On April 20, 2021 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous formulation (sold under the tradename DARZALEX FASPRO in the U.S.), as reported by Johnson & Johnson were USD 1,365 million in the first quarter of 2021 (Press release, Genmab, APR 20, 2021, View Source [SID1234578236]). Net trade sales were USD 691 million in the U.S. and USD 674 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX and DARZALEX FASPRO 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) has become a backbone therapy in the treatment of multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy; in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma.

DARZALEX is indicated for the treatment of adult patients in Europe via intravenous infusion or subcutaneous administration: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy2. Daratumumab is the first subcutaneous CD38 antibody approved in Europe for the treatment of multiple myeloma. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S.

In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit www.DARZALEX.com.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with newly diagnosed light-chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide, and dexamethasone. It is also approved in the U.S. for the treatment of adult patients with multiple myeloma: in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for ASCT; in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.3 DARZALEX FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology. .DARZALEX FASPRO is the first subcutaneous CD38 antibody approved in the U.S. for the treatment of multiple myeloma and the first and only approved treatment for patients with AL amyloidosis in the U.S.

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).1,4,5,6,7

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis and T-cell acute lymphocytic leukemia (ALL). Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

On April 20, 2021 Forbion, a leading European life sciences venture capital firm, reported the final close of its Forbion Growth Opportunities Fund I ("Forbion Growth I") at the hard cap amount of EUR 360 million (USD 428 million) (Press release, Forbion Capital Partners, APR 20, 2021, View Source [SID1234578235]). Forbion Growth I is focused on investing in late-stage European life sciences companies.

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Pantheon, Eli Lilly and Company, Horizon Therapeutics plc (Nasdaq: HZNP), the Belgian Growth Fund, New Waves Investments, Wealth Management Partners, KfW Capital and the European Investment Fund (EIF) are part of a strong base of institutional LPs that supported the fund. Forbion Growth I concentrates on later-stage investments, particularly in European biotech companies that develop novel therapies for areas of high medical need.

The Fund targets this market segment using three distinct strategies that provide: private growth capital for clinical stage development assets, cross-over capital to companies aiming to pursue a public listing in the near-term, as well as capital injections that support existing under-valued public companies. In all cases, Forbion Growth I aims to take leading positions with an investment size of up to EUR 35 million per deal.

In executing its strategy, Forbion Growth I is working closely with its Advisory Group, consisting of CEOs from Europe’s leading BioPharma companies, comprising Jan van de Winkel (CEO Genmab), Tim van Hauwermeiren (CEO ArgenX), Werner Lanthaler (CEO Evotec), Onno van de Stolpe (CEO Galapagos), and Maarten de Jong, a leading Life Sciences banker with Moelis & Co.

Forbion Growth I will aim to build a portfolio of 10-12 investments in the most promising European late-stage life sciences companies. Thus far, the Fund has already made three investments: SynOx Therapeutics (Ireland), New Amsterdam Pharma (Netherlands), and Gyroscope Therapeutics (UK).

Sander Slootweg, Managing Partner and co-founder of Forbion said:

"We were very pleased to see Forbion Growth I reach its final close at the hard cap amount, well exceeding our original target size of EUR 250 million. Since launching the fund, it has become even clearer that this European market segment of late-stage life sciences companies with de-risked assets is rapidly maturing, but remains under-served. Forbion Growth I and its specialized team positions us well to enable the most innovative of these companies to bring new, impactful treatments and therapies to market."

Dirk Kersten, General Partner of Forbion Growth I said:

"The successful close of Forbion Growth I allows us to become a preferred partner for the most promising European biotech companies and ambitious management teams, and be an anchor investor in the final private financing round before an M&A or IPO exit. We are looking to expand our current portfolio of three investments with new opportunities that can deliver meaningful benefits to patients whilst providing strong financial returns. To be optimally positioned to execute this strategy, we will be further expanding our team of key investment professionals with new hires expected to join by mid 2021."

With well over EUR 1.8 billion of assets under management, Forbion has been ranked "…#1 most consistently performing VC Manager in Europe.." by Preqin’s fund performance database in 2019. Forbion’s investment team has built an impressive performance track record with over 70 investments in both the EU and North America over the past 15 years.

Forbion has led the first institutional rounds of several of Europe’s leading biotech companies such as Argenx (ARGX; market cap USD 15 billion), Replimune (REPL; market cap of USD 1.4 billion) Uniqure (QURE; market cap USD 1.5 billion), and Dyne Therapeutics (DYN; market cap 815 million), as well as clinical-stage companies such as Promedior (acquired by Roche for up to EUR 1.4 billion), Dezima Pharma (acquired by Amgen for up to EUR 1.55 billion) and KandY Therapeutics (acquired by Bayer for an upfront payment of EUR 378 million and an undisclosed total deal value), and Achilles Therapeutics (ACHL; market cap USD 612 million).

