On January 12, 2021 GW Pharmaceuticals plc (Nasdaq: GWPH), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, reported preliminary, unaudited net product sales for the fourth quarter and full year 2020 and key priorities for 2021 (Press release, GW Pharmaceuticals, JAN 12, 2021, View Source [SID1234573906]). Justin Gover, GW’s Chief Executive Officer, expects to discuss these updates as part of a webcast presentation at the 38th Annual J.P. Morgan Healthcare Conference on Tuesday, Jan. 12th at 10:00 a.m. ET.

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"Epidiolex sales increased by over 70% in 2020 despite the challenges of COVID-19, reflecting the positive impact this medicine has on patients as well as the performance of our commercial team. We remain encouraged by our patients’ experience on this product, as demonstrated by high persistence and refill rates. This, combined with our expansion of payer coverage and the recently approved Tuberous Sclerosis Complex indication, leads us to expect continued strong growth in 2021 in both the US and Europe," said Justin Gover, GW’s Chief Executive Officer. "Our goals in 2021 include driving further Epidiolex growth and advancing multiple US pivotal trials for nabiximols in the treatment of MS spasticity, with the first data readout expected this year. In addition to our previously announced pipeline activities, we are leveraging our world leadership in cannabinoid science to design and synthesize novel cannabinoid molecules and expect our first novel product candidate to enter the clinic in 2021."

Preliminary Unaudited Fourth Quarter and Full-Year 2020 Net Product Sales

Based on preliminary unaudited financial information, the Company expects total net product sales to be approximately $148 million for the fourth quarter and approximately $526 million for the year ended December 31, 2020. Total net product sales of Epidiolex are expected to be approximately $144 million for the fourth quarter, comprising $129 million in the US and $15 million ex-US. Total net product sales of Epidiolex for the year ended December 31, 2020 are expected to be approximately $510 million compared to $296 million in 2019. Cash and cash equivalents at December 31, 2020 were approximately $486 million.

Key Priorities for 2021

EPIDIOLEX commercialization:

Continue to drive revenue growth in US and Europe:
• Execute on TSC label expansion and continued penetration in Dravet and LGS
• Build further on expanded payer coverage achievements
• Accelerate adoption across a broader prescriber base
• Increase penetration in long-term care segment
• Continue launches in Germany and UK and achieve successful pricing and reimbursement, and launch execution in France, Spain and Italy, as well as other European countries
• Obtain approval of the Tuberous Sclerosis Complex indication in Europe
Supplement existing 14 Orange Book listed patents (expiry 2035) with additional use patents, and obtain grant of the Epidiolex "composition" patent
Commence pivotal trial in fourth target orphan epilepsy indication
Nabiximols in the US:

Continue recruitment of two ongoing pivotal MS spasticity trials and commence three additional pivotal trials in MS spasticity
Achieve data from at least one pivotal MS spasticity trial in 2021
NDA submission expected following first positive pivotal MS spasticity trial
Commence clinical program to expand future label to include spasticity associated with Spinal Cord Injury
Additional pipeline:

Continue recruitment of ongoing Phase 2b study of a cannabidiol formulation for the treatment of schizophrenia
Conduct placebo-controlled trials with both CBDV and CBD in autism
Advance NHIE clinical program utilizing an intravenous formulation of cannabidiol
Complete Phase 1 trial for novel botanical drug candidate GW541
Advance first novel NCE cannabinoid candidate into Phase 1

On January 12, 2021 Enveric Biosciences Inc. (NASDAQ: ENVB), a patient-first biotechnology company developing novel cannabinoid medicines to improve quality of life for cancer patients, reported that it has entered into definitive agreements with several institutional and accredited investors for the purchase and sale of 2,221,358 shares of Enveric’s common stock and common stock equivalents, at a purchase price of $4.5018 per share, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Enveric Biosciences, JAN 12, 2021, View Source [SID1234573905]). Enveric has also agreed to issue to the investors unregistered warrants to acquire 1,666,019 shares of Common Stock at $4.9519 per share, exercisable immediately and terminating five years after the date of issuance. The closing of the offering is expected to occur on or about January 14th, 2021, subject to the satisfaction of customary closing conditions.

