Oncology Corporate Profile
Astellas Pharma US, Inc., is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Located in Deerfield, Illinois, the company serves as the headquarters for the Americas and employs more than 2,300 people. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.
|Tarceva«•||erlotinib||TARCEVA is a kinase inhibitor indicated for:|
_Ê¢ Maintenance treatment of patients with locally advanced or metastatic non-small cell lung
cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based fi rst-line
_Ê¢ Treatment of locally advanced or metastatic non-small cell lung cancer after failure of at least one
prior chemotherapy regimen.
_Ê¢ First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer,
in combination with gemcitabine.
|Xtandi«•||enzalutamide||XTANDI is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.|
View additional information on commercial products here »
|Brand / Product||Class||Area of Study||Phase||Partnership|
|erlotinib tablets||HER1/EGFR tyrosine kinase inhibitor||2nd line metastatic Non Small Cell Lung Cancer (NSCLC)||III||Genentech / Roche|
|gilteritinib / ASP2215||tyrosine kinase inhibitor||Acute Myelogenous Leukemia (AML)||III|
|gilteritinib / ASP2215||FLT3 tyrosine kinase inhibitor||Acute Myelogenous Leukemia (AML)||III|
|OSI-906||dual IGF-1R and IR tyrosine kinase inhibitor||Adrenocortical carcinoma (ACC)||III||OSI Pharmaceuticals|
|erlotinib tablets||HER1/EGFR tyrosine kinase inhibitor||Colorectal cancer||III||Genentech / Roche|
|enzalutamide / MDV3100||androgen receptor inhibitor||Metastatic hormone-sensitive Prostate cancer||III|
|ASP8273||EGFR receptor||Non Small Cell Lung Cancer (NSCLC)||III|
|enzalutamide / MDV3100||androgen receptor inhibitor||Non-metastatic castration-resistant Prostate cancer||III|
|erlotinib tablets||HER1/EGFR tyrosine kinase inhibitor||Ovarian cancer||III||Genentech / Roche|
|ASP3550||GnRH antagonist||Prostate cancer||III|
|enzalutamide / MDV3100||androgen receptor inhibitor||Prostate cancer in patients with non-metastatic biochemical recurrence||III|
|enzalutamide / MDV3100||androgen receptor inhibitor||Triple negative Breast cancer||III|
|YM155||survivin suppressant||1st line metastatic Breast cancer||II|
|OSI-906||dual IGF-1R and IR tyrosine kinase inhibitor||1st line metastatic Hepatocellular carcinoma (HCC)||II||OSI Pharmaceuticals|
|AGS-1C4D4||anti-PSCA monoclonal antibody (humanized)||1st line metastatic Pancreatic cancer||II|
|quizartinib / AC220||FLT3 tyrosine kinase inhibitor||2nd line metastatic Acute Myelogenous Leukemia (AML)||II||Ambit Biosciences Inc.|
|blinatumomab / AMG 103||anti-CD19 monoclonal antibody||Acute Lymphocytic Leukemia (ALL)||II|
|YM155||survivin suppressant||B-cell Non-Hodgkin's Lymphoma (NHL)||II|
|enzalutamide / MDV3100||androgen receptor inhibitor||Breast cancer||II|
|enzalutamide / MDV3100||androgen receptor inhibitor||Hepatocellular carcinoma (HCC)||II|
|OSI-906||dual IGF-1R and IR tyrosine kinase inhibitor||Non Small Cell Lung Cancer (NSCLC)||II||OSI Pharmaceuticals|
|OSI-906||dual IGF-1R and IR tyrosine kinase inhibitor||Ovarian cancer||II||OSI Pharmaceuticals|
|AGS-16C3F||antibody drug conjugate (ADC)||Renal cell carcinoma (RCC)||II|
|enfortumab vedotin / ASG-22ME||antibody drug conjugate (ADC)||Urothelial cancer||II|
|erlotinib tablets||HER1/EGFR tyrosine kinase inhibitor||Various cancer types||II||Genentech / Roche|
