07.21.14
Headquarters: Tokyo, Japan
twitter: @AstellasUS
www.astellas.com
TOP SELLING DRUGS
Astellas, Japan’s second largest pharma company based on revenues, maintains its post. While still overcoming the patent cliff for certain mainstay products, namely Lipitor, Prograf sales remain steady despite generic competition, flagship product sales were steady, and several promising advances in its pipeline hold potential.
It was a big year for Astellas’ oncology efforts with the launch of XTANDI for the treatment of prostate cancer in the U.S. and subsequent launch in the UK in July 2013, marking a major milestone in establishing an oncology franchise, behind urology and transplantation. XTANDI, with sales reaching an impressive $531 million for the fiscal year, is well positioned to grab the market share from J&J’s Zytiga, which had $1.7 billion in 2013 sales. Further success appears to be imminent, as Astellas and its development partner, Medivation, have pending indications, including earlier-stage prostate cancer and treatment naïve patients, with the EU recently recommending approval, and the FDA granting Priority Review designation.
Launched in FY12, overactive bladder (OAB) treatment Myrbetriq is the driving force behind the company’s urology franchise, with sales reaching $274.3 million in FY13, up 306%. Using a distinct mechanism of action versus anticholinergics, such as Vesicare, Myrbetriq is fast becoming another treatment option. Vesicare also performed well, with sale up 24% in the Americas, 42% in Europe, 30% in Asia and Oceania, and in Japan expanded steadily, up 3%. The company continues to tap into the OAB treatment market by raising public awareness of the condition, despite the ongoing gradual decline in the OAB market size.
In addition to stable growth in transplantation, flagship Prograf saw steady sales increases for treating autoimmune diseases, including rheumatoid arthritis (RA), lupus nephritis, myasthenia gravis, and ulcerative colitis. The RA indication now accounts for nearly half of Prograf sales in Japan. Although sales in the Americas were down 6%, sales in Europe were up 24%, and the once-daily formulation Advagraf, was up 35%, while Asia and Oceania and Japan sales were up 32% and 2%, respectively.
In its pursuit of sustainable growth, the company has taken on a series of initiatives to transform its business structure, resulting in several organizational and personnel changes. Measures to reform its research framework include closing its Kashima facility in Osaka in fiscal 2015, and closing or scaling back research units in the U.S., including OSI Pharmaceuticals and Astellas Research Institute of America.
Instead, Astellas is investing in the recently established a Regenerative Medicine Unit that will specialize in a research platform for regenerative medicine and cell therapies, as well as the Astellas Innovation Management (AIM), established to enhance and accelerate the process of screening and acquiring external opportunities during preclinical development. Additionally, based on a series of recent management decisions, Astellas transferred its fermentation research-related assets to Taiho Pharmaceutical, reallocating those R&D resources with the goal of generating innovative drugs.
Also part of ongoing efforts to achieve operational excellence, Astellas inked an agreement with Accenture for the business process outsourcing of multiple business areas and its domestic subsidiaries. And, this past February, reorganized its top management structure, deciding that all heads of global development, regulatory affairs, clinical and research quality assurance, will now report to the chief medical officer.
In the way of pipeline progress, Astellas’ SGLT2 inhibitor Suglat Tablets became available for type 2 diabetes in Japan in April. Suglat, discovered through a research collaboration with Kotobuki Pharmaceutical, reduces blood glucose levels by inhibiting SGLT2 and the reuptake of glucose—the first of its kind approved for type 2 diabetes in Japan.
Astellas and FibroGen initiated a Phase II study of ASP1517/FG-4592 for the treatment of anemia associated with chronic kidney disease (CKD) in patients on dialysis. This orally administered small molecule inhibitor of hypoxia-inducible factor prolyl hydroxylase (HIF-PHI), is among the most clinically advanced candidate in this new class of potential anemia therapies.
