On March 20, 2018 Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, reported that Paul B. Cleveland, a member of the Company’s Board of Directors, has been appointed to serve as Interim President and Chief Executive Officer, effective immediately. Mr. Cleveland will continue to serve as a director of the Company (Press release, , 20 20, 2018, View Source [SID1234524905]).

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Mr. Cleveland’s appointment follows the mutual determination by Randall C. Schatzman and the Board that now is the right time for Dr. Schatzman to step down as President, Chief Executive Officer and as a director. Dr. Schatzman has agreed to serve as a consultant to the Company for an interim period in order to help ensure a smooth transition. Alder has retained Russell Reynolds Associates, a leading executive search firm, to assist with identifying a permanent successor.

Mr. Cleveland has more than two decades of leadership experience with significant operational and financial expertise. He currently serves as the Chairman of the Board of Adverum Biotechnologies, Inc., where he previously served as the President and Chief Executive Officer. Prior to that, he was President and Chief Executive Officer of Celladon Corporation, where he previously served as that company’s Chief Financial Officer. Mr. Cleveland served as Executive Vice President, Corporate Strategy and Chief Financial Officer at Aragon Pharmaceuticals before its acquisition by Johnson & Johnson, and prior to Aragon, he was General Partner and Chief Operating Officer at Mohr Davidow Ventures and Executive Vice President, Corporate Development and Chief Financial Officer for Affymax. Mr. Cleveland was previously a Managing Director at J.P. Morgan Chase and Co. and a predecessor firm, Hambrecht & Quist, and a corporate lawyer at Cooley LLP, Sidley Austin LLP, and Davis Polk & Wardwell LLP.

"I joined the Alder Board in 2015 because of my deep appreciation of Alder’s mission to transform the treatment paradigm for migraine prevention," said Mr. Cleveland. "I look forward to leveraging my prior CEO and CFO experience in this interim role as we work to identify a permanent successor and further build out the team for the next stage of Alder’s growth and development. On behalf of the Board and the Alder team, I want to thank Randy for his immense dedication and invaluable contributions since co-founding the Company in 2004. Randy’s leadership has positioned Alder for continued growth as we advance towards the commercial launch of eptinezumab."

Dr. Schatzman said, "It has been an honor to lead Alder since co-founding the Company in 2004 and work with such a bright and passionate group of employees to change the lives of highly impacted episodic and chronic migraine patients. I am proud of all that we have accomplished at Alder during my tenure including the development of two late-stage therapeutic candidates, eptinezumab and clazakizumab, assembling a talented team of over 190 employees, the majority of which are scientists and drug developers, and positioning Alder to positively impact the lives of migraine sufferers. Now is the right time to pass the baton to the next generation of leadership. I am confident that Alder is well-placed to set a new standard for what can be achieved in migraine prevention to benefit patients and their families."

Mr. Cleveland concluded, "Alder has made tremendous progress over the last year. We achieved positive Phase 3 pivotal data for both episodic and chronic migraine patients, demonstrating that eptinezumab’s clinical profile is highly differentiated and consistently delivered predictable results for rapid, effective and sustained migraine prevention across the spectrum of migraine disease. We plan to share additional data from our PROMISE 1 and PROMISE 2 pivotal trials, and the results from our open-label safety study of eptinezumab, in the first half of this year. We also continue to expect our pharmacokinetic comparability study to be completed in the second half of 2018. In addition, through our recent IP settlement and licensing agreement with Teva, we now have a non-exclusive license to Teva’s CGRP patent portfolio, which, importantly, clarified our ability to develop, manufacture and commercialize eptinezumab in the U.S. and globally. The submission of our planned Biologics License Application (BLA) for eptinezumab is the top priority, and we continue to make progress on all key clinical data milestones, BLA and commercial preparedness activities, including our CMC and manufacturing initiatives. I look forward to reviewing these programs thoroughly in my new role and plan to provide a business update in connection with the announcement of our first quarter 2018 financial and operating results."

As of February 28, 2018, Alder had cash, cash equivalents, short-term investments and restricted cash totaling more than $600 million.

On March 20, 2018 -X4 Pharmaceuticals, a clinical stage biotechnology company developing novel CXCR4 inhibitor drugs to improve immune cell trafficking to treat cancer and rare disease, reported that the company will participate in two upcoming investor conferences (Press release, , 20 20, 2018, View Source [SID1234524907]):

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X4 Pharmaceuticals will participate in two conferences: BioCentury Future Leaders in the Biotech Industry Conf 3/23 and Needham Healthcare Conf 3/28.

