Press Release : FDA accepts application for -2-

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. In May 2019, Roche acquired exclusive rights from Novartis to develop, manufacture, and commercialise ranibizumab in the PDS platform ex-US.

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

References

[1] 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.

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

[3] 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.

[4] Campochiaro P, et al. Primary analysis results of the phase 3 Archway trial of the port delivery system with ranibizumab for patients with neovascular AMD. American Society of Retina Specialists Annual Meeting; 2020 July 24--26.

[5] Holz FG, et al. Multi-country real-life experience of anti-vascular endothelial growth factor therapy for wet age-related macular degeneration. The British Journal of Ophthalmology. 2015;99:220-6. [4] 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.

[6] 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.

[7] ClinicalTrials.gov. Extension study for the port delivery system with ranibizumab (Portal) [Internet; cited June 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 June 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 June 2021]. Available from: https://clinicaltrials.gov/ct2/show/NCT04503551

[10] 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 June 2021]. Available from: https://clinicaltrials.gov/ct2/show/NCT03677934

[11] 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.

[12] 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.

[13] Wykoff CC, et al. Optimizing anti-VEGF treatment outcomes for patients with neovascular age-related macular degeneration. J Manag Care Spec Pharm. 2018;24(2-a Suppl):S3--S15.

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

Roche Group Media Relations

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June 24, 2021 01:00 ET (05:00 GMT)