|Xtandi_ / enzalutamide (formerly MDV3100)||oral androgen receptor antagonist||Breast cancer||II||Medivation|
|quizartinib (+ chemotherapy) / AC220||FLT3 tyrosine kinase inhibitor||1st line metastatic Acute Myelogenous Leukemia (AML)||I||Ambit Biosciences Inc.|
|AGS-16M8F||antibody drug conjugate (ADC)||1st line metastatic Renal cell carcinoma (RCC)||I|
|quizartinib / AC220||FLT3 tyrosine kinase inhibitor||Acute Myelogenous Leukemia (AML)||I||Ambit Biosciences Inc.|
|ASG-5ME||antibody drug conjugate (ADC)||Castrate-resistant Prostate cancer (CRPC)||I||Seattle Genetics|
|ASG-5ME||antibody drug conjugate (ADC)||Pancreatic cancer||I||Seattle Genetics|
|ASP3026||ALK inhibitor||Various cancer types||I|
|OSI-027||mTOR inhibitor||Various cancer types||I||OSI Pharmaceuticals|
|OSI-930||VEGFR-2 inhibitor||Various cancer types||I|
|Xtandi_ / enzalutamide||oral androgen receptor antagonist||Hepatocellular carcinoma (HCC)||I|
|enzalutamide / MDV3100||androgen receptor inhibitor||Metastatic castration-resistant Prostate cancer||Approved|
View additional information on product candidates here »
2/28/2017 10:00 am
[Business Wire] - CAMBRIDGE, Mass. & TOKYO--(BUSINESSWIRE)-- Affinivax, Inc. ("Affinivax") and Astellas Pharma Inc. ("Astellas") today announced they have entered into an exclusive worldwide license agreement to develop and commercialize a vaccine targeting Streptococcus pneumoniae (pneumococcus). The partnership will utilize Affinivax’s proprietary vaccine technology platform – Multiple Antigen Presenting System (MAPS) – to advance a novel MAPS vaccine targeted to prevent and reduce the spread of pneumococcal disease. “I am pleased to enter into this agreement and partner with Affinivax to develop a pneumococcal vaccine using their novel MAPS technology.” said Kenji Yasukawa, Ph.D., Senior Vice President and Chief Strategy Officer of Astellas.
2/14/2017 07:02 pm
2/8/2017 02:02 pm
1/31/2017 03:00 am
[Business Wire] - TOKYO--(BUSINESSWIRE)-- Astellas Pharma Inc. (TOKYO: 4503) (President and CEO: Yoshihiko Hatanaka, “Astellas”) today announced financial results for three quarters of fiscal year 2016 ending March 31, ...
1/30/2017 05:05 pm
1/30/2017 12:03 pm
1/30/2017 12:00 am
[Business Wire] - TOKYO & CAMBRIDGE, Mass.--(BUSINESSWIRE)-- Astellas Pharma Inc. (TSE:4503) and Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD - News) announced today top-line results indicating that the Phase III clinical trial of linaclotide conducted in Japan in adults with chronic constipation (CC) met its primary endpoint. Linaclotide is approved in Japan as the first prescription treatment for adults with irritable bowel syndrome with constipation (IBS-C).
1/20/2017 05:04 pm
12/21/2016 07:00 pm
[PR Newswire] - NORTHBROOK, Ill., Dec. 21, 2016 /PRNewswire/ -- Astellas US, LLC, a subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), today announced that the company's global President and CEO Yoshihiko Hatanaka will ...
12/21/2016 02:00 pm
[PR Newswire] - TOKYO, Dec. 21, 2016 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas" ) today announced that it has completed the acquisition of Ganymed Pharmaceuticals AG ("Ganymed"), a biopharmaceutical company located in Mainz, Germany, and Ganymed has become a wholly owned subsidiary of Astellas as of CET December 20, 2016. Under the agreement executed between Astellas and Ganymed's shareholders, Astellas paid EUR 422 million to acquire 100% of the equity in Ganymed.
