`
`www.archive.org
`
`415.561.6767
`
`415.840-0391 e-fax
`
`
`
`Internet Archive
`
`300 Funston Avenue
`
`San Francisco, CA 94118
`
`_____________________
`
`AFFIDAVIT OF DUNCAN HALL
`
`
`
`1. I am a Records Request Processor at the Internet Archive, located in San Francisco,
`California. I make this declaration of my own personal knowledge.
`
`
`2. The Internet Archive is a website that provides access to a digital library of Internet
`sites and other cultural artifacts in digital form. Like a paper library, we provide
`free access to researchers, historians, scholars, and the general public. The Internet
`Archive has partnered with and receives support from various institutions,
`including the Library of Congress.
`
`
`3. The Internet Archive has created a service known as the Wayback Machine. The
`Wayback Machine makes it possible to browse more than 450 billion pages stored
`in the Internet Archive's web archive. Visitors to the Wayback Machine can search
`archives by URL (i.e., a website address). If archived records for a URL are
`available, the visitor will be presented with a display of available dates. The visitor
`may select one of those dates, and begin browsing an archived version of the Web.
`Links on archived files in the Wayback Machine point to other archived files
`(whether HTML pages or other file types), if any are found for the URL indicated
`by a given link. For instance, the Wayback Machine is designed such that when a
`visitor clicks on a hyperlink on an archived page that points to another URL, the
`visitor will be served the archived file found for the hyperlink’s URL with the
`closest available date to the initial file containing the hyperlink.
`
`
`4. The archived data made viewable and browseable by the Wayback Machine is
`obtained by use of web archiving software that automatically stores copies of files
`available via the Internet, each file preserved as it existed at a particular point in
`time.
`
`
`5. The Internet Archive assigns a URL on its site to the archived files in the format
`http://web.archive.org/web/[Year in yyyy][Month in mm][Day in dd][Time code in
`hh:mm:ss]/[Archived URL] aka an “extended URL”. Thus, the extended URL
`http://web.archive.org/web/19970126045828/http://www.archive.org/ would be the
`URL for the record of the Internet Archive home page HTML file
`(http://www.archive.org/) archived on January 26, 1997 at 4:58 a.m. and 28
`seconds (1997/01/26 at 04:58:28). A web browser may be set such that a printout
`from it will display the URL of a web page in the printout’s footer. The date
`indicated by an extended URL applies to a preserved instance of a file for a given
`URL, but not necessarily to any other files linked therein. Thus, in the case of a
`page constituted by a primary HTML file and other separate files (e.g., files with
`images, audio, multimedia, design elements, or other embedded content) linked
`within that primary HTML file, the primary HTML file and the other files will each
`have their own respective extended URLs and may not have been archived on the
`same dates.
`
`
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00880
`Page 1
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`

`

`
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`6. Attached hereto as Exhibit A are true and accurate copies of printouts of
`screenshots of the Internet Archive's records of the archived files for the URLs and
`the dates specified in the attached coversheet of each printout.
`
`
`7. I declare under penalty of perjury that the foregoing is true and correct.
`
`
`
`
`
`
`
`
`DATE: ________________________
`
`
`________________________
`Duncan Hall
`
`01/20/2021
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00880
`Page 2
`
`

`

`
`
`
`
`
`
`
`
`
`
`EXHIBIT A
`EXHIBIT A
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00880
`Page 3
`Joining Petitioner: Apotex
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00880
`Page 3
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`

`

`https://web.archive.org/web/20110408231012/http://clinicaltrials.gov/ct2/show/NCT0101297
`3
`
`
`
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00880
`Page 4
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`

