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.

On April 23, 2018 Pfizer Inc. (NYSE:PFE) reported that it received a Complete Response Letter (CRL) from the United States Food and Drug Administration (FDA) in response to the Biologics License Application for the company’s proposed trastuzumab biosimilar (Press release, Pfizer, APR 23, 2018, View Source [SID1234525591]). In the CRL, the FDA highlighted the need for additional technical information. The additional requested information does not relate to safety or clinical data submitted in the application. Pfizer is working closely with the FDA to address the contents of the letter and remains committed to bringing this important medicine to patients in the U.S.

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Pfizer believes that biosimilars are critically important to the future of cancer care, with the potential to increase patient access to life-changing therapies that will help address the evolving needs of healthcare systems, patients, physicians and payers.

Pfizer Inc.: Working together for a healthier world

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE: The information contained in this release is as of April 23, 2018. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about Pfizer’s proposed trastuzumab biosimilar, including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated trial commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; uncertainties regarding the company’s ability to address the comments in the complete response letter to the satisfaction of the FDA; whether and when any applications for Pfizer’s proposed trastuzumab biosimilar may be filed with regulatory authorities in any other jurisdictions; whether and when the FDA may approve the biologics license application for Pfizer’s proposed trastuzumab biosimilar and whether and when regulatory authorities in any other jurisdictions may approve any such other applications that are pending or that may be filed for Pfizer’s proposed trastuzumab biosimilar, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted and, if approved, whether Pfizer’s proposed trastuzumab biosimilar will be commercially successful; intellectual property and/or litigation implications; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of Pfizer’s proposed trastuzumab biosimilar ; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 10-Q and Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.