NOVARTIS AG CHF0.50(REGD) Novartis Receives Fda Approval For Beovu(R), Offering Wet Amd Patients Vision Gains And Greater Flu...

Date : 10/08/2019 @ 5:45AM
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NOVARTIS AG CHF0.50(REGD) Novartis Receives Fda Approval For Beovu(R), Offering Wet Amd Patients Vision Gains And Greater Flu...

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   -- In two head-to-head clinical trials, patients on Beovu (brolucizumab) 
      achieved vision gains that were non-inferior to aflibercept at year one 
      with longer treatment intervals in a majority of patients[1],[2] 
 
   -- Beovu demonstrated greater reductions in central subfield thickness (CST, 
      a key indicator of fluid in the retina) as early as week 16 and at one 
      year versus aflibercept[2] 
 
   -- Beovu is the only anti-VEGF in wet AMD recommended to maintain eligible 
      patients on up to three-month dosing intervals immediately after the 
      loading phase with no compromise in efficacy[1],[2] 
 
   -- In both clinical trials, at year one over half of patients were 
      maintained on the three-month dosing interval (56% in HAWK and 51% in 
      HARRIER)[1],[2] 
 
   -- Frequent injection intervals are a common reason patients drop off 
      treatment for wet age-related macular degeneration (AMD), a leading cause 
      of blindness, affecting more than 20M people worldwide[3]-[5] 
 
 
   Basel, October 8, 2019 -- Novartis today announced that the U.S. Food 
and Drug Administration (FDA) approved Beovu(R) (brolucizumab) injection, 
also known as RTH258 for the treatment of wet age-related macular 
degeneration (AMD)[1]. Beovu is the first FDA approved anti-VEGF to 
offer both greater fluid resolution versus aflibercept and the ability 
to maintain eligible wet AMD patients on a three-month dosing interval 
immediately after a three-month loading phase[1] with uncompromised 
efficacy. 
 
   "Beovu meets our goals in clinical practice for treating wet AMD: 
improving vision and drying retinal fluid," said Dr. Pravin U. Dugel, 
Managing Partner, Retinal Consultants of Arizona; Clinical Professor, 
Roski Eye Institute, Keck School of Medicine, University of Southern 
California; and principal investigator of the HAWK clinical trial. "With 
Beovu, greater fluid reduction was demonstrated through larger decreases 
in retinal thickness and a higher proportion of patients with drier 
retinas. Coupled with the potential to treat patients with quarterly 
injections, this approval may change the way we approach the treatment 
of wet AMD." 
 
   The approval of Beovu was based on findings from the Phase III HAWK and 
HARRIER clinical trials, in which Beovu demonstrated non-inferiority 
versus aflibercept in mean change in best-corrected visual acuity (BCVA) 
at year one (week 48)[1],[2]. 
 
   In both clinical trials, approximately 30% of patients gained at least 
15 letters at year one[1],[2]. In HAWK and HARRIER, Beovu showed greater 
reduction in central subfield thickness (CST) as early as week 16 and at 
year one, and fewer patients had intra-retinal (IRF) and/or sub-retinal 
fluid (SRF)[2]. Retinal fluid is a key marker of disease activity[6]. 
 
   Wet AMD is a chronic, degenerative eye disease caused by an excess of 
VEGF, a protein that promotes the growth of abnormal blood vessels 
underneath the macula, the area of the retina responsible for sharp, 
central vision[7],[8]. Fluid that leaks out of these abnormal blood 
vessels disrupts the normal retinal structure and ultimately damages the 
macula[8]-[10]. The Beovu molecule is engineered to deliver the highest 
concentration of drug, providing more active binding agents than other 
anti-VEGFs[2]. By inhibiting VEGF, Beovu suppresses the growth of 
abnormal blood vessels and the potential for fluid leakage into the 
retina[2]. 
 
   "The approval of Beovu delivers on the Novartis commitment to 
reimagining treatments for patients suffering from serious visual 
impairment," said Marie-France Tschudin, President, Novartis 
Pharmaceuticals. "The product labels of existing treatments state that 
they are not as effective when dosed every 12 weeks. Beovu is the first 
to offer less frequent dosing in the first year of therapy while 
maintaining its effectiveness. This gives more time for wet AMD patients 
to focus on what's important in their lives." 
 
