NASDAQ: OTLK outlooktherapeutics.com
This presentation contains forward-looking statements about Outlook Therapeutics, Inc. ("Outlook Therapeutics" or the "Company") based onmanagement's current expectations, which are subject to known and unknown uncertainties and risks. Words such as "anticipate," "believe," "estimate,""expect," "explore," "initiate," "intend," "may," "plan," "potential," "seek," "target," "will," and variations of these words or similar expressions are intended toidentify forward-looking statements. These forward-looking statements include, among others, statements about ONS-5010's potential as the first U.S.
Food and Drug Administration (FDA)-approved and/or European Medicines Agency (EMA) approved ophthalmic formulation of bevacizumab-vikg, our expectations for ONS-5010 market exclusivity, expectations concerning our ability to remediate or otherwise resolve deficiencies identified in our Complete Response Letter (CRL) issued by the FDA, including with respect to an additional clinical trial and chemistry, manufacturing and controls (CMC) issues, expectations concerning the NORSE EIGHT trial design, the timing for initiation and completion of NORSE EIGHT and resubmission of the Biologics License Application (BLA) for ONS-5010, expectations concerning decisions of regulatory bodies, including the FDA and EMA, and the timing thereof, plans for potential commercial launch of ONS-5010 in the United States and European Union, expectations concerning the relationship with Cencora and the benefits and potential expansion thereof, ONS-5010's ability to replace and address issues with off-label use of Avastin, other drug candidates in development, commercial drivers for ONS-5010 and its potential, the success of ongoing ONS-5010 trials for wet age-related macular degeneration (AMD), planned trials for ONS-5010 for diabetic macular edema (DME) and branch retinal vein occlusion (BRVO), expectations concerning the size of the market for, and potential issuers of ONS-5010, the sufficiency of our capital resources and other statements that are not historical fact. Our actual results could differ materially from those discussed due to a number of factors, including, but not limited to, the risks inherent in developing pharmaceutical product candidates, conducting successful clinical trials, and obtaining regulatory approvals, including our ability to resolve issues identified in the CRL issued by the FDA, as well as our ability to raise additional equity and debt financing on favorable terms, among other risk factors. These risks are described in more detail under the caption "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended September 30, 2023, and other filings with the Securities and Exchange Commission, which include the uncertainty of future impacts related to macroeconomic factors,including as a result of the ongoing overseas conflict, high interest rates, inflation and potential future bank failures on the global business environment.Moreover, Outlook Therapeutics operates in a very competitive and rapidly changing environment. New risks emerge from time to time. It isnot possiblefor our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination offactors, may cause actual results to differ materially from those contained in any forward-looking statement. In light of these risks, uncertainties andassumptions, the forward-looking statements discussed in this presentation may not occur and actual results could differ materially and adversely fromthose anticipated or implied.
Redefining the standard of care forretina disorders, including wet AMD,DME and BRVO
Working to achieve the first approvalfor bevacizumab in ophthalmology
*Dates and timelines are listed incalendar year
1. ONS-5010 / LYTENAVA (bevacizumab-vikg) is an investigational ophthalmic formulation of bevacizumab
2. Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group, Daniel F. Martin, Ophthalmology, July 2012 Volume 119, Issue 7, Pages 1388-1398
ONS-5010 / LYTENAVA
(bevacizumab-vikg; bevacizumab gamma)1
Ophthalmic formulation of bevacizumab in development for the treatment of wet AMD
Positive European CHMP Opinion
Serves as basis for final decision of potential EU market approval targeted Q2 2024
US FDA Biologics License Applications (BLA)
resubmission expected before year end 2024
Bevacizumab has been validated2 in wet AMD and is used off-label as a first-line treatment3
Targeting $15.9 Billion global ophthalmic anti-VEGF market4
3. ASRS 2022 Membership Survey Presented at ASRS NY 2022. Q: Considering all indications, what is your most commonly used first-line anti-VEGF agent?
4. Citeline (2023), Global Data (2023) and Market Scope (2022)
3
Bevacizumab (Brand Name Avastin®) Approved as an OncologyDrug in2004
Most Commonly Used First-Line Anti-VEGF for Treatment of Wet AMD
Not Approved for Ophthalmic Use
Current Situation
55.4% of new diagnosed wet AMD patients start with off-label, unapproved bevacizumab1
66.3% of US retina physicians state off-label, unapproved bevacizumab is their most commonly used first-line anti-VEGF2
However, switching to an FDA approved anti-VEGF may occur up to over 40% of the time by year 3 of treatment
This may be occurring due to the limitations of off-label (non-ophthalmic) repackaged bevacizumab, specifically:
• Lack of potency,
• Significant safety issues
•Quality and supply issues
1. Medicare Claims Analysis 2023: Guidehouse Analysis
Outlook Therapeutics Opportunity
Ophthalmic formulation of bevacizumab is a 351 (a) BLA submission in the US and a fullmixed MAA application based on Article 8.3 of Directive 2001/83/EC in the EU12-years regulatory exclusivityexpected upon approval in the United States
10 years market exclusivity expected upon approval in the EU
Potential to eliminate safety risksassociated with repackagedbevacizumab, impurities, particulates, and lack of drugpotency
2. ASRS 2022 Membership Survey Presented at ASRS NY 2022. Q: Considering all indications, what is your most commonly used first-line anti-VEGF agent?
