pharmaceutical Co., Ltd. announced that it has reaffirmed its consolidated full-year outlook for revenue of JPY 48,800 million, and raised its consolidated full-year outlook for operating profit from JPY 2,700 million to JPY 3,400 million, ordinary profit from JPY 2,900 million to JPY 3,500 million, net profit from JPY 1,300 million to JPY 2,100 million and earning per share from JPY 45.93 to JPY 74.20 for the fiscal year ending March 31, 2012. This is due to the increased sale of medical supplies, as well as the decreased selling and general administrative expenses. Full Article
Torii Pharmaceutical Co., Ltd. Amends Consolidated Mid-year Outlook for FY 2012
Torii Pharmaceutical Co., Ltd. announced that it has lowered its consolidated mid-year outlook for revenue from JPY 24,400 million to JPY 24,000 million, but raised the outlook for operating profit from JPY 1,300 million to JPY 1,500 million, ordinary profit from JPY 1,400 million to JPY 1,600 million, net profit from JPY 700 million to JPY 900 million and earning per share from JPY 24.73 to JPY 31.80, for the fiscal year ending March 2012. The Company raised the profit outlook due to the less-than-expected marketing and administrative cost. Full Article
Torii Pharmaceutical Co., Ltd. Issues FY 2012 Outlook-DJ
DJ reported that Torii Pharmaceutical Co., Ltd. has issued its mid-year outlook for revenue of JPY 24.40 billion, operating profit of JPY 1.30 billion, pretax profit of JPY 1.40 billion, net profit of JPY 700.00 million and earning per share of 24.73 for the fiscal year ending March 2012. The Company also issued its full-year outlook for revenue of JPY 48.80 billion, operating profit of JPY 2.70 billion, pretax profit of JPY 2.90 billion, net profit of JPY 1.30 billion and earning per share of JPY 45.93 for the fiscal year ending March 2012. Full Article
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