07.21.14
Headquarters: Tokyo, Japan
www.daiichisankyo.com
Top Selling Drugs
While depreciation of the yen against the U.S. dollar and the euro played a role in generating growth for Daiichi in 2013, major products, including flagship antihypertensive agent olmesartan, antiplatelet agent prasugrel, ulcer treatment NEXIUM, and the Alzheimer’s disease treatment Memary, also contributed. Although Ranbaxy Group revenue grew, largely due to the offsetting effects of the 15-month accounting period, together with higher sales in emerging markets, Daiichi recorded an operating loss of ¥1.0 billion in FY13.
This past January, three days after the latest subpoena for Ranbaxy’s Toansa plant, Daiichi unloaded the troubled subsidiary via a share swap with Sun Pharmaceutical Industries of Mumbai, India, in a transaction valued at $4 billion and providing Daiichi with equity stake of approximately 9%. The combined company will be India’s largest pharmaceutical company and the world’s fifth-largest generic company with estimated annual revenue of $4.2 billion.
The FDA had prohibited Ranbaxy from selling drugs in the U.S. due to poor manufacturing practices, and from distributing any raw materials in the U.S. from its Toansa facility. Ranbaxy has five manufacturing facilities in India that are registered with the FDA: Paonta Sahib, Mohali, Toansa, Gurgaon and Dewas, all of which are now covered under the consent decree with the U.S. Department of Justice. After selling its controlling stake in Ranbaxy following struggles to turn the business around and posting a record full-year loss, Daiichi’s former chairman Takashi Shoda, who headed the acquisition of Ranbaxy as CEO in 2008, has stepped down.
R&D pipeline progression manifested itself in additional local indications for prasugrel in ischemic heart disease in patients undergoing percutaneous coronary intervention, and RANMARK (denosumab) for the treatment of giant cell tumor of the bone, making it the first fully human monoclonal antibody to target RANK Ligand, an essential mediator of osteoclast formation.
Additionally, a Phase III trial is currently proceeding in Japan to evaluate prasugrel in patients with ischemic stroke, and success here will further drive drug sales, which climbed 37% in FY13. Denosumab is proving to be a wise investment, with several potential cancer indications moving through development. Daiichi has been working on the drug since 2007, when it acquired the rights in Japan from Amgen, and subsequently launched in April 2012 for bone complications stemming from multiple myeloma and bone metastases.
New revenue contributors include Pralia, an osteoporosis treatment, which is also being investigated in Phase III studies in breast cancer and rheumatoid arthritis, and subsidiary Luitpold Pharmaceuticals gained FDA approval for Injectafer to treat iron deficiency anemia, a condition that afflicts 7.5 million people in the U.S.
Unfortunately, Daiichi decided to discontinue a Phase III study of Nimotuzumab in non-small cell lung cancer based on the recent recommendation of the Independent Data Monitoring Committee, which observed safety issues in certain patients. The company is also evaluating the drug in gastric cancer; only time will tell if success is possible with potential safety implications on the table.
Among early R&D efforts, Daiichi established several collaborations, forming a compound library partnership with Astellas, inclusive of 400,000 selected compounds, to utilize each other’s assets aimed at fostering open innovation. For a period of three years, both companies will be able to implement broad High Throughput Screening using the shared compounds without restrictions on targeted disease areas.
Also, early this year, Daiichi and UMN Pharma entered a research agreement for a norovirus vaccine. The virus, one of the leading causes of infectious gastroenteritis, has been infamously associated with cruise ships, as reported by the media, and is now popping up in schools and even hotels. UMN will provide a recombinant norovirus Virus-Like Particle (VLP) antigen and Daiichi will conduct research aimed at developing a vaccine. The companies will negotiate further upon meeting certain research criteria.
Daiichi also expanded its Take a New challenge for Drug diScovery (TaNeDS) Global Program, a drug discovery program with universities and research institutions based in Japan, to Germany, Switzerland and Austria, looking to work with innovative partners for research that could result in novel drug discovery candidates and new drugs, namely cancer, diabetes, and genetic disorders.
Additional early stage discovery efforts include an alliance with Sanfron-Burnham to develop therapeutics for cardio-vascular diseases, and with the University of California, San Francisco (UCSF) focused on molecular diagnostics for multiple neurodegenerative diseases.