   In HAWK and HARRIER, eligible patients could be maintained on a 
three-month dosing interval immediately after the loading phase[1],[2]. 
At year one, over half of patients were maintained on the three-month 
dosing interval (56% in HAWK and 51% in HARRIER)[1],[2]. The remaining 
patients in the study were treated on a two-month dosing schedule[1], 
[2]. 
 
   Beovu exhibited an overall safety profile comparable to aflibercept. 
Beovu is contraindicated in patients with ocular or periocular 
infections, active intraocular inflammation or with known 
hypersensitivity to brolucizumab or any of the excipients in Beovu[1]. 
Hypersensitivity reactions may manifest as rash, pruritus, urticaria, 
erythema or severe intraocular inflammation[1]. 
 
   The most common adverse events (>=5% of patients) with Beovu were vision 
blurred, cataract, conjunctival hemorrhage, vitreous floaters and eye 
pain[1],[2]. 
 
   Wet AMD distorts central vision and ultimately causes blindness and loss 
of independence[11],[12]. Estimates suggest that in 2020, 1.75 million 
people in the U.S. will be living with wet AMD[13]-[15], making it a 
growing public health concern. Early symptoms of wet AMD include blurry 
or wavy vision[8]. As the disease progresses, patients lose central 
vision so it becomes difficult to see objects directly in front of 
them[8]. 
 
   "As sight disappears, so does a person's connection to the world," said 
Dawn Prall, Founder and  Executive Director, The Support Sight 
Foundation. "We welcome a new treatment that helps maintain vision and 
has the potential for quarterly treatments, which can reduce the burden 
on patients and their caregivers and help people with wet AMD keep doing 
what they love with the people they love." 
 
   With this approval, Novartis is offering BEOVU Your Way(TM) in the U.S. 
This program provides personalized, one-on-one support for patients and 
caregivers, with access to a care specialist committed to understanding 
patients' unique needs and preferences. Novartis is proud to be 
partnering with patient advocacy organizations to deliver educational 
materials for patients and caregivers, with the goal of empowering wet 
AMD patients to live safely and independently. 
 
   About Beovu (brolucizumab) 
 
   Beovu (brolucizumab) is the most clinically advanced humanized 
single-chain antibody fragment (scFv)[2],[16]. Single-chain antibody 
fragments are highly sought after in drug development due to their small 
size, enhanced tissue penetration, rapid clearance from systemic 
circulation and drug delivery characteristics[16]-[18]. 
 
   The proprietary innovative structure results in a small molecule (26 
kDa) with potent inhibition of, and high affinity to, all VEGF-A 
isoforms[17]. Beovu is engineered to deliver the highest concentration 
of drug, providing more active binding agents than other anti-VEGFs[2], 
[16]. In preclinical studies, Beovu inhibited activation of VEGF 
receptors through prevention of the ligand-receptor 
interaction[17]-[19]. Increased signaling through the VEGF pathway is 
associated with pathologic ocular angiogenesis and retinal edema[20]. 
Inhibition of the VEGF pathway has been shown to inhibit the growth of 
neovascular lesions and suppress endothelial cell proliferation and 
vascular permeability[20]. 
 
   About the HAWK and HARRIER studies 
 
   With more than 1,800 patients across nearly 400 centers worldwide, HAWK 
(NCT02307682) and HARRIER (NCT02434328) are the first and only global 
head-to-head trials in patients with wet AMD that prospectively 
demonstrated efficacy at week 48 using an innovative q12w/q8w regimen, 
with a majority of patients on q12w immediately following the loading 
phase[2]. Both studies are 96-week prospective, randomized, 
double-masked multi-center studies and part of the Phase III clinical 
development of Beovu[2]. The studies were designed to compare the 
efficacy and safety of intravitreal injections of brolucizumab 6 mg 
(HAWK and HARRIER) and 3 mg (HAWK only) versus aflibercept 2 mg in 
patients with wet AMD[2]. 
 