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`INTERNET ARCHIVE
`
`
`
`http://clinicaltrials.gov/ct2/show/NCTO1012973
`
`
`
`
`
`8 Apr 2011 - 14 Nov 2013
`s cansures
`WAEOERMCMN
`LAL
`ClinicalTrials.gov
`Eee Seer aay
`
`Aservice of the U.S. National Institutes of Health
`
`
`Full Text View
`
`Tabular View
`
`No Study Results Posted
`
`Related Studies
`
`Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion
`(CRVO) (GALILEO)
`
`This study is ongoing, but not recruiting participants.
`First Received on October 30, 2009. Last Updated on January 25, 2011 History of Changes
`
`
`
`® Purpose
`To determine the efficacy of vascular endothelial growth factor (VEGF) Trap-Eyeinjected into the eye on vision function in subjects with macular edema as a consequenceofcentralretinal
`vein occlusion
`
`[cenaion——~*sSSSCSCSCSCSCSC~S~*@r
`Retinal Vein Occlusion
`Drug: VEGF Trap-Eye (BAY86-5321)
`PhaseIll
`Other: Sham treatment
`
`
`
`Interventional
`Study Type:
`Study Design: Allocation: Randomized
`Endpoint Classification: Safety/Efficacy Study
`Intervention Model: Parallel Assignment
`Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
`Primary Purpose: Treatment
`Official Title:=A Randomized, Double-masked, Sham-controlled Phase 3 Study of the Efficacy, Safety and Tolerability of Repeated Intravitreal Administration of VEGF Trap-Eyein
`Subjects With Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)
`
`Resource links provided by NLM:
`
`Genetics Home Referencerelated topics: Stargardt macular degeneration X-linked juvenile retinoschisis
`MedlinePlus related topics: Edema
`Drug Information available for: Aflibercept
`U.S. FDA Resources
`
`Further study details as provided by Bayer:
`
`Primary Outcome Measures:
`* The proportion of subjects who gain at least 15 letters in BCVA on the EDTRS chart compared with baseline at the Week 24 endpoint [ Time Frame: Week 24]
`| Designated as safety issue: No ]
`
`Secondary Outcome Measures:
`« Change from baseline in BCVA score [ Time Frame: week 24 ] [ Designated as safety issue: No |
`« Absolute change from baselinein centralretinal thickness, assessed by OCT [ Time Frame: Week 24 | [ Designated as safety issue: No|
`« Proportion of subjects progressing to anterior segment neovascularization, neovascularization of the optic disc (NVD), or neovascularization of the retina elsewhere
`(NVE) requiring pan-retinal photocoagulation [ Time Frame: Week 24 ] [ Designated as safety issue: No |
`« Change in the NEI-VFQ-25 total score from baseline [ Time Frame: Week 24 ][ Designated as safety issue: No ]
`« Change in the EQ-5D score from baseline [ Time Frame: Week 24 }
`[ Designated as safety issue: No ]
`
`165
`Estimated Enrollment:
`October 2009
`Study Start Date:
`March 2012
`Estimated Study Completion Date:
`Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
`
`treatment
`
`[ama [snannn
`Arm 1: Experimental
`Drug: VEGF Trap-Eye (BAY86-5321)
`Intervention:
`Intravitreal injection. Weeks 0 to 20 injection of VEGF Trap-Eye every 4 weeks; weeks 24 to 52 every 4 weeks plus additional on week 60
`Drug: VEGF
`and 68 re-assessment and either (PRN) injection of VEGF Trap-Eye or sham injection; last visit (no treatment) at week 76.
`Trap-Eye
`(BAY86-
`5321)
`Arm 2: Sham
`Comparator
`Intervention:
`Other: Sham
`
`Other: Sham treatment
`Sham treatment. Weeks 0 to 20 sham treatment every 4 weeks; weeks 24 to 48 every 4 weeks re-assessment and sham injection; week
`52 VEGF Trap-Eye injection (unlessinvestigator declines for medical reasons), weeks 60 and 68 re-assessment andeither (PRN)
`injection of VEGF Trap-Eye or sham injection; last visit (no treatment) at week 76.
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00880
`Page 5
`Joining Petitioner: Apotex
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00880
`Page 5
`
`

