Genmab Announces Net Sales of DARZALEX® (daratumumab) for the Third Quarter of 2021

On October 19, 2021 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) formulation (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), as reported by Johnson & Johnson were USD 1,580 million in the third quarter of 2021 (Press release, Genmab, OCT 19, 2021, View Source [SID1234591506]). Net trade sales were USD 841 million in the U.S. and USD 739 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC formulations, under the exclusive worldwide license to Janssen Biotech, Inc. (Janssen) to develop, manufacture and commercialize daratumumab. As previously announced, Janssen is reducing its royalty payments to Genmab by what it claims to be Genmab’s share of Janssen’s royalty payments to Halozyme, cf. company announcement No. 39 of September 22, 2020.

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About DARZALEX(daratumumab)
DARZALEX (daratumumab) is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration approval to treat multiple myeloma and has become a backbone therapy in the treatment of this disease. Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. The subcutaneous formulation of daratumumab (daratumumab and hyaluronidase-fihj) is the first subcutaneous CD38 antibody approved for the treatment of multiple myeloma and the first and only approved treatment for patients with light-chain (AL) amyloidosis. Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death). 1,2,3,4,5,6,7

Please see local country prescribing information for all labeled indication and safety information.

Chugai Announces the Decision of the Termination of Exclusive License Agreement on OBP-301 (Telomelysin), Oncolytic Viral Immunotherapy

On October 19, 2021 Chugai Pharmaceutical Co., Ltd. reported that the company and Oncolys BioPharma Inc. (hereafter, "Oncolys") agreed to terminate the license agreement concluded between the two companies on April 8, 2019 (hereafter, "Agreement") for an oncolytic viral immunotherapy OBP-301 (Telomelysin: suratadenoturev) as follows (Press release, Chugai, OCT 19, 2021, View Source [SID1234591505]). The effective date of the termination will be decided upon consultation with Oncolys, at the latest by October 2022. Upon termination of the Agreement, all rights Chugai may have with respect to OBP-301 will be returned to Oncolys. There will be no payment or receipt of milestone fees between the two companies.

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Reasons for the Termination
Chugai entered into the Agreement with Oncolys on April 8, 2019, and has been developing OBP-301 in Japan. However, Chugai concluded that pursuing the development of the product through collaboration between the two companies will not maximize the product value of the drug. This decision is not attributable to any efficacy or safety issues regarding OBP-301. For the time being, Chugai will continue to conduct ongoing domestic clinical trials and transfer the initiative to Oncolys upon agreement between the two companies.

Details of the Agreement to be Terminated
The Agreement, which will be terminated, granted Chugai an exclusive license, with sublicensing rights, for development, manufacturing and marketing of OBP-301 in Japan and Taiwan as well as exclusive option rights concerning the worldwide development, manufacturing and marketing of OBP-301, excluding Japan, Taiwan, China, Hong Kong, and Macau.

Outline of the Counterparty to the Termination of the Agreement
Name: Oncolys BioPharma Inc.
Address: 4-1-28, Toranomon, Minato-ku, Tokyo, Japan
Title and Name of Representative: Yasuo Urata, President & CEO
Prospects
There is no impact on our consolidated results for the fiscal year ended December 2021.

Race secures sixth US patent for Zantrene

On October 19, 2021 Race Oncology ("Race") reported that it has been issued a new patent (US patent no. 11,147,800) on its cancer drug, Zantrene (bisantrene dihydrochloride), by the United States Patent and Trademarks Office (USPTO) (Press release, Race Oncology, OCT 19, 2021, View Source [SID1234591504]). This patent expires on 25 July 2034.

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This is Race’s sixth granted patent on Zantrene in the United States.

"The new US patent provides Race with further protection around uses of Zantrene (and related chemical structures) that improve the efficacy of Zantrene treatments"

Race’s CEO Phillip Lynch
This new patent further expands the therapeutic utility of Zantrene (and related chemical structures), in particular – methods that improve the therapeutic efficacy of Zantrene and reduce side effects.

The new patent builds on Race’s existing Zantrene patents granted in the USA in 2018 (US 9,993,460 and US 9,974,774), 2019 (US 10,500,192), 2020 (US 10,548,876) and in 2021 (US 11,135,201), further strengthening Race’s growing IP position for Zantrene.

Oncolytics Biotech® to Host Conference Call to Discuss Third Quarter Financial Results and Operational Highlights

On October 19, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that it will host a conference call and webcast on Friday, November 5, 2021, at 8:00 a.m. ET to discuss a corporate update and financial results for the third quarter of 2021 (Press release, Oncolytics Biotech, OCT 19, 2021, https://ir.oncolyticsbiotech.com/news/detail/548/oncolytics-biotech-to-host-conference-call-to-discuss-third-quarter-financial-results-and-operational-highlights [SID1234591503]).

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Conference Call & Webcast

A webcast of the call will also be available on the Investor Relations page of Oncolytics’ website, available by clicking here, and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 859-440#.

AusBiotech Conference

On October 19, 2021 Patrys CEO, Dr James Campbell, reported that it has composed some thoughts about his participation in AusBiotech’s upcoming events – the annual AusBiotech Conference (25-29 Oct 2021) and Australia Biotech Invest & Partnering Conference (26 Oct 2021) (Press release, Patrys, OCT 19, 2021, View Source [SID1234591499]):

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There is no shortage of innovation in the biotech sector. Novel ideas and technologies abound, which makes it an exciting and inspiring space to operate. However, while new discoveries and opportunities are constantly emerging, these ideas rarely make it to market on the strength of science alone.

In my experience, the secret of success lies in the alignment of some key ingredients – the right technology, the right investors, and the right people – all at the right time. In short, great ideas attract great people. And great people attract financial capital.

Bringing people together is one of the key objectives of 2021 AusBiotech Conference. As a long-time participant, and now member of the AusBiotech board, I have seen firsthand the benefits of gathering the best and brightest within the life sciences community in one place. Industry events, such as the AusBiotech conference, are about encouraging conversation, sharing perspectives and strengthening connections, all of which are vital for the continuing growth and advancement of the Australian biotechnology sector.

This year I am honoured to be Chairing a session by international keynote speaker, Dr Niels Emmerich, Vice President, Global Head Search & Evaluation at AbbVie. Drawing on his vast experience, Dr Emmerich will provide valuable insights on what makes for successful research collaborations between academic institutions and biotech companies, and I encourage you to attend this session.

Keynote session overview:

"Current pharma models for accessing novel technologies: opportunities and challenges for biotechs and universities."

Sourcing and identifying novel technology – emerging best practice.
How do they get assessed?
What does stage-appropriate evidence look like?
Models for partnering when data is not mature enough for pharma licensing.
When: 9.00-9.30am AEDT, Thursday 28 Oct 2021
Where: Online / virtual webinar
Register: Click HERE to register for the AusBiotech Conference (25-29 Oct 2021)

I am also presenting on behalf of Patrys at the Australia Biotech Invest & Partnering Conference on Tuesday 26 October, where I’ll be sharing our latest investor presentation alongside other CEOs and executives , followed by a live 20-30 minute Q&A.

When: 9:45 – 11:15am AEDT, Tuesday 26 Oct 2021
Where: Online / virtual webinar
Register: Click HERE to register for the Australia Biotech Invest & Partnering Conference (26 Oct 2021)

Building and strengthening relationships have never been more important, and the virtual format of this year’s conference has made it easy for everyone to participate. I look forward to seeing you there – and joining the conversation online too – #AusBio21 #AusBioInv.