On November 24, 2020 Biopharmaceutical company Alvotech hf. and Alvotech & CCHT Biopharmaceutical Co., Ltd., which is the China joint venture company of Alvotech hf. and Changchun High & New Technology Industries (Group) Inc., reported that have partnered with Yangtze River Pharmaceutical Group, a leading Chinese pharmaceutical company, to form an exclusive strategic partnership for the commercialization of eight biosimilar medicines in China (Press release, Alvotech, NOV 24, 2020, View Source [SID1234571699]). The initial pipeline contains biosimilar candidates for treatment in the fields of autoimmunity, ophthalmology, and oncology, as well for treating severe immune and inflammatory conditions.

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Robert Wessman, founder and chairman of Alvotech, commented, "As our progression continues, we are excited to announce this new partnership with Yangtze River Pharmaceutical Group, one of the largest pharmaceutical companies in China. Through this commercial relationship, Alvotech and Alvotech & CCHT Biopharmaceutical Co., Ltd are gaining an extremely valuable access to Yangtze River Pharmaceutical’s strong brand reputation and market experience in China. This will give patients in China better access to high quality biosimilar medicines and creates a powerhouse in the introduction and adoption of biosimilars in the region."

Under this distribution and marketing agreement, Alvotech and Alvotech & CCHT Biopharmaceutical Co., Ltd will be jointly responsible for the development, registration, and supply of their biosimilars in China, while Yangtze River Pharmaceutical will exclusively commercialize the biosimilar candidates. China is the world’s second largest pharmaceutical market, and this new collaboration follows Alvotech’s recent global partnerships including: Teva Pharmaceuticals in the U.S. market, Stada for key European markets and several others.

Mr. Xu, Jingren, founder and Chairman of Yangtze River Pharmaceutical Group, said, "The commercial partnership with Alvotech and Alvotech & CCHT Biopharmaceutical Co., Ltd. is an attempt on international collaboration of biosimilar medicines. Develop, Manufacture and introduce high quality biosimilars is also Yangtze River’s vision. We aim to make full use of our brand advantage and market experience to deliver the biosimilars with extensive clinical needs to the broad China market. This will help us fulfil our purpose of ‘Committed for the better and Dedicated to caring for all.’"

Alvotech and Alvotech & CCHT Biopharmaceutical Co., Ltd.’s leading innovative capability and technology allow us to have confidence to provide Chinese patients with safe, effective and affordable biosimilar medicines which improves the lives of patients. We sincerely hope that this partnership will be constructive, complementary and have positive outcomes for all involved," Mr. Xu Jingren concluded.

The manufacturing of these biosimilar candidates for the Chinese market will be made in a new state-of-the-art biopharmaceutical facility, currently being built in Changchun, China, through the Alvotech & CCHT Biopharmaceutical Co., Ltd partnership1. The manufacturing site will include the latest best in class technology, including disposable single use bioreactors. The first Phase of the facility is expected to be completed in 2021.

Mr. Ma, Ji, chairman of CCHT, and chairman of Alvotech & CCHT Biopharmaceutical Co., Ltd, added, "Innovation and sharing are the core value of CCHT, establishing Changchun Alvotech & CCHT Biopharmaceutical Co., Ltd with Alvotech is aiming to build a global standard antibody drug producing and manufacturing platform. The cooperation with Yangtze River Pharmaceutical Group, a leading company in the industry, is strategic, constructive, and complementary; both parties could give full play to their advantages in exploring China’s biosimilar drug market, so as to improve the availability and accessibility of the drugs and ameliorate people’s life. We will further discuss cooperation with YZR on more levels in the future."

1 Footnote: Alvotech & CCHT Biopharmaceutical Co., Ltd is a Chinese limited liability Sino-foreign equity joint venture company owned jointly by Alvotech hf and Changchun High & New Technology Industries (Group) Inc.

On November 24, 2020 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, reported 18-month follow-up data from the randomized phase I/II trial of ONCOS-102 in combination with standard-of-care (SoC) chemotherapy in patients with malignant pleural mesothelioma (MPM) (Press release, Targovax, NOV 24, 2020, View Source [SID1234571697]).