12/20/2016 01:00 pm
12/19/2016 05:05 pm
12/19/2016 11:00 am
[Business Wire] - CAMBRIDGE, Mass.--(BUSINESSWIRE)-- Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD - News) today announced that its partner, Astellas Pharma Inc., secured marketing approval from the Japanese Ministry of Health, Labor and Welfare for LINZESS as the first prescription treatment for adults with irritable bowel syndrome with constipation (IBS-C) in Japan. Ironwood anticipates that Astellas will launch the drug in the first half of 2017. Linaclotide is a guanylate cyclase?C (GC?C) receptor agonist currently approved and available for the treatment of adults with IBS-C or chronic idiopathic constipation (CIC) in the United States and more than 30 other countries.
12/14/2016 09:01 pm
[Business Wire] - NEW YORK & TOKYO--(BUSINESSWIRE)-- Pfizer Inc. (NYSE:PFE - News) and Astellas Pharma Inc. (TSE:4503) today announced the Phase 4 PLATO study, evaluating the efficacy and safety of continued treatment with XTANDI® (enzalutamide), plus abiraterone acetate and prednisone as compared to treatment with abiraterone acetate and prednisone alone, did not meet its primary endpoint of improvement in progression-free survival (PFS) in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (CRPC) whose prostate-specific antigen (PSA) has previously progressed on XTANDI. “While the PLATO trial did not meet its primary endpoint, it is critical that we continue to focus on addressing the unmet needs of men with metastatic CRPC, who have a poor prognosis despite treatment advances,” said Mohammad Hirmand, M.D., interim chief medical officer at Medivation, Inc., which is now part of Pfizer.
12/8/2016 07:01 pm
12/8/2016 03:03 am
[Business Wire] - TOKYO--(BUSINESSWIRE)-- Astellas Pharma Inc. (Tokyo: 4503, President and CEO: Yoshihiko Hatanaka, “the Company”) announced that it is holding a research and development (R&D) meeting for securities analysts, institutional investors and the press today on December 8, 2016. Also, the daily advances in scientific innovation represent new opportunities for Astellas. Against the social issue of expanding healthcare cost, Astellas conducts proactive efforts to achieve a balance between patients’ access to medicines and innovation as a pharmaceutical company.” said Yoshihiko Hatanaka, President and CEO of Astellas.
11/14/2016 01:02 pm
11/8/2016 09:01 pm
[PR Newswire] - TOKYO and CHICAGO, Nov. 8, 2016 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, collectively with its subsidiaries "Astellas"), Donate Life America and the World Transplant Games Federation today announced that Astellas and Donate Life America registered thousands of new organ donors and tripled the previous GUINNESS WORLD RECORDS™ title for online organ donor registrations in an eight-hour period. During the same day, a record crowd for a rugby match held in America joined as Astellas provided a $175,000 USD contribution to the World Transplant Games Federation during a halftime celebration featuring transplant recipients from around the world.
11/7/2016 01:03 pm
11/3/2016 03:05 pm
11/2/2016 01:04 pm
10/28/2016 07:04 pm
10/28/2016 01:00 pm
[PR Newswire] - TOKYO and MAINZ, Germany, Oct. 28, 2016 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") and Ganymed Pharmaceuticals AG (CEO; Özlem Türeci, ...
10/28/2016 12:15 pm
(Astellas) Oct 28, 2016 - Astellas Pharma Inc. and Ganymed Pharmaceuticals AG, a biopharmaceutical company located in Mainz, Germany which focuses on the development of antibodies against cancer, announced today that Astellas and Ganymed's shareholders have entered into an agreement for Astellas to acquire Ganymed. The transaction would enable Astellas to continue to build upon its leading oncology franchise as a platform for sustainable growth.
10/21/2016 03:05 pm
[PR Newswire] - TOKYO and NEW YORK, Oct. 21, 2016 /PRNewswire/ -- Astellas Pharma Inc. (TSE:4503) and Pfizer Inc. (PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to update the U.S. product labeling for XTANDI® (enzalutamide) capsules to include new clinical data versus bicalutamide from the TERRAIN study. The data demonstrate improvement in radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (CRPC) who were treated with enzalutamide compared to patients who were treated with bicalutamide.