`

`18 Years and older
`Both
`No
`
`® Eligibility
`Ages Eligible for Study:
`Genders Eligible for Study:
`Accepts Healthy Volunteers:
`Criteria
`Inclusion Criteria:
`« Center-involved macular edema secondary to central retinal vein occlusion (CRVO) for no longer than 9 months with mean central subfield thickness >= 250 ym on optical
`coherence tomography (OCT)
`* Adults >= 18 years
`* early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) of 20/40 to 20/320 (73 to 24 letters) in the study eye
`Exclusion Criteria:
`« Any prior treatment with anti-VEGF agents in the study eye (Pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) or previous administration of
`systemic anti-angiogenic medications
`« Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye
`« CRVOdisease duration > 9 months from date of diagnosis
`« Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1
`+
`Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinalfibrosis involving the macula in either the study eye or fellow eye
`
`® Contacts and Locations
`
`Pleaserefer to this study by its ClinicalTrials.gov identifier: NCT01012973
`
`++] Show 73 Study Locations
`Sponsors and Collaborators
`Bayer
`Regeneron Pharmaceuticals
`Investigators
`Study Director: Bayer Study Director Bayer
`
`® More Information
`AdditionalInformation:
`
`Click here and searchfor drug information provided by the FDA. Et)
`Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. Et)
`
`Click here to find results for studies related to marketed products. 1)
`
`No publications provided
`
`Bayer HealthCare AG ( Therapeutic Area Head )
`Responsible Party:
`ClinicalTrials.gov Identifier: NCTO1012973
`History of Changes
`14130, EudraCT: 2009-010973-19
`Other Study ID Numbers:
`Study First Received:
`October 30, 2009
`Last Updated:
`January 25, 2011
`Health Authority:
`Germany: FederalInstitute for Drugs and Medical Devices; Australia: Department of Health and Ageing Therapeutic Goods Administration; Austria: Agency
`for Health and Food Safety; France: Afssaps - French Health Products Safety Agency; Hungary: NationalInstitute of Pharmacy;
`Italy: Ministry of Health;
`Latvia: State Agency of Medicines;
`Japan: Pharmaceuticals and Medical Devices Agency; Singapore: Health Sciences Authority; South Korea: Korea Food
`and Drug Administration (KFDA)
`
`Keywords provided by Bayer:
`Macular Edema
`Central Retinal Vein Occlusion
`CRVO
`VEGF Trap-Eye
`best-corrected visual acuity
`Additional relevant MeSH terms:
`Macular Edema
`Retinal Vein Occlusion
`Macular Degeneration
`Retinal Degeneration
`Retinal Diseases
`Eye Diseases
`Venous Thrombosis
`Thrombosis
`
`ClinicalTrials.gov processed this record on April 07, 2011
`
`Embolism and Thrombosis
`Vascular Diseases
`Cardiovascular Diseases
`Endothelial Growth Factors
`Growth Substances
`Physiological Effects of Drugs
`Pharmacologic Actions
`
`Gontact Help Desk
`Lister Hill National Genter for Biomedical Gommunications, U.S. National Library of Medicina,
`U.S. National Institutes of Health, U.S. Department of Health & Human Services,
`USA.gov, Copyright, Privacy, Accessibility Freedom of Information Act
`
`B
`WS. Deparment of Health & Human Services
`
`pS.Deparmentofhealth&HumanServices
`
`ros? DOM.
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00880
`Page 6
`Joining Petitioner: Apotex
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00880
`Page 6
`
`

`

`https://web.archive.org/web/20090813064936/https://clinicaltrials.gov/ct2/show/NCT006373
`77
`
`
`
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00880
`Page 7
`
`