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The study is an open-label, exploratory phase I/II trial adding ONCOS-102 to SoC chemotherapy (pemetrexed/cisplatin) in first- and second- (and later) line treatment of MPM to assess safety, immune activation and efficacy versus SoC only. In total, 31 patients have been included in the trial, with 20 patients in the experimental group receiving the ONCOS-102 and SoC combination (8 randomized in first-line), and 11 patients in the control group receiving SoC only (6 in first-line).

At the 18-month follow-up, more than half of the patients in the first-line ONCOS-102-treated group were still alive, and the mOS was not yet reached. Based on current survival data the mOS will be 18.2 months or longer. For the first-line SoC-only control group, less than half of the patients were alive, and mOS will be 14.2 months or less, which is similar to outcomes from previously reported trials where patients received the same chemotherapy treatment1. An analysis of all the first-line patients, including 3 experimental safety lead-in patients, shows similar results as the randomized first-line patients. The next survival analysis is planned in first half of 2021.

In June, it was reported that ONCOS-102 treatment induces broad and powerful immune activation in MPM, far beyond what is achieved with SoC alone. Importantly, this immune activation is associated with better survival outcomes at the 18-month analysis, indicating that the immunological activity of ONCOS-102 drives the observed clinical benefit.

The powerful immune activation generated by ONCOS-102 builds a strong rationale for combining ONCOS-102 with a checkpoint inhibitor in MPM. This combination could provide further clinical benefits in this indication. Targovax and Merck (known as MSD outside of the USA) are currently reviewing next steps for combining ONCOS-102 and pembrolizumab (Keytruda) in MPM. Recently, the U.S. Food and Drug Administration (FDA) approved the combination of ipilimumab and nivolumab (Yervoy and Opdivo) for the first-line treatment of MPM based on mOS of 18.1 months (Baas 2020), and this is expected to serve as a benchmark for further approvals.

Magnus Jäderberg, Chief Medical Officer of Targovax, said: "We are very pleased that overall survival in first-line patients, is tracking well in the ONCOS-102 treated group. We have already established in the current study that ONCOS-102 drives favorable remodeling of the tumor microenvironment, and we are now starting to see this immune activation translating into the encouraging improved survival outcomes in these 18-month results. This is exactly what we had hoped to see and prepares the way for combining ONCOS-102 with checkpoint inhibition. The immune data suggest to us that survival outcomes in combination with Keytruda may be further improved from the results reported today."

The first results from the trial were announced in January 2020 (see press release here), while immunological data and 12-month survival rate were reported in June 2020 (see press release here) and presented at the SITC (Free SITC Whitepaper) annual meeting in November 2020 (see poster here).

On November 24, 2020 Jubilant Therapeutics Inc., a biopharmaceutical company advancing small molecule modulators to address unmet medical needs in oncology and autoimmune diseases, reported that an abstract related to its dual LSD1 and HDAC6 inhibitor, JBI-802, has been accepted for presentation at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Virtual Annual Meeting taking place Dec. 5-8, 2020 (Press release, Jubilant Therapeutics, NOV 24, 2020, View Source [SID1234571696]).

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"We look forward to discussing our novel potent and selective dual inhibitor of LSD1-HDAC6 for the treatment of cancer at the 2020 ASH (Free ASH Whitepaper) Virtual Annual Meeting," said Syed Kazmi, President and Chief Executive Officer of Jubilant Therapeutics. "Our work to progress JBI-802 into the clinic as a potential, differentiated therapeutic for the treatment of select hematological and solid tumors with specific gene signatures is on track and we expect to initiate first-in-human studies in the second half of next year."

The abstract, currently available on the ASH (Free ASH Whitepaper) conference website, is as follows:

Title: Novel Dual Inhibitor of LSD1-HDAC6/8 for Treatment of Cancer

Date: Monday, December 7, 2020

Session: 802. Chemical Biology and Experimental Therapeutics: Poster III

Abstract: 3378

Presenter: Dhanalakshmi Sivanandhan, Ph.D., Associate Vice President & Head of Biology, Jubilant Therapeutics Inc.

