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 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 Eli Lilly and Company (LLY) and Incyte Corporation (INCY) reported that the U.S. Food and Drug Administration’s (FDA) Arthritis Advisory Committee recommended approval of the 2-mg dose of baricitinib, a once-daily oral medication for the treatment of moderately-to-severely active rheumatoid arthritis (RA) for adult patients who have had an inadequate response or intolerance to methotrexate (Press release, Incyte, APR 23, 2018, View Source [SID1234525686]). While the Advisory Committee unanimously supported the efficacy of the 4-mg dose of baricitinib, it did not recommend approval of the 4-mg dose of baricitinib for the proposed indication based on the adequacy of the safety and benefit-risk profiles.

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"We are confident that baricitinib, if approved, can help people in the U.S. manage the challenges of living with RA," said Christi Shaw, president of Lilly Bio-Medicines. "While we are disappointed with the Advisory Committee’s assessment of the data for the 4-mg dose, we are confident in the positive benefit-risk profile of both the 2-mg and the 4-mg doses. We look forward to continuing our work with the FDA on our New Drug Application (NDA) and are hopeful that baricitinib will receive approval in the coming months."

Baricitinib 2-mg and 4-mg doses are approved in more than 40 countries, including the member states of the European Union and Japan.

For both doses, the Advisory Committee voted to support the assessment that baricitinib’s data provide substantial evidence of efficacy. For the 2-mg dose, the Advisory Committee voted in favor of the assessment that baricitinib’s safety data adequately support its approval. For the 4-mg dose, the Advisory Committee voted against the assessment that baricitinib’s safety data was adequate to support its approval based on the proposed indication.

The Advisory Committee’s recommendation was based on baricitinib’s global development program, which included four completed Phase 3 studies. In total, 3,492 patients, who represented a range of treatment experiences, received baricitinib in the global RA development program. The Phase 3 studies evaluated baricitinib’s treatment impact related to RA signs and symptoms, physical function, joint damage progression and other patient-reported outcomes. The Phase 3 program also evaluated recognized risks for RA patients, including serious infection, malignancy, major adverse cardiovascular events (MACE), venous thromboembolism (VTE), and gastrointestinal perforations, along with key laboratory changes. The safety profile of baricitinib is based on 7,860 patient-years of exposure.

"Despite advances in the management of RA over the last 20 years, which include early treatment, optimized use of traditional therapies for rheumatic disease and the advent of newer medications such as biologics, many patients are still struggling to meet treatment targets, and live with debilitating pain, fatigue and other symptoms of RA," said Peter Taylor, MA, PhD, professor, University of Oxford, an expert who attended the Advisory Committee Meeting. "Baricitinib could be a promising option for RA patients in the U.S. who are not achieving adequate disease control with currently available treatments."

The FDA is not required to follow the Advisory Committee’s recommendation, but will consider it during its review of the NDA for baricitinib.

About Baricitinib
Baricitinib is a once-daily oral JAK inhibitor currently in clinical studies for inflammatory and autoimmune diseases. There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for the treatment of a broad range of inflammatory conditions, including rheumatoid arthritis.

In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases. Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., the European Union and Japan in 2016. Baricitinib was approved in the EU in February 2017 and in Japan in July 2017. In April 2017, the U.S. Food and Drug Administration issued a Complete Response Letter on the New Drug Application for baricitinib. To date, baricitinib has been approved in more than 40 countries and remains under review in several other markets.

On April 23, 2018 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY; NASDAQ: MOR) reported the closing of its initial public offering (IPO) in the United States (Press release, MorphoSys, APR 23, 2018, View Source [SID1234556334]). The offering comprised the sale of 2,075,000 new ordinary shares in the form of 8,300,000 American Depositary Shares ("ADSs") at a price of USD 25.04 per ADS. Each ADS represents 1/4 of a MorphoSys ordinary share.

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In addition, on April 23, 2018 the underwriters exercised in full an option granted by MorphoSys to purchase up to 311,250 additional new ordinary shares in the form of 1,245,000 additional ADSs at a price of USD 25.04 per ADS, representing 15% of the total number of ADSs placed in the offering. The closing of the purchase of the additional ADSs is expected to occur on April 30, 2018 and is subject to customary closing conditions.

In total, MorphoSys expects the gross proceeds of the transaction to amount to USD 239,006,800, comprising the base offering of 8,300,000 ADSs (USD 207,832,000) and, upon closing, the exercised option to purchase 1,245,000 additional ADSs (USD 31,174,800).

The new ordinary shares underlying the ADSs from the base offering were issued and the new ordinary shares underlying the additional ADSs in relation to the option to purchase will be issued from MorphoSys’s authorized capital 2017-II, excluding pre-emptive rights of existing shareholders and representing a total of 8.1% of the registered share capital of MorphoSys prior to the consummation of the offering.

MorphoSys’s ordinary shares are listed on the Frankfurt Stock Exchange under the symbol "MOR". The ADSs are listed on the Nasdaq Global Market under the symbol "MOR".

Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC and Leerink Partners LLC, acted as lead book-running managers, and Berenberg Capital Markets, LLC and JMP Securities LLC acted as co-managers for the ADS offering.

A Registration Statement relating to these securities was declared effective by the U.S. Securities and Exchange Commission on April 18, 2018.

Within the United States of America, the securities referred to in this release are offered only by means of a prospectus. A copy of the prospectus can be obtained from Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 1-212-902-9316 or by e-mailing [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 1-866-803-9204; Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6132, or by e-mailing [email protected].

This announcement does not constitute an offer to sell nor a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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.