On January 12, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that it will present updated overall survival (OS) data from the Phase III IMbrave150 study evaluating Tecentriq (atezolizumab) in combination with Avastin (bevacizumab), compared with sorafenib, in people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy (Press release, Hoffmann-La Roche, JAN 12, 2021, View Source [SID1234573895]).

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After a median follow-up of 15.6 months, an updated analysis showed that Tecentriq in combination with Avastin reduced the risk of death (OS) by 34%, with a median OS of 19.2 months, compared with 13.4 months for sorafenib (hazard ratio [HR]=0.66; 95% CI: 0.52–0.85). The updated OS, along with progression free survival (PFS) and objective response rate (ORR) results, were consistent with the primary analysis and support the use of the combination in HCC. Safety data for Tecentriq and Avastin were consistent with the known safety profiles of each individual drug, with no new safety signals identified.

"These results show that Tecentriq in combination with Avastin provides the longest survival that we’ve ever seen in a front-line Phase III study in unresectable HCC," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "The combination, which has now been approved in more than 60 countries around the world, represents a significant treatment advancement for patients with this challenging malignancy."

"After an additional year of follow-up, these data confirm the superiority of Tecentriq in combination with Avastin compared to sorafenib in patients with advanced HCC," said Dr Laura Kulik, Professor of Medicine, Interventional Radiology and Transplant, Feinberg School of Medicine, Northwestern University and member of the ASCO (Free ASCO Whitepaper) GI programme committee. "These results provide further confidence for physicians and patients in the use of this combination as first-line therapy."

These data will be presented in the Rapid Abstract Session: Hepatobiliary Cancer, Neuroendocrine/Carcinoid, Pancreatic Cancer, and Small Bowel Cancer at the Gastrointestinal Cancers Symposium on Sunday 17 January at 15:30-16:15 ET.

Tecentriq in combination with Avastin is now approved around the world, including in the US, China, Japan and the EU, for people with unresectable HCC and is recommended in many clinical practice guidelines globally.

Roche is committed to tackling liver disease right across the disease journey, from the earliest stages through to advanced disease, with the ultimate goal of one day stopping chronic liver disease.

Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies, across several types of lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

Updated OS, PFS, response and duration of response data
Global results
Tecentriq + Avastin (n=336) Sorafenib (n=165)
Median OS (95% CI), mo 19.2
(17.0–23.7) 13.4
(11.4–16.9)
OS, HR
(95% CI), mo 0.66
(0.52–0.85)
Tecentriq + Avastin (n=336) Sorafenib (n=165)
Median PFS (95% CI), mo 6.9
(5.7–8.6) 4.3
(4.0–5.6)
PFS, HR
(95% CI), mo 0.65
(0.53–0.81)
Tecentriq + Avastin (n=326) Sorafenib (n=159)
Confirmed ORR (95% CI) (%) 30%
(25–35) 11%
(7–17)
CR, n (%) 25 (8%) 1 (< 1%)
PR, n (%) 72 (22%) 17 (11%)
SD, n (%) 144 (44%) 69 (43%)
Ongoing response, n (%) 54 (56%) 5 (28%)
Tecentriq + Avastin (n=97) Sorafenib (n=18)
Median DOR (95% CI), mo 18.1
(14.6, NE) 14.9
(4.9–17.0)
Overall survival results in the Chinese subpopulation
Tecentriq + Avastin (n=133) Sorafenib (n=61)
Median OS (95%CI), mo – Chinese subpopulation 24.0
(17.1, NE) 11.4
(6.7–16.1)
OS, HR
(95% CI), mo 0.53
(0.35–0.80)
PFS and all response data are reported by RECIST v1.1 assessed by an independent review facility.
Median follow-up: 15.6 months.
CR, complete response; DOR, duration of response; HR, hazard ratio; NE, not estimable; ORR, objective response rate; OS, overall survival; PFS, progression free response; PR, partial response; SD, stable disease.
See below for OS data from the primary analysis.