Currently Estimated to be in Excess of $15.9 Billion Worldwide1
Market | Number of Treated Patients | Physician Interest in an Approved Bevacizumab | Total Market Opportunity |
United States | 1.75 Million2 | 85% | $8.5 Billion1 |
EU+UK | 1.52 Million3 | 82% | $3.6 Billion1 |
1. Citeline (2023), GlobalData (2023) and Market Scope (2022)
2. Triangulation of Global Data, Market Scope Data, CDC Vision and Eye Health Surveillance System (VEHSS)
3. Guidehouse Triangulation of Global Data, Market Scope 2022 Retinal Pharmaceuticals Market Report
Price according to what payers and retina specialists have indicated is reasonable
United States
$75+
Unapproved
Repackaged Avastin (off-label)
$500
EU+ UK
€30-€80
Compounded Bevacizumab
€300-€900
Biosimilars (ranibizumab or aflibercept)
$1,000
Ranibizumab Biosimilars
€400-€1000
Branded Premium Priced
$1,300
$2,000+
Branded Premium Priced
NotHeld to FDA Ophthalmic Quality Standards When Repackaged
Variability in
Potency1
Repackaged at Compounding Pharmacies
81% of samples had lower protein
concentrationsthanrequired.
Demonstratedinconsistenciesof
compounded Avastinfromsyringe
Safety and Sterility Adverse Events2
Frequent recalls and compliance issues by compounders cause service interruptions and endanger patient safety and consistency of treatment
tosyringe
1. JAMA Ophthalmol.2015Jan;133(1):32-9. doi: 10.1001/jamaophthalmol.2014.3591
2. Goldberg, Roger A et al. "An outbreak of streptococcus endophthalmitis after intravitreal injection of bevacizumab." American Journal of Ophthalmology vol. 153,2 (2012): 204-208.e1. doi:10.1016/j.ajo.2011.11.035
3. ASRS Member Alert, April 2019
SyringeAdverse Events3
Include mechanical failures,visibleparticulates, and quality challengescaused by long-term storage inimmediate use syringes
Ophthalmic Solution Requirement | Off-Label Compounded Repackaged IV Solution Matches to Ophthalmic Approval Requirements | FDA Approved Ophthalmic Solution for Intravitreal Injection |
Sterile USP<71>1 | Unknown | Yes |
ParticulatesperUSP <789> for ophthalmic solutions1 | Unknown | Yes |
GMP2,3 | Unknown | Yes |
Bacterial endotoxinsUSP <85>1 | No | Yes |
FDA approvedophthalmicpackageconsistent with USP <771>1 | No | Yes |
FDA reviewedstability data supportingshelf life2,3 | No | Yes |
pH FDA approvedand consistent withUSP<771>1,2,3 | No | Yes |
Potency FDAapproved specificationsforshelf life2,3 | No | Yes |
Osmolarity specificationfor ophthalmicsolution2,3 | No | Yes |
1. USP general Chapter<771>OPHTHALMIC PRODUCTS-QUALITY TESTS USP40-NF35, second supplement, June 1, 2017; 2: Aldrich, Dale S., Bach, Cynthia M.,Brown, William,Chambers, Wiley, Fleitman,Jeffrey, Hunt, Desmond, Marques, Margareth R. C., Mille, Yana, Mitra, Ashim K., Platzer, Stacey M., Tice, Tom, Tin, George W.; Ophthalmic Preparations USP STIMULI TO THE REVISIONPROCESSVol.39(5)[Sept.-Oct. 2013]; 3: Missel PJ, Lang JC, Rodeheaver DP, Jani R, Chowhan MA, Chastain J, Dagnon T. Design and evaluation of ophthalmic pharmaceutical products. In: Florence,AT, Siepmann J. Modern Pharmaceutics-Applications and Advances. New York: Informa; 2009:101-189.
ONS-5010 must meet or exceed ophthalmic standards
Ensuring quality (e.g. cold chain) from "dock to doctor"
Achieved ~42% 3-line gainers
ONS-50101:Achieved 11.2 BCVA lettersAllowed ~85% of patients to "gain or maintain" vision through every study endpoint through 11 months
Up to 40.7% of patients switch to an approved ophthalmic anti-VEGF agent by year 3 of treatment2
This allows physicians to "Start and Stay" on ONS-5010, if approved, avoiding the need to switch to anew anti-VEGF
Ophthalmologists Have Told Us…
Surveyed Believe an FDA Approved Bevacizumab for Wet AMD is Important1
Surveyed Said They are Likely to Prescribe ONS-5010 if Approved1
"Repackaging a drug or biological product could change its characteristics in ways that have not been evaluated during the approval process and that could affect the safety and effectiveness of the product. Improperrepackaging of drugs and biological products can cause serious adverse events.2"
1. Spherix Global Insight Market Research; N=97, April 2022
2. Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application Guidance for Industry - January 2018 Compounding and Related Documents
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Outlook Therapeutics Inc. published this content on 28 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 28 March 2024 21:51:26 UTC.