SAKIGAKE Designation System

Daiichi Sankyo Company, Limited (Daiichi Sankyo) announced that the oncolytic virus therapy for cancer (G47?) jointly developed with Dr. Tomoki Todo, a professor at the University of Tokyo’s Institute of Medical Science, has been designated under the SAKIGAKE Designation System for medical equipment and in vitro diagnostic pharmaceuticals and regenerative medicine products, which was launched this year.

Professor Todo initiated the GCP based second-phase G47? clinical trial targeting glioblastoma in 2015. G47? has performed well in the study, and non-clinical researches and clinical researches for other carcinomas have already begun. Based on data obtained thus far, it has also been suggested that there is a possibility of expanding indications to other types of cancer. In the future, Daiichi Sankyo intends to collaborate with Professor Todo on the further development of this cancer treatment method.

Daiichi Sankyo remains committed to meeting the needs of more patients and medical professionals through drug development and contributing to medical care by providing new treatment options.

AstraZeneca, Daiichi Sankyo to jointly commercialise Movantik in US

AstraZeneca announced a co-commercialisation agreement with Daiichi Sankyo, Inc. for Movantik (naloxegol) in the US, in line with the Company’s strategy of delivering value through its own development and commercial capabilities as well as through external collaboration. Movantik is a first-in-class once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain.

Movantik was approved by the US Food and Drug Administration in September 2014. It was descheduled by the US Drug Enforcement Administration in January 2015 and is no longer labelled as a controlled substance. The launch of Movantik in the US is planned for early April 2015.

Under the terms of the agreement, Daiichi Sankyo Inc. will pay a $200 million up-front fee and subsequent sales-related payments of up to $625 million. AstraZeneca will be responsible for manufacturing, will book all sales and will make sales-related commission payments to Daiichi Sankyo, Inc. Both companies will be jointly responsible for commercial activities. AstraZeneca’s 2015 financial guidance, provided on 6 March 2015, is unaffected by today’s announcement.

Paul Hudson, president, AstraZeneca US and executive vice president, North America, said: “We are delighted to collaborate with Daiichi Sankyo to expand our commercialisation efforts in the US in order to get this important medicine to the large number of patients suffering with opioid-induced constipation. Our agreement reflects our evolving business model by creating value from our portfolio through externalisation activity. Together, we will grow the potential of this important treatment, while we retain our significant interest in the long-term commercial success of Movantik in our largest market.”

Daiichi Sankyo receives Japanese approval for methylene blue injection 50 mg

Daiichi Sankyo Company,  a global pharmaceutical company,  has received approval in Japan for the manufacture and marketing of the methemoglobinemia treatment, methylene blue injection 50 mg (methylthioninium chloride hydrate) for toxic methemoglobinemia.

Toxic methemoglobinemia is a toxic disorder in which the methemoglobin concentration in the blood is elevated due to various substances found in drugs, pesticides, etc., causing symptoms such as cyanosis, headache, dizziness, shortness of breath, and loss of consciousness.

Methylene blue is one of the agents publicly offered for development by the Review Committee on Unapproved Drugs and Indications with High Medical Needs), set up by the Ministry of Health, Labour and Welfare (MHLW). Daiichi Sankyo acquired sole development and marketing rights for Japan from Provepharm SAS before developing Methylene Blue. In March 2014, Daiichi Sankyo filed an NDA for the manufacture and marketing in Japan for the indication. Daiichi Sankyo received a grant from Pharmaceutical Development Support Center for the development.

In order to collect data on both the safety and efficacy of Methylene Blue, Daiichi Sankyo will conduct a drug use-results survey covering all patients treated with the product during a certain period following its launch.