Additionally, Astellas and Vical initiated a Phase III trial of ASP0113 (TransVax) in approximately 500 hematopoietic cell transplant (HCT) recipients, making it the first investigational Cytomegalovirus (CMV) vaccine to reach Phase III testing. It’s also being studied in solid organ transplant recipients.
Among several notable collaborative efforts, Astellas and ClearPath entered a strategic pact to form a portfolio of development companies focused on vaccines that target infectious diseases. This partnership supports Astellas’ goal of building a global vaccine franchise and the launch of its first company, RSV Corp. in December 2013, which will fund the development of a virosome vaccine technology licensed from Mymetics Corp. for respiratory syncytial virus (RSV).
Other R&D ventures include collaborations with Mitokyne, focused on developing drugs that improve mitochondrial functions to potentially treat genetic, metabolic or neurodegenerative disorders, as well as conditions of aging, and another with Cytokinetics for the development of skeletal muscle activators for diseases and medical conditions associated with muscle weakness.
With these agreements, Astellas has the exclusive right to acquire Mitokyne during the term of their five–year agreement. Including upfront, R&D funding, acquisition and milestone payments, the total value of the partnership could reach as much as $730 million. In the Cytokinetics alliance, Astellas will have the exclusive rights to develop and commercialize drug candidates, including CK-2127107, a fast skeletal troponin activator drug currently in Phase II trials.
So far, the company’s 2014 mid-term management plan, dating back to 2010, has accomplished several milestones related to therapeutic and R&D innovation aspirations. Gaining approval of XTANDI certainly places them closer to their oncology category leader goal. Additionally, should several key portfolio assets meet with success, Astellas might achieve its plan to become a global category leader in immunology and infectious disease, neuroscience, diabetes complications, and kidney disease.
twitter: @AstellasUS
www.astellas.com
Headcount: | 17,454 | |
Year Established: | 2005 | |
Pharma Reveneus: | $11,086 | 16% |
Total Revenues: | $11,086 | 16% |
Net Income: | $884 | -2% |
R&D Budget: | $1,862 | 20% |
TOP SELLING DRUGS
Drug | Indication | 2013 Sales | (+/- %) |
Prograf | transplantation | $1,764 | 12% |
Vesicare | overactive bladder | $1,319 | 23% |
Micardis | hypertention | $1,035 | 5% |
Liptor | cholesterol | $662 | -22% |
Harnal/Omnic | BPH | $632 | 10% |
Celecox | anti-inflamatory | $470 | 4% |
Astellas, Japan’s second largest pharma company based on revenues, maintains its post. While still overcoming the patent cliff for certain mainstay products, namely Lipitor, Prograf sales remain steady despite generic competition, flagship product sales were steady, and several promising advances in its pipeline hold potential.
It was a big year for Astellas’ oncology efforts with the launch of XTANDI for the treatment of prostate cancer in the U.S. and subsequent launch in the UK in July 2013, marking a major milestone in establishing an oncology franchise, behind urology and transplantation. XTANDI, with sales reaching an impressive $531 million for the fiscal year, is well positioned to grab the market share from J&J’s Zytiga, which had $1.7 billion in 2013 sales. Further success appears to be imminent, as Astellas and its development partner, Medivation, have pending indications, including earlier-stage prostate cancer and treatment naïve patients, with the EU recently recommending approval, and the FDA granting Priority Review designation.
Launched in FY12, overactive bladder (OAB) treatment Myrbetriq is the driving force behind the company’s urology franchise, with sales reaching $274.3 million in FY13, up 306%. Using a distinct mechanism of action versus anticholinergics, such as Vesicare, Myrbetriq is fast becoming another treatment option. Vesicare also performed well, with sale up 24% in the Americas, 42% in Europe, 30% in Asia and Oceania, and in Japan expanded steadily, up 3%. The company continues to tap into the OAB treatment market by raising public awareness of the condition, despite the ongoing gradual decline in the OAB market size.
