On October 24, 2018 Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that the Company expects to report financial results for the third quarter of 2018 after 5:00 p.m. ET on Tuesday, November 6, 2018 (Press release, Supernus, OCT 24, 2018, View Source [SID1234530634]).

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Jack Khattar, President and Chief Executive Officer, and Greg Patrick, Chief Financial Officer, will host a conference call to present the third quarter 2018 business results on Wednesday, November 7, 2018 at 9:00 a.m. ET. Following management’s prepared analysis and discussion of business results, the call will be open for questions.

A live webcast will be available at www.supernus.com.

Please refer to the information below for conference call dial-in information. Callers should dial in approximately 10 minutes prior to the start of the call.

Conference dial-in:

(877) 288-1043

International dial-in:

(970) 315-0267

Conference ID:

2697616

Conference Call Name:

Supernus Pharmaceuticals Third Quarter 2018 Earnings

Conference Call

Following the live call, a replay will be available on the Company’s website under the ‘Investors’ section. The webcast will be available on the Company’s website for 60 days following the live call.

On October 26, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported the acceptance by the China National Medical Products Administration (NMPA) of a new drug application (NDA) for zanubrutinib, an investigational Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (Press release, BeiGene, OCT 24, 2018, View Source;p=RssLanding&cat=news&id=2373150 [SID1234530153]). Zanubrutinib was discovered in BeiGene’s research facilities in Beijing, China, and is being developed globally by BeiGene as a monotherapy and in combination with other therapies to treat various hematologic malignancies. In August, the NMPA accepted BeiGene’s first NDA for zanubrutinib for the treatment of patients with R/R mantle cell lymphoma (MCL).

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"Our team has made three NDA submissions in China this year, including two for zanubrutinib and one for tislelizumab, our investigational anti-PD-1 antibody. We are hopeful that these submissions, if approved, could further transform BeiGene as well as bring important new treatment options to cancer patients," commented John Oyler, co-founder, CEO and Chairman of BeiGene.

"We are delighted that the submission for zanubrutinib in patients with relapsed/refractory CLL/SLL was accepted by the NMPA in China, and we are excited to announce the top-line pivotal data for zanubrutinib in these patients, which demonstrated a high overall response rate of 80 percent despite a relatively short follow-up. These results in China are also consistent with the data from our global studies," said Dr. Xiaobin Wu, General Manager of China and President of BeiGene, Ltd.

The NDA is supported by an extensive clinical, non-clinical and chemistry, manufacturing and control (CMC) data package, including the results from a 91-patient single-arm pivotal Phase 2 study in Chinese patients with R/R CLL/SLL treated with zanubrutinib, dosed at 160 mg orally twice daily. An independent review of response data from this study, with a data cut-off of June 15, 2018 and a median follow-up of 9.1 months, showed an overall response rate (ORR) of 80 percent, inclusive of complete response (2%), partial response (39%), and partial response with lymphocytosis (40%). The median duration of response has not been reached, as a majority of the responders remain in a response. The safety profile was consistent with previously reported clinical data for zanubrutinib. Updated data with additional follow-up of the patients in the study will be submitted to the NMPA as an additional document of the NDA and are planned to be presented at an upcoming medical conference.

Zanubrutinib was recently granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with Waldenström macroglobulinemia (WM). BeiGene plans to submit an NDA to the FDA for zanubrutinib as a potential treatment for patients with WM in the first half of 2019 based on results from a global Phase 1 study.

Zanubrutinib is being evaluated in a broad global registration program, including a fully enrolled Phase 3 clinical trial in patients with WM, comparing zanubrutinib with ibrutinib, the currently approved BTK inhibitor for WM. Zanubrutinib is also being studied in comparison to bendamustine/ rituximab in a Phase 3 clinical trial in patients with previously untreated CLL/SLL, as well as in a pivotal randomized Phase 2 trial in combination with GAZYVA (obinutuzumab) in patients with R/R follicular lymphoma. In China, besides the pivotal Phase 2 trials in R/R MCL and R/R CLL/SLL, BeiGene has completed enrollment in a pivotal Phase 2 clinical trial in patients with WM. BeiGene also plans to initiate a Phase 3 trial comparing zanubrutinib to ibrutinib in patients with R/R CLL/ SLL.

About Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are forms of non-Hodgkin lymphoma, a type of blood cancer, that arise from B lymphocytes. CLL and SLL are essentially the same disease, with the only difference being the location where the cancer primarily occurs.i When most of the cancer cells are located in the bloodstream and the bone marrow, the disease is referred to as CLL, although the lymph nodes and spleen are often involved. When the cancer cells are located mostly in the lymph nodes, the disease is called SLL.ii

About Zanubrutinib
Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) that is currently being evaluated in a broad pivotal clinical program globally and in China as a monotherapy and in combination with other therapies to treat various B cell malignancies.

On October 24, 2018 The Phase III ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) trial that investigated darolutamide in men with non-metastatic castration-resistant prostate cancer (nmCRPC), met its primary endpoint (Press release, Bayer, OCT 24, 2018, View Source [SID1234530182]). Darolutamide significantly extended metastasis-free survival (MFS) compared to placebo. The safety profile and the tolerability of darolutamide observed in the ARAMIS trial were consistent with previously published data on darolutamide. ARAMIS is a randomized, multi-center, double-blind, placebo-controlled trial in patients with nmCRPC. Darolutamide is an investigational, oral androgen receptor (AR) antagonist developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

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"Despite recent advances in nmCRPC, there remains a high unmet need for additional treatment options that delay the time to metastases," said Scott Fields, MD, senior vice president and head of Oncology Development at Bayer’s Pharmaceutical Division. "We are encouraged by the results of the ARAMIS trial and look forward to presenting the full data at an upcoming scientific meeting."

Bayer plans to discuss the data from the ARAMIS trial with health authorities regarding the submission of a new drug application. Bayer has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for darolutamide in men with nmCRPC.

About the ARAMIS Trial
The ARAMIS trial is a randomized, Phase III, multi-center, double-blind, placebo-controlled trial evaluating the safety and efficacy of oral darolutamide in patients with nmCRPC who are currently being treated with androgen deprivation therapy (ADT) and are at risk for developing metastatic disease. More than 1,500 patients were randomized in a 2:1 ratio to receive 600 mg of darolutamide twice a day or matching placebo.

The primary endpoint of this trial is metastasis-free survival (MFS), defined as time between randomization and evidence of metastasis or death from any cause. The secondary objectives of this trial are overall survival (OS), time to first symptomatic skeletal event (SSE), time to initiation of first cytotoxic chemotherapy, time to pain progression and characterization of the safety and tolerability of darolutamide.

About Castration-Resistant Prostate Cancer (CRPC)
Prostate cancer is the second most commonly diagnosed malignancy in men worldwide. In 2018, an estimated 1.2 million men will be diagnosed with prostate cancer, and about 358,000 will die from the disease worldwide. Prostate cancer is the fifth leading cause of death from cancer in men.

Prostate cancer results from the abnormal proliferation of cells within the prostate gland, which is part of a man’s reproductive system. It mainly affects men over the age of 50, and the risk increases with age.

Treatment options range from surgery to radiation treatment to therapy using hormone-receptor antagonists, i.e. substances that stop the formation of testosterone or prevent its effect at the target location. However, in nearly all cases, the cancer will become resistant to conventional hormone therapy1.

CRPC is an advanced form of the disease where the cancer keeps progressing even when the amount of testosterone is reduced to very low levels in the body. The field of treatment options for castration-resistant patients is evolving rapidly, but until recently, there have been no approved treatment options for CRPC patients who have rising Prostate-Specific Antigen (PSA) levels during ADT and no detectable metastases. In men with progressive nmCRPC, a short PSA doubling time has been consistently associated with reduced time to first metastasis and death2.

About Darolutamide
Darolutamide is an investigational, non-steroidal androgen receptor antagonist with a chemical structure that binds to the receptor and exhibits antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. Darolutamide has also completed Phase 1/2 studies in patients with mCRPC. A Phase 3 study in metastatic hormone-sensitive prostate cancer (ARASENS) is ongoing. Information about these trials can be found at www.clinicaltrials.gov.

Darolutamide is not approved by the U.S. FDA, the European Medicines Agency or any other health authority.

On October 24, 2018 Melinta Therapeutics, Inc., (NASDAQ: MLNT), a commercial-stage company discovering, developing and commercializing novel antibiotics to treat serious bacterial infections, reported that its board of directors has appointed John H. Johnson as interim chief executive officer (CEO), effective immediately (Press release, Cempra, OCT 24, 2018, View Source [SID1234530248]). Mr. Johnson, a director of Melinta, succeeds Dan Wechsler, who is stepping down from his role as president, CEO and director to pursue other opportunities. The Board and Mr. Wechsler mutually agreed that now is the right time to transition leadership of the Company.