About the IMbrave150 study
IMbrave150 is a global Phase III, multicentre, open-label study of 501 people with unresectable HCC who had not received prior systemic therapy. People were randomised 2:1 to receive the combination of Tecentriq and Avastin or sorafenib. Tecentriq was administered intravenously (IV), 1200 mg on day 1 of each 21-day cycle, and Avastin was administered IV, 15 mg/kg on day 1 of each 21-day cycle. Sorafenib was administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle. People received the combination or the control arm treatment until disease progression or unacceptable toxicity. The two primary endpoints were OS and independent review facility (IRF)-assessed PFS per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Additional study endpoints included IRF-assessed overall response rate (ORR) per RECIST v1.1 and HCC mRECIST.

The primary analysis from the IMbrave150 study showed that after 8.6 months follow-up, Tecentriq in combination with Avastin reduced the risk of death (OS) by 42% (HR=0.58; 95% CI: 0.42–0.79; p=0.0006).

About hepatocellular carcinoma
HCC is an aggressive cancer with limited treatment options and is a major cause of cancer deaths worldwide.1 Every year, more than 815,000 people worldwide are diagnosed with HCC,1,2 with the majority of cases in Asia and almost half of all cases in China.2,3 In the US, the number of liver cancer cases have more than tripled since 1980 and HCC represents the fastest-rising cause of cancer-related death, while in Europe, liver cancer is also on the rise, accounting for more than 87,000 diagnoses and approximately 78,000 deaths in 2020.4-7 HCC develops predominantly in people with cirrhosis due to chronic hepatitis (B or C) or alcohol consumption, and typically presents at an advanced stage.1 The prognosis for unresectable HCC remains poor, with few systemic therapeutic options and a 1-year survival rate of less than 50% following diagnosis.8

About the Tecentriq and Avastin combination
There is a strong scientific rationale to support the use of Tecentriq plus Avastin in combination. The Tecentriq and Avastin regimen may enhance the potential of the immune system to combat a broad range of cancers. Avastin, in addition to its established anti-angiogenic effects, may further enhance Tecentriq’s ability to restore anti-cancer immunity, by inhibiting vascular endothelial growth factor (VEGF)-related immunosuppression, promoting T-cell tumour infiltration and enabling priming and activation of T-cell responses against tumour antigens.

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell lung cancer, small cell lung cancer, certain types of metastatic urothelial cancer, in PD-L1-positive metastatic triple-negative breast cancer and for hepatocellular carcinoma. In the US, Tecentriq is also approved in combination with Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma.

About Avastin
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called VEGF that plays an important role throughout the lifecycle of the tumour to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumour blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumour blood supply is thought to be critical to a tumour’s ability to grow and spread in the body (metastasise).

About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with Tecentriq to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.

On January 12, 2021 Medivir AB (publ) (Nasdaq Stockholm: MVIR) reported that it has entered into an exclusive licensing agreement, through which IGM Biosciences, Inc. (Nasdaq: IGMS), will receive global, exclusive development rights for birinapant, a clinical-stage SMAC mimetic that binds to and degrades Inhibitors of Apoptosis Proteins (IAPs), leading to cell death (apoptosis) in tumor cells (Press release, Medivir, JAN 12, 2021, View Source [SID1234573855]). The combination of IGM-8444, an IgM antibody targeting Death Receptor 5 (DR5) being developed by IGM, and birinapant has been shown to enhance anti-tumor activity preclinically. Medivir will receive an upfront payment of USD 1 million upon signing the agreement, followed by an additional USD 1.5 million when birinapant is included by IGM in clinical phase I studies. The terms of the agreement furthermore entitle Medivir, should birinapant be successfully developed and approved, to receive milestone payments up to a total of approximately USD 350 million, plus tiered royalties up to mid-teens on net sales.