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The gross proceeds to Enveric from this offering are expected to be approximately $10 million, before deducting advisory and other offering expenses. Enveric intends to use the net proceeds from this offering for working capital and general corporate purposes.

Palladium Capital Group, LLC acted as a financial advisor to the issuer.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) are being offered by Enveric pursuant to a "shelf" registration statement on Form S-3 (File No. 333-233260) previously filed with the Securities and Exchange Commission (the "SEC") on August 14, 2019, and declared effective by the SEC on November 19, 2019. The offering of the securities will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws. Enveric has agreed to register the shares of common stock issuable upon exercise of the warrants for resale pursuant to a customary registration rights agreement.

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

On January 12, 2021 Elevar Therapeutics, Inc. ("Elevar"), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported that Mark Gelder, M.D., has been promoted to chief medical officer of Elevar Therapeutics (Press release, Elevar Therapeutics, JAN 12, 2021, View Source [SID1234573904]).

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Dr. Gelder joined Elevar in 2020 as vice president of medical affairs where he was responsible for building and leading Elevar’s global medical organization, setting the strategy for development programs from clinical trials through regulatory filings, new product launches and lifecycle opportunities. In his role as chief medical officer, Dr. Gelder will oversee the Company’s clinical development, medical affairs, regulatory affairs, and preclinical teams.

"Since joining Elevar in 2020, Mark has been integral in advancing our proprietary drug candidates through the clinic and has been a key member of our development team. His medical expertise and leadership will be especially important as we advance the ovarian cancer program for Apealea (paclitaxel micellar) and as we move rivoceranib (apatinib) from the clinic towards potential regulatory approval as a new treatment option for some of the largest unmet medical needs in oncology," said Alex Kim, chief executive officer of Elevar. "Mark has the leadership, track record, and breadth of experience that uniquely position him for this role. I look forward to our continued close partnership in this next phase of Elevar’s evolution."

Dr. Gelder brings more than 35 years of clinical development, medical affairs and medical marketing experience including 17 years of global medical affairs experience leading therapeutic oncology programs for companies such as Pfizer, Wyeth and Bayer, where he was involved in the approval and launch of several cancer therapeutics. Dr. Gelder has led successful global trials, launch plans and Phase I-Phase IV studies for several emerging oncology organizations and has been instrumental in the approval and launch of numerous oncology products. Prior to his work in the biopharmaceutical industry, Dr. Gelder was an investigator in multiple clinical trials and has authored numerous scientific papers in the areas of women’s health and oncology.

Dr. Gelder earned his medical doctorate from the University of Virginia School of Medicine and completed his residency training internal medicine and obstetrics and gynecology followed by a gynecologic oncology fellowship. He is a Fellow of the American College of Physicians and the American College of Obstetrics and Gynecology and has extensive clinical experience in both the academic and private practice settings.

On January 12, 2021 AstraZeneca reported that it will present new data from across the innovative lung cancer portfolio at the IASLC 2020 World Conference on Lung Cancer (WCLC), hosted by the International Association for the Study of Lung Cancer, 28 to 31 January 2021 (Press release, AstraZeneca, JAN 12, 2021, View Source [SID1234573903]).

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Eleven AstraZeneca medicines and potential new medicines from the pipeline feature in 39 abstracts showcasing the Company’s leadership across different types and stages of lung cancer, including eight oral presentations with two late breakers.

Presentations include:

Updated data from the TROPION-PanTumor01 Phase I trial of datopotamab deruxtecan (Dato-DXd; DS-1062) with additional patients, supporting its potential to redefine treatment outcomes in advanced non-small cell lung cancer (NSCLC). Datopotamab deruxtecan is a novel trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC)
New data from the DESTINY-Lung01 Phase II trial highlighting the potential of Enhertu (trastuzumab deruxtecan) in HER2-expressing metastatic NSCLC, and data in metastatic HER2-mutant (HER2m) NSCLC, two groups of patients for whom no HER2-directed medicine is currently approved
New analyses from the ADAURA Phase III trial featured in two oral presentations reinforcing the unprecedented benefit of Tagrisso (osimertinib) regardless of prior adjuvant chemotherapy or disease stage in the adjuvant treatment of epidermal growth factor receptor-mutated (EGFRm) NSCLC, and showing patients treated with Tagrisso maintained their quality of life
José Baselga, Executive Vice President, Oncology R&D, said: "AstraZeneca is leading the next wave of precision-medicine innovations in lung cancer that aim to change clinical practice and ultimately alter the course of the disease. Our data at WCLC for datopotamab deruxtecan and Enhertu illustrate the potentially transformative role next-generation antibody drug conjugates may play in advanced non-small cell lung cancer. New results for Tagrisso and Imfinzi continue to validate our strategy to treat patients earlier, as we progress the science of identifying patients most likely to respond to treatment."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: "AstraZeneca is committed to advancing early detection and treatment of lung cancer – and the urgency to achieve this goal has only increased during the pandemic, which has significantly impacted cancer care for patients around the world. Our Tagrisso and Imfinzi data at WCLC show how we are driving progress in early-stage lung cancer, while also pushing the scientific boundaries in resistant and advanced disease to identify new solutions for patients."

Harnessing the emerging potential of ADCs to treat different types of lung cancer
Updated data from the TROPION-PanTumor01 Phase I trial of the novel ADC datopotamab deruxtecan will be featured in an oral presentation, demonstrating early antitumour activity in patients with advanced/metastatic NSCLC who had progressed on standard treatment. Additionally, two presentations on the data from the DESTINY-Lung01 Phase II trial will show results of Enhertu patients with NSCLC, including new data from the HER2-expressing cohort and data from the HER2 mutant cohort.

Collaboration in the scientific community is critical to improving outcomes for patients. AstraZeneca is collaborating with Daiichi Sankyo Company, Limited (Daiichi Sankyo) to develop and commercialise Enhertu and datopotamab deruxtecan globally.

Treating patients with NSCLC in early stages
A late-breaking analysis from the ADAURA Phase III trial will underscore the practice-changing results for adjuvant Tagrisso in Stage IB-IIIA EGFRm NSCLC and show the disease-free survival benefit for patients who had been treated with adjuvant chemotherapy prior to Tagrisso and those who were not by stage of disease. A second exploratory analysis from the Phase III ADAURA trial will highlight the impact of treatment with adjuvant Tagrisso on quality of life based on patient-reported outcomes. Tagrisso was recently approved in the adjuvant setting in the US.

The ongoing NeoADAURA Phase III trial testing the benefit of treating patients with resectable EGFRm NSCLC with neoadjuvant Tagrisso will be highlighted in a poster presentation.

The MERMAID-1 Phase III trial testing Imfinzi (durvalumab) in patients with completely resected, Stage II and III NSCLC who show evidence of minimal residual disease (MRD), will also be highlighted in a poster. MERMAID-1 is an early-stage NSCLC Phase III trial evaluating circulating tumour DNA measurements to monitor for MRD and to identify patients at high risk of recurrence after surgery who may benefit from intervention with immunotherapy.

Progressing research in advanced lung cancer
AstraZeneca will also present data from several trials exploring targeted therapies and novel combinations for advanced lung cancer, including:

Additional data from the CASPIAN Phase III trial of Imfinzi in extensive-stage small cell lung cancer (ES-SCLC) showing exposure response and pharmacokinetics as well as exploratory analyses based on extent of disease
The biomarker-directed HUDSON Phase II platform trial of Imfinzi in combination with Lynparza (olaparib) and other novel anti-cancer medicines, including danvatirsen (STAT3 antisense oligonucleotide), ceralasertib (ATR inhibitor) and oleclumab (anti-CD73), in patients with NSCLC who progressed on anti-PD(L)1 therapy
The ODIN BM Phase I trial assessing Tagrisso brain exposure in patients with EGFRm NSCLC central nervous system (CNS) metastases
The TATTON Phase Ib trial of Tagrisso plus savolitinib in patients with EGFRm MET-overexpressed/amplified NSCLC
A trial-in-progress update on the Phase I trial of Tagrisso in combination with patritumab deruxtecan (HER3-DXd; U3-1402) in patients with locally advanced or metastatic EGFRm NSCLC
Key-AstraZeneca-presentations-during-WCLC-20201
AstraZeneca in lung cancer
AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage development for the treatment of different forms of lung cancer spanning different histologies, several stages of disease, lines of therapy and modes of action.