In addition to stable growth in transplantation, flagship Prograf saw steady sales increases for treating autoimmune diseases, including rheumatoid arthritis (RA), lupus nephritis, myasthenia gravis, and ulcerative colitis. The RA indication now accounts for nearly half of Prograf sales in Japan. Although sales in the Americas were down 6%, sales in Europe were up 24%, and the once-daily formulation Advagraf, was up 35%, while Asia and Oceania and Japan sales were up 32% and 2%, respectively.
In its pursuit of sustainable growth, the company has taken on a series of initiatives to transform its business structure, resulting in several organizational and personnel changes. Measures to reform its research framework include closing its Kashima facility in Osaka in fiscal 2015, and closing or scaling back research units in the U.S., including OSI Pharmaceuticals and Astellas Research Institute of America.
Instead, Astellas is investing in the recently established a Regenerative Medicine Unit that will specialize in a research platform for regenerative medicine and cell therapies, as well as the Astellas Innovation Management (AIM), established to enhance and accelerate the process of screening and acquiring external opportunities during preclinical development. Additionally, based on a series of recent management decisions, Astellas transferred its fermentation research-related assets to Taiho Pharmaceutical, reallocating those R&D resources with the goal of generating innovative drugs.
Also part of ongoing efforts to achieve operational excellence, Astellas inked an agreement with Accenture for the business process outsourcing of multiple business areas and its domestic subsidiaries. And, this past February, reorganized its top management structure, deciding that all heads of global development, regulatory affairs, clinical and research quality assurance, will now report to the chief medical officer.
In the way of pipeline progress, Astellas’ SGLT2 inhibitor Suglat Tablets became available for type 2 diabetes in Japan in April. Suglat, discovered through a research collaboration with Kotobuki Pharmaceutical, reduces blood glucose levels by inhibiting SGLT2 and the reuptake of glucose—the first of its kind approved for type 2 diabetes in Japan.
Astellas and FibroGen initiated a Phase II study of ASP1517/FG-4592 for the treatment of anemia associated with chronic kidney disease (CKD) in patients on dialysis. This orally administered small molecule inhibitor of hypoxia-inducible factor prolyl hydroxylase (HIF-PHI), is among the most clinically advanced candidate in this new class of potential anemia therapies.
Additionally, Astellas and Vical initiated a Phase III trial of ASP0113 (TransVax) in approximately 500 hematopoietic cell transplant (HCT) recipients, making it the first investigational Cytomegalovirus (CMV) vaccine to reach Phase III testing. It’s also being studied in solid organ transplant recipients.
Among several notable collaborative efforts, Astellas and ClearPath entered a strategic pact to form a portfolio of development companies focused on vaccines that target infectious diseases. This partnership supports Astellas’ goal of building a global vaccine franchise and the launch of its first company, RSV Corp. in December 2013, which will fund the development of a virosome vaccine technology licensed from Mymetics Corp. for respiratory syncytial virus (RSV).
Other R&D ventures include collaborations with Mitokyne, focused on developing drugs that improve mitochondrial functions to potentially treat genetic, metabolic or neurodegenerative disorders, as well as conditions of aging, and another with Cytokinetics for the development of skeletal muscle activators for diseases and medical conditions associated with muscle weakness.
With these agreements, Astellas has the exclusive right to acquire Mitokyne during the term of their five–year agreement. Including upfront, R&D funding, acquisition and milestone payments, the total value of the partnership could reach as much as $730 million. In the Cytokinetics alliance, Astellas will have the exclusive rights to develop and commercialize drug candidates, including CK-2127107, a fast skeletal troponin activator drug currently in Phase II trials.
So far, the company’s 2014 mid-term management plan, dating back to 2010, has accomplished several milestones related to therapeutic and R&D innovation aspirations. Gaining approval of XTANDI certainly places them closer to their oncology category leader goal. Additionally, should several key portfolio assets meet with success, Astellas might achieve its plan to become a global category leader in immunology and infectious disease, neuroscience, diabetes complications, and kidney disease.