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– "Agreements, such as the one announced today with IGM, continue to be a core component of Medivir’s corporate mission and business model," said Yilmaz Mahshid, Chief Executive Officer of Medivir. "Today’s announcement further exemplifies our focus and commitment to the development and commercialization of innovative treatments for cancer, and we look forward to IGM’s progress with birinapant in the clinic and beyond."

– "Based on our in vitro and in vivo models, which have shown remarkable synergy between IGM-8444 and birinapant, we are excited to explore this combination’s potential to deliver superior anti-tumor activity in patients with solid tumors," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "This agreement is part of a broader strategy to realize the full potential of our IgM drug candidates by maintaining control over the timing and development path of the more promising combinations to emerge from our preclinical and clinical work. We look forward to moving the IGM-8444-birinapant combination into clinical testing to begin validating the significance of targeting DR5 with an IgM antibody in certain combinations and to continuing to explore similar strategic options across our IgM platform."

In addition to its apoptotic activity, birinapant augments anti-tumor immune system activity. Through this double action, on both tumor cells and cells of the immune system, birinapant has the potential to improve the treatment of several types of cancer when used in combination with other drugs. IGM-8444 is currently being tested in a phase I dose escalation study in patients with solid and hematologic malignancies. DR5 is a member of the tumor necrosis factor receptor superfamily (TNFRSF) and is often expressed on the surface of cancer cells. Subject to regulatory review, IGM hopes to begin the clinical testing of birinapant in combination with IGM-8444 for the treatment of solid cancers later this year.

Conference call for investors, analysts and the media

Presenters: Yilmaz Mahshid, CEO Medivir, Fredrik Öberg, CSO Medivir and Fred Schwarzer, CEO IGM Biosciences.

The conference call will also be streamed via a link on the website: www.medivir.com

The presentation will be available on Medivir’s website after completion of the conference.

For further information, please contact:

Dr Yilmaz Mahshid, CEO, Medivir AB, phone: +46 (0)8 5468 3100.

E-mail: [email protected]

Medivir AB is obliged to make this information public pursuant to the EU Market Abuse Regulation.

The information was submitted for publication, through the agency of the contact person set out above, at 23.59 CET on January 11, 2021.

About birinapant

Birinapant is a SMAC mimetic that was acquired from TetraLogic Pharmaceuticals Corporation (TetraLogic) in 2016 and has since then been developed by Medivir. Medivir recently renegotiated the original agreement with TetraLogic so that the compensation Medivir is obliged to pay in connection with a licensing agreement is based on the distribution of actual future revenues to Medivir.

On January 11, 2021 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported a business update, including preliminary total revenue, TAVALISSE (fostamatinib disodium hexahydrate) bottles sold for the quarter, Fast Track designation granted for warm autoimmune hemolytic anemia (wAIHA), and the company’s expanding COVID-19 program (Press release, Rigel, JAN 11, 2021, View Source [SID1234577477]). The company’s president and CEO, Raul Rodriguez, will provide a more detailed company overview during his presentation taking place on Thursday, January 14, 2020 at 10:00 am ET at the 39th Annual J.P. Morgan Virtual Healthcare Conference.

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"Rigel’s accomplishments during the extraordinary global events of 2020 position the company well as we enter the new year," said Raul Rodriguez, Rigel’s president and CEO. "Annual sales of TAVALISSE grew by 41% compared to 2019, and its use as an earlier line treatment option for ITP is resonating with both patients and physicians. We are continuing to enroll our Phase 3 trial in wAIHA and we have received Fast Track designation from the FDA which is intended to expedite the review of a potential regulatory filing.

"The availability of vaccines is a critical step in managing the COVID-19 pandemic, but we expect there will continue to be a significant need for therapeutics. Our Phase 3 trial in COVID-19 has launched and topline data from the National Institutes of Health Phase 2 trial is expected in April, which will provide a near-term look at the potential of fostamatinib in this disease."

Commercial and Preliminary Financial Update
In the fourth quarter of 2020, a total of 1,899 bottles of TAVALISSE were sold in the U.S., of which 1,725 were shipped directly to patients and clinics. While Rigel is still in the process of determining final results for the fourth quarter of 2020, the company expects to report net product sales of approximately $17.7 million, compared to $13.8 million in the same period of 2019, an increase of 28%.

