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    ROG   CH0012032048

ROCHE HOLDING AG

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Press Release : FDA approves Roche's Susvimo, a -2-

10/22/2021 | 02:30pm EST

vision in people with certain retinal conditions, and SusvimoTM (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant, the first FDA-approved refillable eye implant for nAMD that continuously delivers a customised formulation of ranibizumab over a period of months.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person.

Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. In recent years, Roche has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

*Lucentis(R) (ranibizumab injection) was developed by Genentech, a member of the Roche Group. Genentech retains commercial rights in the United States and Novartis has exclusive commercial rights for the rest of the world.

All trademarks used or mentioned in this release are protected by law.

References

[1] Pennington KL, DeAngelis MM. Epidemiology of age-related macular degeneration (AMD): associations with cardiovascular disease phenotypes and lipid factors. Eye and Vision. 2016;3:34.

[2] Little K, et al. Myofibroblasts in macular fibrosis secondary to neovascular age-related macular degeneration-the potential sources and molecular cues for their recruitment and activation. EBioMedicine. 2018;38:283-91.

[3] Schmidt-Erfurth U, et al. Intravitreal aflibercept injection for neovascular age-related macular degeneration: ninety-six-week results of the VIEW studies. Ophthalmology. 2014;121:193-201.

[4] Heier JS, et al. The Angiopoietin/Tie pathway in retinal vascular diseases: a review. Retina-J Ret Vit Dis. 2021;41:1-19.

[5] Holekamp N, Campochiaro P, et al. Archway Randomized Phase 3 Trial of the Port Delivery System With Ranibizumab for Neovascular Age-Related Macular Degeneration. Ophthalmology. 2021.

[6] FDA. Highlights of prescribing information, Susvimo. 2021

[7] ClinicalTrials.gov. Extension study for the port delivery system with ranibizumab (Portal) [Internet; cited October 2021]. Available from: https://clinicaltrials.gov/ct2/show/NCT03683251

[8] ClinicalTrials.gov. This study will evaluate the efficacy, safety, and pharmacokinetics of the port delivery system with ranibizumab in participants with diabetic macular edema compared with intravitreal ranibizumab (Pagoda) [Internet; cited October 2021]. Available from: https://clinicaltrials.gov/ct2/show/NCT04108156

[9] ClinicalTrials.gov. A multicenter, randomized study in participants with diabetic retinopathy without center-involved diabetic macular edema to evaluate the efficacy, safety, and pharmacokinetics of ranibizumab delivered via the port delivery system relative to the comparator arm (PAVILION) [Internet; cited October 2021]. Available from: https://clinicaltrials.gov/ct2/show/NCT04503551

[10] ClinicalTrials.gov. A study of the efficacy, safety, and pharmacokinetics of a 36-week refill regimen for the Port Delivery System with ranibizumab in patients with neovascular age-related macular degeneration (Velodrome) [Internet; cited October 2021]. Available from: https://clinicaltrials.gov/ct2/show/NCT04657289

[11] ClinicalTrials.gov. A phase III study to evaluate the Port Delivery System with ranibizumab compared with monthly ranibizumab injections in participants with wet age-related macular degeneration (ARCHWAY) [Internet; cited October 2021]. Available from: https://clinicaltrials.gov/ct2/show/NCT03677934

[12] Regillo C, et al. Port delivery system with ranibizumab (PDS) for nAMD: Updated data from the Archway phase 3 trial. Angiogenesis, Exudation, and Degeneration 2021 Annual Meeting; 2021 February 12--13.

[13] Bright Focus Foundation. Age-Related Macular Degeneration: Facts & Figures. [Internet; cited October 2021]. Available from: https://www.brightfocus.org/macular/article/age-related-macular-facts-figures

[14] Wong WL ,et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. The Lancet Global Health. 2014;2:106-16.

[15] Connolly E, et al. Prevalence of age-related macular degeneration associated genetic risk factors and 4-year progression data in the Irish population. Br J Ophthalmol. 2018;102:1691-95.

[16] FDA. Highlights of prescribing information, Lucentis. 2012 [Internet; cited October 2021]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076lbl.pdf

[17] Khan M, et al. Targeting Angiopoietin in retinal vascular diseases: A literature review and summary of clinical trials involving faricimab. Cells. 2020;9:1869.

Roche Group Media Relations

Phone: +41 61 688 8888 / e-mail: media.relations@roche.com https://www.globenewswire.com/Tracker?data=iQBwps7Cuv4M5BKY526pmHwFXLZWlDt0JKhTcKxNxbmjaOl2BmrmWEB8FXQz-f69we53RMXZlDmy04ngJ2XFug6v0rsbDWY5EAlDJVRwxJJ2ec-jL4qvbPHphoM4up56

 
Dr. Nicolas Dunant          Patrick Barth 
 Phone: +41 61 687 05 17     Phone: +41 61 688 44 86 
Dr. Barbara von Schnurbein  Karsten Kleine 
 Phone: +41 61 687 89 67     Phone: +41 61 682 28 31 
Nina Mählitz           Nathalie Meetz 
 Phone: +41 79 327 54 74     Phone: +41 61 687 43 05 
Sileia Urech 
 Phone: +41 79 935 81 48 
 

Roche Investor Relations

 
Dr. Karl Mahler                               Jon Kaspar Bayard 
 Phone: +41 61 68-78503                        Phone: +41 61 68-83894 
 e-mail: mailto:karl.mahler@roche.com          e-mail: jon_kaspar.bayard@roche.com 
 karl.mahler@roche.com 
--------------------------------------------  -------------------------------------- 
Dr. Sabine Borngräber                    Dr. Bruno Eschli 
 Phone: +41 61 68-88027                        Phone: +41 61 68-75284 
 e-mail: mailto:sabine.borngraeber@roche.com   e-mail: bruno.eschli@roche.com 
 sabine.borngraeber@roche.com 
--------------------------------------------  -------------------------------------- 
Dr. Birgit Masjost                            Dr. Gerard Tobin 
 Phone: +41 61 68-84814                        Phone: +41 61 68-72942 
 e-mail: mailto:birgit.masjost@roche.com       e-mail: mailto:gerard.tobin@roche.com 
 birgit.masjost@roche.com                      gerard.tobin@roche.com 
--------------------------------------------  -------------------------------------- 
 
 
 
Investor Relations North America 
Loren Kalm 
 Phone: +1 650 225 3217 
 e-mail: mailto:kalm.loren@gene.com 
 kalm.loren@gene.com 
----------------------------------- 
 

Attachment

   -- 22102021_MR_Susvimo_en 
      https://ml-eu.globenewswire.com/Resource/Download/7ff99201-7192-4e4d-9197-6875030b37f1 
 
 
 

(END) Dow Jones Newswires

October 22, 2021 14:30 ET (18:30 GMT)

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Sales 2021 62 134 M 67 058 M 67 058 M
Net income 2021 15 285 M 16 496 M 16 496 M
Net cash 2021 4 385 M 4 732 M 4 732 M
P/E ratio 2021 19,5x
Yield 2021 2,60%
Capitalization 310 B 336 B 335 B
EV / Sales 2021 4,92x
EV / Sales 2022 4,81x
Nbr of Employees 101 465
Free-Float 83,5%
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Severin Schwan Chief Executive Officer & Executive Director
Alan Hippe Chief Financial & Information Technology Officer
Christoph Franz Chairman
Urs Jaisli Chief Compliance Officer
AndrÚ S. Hoffmann Vice Chairman
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