   About wet age-related macular degeneration 
 
   Wet AMD is the leading cause of severe vision loss and legal blindness 
in people over the age of 65 in North America, Europe, Australia and 
Asia, impacting an estimated 20 million people worldwide[4],[5],[11]. It 
is estimated that 1.75 million people in the U.S. will be living with 
wet AMD in 2020[13]-[15]. Wet AMD occurs when abnormal blood vessels 
form underneath the macula, the area of the retina responsible for sharp, 
central vision[8]-[10]. These blood vessels are fragile and leak fluid, 
disrupting the normal retinal architecture and ultimately causing damage 
to the macula[8]-[10]. 
 
   Early symptoms of wet AMD include distorted vision (or metamorphopsia) 
and difficulties seeing objects clearly[8],[21]. Prompt diagnosis and 
intervention are essential[10]. As the disease progresses, cell damage 
increases, further reducing vision quality[8]. This progression can lead 
to a complete loss of central vision, leaving the patient unable to read, 
drive or recognize familiar faces and potentially depriving them of 
their independence[8],[12]. Without treatment, vision can rapidly 
deteriorate[22]. 
 
   About Novartis in ophthalmology 
 
   At Novartis, our mission is to discover new ways to improve and extend 
people's lives. In ophthalmology, we develop and deliver life-changing 
medicines and therapies for diseases and conditions from front to back 
of the eye, enabled by data and transformative technologies. Our 
ophthalmic solutions reach more than 150M people per year, from 
premature infants to the elderly. 
 
   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. 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; global trends toward health care cost containment, 
including government, payor and general public pricing and reimbursement 
pressures and requirements for increased pricing transparency; our 
ability to obtain or maintain proprietary intellectual property 
protection; the particular prescribing preferences of physicians and 
patients; general political and economic conditions; 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 Novartis 
 
   Novartis is reimagining medicine to improve and extend people's lives. 
As a leading global medicines company, we use innovative science and 
digital technologies to create transformative treatments in areas of 
great medical need. In our quest to find new medicines, we consistently 
rank among the world's top companies investing in research and 
development. Novartis products reach more than 750 million people 
globally and we are finding innovative ways to expand access to our 
latest treatments. About 108 000 people of more than 140 nationalities 
work at Novartis around the world. Find out more at www.novartis.com. 
 
   Novartis is on Twitter. Sign up to follow @Novartis at 
http://twitter.com/novartisnews 
 
   For Novartis multimedia content, please visit 
www.novartis.com/news/media-library 
 
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   References 
 
   [1]            BEOVU [prescribing information] East Hanover, NJ. 
Novartis: 2019. 
 
   [2]            Dugel P, et al. HAWK and HARRIER: Phase 3, multicenter, 
randomized, double-masked trials of brolucizumab for neovascular 
age-related macular degeneration [published online ahead of print]. 
Ophthalmology. 2019. 
 
   [3]            Varano M, et al. Current barriers to treatment for wet 
age-related macular degeneration (wAMD): findings from the wAMD patient 
and caregiver survey. Clin Ophthalmol. 2015;9:2243--2250. 
 
   [4]            Wong WL, Su X, Li X, et al. Global prevalence of 
age-related macular degeneration and disease burden projection for 2020 
and 2040: a systematic review and met analysis. Lancet Glob Health. 
2014;2:106-16. 
 
   [5]            Singer M. Advances in the management of macular 
degeneration. F1000Prime Rep. 2014;6:29. 
 
   [6]            Arnold J, et al. The role of sub-retinal fluid in 
determining treatment outcomes in patients with neovascular age-related 
macular degeneration--a phase IV randomised clinical trial with 
ranibizumab: the FLUID study. BMC Ophthalmol. 2016;143(4):679-680. 
 
   [7]            Qazi Y, et al. Mediators of ocular angiogenesis. J. 
Genet. 2009;88(4):495-515. 
 
   [8]            National Eye Institute. Facts About Age-Related Macular 
Degeneration. Available at 
https://nei.nih.gov/health/maculardegen/armd_facts (link is external). 
Accessed September 2019. 
 
