On April 23, 2018 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas" ) reported that it submitted on March 23, 2018, a new drug application (NDA) for marketing approval of gilteritinib (generic name) in Japan for the treatment of adult patients with FLT3 mutation-positive (FLT3mut+) relapsed or refractory acute myeloid leukemia (AML) (Press release, Astellas Pharma US, APR 23, 2018, View Source [SID1234525608]). Astellas also submitted a NDA for approval of gilteritinib in the same patient population to the U.S. Food and Drug Administration (FDA) on March 29, 2018 (U.S. time) following the submission in Japan. The applications for marketing approval for gilteritinib are based on data from the ongoing pivotal Phase 3 ADMIRAL study investigating gilteritinib in adult patients with FLT3mut+ relapsed or refractory AML.

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Astellas is a pharmaceutical company dedicated to improving the health of people around the world. (PRNewsFoto/Astellas Pharma Inc.)

AML is a cancer that impacts the blood and bone marrow, and its incidence increases with age. In Japan, approximately 5,500 patients are diagnosed with AML each year1. Gilteritinib is an investigational compound that has demonstrated inhibitory activity against both internal tandem duplication (ITD) and tyrosine kinase domain (TKD), FLT3 mutations that are seen in approximately one-third of patients with AML.

In October 2015, the Japanese Ministry of Health, Labor and Welfare (MHLW) announced the selection of gilteritinib as one of the first products designated for SAKIGAKE2.

(1)

KantarHealth. TREATMENT ARCHITECTURE: JAPAN LEUKEMIA, ACUTE MYELOID. CancerMPact Japan, February 2017.

(2)

SAKIGAKE: SAKIGAKE designation system can shorten the review period with the following 3 approaches: 1) Prioritized Consultation, 2) Substantial Pre-application Consultation and 3) Prioritized Review.

And also, the system will help promote the development with the following 2 approaches: 4) Review Partner System (to be conducted by the Pharmaceuticals and Medical Devices Agency) and 5) Substantial Post-Marketing Safety Measures.

About Gilteritinib
Astellas is currently investigating gilteritinib in various FLT3 mutation-positive AML patient populations through several Phase 3 trials. Visit View Source to learn more about ongoing gilteritinib clinical trials.

Gilteritinib was discovered through a research collaboration with Kotobuki Pharmaceutical Co., Ltd., and Astellas has exclusive global rights to develop, manufacture and potentially commercialize gilteritinib. Gilteritinib has been granted Orphan Drug and Fast Track designation by the U.S. FDA, Orphan Drug Designation by the European Commission, and SAKIGAKE Designation and Orphan Drug Designation by the Japan Ministry of Health, Labor and Welfare.

About the ADMIRAL Study
The Phase 3 ADMIRAL trial is an open-label, multicenter, randomized study of gilteritinib versus salvage chemotherapy in adult patients with FLT3 mutations who are refractory to or have relapsed after first-line AML therapy. The co-primary endpoints of the trial are OS (Overall Survival) and CR (complete remission) / CRh (CR with partial hematological recovery) rate and the study is still ongoing. The study enrolled 371 patients with FLT3 mutations present in bone marrow or whole blood, as determined by central lab. Subjects have been randomized in a 2:1 ratio to receive gilteritinib (120 mg) or salvage chemotherapy.

On April 23, 2018 Alder Biopharmaceuticals, Inc., (NASDAQ:ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, reported that Eric Carter, Ph.D., M.D., has been named Interim Chief Medical Officer, effective immediately (Press release, Alder Biopharmaceuticals, 23 23, 2018, View Source [SID1234525596]). His primary responsibilities will include leading the Company through its ongoing Biologics License Application (BLA) submission process for eptinezumab, Alder’s lead investigational product candidate for migraine prevention, and facilitating other clinical and commercial advancement activities. He will report to Paul B. Cleveland, Interim President and Chief Executive Officer. Dr. Carter has served as a consultant to the Company since March 2018.

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Dr. Carter served as Senior Vice President, Chief Medical Officer and Global Head of Clinical & Non-Clinical Development of Allergan Inc. from 2011 to 2015, where he led the organization through 11 domestic and international drug candidate approvals and managed an annual budget of approximately $700 million. With more than 20 years of experience as a physician and as an executive in the pharmaceutical industry, Dr. Carter has overseen the introduction of new drug candidates into clinical development and practice, managed complex processes and global teams and provided support around key commercialization activities for numerous organizations. Dr. Carter currently serves as Chairman of the Scientific Advisory Board of Bioniz Therapeutics, a clinical-stage biopharmaceutical company, and serves on the Board of Directors of Adverum Biotechnologies, a public gene therapy company focused on rare diseases. Dr. Carter received his M.D. from the University of Miami School of Medicine and his Ph.D. in Biochemistry from the University of Cambridge in Cambridge, England.

"Our planned BLA submission for eptinezumab remains our top priority, and we are pleased to welcome Eric to the team as we advance towards commercialization," said Paul B. Cleveland. "Eric has a proven record of success with the clinical development and approval of major drug candidates, and we are confident Alder will benefit from his expertise and leadership during this important time."

"I’m excited to join Alder and lead eptinezumab’s clinical development program in support of the Company’s planned BLA submission," said Dr. Carter. "I look forward to working closely with the Alder team and the physician community as we progress eptinezumab towards approval, with an opportunity to provide a treatment option for millions of migraine sufferers debilitated by their disease."