`

`INTERNET ARCHIVE
`waydgelMachine
`
`
`
`https:/ /clinicaltrials.gov/ct2 /show/NCT00637377
`
`
`
`
`21 captures
`18 Jan 2009 - 23 Jan 2017
`
`
`ClinicalTrials.gov
`Eee Seer aay
`
`Aservice of the U.S. National Institutes of Health
`
`
`Full Text View
`
`Tabular View
`
`No Study Results Posted
`
`Related Studies
`
`Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular
`Degeneration (AMD) (VIEW 2)
`
`This study is currently recruiting participants.
`Verified by Bayer, July 2009
`First Received: March 12, 2008 Last Updated: July 3, 2009 History of Changes
`
`
`
`® Purpose
`This study is a phaseIll, double-masked, randomized,studyof the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately
`1200 patients will be randomized in Europe, Asia, Japan, Australia and South America.
`
`zene
`Drug: VEGF Trap-Eye
`PhaseIll
`Drug: Ranibizumab
`
`————*iSSSSC=i Macular Degeneration
`
`Interventional
`Study Type:
`Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
`Official Title:©A Randomized, Double Masked, Active Controlled, Phase 3 Study ofthe Efficacy, Safety, and Tolerability of Repeated Dosesof Intravitreal VEGF Trap in Subjects With
`Neovascular Age-Related Macular Degeneration (AMD).
`
`Resource links provided by NLM:
`
`Genetics Home Reference related topics: X-linked juvenile retinoschisis
`MedlinePlus related topics: Macular Degeneration
`Drug Information available tor: Ranibizumab Aflibercept
`U.S. FDA Resources
`
`Further study details as provided by Bayer:
`
`Primary Outcome Measures:
`« The proportion of subjects who maintain vision at Week 52, where a subject is classified as maintaining visionif the subject has lost fewer than 15 letters on the ETDRS
`chart compared to baseline(ie, prevention of moderate vision loss) [ Time Frame: week 52 ] [ Designated as safety issue: Yes |
`
`Secondary Outcome Measures:
`« Mean change from baseline in BCVA as measured by ETDRSletter score at Week 52 [ Time Frame: week 52 | [ Designated as safety issue: Yes ]
`« The proportion of subjects who gain atleast 15 letters of vision at Week 52 [ Time Frame: week 52 ] [ Designated as safety issue: No }
`* Mean changefrom baseline in total NEI VFQ-25 score at Week 52 [ Time Frame: week 52 | [ Designated as safety issue: No ]
`« Mean change from baseline in CNV area at Week 52 [ Time Frame: week 52 ] [ Designated as safety issue: Yes |
`
`Estimated Enrollment:
`Study Start Date:
`Estimated Study Completion Date:
`Estimated Primary Completion Date:
`
`1200
`April 2008
`September 2011
`July 2011 (Final data collection date for primary outcome measure)
`
`jarms Assigned Interventions
`Arm 3:
`Drug: VEGF Trap-Eye
`Experimental
`2.0 mg VEGF Trap-Eye administered every 8 weeks (including one additional 2,0 mg dose at Week 4) during the first year. Thereafter a dose may be
`administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
`
`frequently than every 12 weeks.
`
`Arm 1:
`Experimental
`
`Arm 2:
`Experimental
`
`Arm 4: Active
`Comparator
`
`Drug: VEGF Trap-Eye
`0.5 mg VEGFTrap-Eye administered every 4 weeks during thefirst year. Thereafter a dose may be administered as frequently as every 4 weeks, but
`no less frequently than every 12 weeks.
`
`Drug: VEGF Trap-Eye
`2.0 mg VEGF Trap-Eye administered every 4 weeks during thefirst year. Thereafter a dose may be administered as frequently as every 4 weeks, but
`no less frequently than every 12 weeks.
`Drug: Ranibizumab
`0.5 mg administered every 4 weeks during the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less
`
`& Eligibility
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00880
`Page 8
`Joining Petitioner: Apotex
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00880
`Page 8
`
`