On November 24, 2020 Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, reported management’s participation in the following investor conferences in December (Press release, Immunic, NOV 24, 2020, View Source [SID1234571695]):

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November 30 – December 3: Piper Sandler 32nd Virtual Healthcare Conference. Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic, will participate in a fireside chat. Beginning November 23, the fireside chat will be available for viewing anytime through December 3 by accessing the recording library on the Piper Sandler conference site. An archived replay of the presentation will be available on the "Events and Presentations" section of Immunic’s website at: ir.imux.com/events-and-presentations for a period of 90 days after the conference.
December 1-3: Evercore ISI 3rd Annual HEALTHCONx Conference. Dr. Vitt will participate in a fireside chat on Thursday, December 3, at 12:10 pm ET. A live audio webcast of the presentation will be available on the "Events and Presentations" section of Immunic’s website at: ir.imux.com/events-and-presentations. An archived replay will be available on the company’s website for a period of one year after the conference.

On November 24, 2020 Medtronic plc (NYSE:MDT) reported financial results for its second quarter of fiscal year 2021, which ended October 30, 2020 (Press release, Medtronic, NOV 24, 2020, View Source [SID1234571694]).

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The company reported second quarter worldwide revenue of $7.647 billion, a decrease of 0.8 percent as reported and 1.5 percent on an organic basis, which adjusts for the $59 million benefit of foreign currency translation. Unless otherwise stated, all revenue growth rates in this press release are stated on an organic basis, which adjusts for the impact of foreign currency translation. There were no acquisitions made in the last year that had a significant impact on the company’s second quarter revenue growth.

As reported, second quarter GAAP net income and diluted earnings per share (EPS) were $489 million and $0.36, respectively. As detailed in the financial schedules included through the link at the end of this release, second quarter non-GAAP net income and non-GAAP diluted EPS were $1.380 billion and $1.02, respectively, both decreases of 22 percent. Adjusting for the negative 4 cent impact from foreign currency, second quarter non-GAAP diluted EPS decreased 19 percent.

Second quarter U.S. revenue of $4.054 billion represented 53 percent of company revenue and decreased 2 percent as reported and organic. Non-U.S. developed market revenue of $2.446 billion represented 32 percent of company revenue and increased 6 percent as reported and 1 percent organic. Emerging Markets revenue of $1.147 billion represented 15 percent of company revenue and decreased 9 percent as reported and 6 percent organic.

"We’re seeing a faster-than-expected recovery and approaching year-over-year growth. Our revenue growth is improving, our pipeline is advancing, and we’re gaining share in an increasing number of businesses. At the same time, we’re in the process of implementing our new operating model and augmenting our culture with a focus on market share and being bold," said Geoff Martha, Medtronic chief executive officer. "Despite the challenges posed by the pandemic, we’re well positioned to accelerate growth over the medium- and long-term as we continue investing in and progressing a number of opportunities, creating value for society and our shareholders."

Cardiac and Vascular Group
The Cardiac and Vascular Group (CVG) includes the Cardiac Rhythm & Heart Failure (CRHF), Coronary & Structural Heart (CSH), and Aortic, Peripheral & Venous (APV) divisions. CVG second quarter revenue of $2.725 billion decreased 4.6 percent as reported and 5.5 percent organic. CVG’s revenue reflected a year-over-year decline in procedure volumes as a result of the COVID-19 pandemic; however, revenue did improve sequentially as procedures volumes continued to improve. CVG’s organic performance was impacted by low-single digit declines in CRHF, mid-teens decline in CSH, and low-single digit declines in APV.

Cardiac Rhythm & Heart Failure second quarter revenue of $1.426 billion was flat as reported and decreased 1.3 percent organic. Arrhythmia Management revenue, including implantable defibrillators (ICDs), Pacemakers, Implantable Diagnostics, and Cardiac Ablation Solutions declined in the low-single digits. This included mid-seventies growth in Leadless Pacemakers, and specifically mid-eighties growth in the United States, on the continued global adoption of the company’s Micra transcatheter pacing systems. Heart Failure declined low-single digits, as flat results in cardiac resynchronization therapy pacemakers (CRT-Ps) and mid-twenties declines in left ventricular assist devices (LVADs) were partially offset by mid-single digit growth in cardiac resynchronization therapy defibrillators (CRT-Ds) from the recent launch of Cobalt and Crome.

Coronary & Structural Heart second quarter revenue of $831 million decreased 13.0 percent as reported and 13.6 organic, reflecting high-twenties declines in drug-eluting stents (DES). The company experienced a slowdown in DES sales in China ahead of the national tender announcement in mid-October. In addition, the company recorded a $26 million reserve as a result of the tender. Outside of China, DES sales declined in the mid-teens. While transcatheter aortic valves (TAVR) declined high-single digits versus the prior year, the company estimates it held share in the third calendar quarter versus the prior quarter.