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"John is an accomplished biopharmaceutical industry leader with more than 20 years of direct expertise in the antibiotics space, and we are pleased that he is leading Melinta during this pivotal time. Under John’s leadership, we are confident that sales of commercial products, Baxdela (delafloxacin), Vabomere (meropenem and vaborbactam), Orbactiv (oritavancin), and Minocin (minocycline) for Injection, will continue to accelerate, and that he will focus on strengthening the financial position of Melinta by optimizing the integrations of the infectious disease business of The Medicines Company and Cempra," said Kevin Ferro, chairman of Melinta Therapeutics.

"I am pleased to serve as interim CEO of Melinta and will continue to work closely with the board of directors, executive management and the broader team to further advance the Company’s mission to provide life-saving therapeutic solutions that address the evolving global threat of bacterial infections and antibiotic resistance. This is an exciting time for Melinta and I look forward to contributing to the continued growth and future success of the Company by delivering anti-infective solutions to patients," said John H. Johnson, interim chief executive officer and director of Melinta Therapeutics.

Mr. Ferro added, "On behalf of the board of directors, we would like to thank Dan for his contributions to the Company and we wish him well in his future endeavors."

John H. Johnson has more than 30 years of biopharmaceutical industry, executive leadership and commercial experience at leading global organizations, including Johnson & Johnson, Eli Lilly & Company, ImClone and Pfizer, Inc. In addition to Melinta, Mr. Johnson currently serves on the boards of Aveo Oncology, Histogenics Corporation, Portola Pharmaceuticals, Inc., and is chairman of Strongbridge Biopharma plc. Mr. Johnson previously served as a director at Cempra and Sucampo. He also previously served as president and chief executive officer of Dendreon Corporation from February 2012, became chairman in July 2013, and served as chairman until June 2014 and president and chief executive officer until August 2014. Prior to this role, Mr. Johnson served as president of Eli Lilly & Company’s Global Oncology Unit following the company’s 2008 acquisition of ImClone Systems Incorporated, where he served as chief executive officer and on ImClone’s board. Prior to ImClone, Mr. Johnson served as the company group chairman of biopharmaceuticals within Johnson & Johnson, where he was responsible for biotechnology, immunology and oncology commercial business units. Prior to that role, he held several executive

positions at Johnson & Johnson, Parkstone Medical Information Systems, Inc., Ortho-McNeil Pharmaceutical Corporation and Pfizer Inc. While at Ortho-McNeil, Mr. Johnson was responsible for the company’s anti-infectives portfolio. During his career, Mr. Johnson also served as a member of the board of directors of Pharmaceutical Research and Manufacturers of America (PhRMA), the Health Section Governing Board of Biotechnology Industry Organizations (BIO), and BioNJ.

On October 24, 2018 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, reported that a Pre-Submission (Pre-Sub) meeting with the US FDA has been scheduled on Monday, December 17, 2018 (Press release, Anixa Biosciences, OCT 24, 2018, View Source [SID1234530499]). The meeting is to discuss the proposed preclinical and clinical performance testing plan required to support a pre-market application, and to determine the appropriate regulatory pathway for the Cchek prostate cancer confirmation test.

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The purpose of a Pre-Sub meeting is to permit a dialogue between the FDA and a diagnostic developer to facilitate a better understanding of the regulatory path enabling commercialization. With the Pre-Sub request, Anixa presented to the FDA a clinical trial plan and a group of questions on which it would like comment and clarification. After the meeting, and receipt of official minutes from the meeting, Anixa expects to have a better understanding of the regulatory pathway and anticipated timeline for commercialization.

"We are pleased that we were able to get our meeting with the FDA scheduled before the end of the year. We are looking forward to a productive discussion with the FDA that will help clarify the commercialization pathway for Cchek as a prostate cancer diagnostic test. I want to make clear that this new dialogue with the FDA is independent of and in addition to the dialogue we have already started regarding our CAR-T therapy. Both programs and corresponding interactions with the FDA will move forward independently at their own pace," stated Dr. Amit Kumar, President and CEO of Anixa Biosciences. "For Anixa Biosciences, this is an exciting time as we now have two technologies and products, regarding which we are working with regulators."