-- Sandoz to begin enrolling patients with neovascular age-related macular 
      degeneration in MYLIGHT Phase lll confirmatory efficacy and safety study1 
 
   -- Neovascular age-related macular degeneration accounts for 10% of 
      age-related macular degeneration cases, but is responsible for 90% of 
      AMD-related blindness2 
 
   -- With eight marketed biosimilar medicines globally and 15+ molecules in 
      pipeline, Sandoz is investing in future of biosimilars for patients and 
      healthcare systems 
 
 
   Holzkirchen, May 3, 2021 -- Sandoz, a Novartis division, today announced 
progress in the late-stage clinical development program for its proposed 
biosimilar aflibercept. Sandoz will begin enrolling the first patient in 
MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, 
shortly(1) . 
 
   Aflibercept is indicated to improve visual acuity in patients with 
neovascular age-related macular degeneration (nAMD), diabetic macular 
oedema, macular oedema secondary to retinal vein occlusion, and other 
specific neovascular retinal diseases(3) . 
 
   "nAMD accounts for 10% of all age-related macular degeneration cases, 
but is responsible for 90% of AMD-related blindness(2) ," said Florian 
Bieber, Global Head of Biopharmaceuticals Development, Sandoz. 
"Aflibercept is a key treatment in ophthalmology. The initiation of this 
study marks an important milestone in the development of our biosimilar 
aflibercept. As with all our biosimilar programs, we aim to expand 
access to high-quality, more affordable biologics." 
 
   MYLIGHT is part of a comprehensive biosimilar development program 
including analytical, preclinical and clinical data. The study aims to 
confirm that the proposed biosimilar has equivalent efficacy and 
comparable safety to the reference medicine* in patients with nAMD(1) . 
 
   Sandoz biosimilars help patients to access advanced biologic medicines 
more sustainably and affordably. The Sandoz division has a leading 
global portfolio with eight marketed biosimilars and a further 15-plus 
in various stages of development. The Sandoz biosimilar pipeline is a 
blend of in-house development and collaborations, both for 
co-development and commercialization, targeting key biologics in 
oncology, immunology, endocrinology and underserved complex disease 
areas. 
 
   About aflibercept 
 
   Aflibercept binds and inhibits ocular VEGF-A, and prevents abnormal 
growth of blood vessels in the choroid which impact visual function. It 
improves visual acuity in patients with neovascular retinal diseases 
like nAMD, Diabetic macular edema (DME), and Retinal vein occlusion 
(RVO). 
 
   About MYLIGHT 
 
   The MYLIGHT is a randomized, double-blind, parallel 2-arm study, which 
is projected to include 460 patients across 20 countries. The MYLIGHT 
study will be conducted in neovascular (wet) age-related macular 
degeneration as this is an adequately sensitive indication and 
representative of many patients who are treated with the medicine.(1) 
nAMD patients will be randomized to receive either biosimilar 
aflibercept or the reference medicine for 48 weeks. The primary endpoint 
is the mean change in best corrected visual acuity (BCVA) score from 
baseline to week 8, using a standard test chart (EDTRS). 
 
   The global development program for Sandoz' biosimilar aflibercept was 
developed in consultation with major regulatory agencies and the results 
from this clinical study are expected to support regulatory submissions. 
 
   *Eylea(R) is a trademark of Bayer AG and in the US of Regeneron 
Pharmaceuticals, Inc. 
 