Aortic, Peripheral & Venous second quarter revenue of $468 million decreased 1.3 percent as reported and 1.9 percent organic. Aortic grew in the low-single digits, Peripheral declined in the low-single digits, and Venous declined in the high-single digits.
Minimally Invasive Therapies Group
The Minimally Invasive Therapies Group (MITG) includes the Surgical Innovations (SI) and the Respiratory, Gastrointestinal & Renal (RGR) divisions. MITG second quarter revenue of $2.285 billion increased 6.7 percent as reported and 6.2 percent organic. MITG’s revenue reflected a year-over-year decline in procedure volumes offset by increased demand for COVID-19 related diagnostics and therapies. SI’s mid-single digit organic decline was offset by low-thirties organic growth in RGR.

Surgical Innovations second quarter revenue of $1.393 billion decreased 4.2 percent as reported and 4.9 percent organic. Advanced Surgical declined low-single digits, reflecting the decline of worldwide surgical procedures. General Surgery products declined in the high-single digits.

Respiratory, Gastrointestinal & Renal second quarter revenue of $893 million increased 29.8 percent as reported and 29.7 organic, reflecting the increased demand for Respiratory Interventions products. Respiratory & Patient Monitoring grew in the low-forties, with sales of ventilators increasing nearly four-fold, as the company increased production of its PB980 high-acuity ventilator to address global demand.
Restorative Therapies Group
The Restorative Therapies Group (RTG) includes the Cranial and Spinal Technologies, Specialty Therapies, and Neuromodulation divisions. RTG second quarter revenue of $2.063 billion decreased 2.3 percent as reported and 2.9 percent organic. RTG’s revenue reflected a year-over-year decline in procedure volumes as a result of the COVID-19 pandemic. RTG’s organic performance this quarter included mid-single-digit declines in Cranial and Spinal Technologies, flat results in Specialty Therapies, and low-single digit declines in Neuromodulation.

Cranial and Spinal Technologies second quarter revenue of $1.071 billion decreased 4.1 percent as reported and 4.6 organic, including low-single digit declines in Spine and high-single digit declines in Enabling Technology. Core Spine declined in the low-single digits globally and grew in the low-single digits in the US. China Orthopedics (Kanghui) grew in the high-single digits.

Specialty Therapies second quarter revenue of $581 million increased 1.0 percent as reported and 0.3 percent organic. ENT declined in the high-single digits, Neurovascular increased in the low-single digits, and Pelvic Health increased in the mid-single digits.

Neuromodulation second quarter revenue of $411 million decreased 2.1 percent as reported and 3.1 percent organic, including mid-single digit declines in Pain Therapies and low-single digit growth in DBS.
Diabetes Group
Diabetes Group second quarter revenue of $574 million decreased 3.7 percent as reported and 5.0 percent organic. Diabetes Group revenue performance was impacted by a delay in new patient starts on insulin pumps and continued competitive pressure. CGM grew in the mid-single digits.

Guidance
Given the uncertainty on near-term financial results caused by the COVID-19 pandemic, the company is not providing formal annual or quarterly financial guidance at this time.

Webcast Information
Medtronic will host a webcast today, November 24, at 8:00 a.m. EST (7:00 a.m. CST) to provide information about its businesses for the public, investors, analysts, and news media. This quarterly webcast can be accessed by clicking on the Investor Events link at investorrelations.medtronic.com and this earnings release will be archived at newsroom.medtronic.com. Medtronic will be live tweeting during the webcast on its Newsroom Twitter account, @Medtronic. Within 24 hours of the webcast, a replay of the webcast and transcript of the company’s prepared remarks will be available by clicking on the Investor Events link at investorrelations.medtronic.com.

Medtronic plans to report its fiscal year 2021 third and fourth quarter results on Tuesday, February 23, 2021 and Thursday, May 27, 2021, respectively, and its fiscal year 2022 first quarter results on August 24, 2021. Confirmation and additional details will be provided closer to the specific event.

Financial Schedules
To view the second quarter financial schedules and non-GAAP reconciliations, click here. To view the second quarter earnings presentation, click here. Both documents can also be accessed by visiting newsroom.medtronic.com.