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On Friday, March 23, at 3:00 p.m. ET, Paula Ragan, PhD, President and Chief Executive Officer, will present a company overview at BioCentury’s 25th Annual Future Leaders in the Biotech Industry Conference at the Millennium Broadway Hotel & Conference Center in New York, NY. A breakout session will follow the presentation at 3:30 p.m.

On Wednesday, March 28, at 11:00 a.m ET, Dr. Ragan will make a presentation on X4 at Needham & Company’s 17thAnnual Healthcare Conference at the Westin Grand Central in New York, NY.

Oncolytics Biotech has filed a 20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 20-F, Oncolytics Biotech, 2018, MAR 19, 2018, View Source [SID1234524879]).

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On March 19, 2018 Cellectar Biosciences (Nasdaq: CLRB), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that management will host a teleconference and live webcast to report financial results for the 12 months ended December 31, 2017 and to provide a business update on Thursday, March 22, 2018 at 8:30 AM ET (Press release, Cellectar Biosciences, MAR 19, 2018, View Source [SID1234524883]).

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Event Details

Interested investors may participate in the conference call by dialing 844-751-1093 (US domestic) or 574-990-2954 (international) and providing conference ID 6674595, or participate via webcast at View Source The live and archived webcast can be accessed via the company’s website at investor.cellectarbiosciences.com/events-and-presentations.

For those unable to participate in the live conference call or webcast, a replay will be available beginning March 22, 2018 two hours after the close of the conference call. To access the replay, dial 855-859-2056 or 404-537-3406. The replay passcode is 6674595.

On March 19, 2018 Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") reported that a supplemental New Drug Application (sNDA) for XTANDI (enzalutamide) has been accepted for filing and granted Priority Review designation by the U.S. Food and Drug Administration (FDA) (Press release, Astellas Pharma US, MAR 19, 2018, View Source [SID1234525408]). If approved, the sNDA would expand the indication of XTANDI to include men with non-metastatic Castration-Resistant Prostate Cancer (CRPC), based on data from the Phase 3 PROSPER trial. XTANDI is currently indicated for the treatment of patients with metastatic CRPC.

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The FDA grants Priority Review designation to applications for drugs that, if approved, may offer significant improvements in the safety and effectiveness of the treatment of serious conditions when compared to standard applications. Under Priority Review, the FDA aims to take action on an application within six months of receipt, as compared to ten months under standard review. The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA is July 2018. In addition, the European Medicines Agency (EMA) has validated the Type II Variation submitted for XTANDI seeking to expand the current indication to the same patient population and started the review process on March 5.
"Once cancer spreads and metastasizes, men with castration-resistant prostate cancer face a daunting prognosis and challenging odds," said Steven Benner, M.D., senior vice president and global therapeutic area head, Oncology Development, Astellas. "We’re pleased to see the FDA’s Priority Review designation as we work to potentially bring XTANDI to men living with non-metastatic CRPC."
"Treatment options have been limited for men with non-metastatic CRPC, in whom the only evidence of progressive disease is a rapidly rising PSA," said Mace Rothenberg, M.D., chief development officer, Oncology, Pfizer Global Product Development. "XTANDI is already established as a standard of care for men with metastatic CRPC. This milestone marks an important step toward our ability to bring XTANDI to CRPC patients in an earlier setting."
The PROSPER trial evaluated XTANDI plus androgen deprivation therapy (ADT) versus ADT alone in 1,401 patients with non-metastatic CRPC. The study met its primary endpoint, demonstrating that the use of XTANDI plus ADT significantly reduced the risk of developing metastasis or death compared to ADT alone. Adverse events in the PROSPER trial were higher in the enzalutamide plus ADT arm compared to ADT alone (87% vs. 77%), and were generally consistent with those reported in prior enzalutamide clinical trials in patients with metastatic CRPC. Results from the PROSPER trial were presented at the 2018 Genitourinary Cancers Symposium (ASCO GU) in February.1 For more information on the PROSPER trial, go to www.clinicaltrials.gov.

The FDA approved XTANDI in 2012 for the treatment of patients with metastatic CRPC who had previously received docetaxel. In 2014, the FDA approved XTANDI to treat patients with metastatic CRPC.