Contract revenues from collaborations for the quarter ended December 31, 2020, are expected to be approximately $697,000, which consists of $500,000 from Grifols related to an option for commercialization in additional territories and $197,000 in revenues earned from the performance of certain research and development services from Rigel’s collaboration agreement with Grifols.

For the fourth quarter 2020, Rigel expects to report total revenue of approximately $18.4 million.

The company expects to report cash, cash equivalents and short-term investments as of December 31, 2020 of approximately $57.3 million, compared to $98.0 million as of December 31, 2019.

The above information is preliminary, has not been audited and is subject to change upon completion of the audit of the company’s financial statements as of and for the year ended December 31, 2020.

Portfolio Update
Phase 3 Trial in wAIHA
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to TAVALISSE for the treatment of wAIHA based on the significant medical need that exists and the product’s potential in the treatment of these patients. Fast Track designation is designed to enable an expedited review process for any potential regulatory filings. Currently, the study has enrolled 64 of 90, or 71%, of the patients planned for enrollment.

COVID-19 Program
The Phase 2 clinical trial sponsored by NIH/NHLBI, in collaboration with Inova Health System, to evaluate the safety of fostamatinib for the treatment of COVID-19 has enrolled 44 of the 60 patients planned for enrollment. In this trial, patients are being randomized to fostamatinib plus standard of care (SOC) or matched placebo plus SOC (1:1), administered orally twice daily for 14 days. There will be a follow-up period to day 60. The primary endpoint of this study is cumulative incidence of serious adverse events (SAE) through day 29, with multiple secondary endpoints designed to assess the early efficacy and clinically relevant endpoints of disease course as well as in vitro biological correlatives evaluating the effects of the drug on pathways involved in the pathophysiology of COVID-19, including NETosis. Rigel anticipates topline data to be reported in April of this year.

In addition, Rigel has launched its Phase 3 clinical trial to evaluate the safety and efficacy of fostamatinib in hospitalized COVID-19 patients without respiratory failure that have certain high-risk prognostic factors. The multi-center, double-blind, placebo-controlled, adaptive design study is expected to enroll over 300 evaluable patients that will be randomly assigned to either fostamatinib plus SOC or matched placebo plus SOC (1:1). Treatment will be administered orally twice daily for 14 days with a follow-up period to day 60. The primary endpoint of this study is the proportion of subjects who progress to severe/critical disease within 29 days.

In December, the Journal of Infectious Diseases (JID) published research from NIH which demonstrated that R406, the active metabolite of fostamatinib, was able to inhibit NETosis ex vivo in donor plasma from patients with COVID-19. NETosis is a unique type of cell death resulting in the release of neutrophil extracellular traps (NETs). NETs contribute to thromboinflammation and have been associated with mortality in COVID-19. These data provide insights for how fostamatinib may mitigate neutrophil-associated mechanisms contributing to COVID-19 immunopathogenesis.1

Clinical Development Pipeline
Rigel’s IRAK1/4 program includes R835, an orally available, potent and selective inhibitor and the only molecule in clinical development that inhibits both IRAK1 and IRAK4. The company plans to pursue this program’s potential in hematology/oncology and rare diseases, where it believes there are areas of significant unmet medical need.

Rigel has an extensive RIPK1 inhibitor program. This program includes R552, an oral systemic RIPK1 inhibitor which has completed a Phase 1 study, as well as RIPK1 inhibitor candidates that cross the blood-brain barrier (CNS-penetrants). RIPK1 inhibitors have broad potential in numerous large indications. In order to fully develop these assets, Rigel intends to enter into a collaboration for this program.

39th Annual J.P. Morgan Webcast Presentation Details
Rigel’s presentation will be webcast and is scheduled to take place Thursday, January 14 at 10:00 am ET. To access the live and subsequently archived webcast, go to the Investor Relations section of the company’s website at www.rigel.com. Please connect to the website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.