AstraZeneca aims to address the unmet needs of patients with EGFRm tumours as a genetic driver of disease, which occur in 10-15% of NSCLC patients in the US and EU and 30-40% of NSCLC patients in Asia, with the approved medicines Iressa (gefitinib) and Tagrisso and its ongoing LAURA, NeoADAURA and FLAURA2 Phase III trials.1-3 AstraZeneca is committed to addressing tumour mechanisms of resistance through the ongoing SAVANNAH and ORCHARD Phase II trials, which test Tagrisso in combination with savolitinib, a selective inhibitor of c-MET receptor tyrosine kinase, along with other potential new medicines.

The Company is also evaluating the potential of ADCs to improve patient outcomes in tumours with targetable gene alterations, including HER2m NSCLC which affects approximately 2-4% of patients with NSCLC.4,5 Enhertu, a HER2-directed antibody drug conjugate, is in development for metastatic non-squamous HER2-overexpressing or HER2m NSCLC including trials in combination with other anticancer treatments. In addition, a broad and comprehensive clinical development programme is evaluating the efficacy and safety of datopotamab deruxtecan (a TROP2-directed ADC) across multiple TROP2 cancers, as both a monotherapy and in combination with other anticancer treatments.

An extensive Immuno-Oncology (IO) development programme focuses on lung cancer patients without a targetable genetic mutation, which represent up to three-quarters of all patients with lung cancer.6 Imfinzi, an anti-PDL1 antibody, is in development for patients with advanced disease (POSEIDON and PEARL Phase III trials) and for patients in earlier stages of disease, including potentially curative settings (MERMAID-1, MERMAID-2, AEGEAN, ADJUVANT BR.31, PACIFIC-2, PACIFIC-4, PACIFIC-5, and ADRIATIC Phase III trials) both as monotherapy and in combination with tremelimumab and/or chemotherapy. Imfinzi is also in development in the NeoCOAST, COAST and HUDSON Phase II trials in combination with potential new medicines from the early-stage pipeline, including Enhertu.

AstraZeneca in oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With seven new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers.

By harnessing the power of six scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

On January 12, 2021 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that it has entered into a Securities Purchase Agreement pursuant to which MediciNova has agreed to issue US$20 million in shares of its common stock to 3D Opportunity Master Fund, a fund managed by 3D Investment Partners Pte. Ltd. ("3D"), in a private placement transaction (Filing, 8-K, MediciNova, JAN 12, 2021, View Source [SID1234573902]).

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MediciNova intends to use the proceeds received from the private placement primarily for the following three programs:

1) To initiate a new clinical trial of MN-166 (ibudilast) for glioblastoma, which could be a pivotal trial.

2) To develop an intravenous formulation of MN-166 (ibudilast), which is ideal for amyotrophic lateral sclerosis (ALS) patients who have difficulty with swallowing.

3) To initiate a Phase 2 clinical trial of MN-001 (tipelukast) in nonalcoholic steatohepatitis (NASH).

Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, "We are very pleased to reach this agreement with 3D Opportunity Master Fund. This investment will enable us to accelerate development of additional programs in our diverse pipeline. We believe that it is essential for shareholders and management to share the goal of increasing corporate value and to have investments that are accompanied by capital discipline. In this regard, we believe that 3D is an investor with a sincere desire to support our efforts to increase the true corporate value of MediciNova, which is our ultimate goal."

Motoki Sato, MD, Managing Director of 3D Investment Partners Pte. Ltd., commented, "We believe that this investment will meaningfully accelerate MediciNova’s drug development in the pipeline and could lead to unleashing its highest potential in value. Significant benefits could be brought to and shared among patients and healthcare professionals in need of effective drugs to combat rare diseases, as well as MediciNova’s stakeholders. We are pleased to have built an effective relationship with MediciNova through incentive alignment between management and shareholders."