   Disclaimer 
 
   This press release contains forward-looking statements within the 
meaning of the United States Private Securities Litigation Reform Act of 
1995. Forward-looking statements can generally be identified by words 
such as "potential," "can," "will," "plan," "expect," "anticipate," 
"look forward," "believe," "committed," "investigational," "pipeline," 
"launch," or similar terms, or by express or implied discussions 
regarding potential marketing approvals, new indications or labeling for 
the investigational or approved products described in this press release, 
or regarding potential future revenues from such products. You should 
not place undue reliance on these statements. Such forward-looking 
statements are based on our current beliefs and expectations regarding 
future events, and are subject to significant known and unknown risks 
and uncertainties. Should one or more of these risks or uncertainties 
materialize, or should underlying assumptions prove incorrect, actual 
results may vary materially from those set forth in the forward-looking 
statements. There can be no guarantee that the investigational or 
approved products described in this press release will be submitted or 
approved for sale or for any additional indications or labeling in any 
market, or at any particular time. Neither can there be any guarantee 
that, if approved, such generic or biosimilar products will be approved 
for all indications included in the reference product's label. Nor can 
there be any guarantee that such products will be commercially 
successful in the future. In particular, our expectations regarding such 
products could be affected by, among other things, the uncertainties 
inherent in research and development, including clinical trial results 
and additional analysis of existing clinical data; regulatory actions or 
delays or government regulation generally; the particular prescribing 
preferences of physicians and patients; competition in general, 
including potential approval of additional generic or biosimilar 
versions of such products; global trends toward health care cost 
containment, including government, payor and general public pricing and 
reimbursement pressures and requirements for increased pricing 
transparency; litigation outcomes, including intellectual property 
disputes or other legal efforts to prevent or limit Sandoz from selling 
its products; general political, economic and business conditions, 
including the effects of and efforts to mitigate pandemic diseases such 
as COVID-19; safety, quality or manufacturing issues; potential or 
actual data security and data privacy breaches, or disruptions of our 
information technology systems, and other risks and factors referred to 
in Novartis AG's current Form 20-F on file with the US Securities and 
Exchange Commission. Novartis is providing the information in this press 
release as of this date and does not undertake any obligation to update 
any forward-looking statements contained in this press release as a 
result of new information, future events or otherwise. 
 
   About Sandoz 
 
   Sandoz, a Novartis division, is a global leader in generic 
pharmaceuticals and biosimilars. Our purpose is to pioneer access for 
patients by developing and commercializing novel, affordable approaches 
that address unmet medical needs. Our ambition is to be the world's 
leading and most valued generics company. Our broad portfolio of 
high-quality medicines, covering all major therapeutic areas, accounted 
for 2020 sales of USD 9.6 billion. 
 
   Sandoz on social media: 
 
   LinkedIn: https://www.linkedin.com/company/sandoz/ 
 
   Twitter: https://twitter.com/sandoz_global 
 
   Facebook: https://www.facebook.com/sandozglobal/ 
 
   Instagram: https://www.instagram.com/sandozglobal 
 
   CEO Richard Saynor on LinkedIn: 
https://www.linkedin.com/in/richard-saynor/ 
 
   # # # 
 
   Sandoz Global Communications 
 
 
 
 
Chris Lewis 
 Sandoz Global Communications 
 +49 174 244 9501 (mobile) 
 chris.lewis@sandoz.com 
 
   Novartis Media Relations 
 
   E-mail: media.relations@novartis.com 
 
   Novartis Investor Relations 
 
   Central investor relations line: +41 61 324 7944 
 
   E-mail: investor.relations@novartis.com 
 
 
 
 
Central                                  North America 
Samir Shah              +41 61 324 7944  Sloan Simpson  +1 862 778 5052 
Thomas Hungerbuehler   +41 61 324 8425 
 Isabella Zinck         +41 61 324 7188 
 
 
 
   References 
 
 
   1. Phase III Study Assessing the Efficacy, Safety and Immunogenicity of 
      SOK583A1 Versus Eylea(R) in Patients With Neovascular Age-related Macular 
      Degeneration (Mylight). Availabel from: 
      https://clinicaltrials.gov/ct2/show/NCT04864834?term=CSOK583A12301&draw=2&rank=1. 
      [Accessed April 2021] 
 
   2. Morris B, et al. Postgrad Med J 2007;83:301--307 
 
   3. Decision Resources Group, Clarivate. Dry and wet age-related macular 
      degeneration. Disease Landscape and Forecast 2020. Available from: 
      https://decisionresourcesgroup.com/report/sptoop0004-biopharma-dry-and-wet-age-related-macular-degeneration [Accessed 
      April 2021] 
 
 
 
 
 
 

(END) Dow Jones Newswires

May 03, 2021 01:15 ET (05:15 GMT)