About ITP
In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP include fatigue, excessive bruising, and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. In addition to fostamatinib, current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs) and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About AIHA
Autoimmune hemolytic anemia (AIHA) is a rare, serious blood disorder in which the immune system produces antibodies that recognize and mediate the destruction of the body’s own red blood cells. AIHA affects approximately 45,000 adult patients in the U.S. and can be a severe, debilitating disease. Warm AIHA (wAIHA), the most common form of AIHA, is characterized by the presence of antibodies that react with the red blood cell surface at body temperature. To date, there are no disease-targeted therapies approved for AIHA, despite the unmet medical need that exists for these patients.

About COVID-19 & SYK Inhibition
COVID-19 is the infectious disease caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). SARS-CoV-2 primarily infects the upper and lower respiratory tract and can lead to acute respiratory distress syndrome (ARDS). Additionally, some patients develop other organ dysfunction including myocardial injury, acute kidney injury, shock resulting in endothelial dysfunction and subsequently micro and macrovascular thrombosis.2 Much of the underlying pathology of SARS-CoV-2 is thought to be secondary to a hyperinflammatory immune response associated with increased risk of thrombosis.3

SYK is involved in the intracellular signaling pathways of many different immune cells. Therefore, SYK inhibition may improve outcomes in patients with COVID-19 via inhibition of key Fc gamma receptor (FcγR) and c-type lectin receptor (CLR) mediated drivers of pathology, such as inflammatory cytokine release by monocytes and macrophages, production of neutrophil extracellular traps (NETs) by neutrophils, and platelet aggregation.4,5,6 Furthermore, SYK inhibition in neutrophils and platelets may lead to decreased thromboinflammation, alleviating organ dysfunction in critically ill patients with COVID-19.

About TAVALISSE
Indication
TAVALISSE (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Important Safety Information
Warnings and Precautions

Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.
Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.
Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.
TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.
Drug Interactions

Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.
It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.
Adverse Reactions

Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).
Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.
Please see www.TAVALISSE.com for full Prescribing Information.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

TAVALISSE and TAVLESSE are registered trademarks of Rigel Pharmaceuticals, Inc.

On January 11, 2021 Herantis Pharma Plc ("Herantis"), an innovative drug development company pioneering new disease modifying and regenerative biologic and gene therapies, reported that Craig Cook, Chief Executive Officer of Herantis, will present at the H.C. Wainwright BioConnect 2021 Virtual Conference taking place January 11-14, 2021 (Press release, Herantis Pharma, JAN 11, 2021, View Source;wainwright-bioconnect-2021-virtual-conference,c3265921 [SID1234577473]).

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The video webcast presentation will be available for viewing on-demand beginning Monday, January 11, 2021, at 6:00 ET / 13:00 EET / 12:00 CET. To access the live webcast of Herantis’ live presentation, please visit: View Source

A replay of the webcast can be accessed for up to 90 days following the live presentation.

On January 11, 2021 Galapagos NV (Euronext & NASDAQ: GLPG) reported that received a transparency notification from Gilead Sciences, Inc (Press release, Galapagos, JAN 11, 2021, View Source [SID1234577427]).

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Pursuant to Belgian transparency legislation1, Galapagos received a transparency notification on 6 January 2021 from Gilead Sciences, Inc., who notified a change in the chain of intermediary companies through which Gilead holds its shares in Galapagos. The change in the chain of intermediary companies is the result of an internal reorganization as a result of which Gilead holds its shares in Galapagos as of 31 December 2020 through its direct subsidiary Gilead Biopharmaceutics US, LLC, which through Gilead Sciences Ireland UC controls Gilead Therapeutics A1 Unlimited Company, which in turn holds 16,707,477 of Galapagos’ voting rights, consisting of 16,707,477 shares (unchanged). Those 16,707,477 shares represent 25.54% of Galapagos’ currently outstanding 65,411,767 shares.