On April 23, 2018 Verastem, Inc. (NASDAQ: VSTM), focused on developing and commercializing drugs to improve the survival and quality of life of cancer patients, reported that it will host an Analyst and Investor Day titled, "Duvelisib: Harnessing the Power of Dual PI3K Inhibition," on Wednesday, May 2, 2018 from 10:30 am – 1:00 pm ET in New York City (Press release, Verastem, APR 23, 2018, View Source;p=RssLanding&cat=news&id=2343842 [SID1234525595]).

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The agenda will include an in-depth discussion of the Company’s lead oral oncology candidate, duvelisib, including the unmet need of patients, where phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma inhibitors fit into the treatment paradigm and the opportunity for duvelisib in the growing chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and follicular lymphoma (FL) population and beyond.

The program will also feature key opinion leaders in the hematologic oncology field, including:

Jennifer Brown, MD, PhD
Associate Professor of Medicine, Harvard Medical School Director, and Director, CLL Center of the Division of Hematologic Malignancies, Dana-Farber Cancer Institute
Ian Flinn, MD, PhD
Director, Blood Cancer Research Program at Sarah Cannon Research Institute, and Lead Investigator of the DUO and DYNAMO Studies
Steven Horwitz, MD
Medical Oncologist, Memorial Sloan Kettering Cancer Center and NYC Health + Hospitals/Bellevue
Brian Koffman, MDCM, DCFP, FCFP, DABFP, MSEd
Physician, Medical Director of the Chronic Lymphocytic Leukemia (CLL) Society and CLL Patient
Lori Kunkel, MD
Oncology Drug Development Expert and Biotech Advisor, Member of the Board of Directors at Tocagen Inc., Former Chief Medical Officer, Pharmacyclics
Kindly reach out to Marianne Lambertson at [email protected] for any inquiries.

A live and archived webcast of the event will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at www.verastem.com. The webcast will be archived for a period of 90 days following the conclusion of the live event.

On April 23, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology Company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported a publication entitled, "Mechanisms and clinical activity of an EGFR and HER2 exon 20–selective kinase inhibitor in non–small cell lung cancer (Press release, Spectrum Pharmaceuticals, APR 23, 2018, View Source [SID1234525593])." The publication appears in the April 23, 2018 online issue at View Source and will be published in a future print issue of Nature Medicine.

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"We are honored to have data from poziotinib published in this prestigious journal," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "The excitement around poziotinib is palpable among the medical community. For cancer patients that have exon 20 mutations, physicians have very few options. The publication shows that poziotinib has a strong potential to be a promising therapy for such patients. We are collaborating with the medical community, regulatory agencies and corporate partners to expedite the rapid development of this drug."

The Nature Medicine publication summarizes the current preclinical and clinical data with poziotinib for EGFR and HER2 exon 20 mutations. MD Anderson utilized in silico, in vitro, and in vivo testing to model structural alterations induced by exon 20 mutations and identify potentially effective inhibitors. 3-D modeling indicated alterations restricted the size of the drug binding pocket, limiting the binding of large, rigid inhibitors. It was found that poziotinib, due to its small size and flexibility, can circumvent these steric changes, and is a potent inhibitor of the most common EGFR and HER2 exon 20 mutants. Poziotinib demonstrated greater activity than approved EGFR TKIs in vitro and in EGFR or HER2 exon 20 mutant patient-derived xenograft models, and genetically engineered mouse models of NSCLC.

According to the Nature Medicine publication, the first 11 NSCLC patients with EGFR exon 20 mutations receiving poziotinib in MD Anderson’s Phase 2 clinical trial had a confirmed objective response rate of 64%. At the time of the publication, the median progression-free survival had not been reached, with a median follow up of 6.6 months. 55% of patients received a dose reduction, with the two most common adverse events being known EGFR inhibitor-related toxicities: skin rash and diarrhea. At the World Conference on Lung Cancer in October 2017, MD Anderson presented that all of the 11 patients had a radiologic improvement in their disease, and 8 out of the 11 patients had a partial response (73% objective response rate). In the Nature Medicine publication it was reported that 7 out of those 11 patients had confirmed partial response (64% objective response rate).

The MD Anderson Phase 2 clinical trial is nearing completion of enrollment in the EGFR cohort, and the Spectrum Phase 2 study is enrolling at approximately 20 centers in the United States today, with further study center expansion in the U.S. and other countries in progress.

About Poziotinib

Poziotinib is a novel, Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. Spectrum received exclusive license to develop, manufacture, and commercialize worldwide excluding Korea and China from Hanmi Pharmaceuticals. Poziotinib is currently being investigated by Spectrum and Hanmi in several mid-stage trials in multiple solid tumor indications

On April 23, 2018 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported taht it will webcast management presentations as follows (Press release, Regeneron, APR 23, 2018, View Source [SID1234525592]):

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J.P. Morgan 2018 Spring Biotech Conference Call Series at 10:00 a.m. Eastern Time on Tuesday, May 8, 2018
Bank of America Merrill Lynch 2018 Healthcare Conference at 8:00 a.m. Pacific Time (11:00 a.m. Eastern Time) on Wednesday, May 16, 2018
Barclays 2018 Biopharmaceuticals CEO/CFO Conference Call Series at 11:00 a.m. Eastern Time on Friday, June 1, 2018
The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays of the conference calls and webcasts will be archived on the Company’s website and will be available for 30 days.