About Prostate Cancer
Prostate cancer is the second most common cancer in men worldwide.2 More than 164,000 men in the United States are estimated to be newly diagnosed with prostate cancer in 2018.3 In the European Union, the estimated number of new prostate cancer cases in 2015 was 365,000.4
Castration-resistant prostate cancer (CRPC) refers to the subset of men whose prostate cancer progresses despite castration levels of testosterone.5 Non-metastatic CRPC means there is no clinically detectable evidence of the cancer spreading to other parts of the body (metastases), and there is a rising prostate-specific antigen (PSA) level.6 Many men with non-metastatic CRPC and a rapidly rising PSA level go on to develop metastatic CRPC.7

About XTANDI (enzalutamide) capsules
XTANDI (enzalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-resistant prostate cancer.
Important Safety Information for XTANDI
Contraindications
XTANDI is not indicated for women. XTANDI can cause fetal harm and potential loss of pregnancy.

Warnings and Precautions
Seizure occurred in 0.5% of patients receiving XTANDI in clinical studies. In a study of patients with predisposing factors, seizures were reported in 2.2% of patients. See section 5.1 of the Prescribing Information for the list of predisposing factors. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Permanently discontinue XTANDI in patients who develop a seizure during treatment.
Posterior Reversible Encephalopathy Syndrome (PRES) In post approval use, there have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder which can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.

Adverse Reactions
The most common adverse reactions (≥10%) that occurred more commonly (≥2% over placebo) in the XTANDI patients from the two placebo-controlled clinical trials were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and dizziness/vertigo. In the bicalutamide-controlled study of chemotherapy-naïve patients, the most common adverse reactions (≥10%) reported in XTANDI patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, upper respiratory tract infection, diarrhea, and weight loss.
In the placebo-controlled study of patients taking XTANDI who previously received docetaxel, Grade 3 and higher adverse reactions were reported among 47% of XTANDI patients and 53% of placebo patients. Discontinuations due to adverse events were reported for 16% of XTANDI patients and 18% of placebo patients. In the placebo-controlled study of chemotherapy-naïve patients, Grade 3-4 adverse reactions were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to adverse events were reported for 6% of both study groups. In the bicalutamide-controlled study of chemotherapy-naïve patients, Grade 3-4 adverse reactions were reported in 38.8% of XTANDI patients and 37.6% of bicalutamide patients. Discontinuations due to adverse events were reported for 7.6% of XTANDI patients and 6.3% of bicalutamide patients.
Lab Abnormalities: In the two placebo-controlled trials, Grade 1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4) and 6% of placebo patients (0.5% Grade 3-4). Grade 1-4 thrombocytopenia occurred in 6% of XTANDI patients (0.3% Grade 3-4) and 5% of placebo patients (0.5% Grade 3-4). Grade 1-4 elevations in ALT occurred in 10% of XTANDI patients (0.2% Grade 3-4) and 16% of placebo patients (0.2% Grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of XTANDI patients (0.1% Grade 3-4) and 2% of placebo patients (no Grade 3-4).

Infections: In the study of patients taking XTANDI who previously received docetaxel, 1% of XTANDI patients compared to 0.3% of placebo patients died from infections or sepsis. In the study of chemotherapy-naïve patients, 1 patient in each treatment group (0.1%) had an infection resulting in death.
Falls (including fall-related injuries) occurred in 9% of XTANDI patients and 4% of placebo patients in the two placebo-controlled trials. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in XTANDI patients, and included non-pathologic fractures, joint injuries, and hematomas.
Hypertension occurred in 11% of XTANDI patients and 4% of placebo patients in the two placebo-controlled trials. No patients experienced hypertensive crisis. Medical history of hypertension was balanced between arms. Hypertension led to study discontinuation in <1% of patients in each arm.
Drug Interactions

Effect of Other Drugs on XTANDI Avoid strong CYP2C8 inhibitors, as they can increase the plasma exposure to XTANDI. If co-administration is necessary, reduce the dose of XTANDI.
Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. If co-administration is necessary, increase the dose of XTANDI.

Effect of XTANDI on Other Drugs Avoid CYP3A4, CYP2C9, and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring.

Please see Full Prescribing Information for additional safety information.
About the Enzalutamide Development Program
Pfizer and Astellas are collaborating on a comprehensive development program that includes studies of enzalutamide across the full spectrum of advanced prostate cancer. Ongoing studies of enzalutamide in prostate cancer include the ARCHES trial in metastatic hormone-sensitive prostate cancer and the EMBARK trial in non-metastatic hormone-sensitive prostate cancer