With olmesartan losing patent protection beginning in 2016, and Nimotuzumab failing in Phase III lung cancer trials, Daiichi needs to move its assets closer to market. Pending studies for Prasugrel and Denosumab may prove vital in buying time for
future pipeline progress.
www.daiichisankyo.com
Headcount: | 32,000 | |
Year Established: | 2005 | |
Pharma Reveneus: | $10,881 | 12% |
Total Revenues: | $10,881 | 12% |
Net Income: | $639 | -5% |
R&D Budget: | $1,845 | 2% |
Top Selling Drugs
Drug | Indication | 2013 Sales | (+/- %) |
Olmesartan | hypertension | $2,919 | 16% |
Welchol | hypercholesterolemia | $422 | 6% |
Venofer | anemia | $248 | -13% |
Prasugrel | antiplatelet agent | $216 | 37% |
While depreciation of the yen against the U.S. dollar and the euro played a role in generating growth for Daiichi in 2013, major products, including flagship antihypertensive agent olmesartan, antiplatelet agent prasugrel, ulcer treatment NEXIUM, and the Alzheimer’s disease treatment Memary, also contributed. Although Ranbaxy Group revenue grew, largely due to the offsetting effects of the 15-month accounting period, together with higher sales in emerging markets, Daiichi recorded an operating loss of ¥1.0 billion in FY13.
This past January, three days after the latest subpoena for Ranbaxy’s Toansa plant, Daiichi unloaded the troubled subsidiary via a share swap with Sun Pharmaceutical Industries of Mumbai, India, in a transaction valued at $4 billion and providing Daiichi with equity stake of approximately 9%. The combined company will be India’s largest pharmaceutical company and the world’s fifth-largest generic company with estimated annual revenue of $4.2 billion.
The FDA had prohibited Ranbaxy from selling drugs in the U.S. due to poor manufacturing practices, and from distributing any raw materials in the U.S. from its Toansa facility. Ranbaxy has five manufacturing facilities in India that are registered with the FDA: Paonta Sahib, Mohali, Toansa, Gurgaon and Dewas, all of which are now covered under the consent decree with the U.S. Department of Justice. After selling its controlling stake in Ranbaxy following struggles to turn the business around and posting a record full-year loss, Daiichi’s former chairman Takashi Shoda, who headed the acquisition of Ranbaxy as CEO in 2008, has stepped down.
R&D pipeline progression manifested itself in additional local indications for prasugrel in ischemic heart disease in patients undergoing percutaneous coronary intervention, and RANMARK (denosumab) for the treatment of giant cell tumor of the bone, making it the first fully human monoclonal antibody to target RANK Ligand, an essential mediator of osteoclast formation.
Additionally, a Phase III trial is currently proceeding in Japan to evaluate prasugrel in patients with ischemic stroke, and success here will further drive drug sales, which climbed 37% in FY13. Denosumab is proving to be a wise investment, with several potential cancer indications moving through development. Daiichi has been working on the drug since 2007, when it acquired the rights in Japan from Amgen, and subsequently launched in April 2012 for bone complications stemming from multiple myeloma and bone metastases.
New revenue contributors include Pralia, an osteoporosis treatment, which is also being investigated in Phase III studies in breast cancer and rheumatoid arthritis, and subsidiary Luitpold Pharmaceuticals gained FDA approval for Injectafer to treat iron deficiency anemia, a condition that afflicts 7.5 million people in the U.S.
Unfortunately, Daiichi decided to discontinue a Phase III study of Nimotuzumab in non-small cell lung cancer based on the recent recommendation of the Independent Data Monitoring Committee, which observed safety issues in certain patients. The company is also evaluating the drug in gastric cancer; only time will tell if success is possible with potential safety implications on the table.
Among early R&D efforts, Daiichi established several collaborations, forming a compound library partnership with Astellas, inclusive of 400,000 selected compounds, to utilize each other’s assets aimed at fostering open innovation. For a period of three years, both companies will be able to implement broad High Throughput Screening using the shared compounds without restrictions on targeted disease areas.
Also, early this year, Daiichi and UMN Pharma entered a research agreement for a norovirus vaccine. The virus, one of the leading causes of infectious gastroenteritis, has been infamously associated with cruise ships, as reported by the media, and is now popping up in schools and even hotels. UMN will provide a recombinant norovirus Virus-Like Particle (VLP) antigen and Daiichi will conduct research aimed at developing a vaccine. The companies will negotiate further upon meeting certain research criteria.
Daiichi also expanded its Take a New challenge for Drug diScovery (TaNeDS) Global Program, a drug discovery program with universities and research institutions based in Japan, to Germany, Switzerland and Austria, looking to work with innovative partners for research that could result in novel drug discovery candidates and new drugs, namely cancer, diabetes, and genetic disorders.
Additional early stage discovery efforts include an alliance with Sanfron-Burnham to develop therapeutics for cardio-vascular diseases, and with the University of California, San Francisco (UCSF) focused on molecular diagnostics for multiple neurodegenerative diseases.
With olmesartan losing patent protection beginning in 2016, and Nimotuzumab failing in Phase III lung cancer trials, Daiichi needs to move its assets closer to market. Pending studies for Prasugrel and Denosumab may prove vital in buying time for
future pipeline progress.