   [9]            World Health Organization. Priority eye diseases: 
Age-related macular degeneration. Available at 
http://www.who.int/blindness/causes/priority/en/index7.html (link is 
external). Accessed September 2019. 
 
   [10]          NHS Choices. Macular Degeneration. Available at 
http://www.nhs.uk/Conditions/Macular-degeneration/Pages/Introduction.aspx 
(link is external). Accessed September 2019. 
 
   [11]          Schmidt-Erfurth U, et al. Guidelines for the management of 
neovascular age-related macular degeneration by the European Society of 
Retina Specialists (EURETINA). Br J Ophthalmol. 2014;98:1144-1167. 
 
   [12]          Mitchell J, Bradley C. Quality of life in age-related 
macular degeneration: a review of the literature. Health Qual Life 
Outcomes. 2006;4:97. 
 
   [13]          Friedman DS, O'Colmain BJ, Munoz B, et al. Prevalence of 
age-related macular degeneration in the United States. Arch Ophthalmol. 
2004;122(4):564-72. 
 
   [14]          Klein R, Chou CF, Klein BE, Zhang X, Meuer SM, Saaddine 
JB. Prevalence of age-related macular degeneration in the U.S. 
population. Arch Ophthalmol. 2011;129(1):75-80. 
 
   [15]          American Academy of Ophthalmology. Age-related macular 
degeneration preferred practice patterns. Available at: 
https://www.aao.org/preferred-practice-pattern/age-related-macular-degeneration-ppp-2015 
(link is external). Accessed September 2019. 
 
   [16]          Nimz EL, et al. Intraocular and systemic pharmacokinetics 
of brolucizumab (RTH258) in nonhuman primates. The Association for 
Research in Vision and Ophthalmology (ARVO) annual meeting. 2016. 
Abstract 4996. 
 
   [17]          Escher D, et al. Single-chain antibody fragments in 
ophthalmology. Oral presentation at EURETINA congress. 2015. Abstract. 
 
   [18]          Gaudreault J, et al. Preclinical pharmacology and safety 
of ESBA1008, a single-chain antibody fragment, investigated as potential 
treatment for age related macular degeneration. ARVO Annual Meeting 
abstract. Invest Ophthalmol Vis Sci 2012;53:3025. 
http://iovs.arvojournals.org/article.aspx?articleid=2354604 (link is 
external). Accessed September 2019. 
 
   [19]          Tietz J, et al. Affinity and Potency of RTH258 (ESBA1008), 
a Novel Inhibitor of Vascular Endothelial Growth Factor A for the 
Treatment of Retinal Disorders. IOVS. 2015; 56(7):1501. 
 
   [20]          Kim R. Introduction, mechanism of action and rationale for 
anti-vascular endothelial growth factor drugs in age-related macular 
degeneration. Indian J Ophthalmol. 2007;55(6):413-415. 
 
   [21]          Healthline. What is metamorphopsia? Available at 
https://www.healthline.com/health/metamorphopsia (link is external). 
Accessed September 2019. 
 
   [22]          van Lookeren Campagne M, et al. Mechanisms of age-related 
macular degeneration and therapeutic opportunities. J Pathol. 2014; 
232(2):151-64. doi: 10.1002/path.4266. 
 
   # # # 
 
   Novartis Media Relations 
 
   E-mail: media.relations@novartis.com 
 
 
 
 
Antonio Ligi                          Amy Wolf 
 Novartis External Communications      Global Head, Ophthalmology Communications 
 +41 61 324 1374 (direct)              +41 61 696 5894 (direct) 
 antonio.ligi@novartis.com             +41 79 576 0723 (mobile) 
 Eric Althoff                          amy.wolf@novartis.com 
 Novartis US External Communications 
 +1 646 438 4335 
 eric.althoff@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 
Pierre-Michel Bringer   +41 61 324 1065    Cory Twining  +1 862 778 3258 
Thomas Hungerbuehler    +41 61 324 8425 
Isabella Zinck          +41 61 324 7188 
 
 
 
 
 
 

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October 08, 2019 01:30 ET (05:30 GMT)

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