On April 20, 2021 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported the closing of the sale of Coherus common stock to Junshi Biosciences. Under the terms of the February 2, 2021 stock purchase agreement, Coherus has received $50 million from Junshi Biosciences’ acquisition of 2,491,988 shares at a price per share of $20.06 (Press release, Coherus Biosciences, APR 20, 2021, View Source [SID1234578234]). The collaboration agreement between the companies for the development and commercialization in the United States and Canada of toripalimab, Junshi Biosciences’ PD-1 antibody, became effective in March.

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"This collaboration is a tremendous opportunity for Junshi Biosciences given Coherus’ commercial expertise and track record in bringing affordable high-quality medicines to patients," said Dr. Ning LI, CEO of Junshi Biosciences. "Since the collaboration was announced two months ago, we have already made progress toward the introduction of toripalimab in the United States with the initiation of the rolling submission of the Biologics License Application (BLA) for treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC)."

"It is an honor to welcome Junshi Biosciences as both collaborators and investors as we build on our oncology biosimilar success with the expansion of our mission into immuno-oncology. This investment speaks volumes about Junshi Biosciences’ commitment to our partnership," said Denny Lanfear, Chief Executive Officer of Coherus. "Our teams are already making excellent progress with the NPC BLA submission and are working together closely on the registration strategy for additional toripalimab indications."

About the Exclusive License and Commercialization Agreement
Under the terms of the collaboration agreement, Coherus paid $150 million upfront for exclusive rights to toripalimab in the United States and Canada, options in these territories to Junshi Biosciences’ anti-TIGIT antibody and next-generation engineered IL-2 cytokine, and certain negotiation rights to two undisclosed preclinical immuno-oncology drug candidates. Coherus will also pay Junshi Biosciences a 20% royalty on net sales of toripalimab and up to an aggregate $380 million in one-time payments for the achievement of various milestones. The option exercise fee for each of the anti-TIGIT antibody and the IL-2 cytokine is $35 million per program. Additionally, for each option program, Coherus will pay Junshi Biosciences an 18% royalty on net sales and up to an aggregate $255 million for the achievement of various milestones. The Companies will collaborate in the development of toripalimab and other licensed compounds, and Coherus will pay for a portion of these co-development activities up to a maximum of $25 million per licensed compound per year.

On April 20, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported the initiation of the process of seeking marketing approval from the U.S. Food and Drug Administration (US FDA) for its lead product candidate eryaspase in patients with acute lymphoblastic leukemia (ALL) who developed hypersensitivity reactions to PEG-asparaginase based on the positive results of the NOPHO-sponsored Phase 2 clinical trial (Press release, ERYtech Pharma, APR 20, 2021, View Source [SID1234578232]).

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On April 20, 2021 Race Oncology Limited ("Race") reported the appointment of Dr David Fuller as Chief Medical Officer (CMO) (Press release, Race Oncology, APR 20, 2021, View Source [SID1234578231]). This appointment follows the announcement by Race on 19 February 2021 that the Company would be recruiting a full-time, Australian- based CMO to drive its three-pillar strategy forward.

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An internationally experienced biopharmaceutical executive and physician, Dr Fuller brings a deep understanding of the successful development & commercialisation of novel pharmaceuticals. His 30 years of R&D experience spans large, mid and small cap companies including pre-clinical and clinical development, medical and regulatory affairs, and commercialisation.

Dr Fuller will join Race Oncology on 1 July 2021 from Syneos Health Clinical Solutions, where he has been the Senior Vice President of Clinical Development in the Oncology Business Unit. Dr Fuller also currently serves as Chairman for EpiAxis Therapeutics, a privately owned epigenetic therapeutic and diagnostic company, and is a Non-Executive Director of the ASX- listed biotech company, AdAlta (ASX: 1AD).

Dr Fuller was formerly a Director at Linear Clinical Research, Chairman of Dimerix Bioscience, CMO/COO at Trident Clinical Research, CMO at Arana Therapeutics, and Vice-President Clinical at Genzyme Europe.

During his career, he has directly led successful major market drug approvals including Moraxen (UK), Busulfex (US Paediatrics and EU Adult indications), Xyrem (US) and Renagel (EU). He has also designed and executed multiple Phase I, II and III studies (US, EU, Asia) for both orphan and non-orphan drug products.

This is an important appointment for Race as David brings significant experience and capability. David has been successful in developing a number of pharmaceutical products across various international markets and we look forward to his future guidance in optimising plans for the execution of our Three Pillar strategy and maximising the significant opportunities we have ahead for Bisantrene.

Race Oncology CEO and Managing Director, Phil Lynch
I am honoured and excited to be joining Race at such a critical time in the Company’s evolution given the huge potential of Bisantrene as both a targeted precision oncology drug and a differentiated chemotherapeutic. I look forward to applying my experience and expertise to help Race successfully realise the objectives of its three-pillar strategy. And I am pleased to have a new opportunity to again work with Professor Borje Anderson after our successful prior collaboration on Busulfex.

Dr David Fuller
Dr Fuller holds a Bachelor of Medicine / Bachelor of Surgery degree, and a Bachelor of Pharmacy (First Class Honours in Pharmacology), both from University of Sydney. He is also a Member of the American Society Clinical Oncology (ASCO) (Free ASCO Whitepaper).