Aug 12 (Reuters) - U.S. FDA::FDA APPROVES TARGETED TREATMENT FOR RARE DUCHENNE MUSCULAR DYSTROPHY MUTATION.FDA SAYS GRANTING ACCELERATED APPROVAL TO NS PHARMA'S VILTEPSO INJECTION FOR TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY.
March 19 (Reuters) - Zogenix Inc <ZGNX.O>::ZOGENIX ENTERS EXCLUSIVE DISTRIBUTION AGREEMENT WITH NIPPON SHINYAKU FOR FINTEPLA® IN JAPAN.ZOGENIX INC - NIPPON SHINYAKU WILL RECEIVE EXCLUSIVE COMMERCIAL RIGHTS TO FINTEPLA IN JAPAN..ZOGENIX INC - ZOGENIX WILL RECEIVE PAYMENTS TOTALING $20 MILLION FROM DEAL.ZOGENIX INC - ZOGENIX WILL ALSO BE ELIGIBLE TO RECEIVE FUTURE REGULATORY AND SALES-BASED MILESTONE PAYMENTS..ZOGENIX - TO SUPPLY PRODUCT TO NIPPON SHINYAKU, RECEIVE TIERED TRANSFER PRICE BASED ON MANUFACTURING COSTS, ANNUAL NET SALES OF FINTEPLA IN JAPAN.ZOGENIX INC - ZOGENIX WILL RETAIN RESPONSIBILITY FOR COMPLETING ITS GLOBAL CLINICAL DEVELOPMENT PROGRAMS FOR FINTEPLA.
April 21 (Reuters) - Nikkei::Nippon Shinyaku Co Ltd appears to have generated around 15.5 billion yen in group operating profit in fiscal 2016 - Nikkei.Nippon Shinyaku Co's sales likely rose 20% to nearly 100 billion yen in fiscal 2016, about 3.5 billion yen higher than the earnings guidance - Nikkei.Nippon Shinyaku Co Ltd is expected to increase its annual dividend payout to 45-50 yen per share from the projected 37 yen - Nikkei.
Actelion Ltd <ATLN.S> : Says receives Swissmedic approval for uptravi (selexipag) for treatment of pulmonary arterial hypertension .Swissmedic has granted approval for orally active originally discovered and synthesized by Nippon Shinyaku, for patients with PAH in Switzerland.
Nippon Shinyaku Co Ltd <4516.T> : Says the company obtained the marketing approval of Uptravi in EU on May 12 .Says Uptravi is a medicine for the treatment of hypertension.
Nippon Shinyaku Co Ltd:Submitted to the Food and Drug Administration (FDA) on March 25, 2016, an Investigational New Drug (IND) Application for a phase 2 clinical study of NS-065, the first antisense oligonucleotide discovered in Japan for the treatment of Duchenne Muscular Dystrophy (DMD).
Nippon Shinyaku Co Ltd announced that it has raised its consolidated mid-year outlook for revenue from JPY 33,000 million to JPY 33,100 million, operating profit from JPY 2,500 million to JPY 3,050 million, ordinary profit from JPY 2,600 million to JPY 3,300 million, net profit from JPY 1,600 million to JPY 2,100 million and earning per share from JPY 23.71 to JPY 31.12, for the fiscal year ending March 2013. In addition, the Company has also raised its consolidated full-year outlook for revenue from JPY 69,100 million to JPY 69,400 million, operating profit from JPY 6,400 million to JPY 6,600 million, ordinary profit from JPY 6,600 million to JPY 6,800 million, net profit from JPY 4,200 million to JPY 4,300 million and earning per share from JPY 62.23 to JPY 63.71, for the fiscal year ending March 2013. The Company raised the outlook due to the increased sales and the cost reduction, among others. According to I/B/E/S Estimates, analysts were expecting the Company to report full-year revenue of JPY 69.88 billion and net profit of JPY 4.40 billion.
Nippon Shinyaku Co., Ltd. announced that it has signed a medical license contract regarding the product under the name of Cialis, which is a therapeutic substance for erectile dysfunction, with Eli Lilly Japan K.K. and Eli Lilly and Company. The contract entitles the Company to sell the therapeutic substance in the domestic market exclusively, effective July 1, 2009.
Nippon Shinyaku Co., Ltd. announced that it has signed an exclusive sale licenses for synthetic antibacterial drug with a Lee's Pharmaceutical Holdings Limited, which is engaged in the manufacturing, development and sale of medical supplies and medical equipment in Hong Kong, on March 2, 2009. The licenses allow the Company to sell the drug in China.
Nippon Shinyaku Co., Ltd. announced that it has signed a licensing agreement with a South Korea-based company, BL & H Co., Ltd., which is mainly engaged in the development and sales of medical drugs for cancer. The agreement is regarding the distribution of a therapeutic drug for Acute Promyelocytic Leukemia (APL). The Company has been distributing the drug in Japan since December 2002. Upon the signing of the agreement, the Company will receive a contract fee, as well as milestone payment based on the development of the drug, from BL & H.