07.17.13
2-3-11, Nihonbashi-Honcho 2-chome, Chuo-ku
Tokyo, Japan 103-8411
Tel: (81) 3 3244 3000
Fax: (81) 3 3244 3272
www.astellas.com
Top Selling Drugs
Account for 52% of total pharma sales, down from 54% in 2011
Astellas maintains a stronghold through its transplantation/immunology and urology franchises. With only mild declines, its immunosuppressant Prograf continues to provide steady revenues despite generic competition in the U.S. Part of the reason is that these drugs are often taken long-term and generics are not as sought after in transplantation as with other therapeutic areas. In Europe, Prograf sales are steady thanks to an exclusive once-daily injectable, while continued sales growth is expected in Japan and Asia. In the meantime, Astellas has several clinical-stage drug candidates in clinical development, including ASP015K (to treat rheumatoid arthritis, etc.), ASKP1240 (prevention of organ transplant rejection), and Diannexin (prevention of delayed graft function in kidney transplantation).
In the overactive bladder space (OAB), Vesicare is the leading treatment in Japan, the U.S., and Europe. Thwarting impending declines with Vesicare’s first patent expiry in 2015, newly approved Myrbetriq, which offers a different mechanism of action to treat OAB, will likely pick up any slack. Myrbetriq became available in the U.S. in late October 2012. This should provide plenty of time to implement its strategy of launching a new-generation drug to supplement the one heading toward expiry, and moving patients over to the newer therapy.
As parts of its 2014 MTP strategy, Astellas is striving to become a global category leader in a third therapeutic area, oncology. A step towards realizing this goal comes with the September 2012 FDA approval of XTANDI (enzalutamide), an androgen receptor inhibitor for the treatment of prostate cancer (developed in partnership with Medivation). On the not-so-bright side, this past May, the FDA Oncologic Drugs Advisory Committee (ODAC) voted that the application for tivozanib did not demonstrate a favorable benefit/risk profile for the treatment of advanced renal cell carcinoma (RCC). While the FDA is not bound by the Committee’s guidance, its input will be considered in the review of the tivozanib, which is expected in late July.
Other oncologic efforts include the recent partnership with Ambrx for the discovery and development of novel antibody drug conjugates (ADCs), which allow for the targeted delivery of drugs. Astellas paid $15 million upfront, and will pay as much as $285 million in research, development, regulatory and sales milestones for an undisclosed number of oncology targets, which Astellas would have worldwide rights to develop and commercialize.
In May, president and CEO, Yoshihiko Hatanaka, announced plans to restructure its R&D framework. Initiatives include utilizing more external capabilities and resources, undertaking new therapeutic areas and technologies, including regenerative medicine and vaccines, and ensuring sufficient late-stage pipeline investment. Through the establishment of Astellas Innovation Management (AIM), the company aims to enhance external opportunities during the preclinical development stage, and consolidate research functions. These initiatives, scheduled during FY2013, involve reallocating resources by closing and scaling back U.S.-based research functions, some of which will transfer to the Tsukuba Research Center. OSI Pharmaceuticals will be closed, along with Perseid Therapeutics. Astellas Research Institute of America LLC will be scaled back to focus on CNS therapies. The losses related to these initiatives are approximately JPY 11 billion have been accounted for in the FY14 forecast.
As a strictly innovative drug firm, the company prides itself on its drug discovery capabilities and development portfolio, as well as a well-balanced business platform. If its OAB strategy works, Myrbetriq will make up for any losses Vesicare may suffer under pending expiry, steadying revenues as other oncology initiatives ranging from early to late-stage development candidates, progress.
Tokyo, Japan 103-8411
Tel: (81) 3 3244 3000
Fax: (81) 3 3244 3272
www.astellas.com
Headcount | 17,454 | |
Year Established | 2005 | |
Pharma Revenues | $12,168 | -1% |
Total Revenues | $12,168 | -1% |
Net Income | $1,002 | 1% |
R&D Budget | $2,202 | -9% |
Top Selling Drugs
Drug | Indication | $ | (+/- %) |
Prograf | transplantation | $1,957 | 0% |
Vesicare | bladder | $1,330 | 8% |
Micardis | hypertension | $1,084 | 0% |
Lipitor | cholesterol | $854 | -30% |
Harnal | BPH | $653 | -15% |
Celecox | anti-inflammatory | $453 | 8% |
Astellas maintains a stronghold through its transplantation/immunology and urology franchises. With only mild declines, its immunosuppressant Prograf continues to provide steady revenues despite generic competition in the U.S. Part of the reason is that these drugs are often taken long-term and generics are not as sought after in transplantation as with other therapeutic areas. In Europe, Prograf sales are steady thanks to an exclusive once-daily injectable, while continued sales growth is expected in Japan and Asia. In the meantime, Astellas has several clinical-stage drug candidates in clinical development, including ASP015K (to treat rheumatoid arthritis, etc.), ASKP1240 (prevention of organ transplant rejection), and Diannexin (prevention of delayed graft function in kidney transplantation).
In the overactive bladder space (OAB), Vesicare is the leading treatment in Japan, the U.S., and Europe. Thwarting impending declines with Vesicare’s first patent expiry in 2015, newly approved Myrbetriq, which offers a different mechanism of action to treat OAB, will likely pick up any slack. Myrbetriq became available in the U.S. in late October 2012. This should provide plenty of time to implement its strategy of launching a new-generation drug to supplement the one heading toward expiry, and moving patients over to the newer therapy.
As parts of its 2014 MTP strategy, Astellas is striving to become a global category leader in a third therapeutic area, oncology. A step towards realizing this goal comes with the September 2012 FDA approval of XTANDI (enzalutamide), an androgen receptor inhibitor for the treatment of prostate cancer (developed in partnership with Medivation). On the not-so-bright side, this past May, the FDA Oncologic Drugs Advisory Committee (ODAC) voted that the application for tivozanib did not demonstrate a favorable benefit/risk profile for the treatment of advanced renal cell carcinoma (RCC). While the FDA is not bound by the Committee’s guidance, its input will be considered in the review of the tivozanib, which is expected in late July.
Other oncologic efforts include the recent partnership with Ambrx for the discovery and development of novel antibody drug conjugates (ADCs), which allow for the targeted delivery of drugs. Astellas paid $15 million upfront, and will pay as much as $285 million in research, development, regulatory and sales milestones for an undisclosed number of oncology targets, which Astellas would have worldwide rights to develop and commercialize.
In May, president and CEO, Yoshihiko Hatanaka, announced plans to restructure its R&D framework. Initiatives include utilizing more external capabilities and resources, undertaking new therapeutic areas and technologies, including regenerative medicine and vaccines, and ensuring sufficient late-stage pipeline investment. Through the establishment of Astellas Innovation Management (AIM), the company aims to enhance external opportunities during the preclinical development stage, and consolidate research functions. These initiatives, scheduled during FY2013, involve reallocating resources by closing and scaling back U.S.-based research functions, some of which will transfer to the Tsukuba Research Center. OSI Pharmaceuticals will be closed, along with Perseid Therapeutics. Astellas Research Institute of America LLC will be scaled back to focus on CNS therapies. The losses related to these initiatives are approximately JPY 11 billion have been accounted for in the FY14 forecast.
As a strictly innovative drug firm, the company prides itself on its drug discovery capabilities and development portfolio, as well as a well-balanced business platform. If its OAB strategy works, Myrbetriq will make up for any losses Vesicare may suffer under pending expiry, steadying revenues as other oncology initiatives ranging from early to late-stage development candidates, progress.