`

`50 Years and older
`Both
`No
`
`AgesEligible for Study:
`Genders Eligible for Study:
`Accepts Healthy Volunteers:
`Criteria
`Inclusion Criteria:
`* Signed informed consent.
`* Men and women >/=50 years of age.
`* Active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveallesions that affect the fovea as evidenced by FAin the study eye.
`+ ETDRSbest-corrected visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye at 4 meters.
`« Willing, committed, and able to return for ALLclinic visits and complete all study-related procedures.
`* Able to read,(or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consentor a family member) understand and
`willing to sign the informed consent form.
`Exclusion Criteria:
`* Any prior ocular(in the study eye) or systemic treatmentor surgery for neovascular AMD, except dietary supplementsorvitamins.
`« Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye.
`« Anyprior treatment with anti-VEGF agents in the study eye.
`* Total lesion size >12 disc areas (30.5 mm&#xftfd;, including blood, scars and neovascularization) as assessed by FA in the study eye.
`* Subretinal hemorrhages thatis either 50% or more ofthe total lesion area,or if the blood is under the fovea and is 1 or more disc areas in size in the study eye(if the blood
`is under the fovea, then the fovea must be surrounded by 270 degrees by visible CNV).
`« Sear orfibrosis making up >50%of the total lesion in the study eye.
`* Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
`* Presence ofretinal pigment epithelial tears or rips involving the macula in the study eye.
`« History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
`« Presence of other causes of CNV in the study eye.
`* Prior vitrectomy in the study eye.
`« History of retinal detachmentor treatment or surgery for retinal detachmentin the study eye.
`+ Any history of macular hole of stage 2 and abovein the study eye.
`+ Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, exceptlid surgery, which may not have taken place within 1 month of Day 1, as long asit is
`unlikely to interfere with the injection.
`« History or clinical evidence of diabetic retinopathy, diabetic macular edema or any retinal vascular disease other than AMD in either eye.
`
`® Contacts and Locations
`
`Pleaserefer to this study byits ClinicalTrials.gov identifier: NCTO0637377
`
`Contacts
`Contact: Bayer Clinical Trials Contact_clinical-trials-contact@bayerhealthcare.com
`
`fp] Show 212 Study Locations
`Sponsors and Collaborators
`Bayer
`Investigators
`Study Director: Bayer Study Director Bayer
`
`® MoreInformation
`Additional Information:
`
`Glick here and search for drug information provided by the FDA =]
`Glick here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product FE)
`
`Click here to find results for studies related to marketed products =
`
`No publications provided
`
`Bayer Schering Pharma AG ( Therapeutic Area Head )
`Responsible Party:
`91689, EurdaCGT No.: 2007-000583-25
`Study ID Numbers:
`March 12, 2008
`Study First Received:
`July 3, 2009
`Last Updated:
`History of Changes
`ClinicalTrials.gov Identifier: NCTOO637377
`Health Authority:
`Switzerland: Ethikkormmission
`
`Keywords provided by Bayer:
`Eye diseases
`Vision Impairment and Blindness
`Eyes and Vision
`
`Seniors
`Neovascular Age-Related Macular Degeneration (AMD)
`Retinal Disease
`
`Study placed in the following topic categories:
`Eye Diseases
`Mitogens
`Retinal Degeneration
`Macular Degeneration
`Additional relevant MeSH terms:
`Growth Substances
`Macular Degeneration
`Eye Diseases
`Endothelial Growth Factors
`Physiological Effects of Drugs
`Pharmacologic Actions
`Retinal Degeneration
`Retinal Diseases
`ClinicalTrials.gov processed this record on August 12, 2009
`Contact Help Desk
`Lister Hill National Center for Biomedical Communications, U.S. National Library of Medicina,
`U.S. NationalInstitutes of Health, U.S. Department of Health & Human Services,
`
`Blindness
`Endothelial Growth Factors
`Retinal Diseases
`Vision, Low
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00880
`Page 9
`Joining Petitioner: Apotex
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00880
`Page 9
`
`

`

`
`USA.gov, Copyright, Privacy, Accossibility, Freedom of Information Act
`
`
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00880
`Page 10
`Joining Petitioner: Apotex
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00880
`Page 10
`
`

`

`https://web.archive.org/web/20090911163626/https://clinicaltrials.gov/ct2/show/NCT005097
`95
`
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00880
`Page 11
`
`

`

`INTERNET ARCHIVE
`waydgelMachine
`
`
`
`https:/ /clinicaltrials.gov/ct2 /show/NCT00509795
`
`
`
`
`21 captures
`1 Dec 2008 - 23 Sep 2020
`
`
`ClinicalTrials.gov
`Eee Seer aay
`
`Aservice of the U.S. National Institutes of Health
`
`
`Full Text View
`
`Tabular View
`
`No Study Results Posted
`
`Related Studies
`
`Vascular Endothelial Growth Factor(VEGF)Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related Macular
`Degeneration(AMD) (VIEW 1)
`
`This study is currently recruiting participants.
`Verified by Regeneron Pharmaceuticals, April 2009
`First Received: July 31, 2007 Last Updated: April 28, 2009 History of Changes
`
`Regeneron Pharmaceuticals
`
`Bayer
`
`® Purpose
`This study is a phaseIII, double-masked, randomized, studyof the efficacy and safety of VEGF Trap-Eyein patients with neovascular age-related macular degeneration. Approximately
`1200 patients will be randomized in the US and Canada.
`
`Cn
`Macular Degeneration
`Drug: VEGF Trap-Eye
`PhaseIll
`Drug: Ranibizumab
`
`
`
`Interventional
`Study Type:
`Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
`Official Title:©A Randomized, Double Masked, Active Controlled PhaseIll Study of the Efficacy, Safety, and Tolerability of Repeated Dosesof Intravitreal VEGF Trap in Subjects With
`Neovascular Age-Related Macular Degeneration
`
`Resourcelinks provided by NLM:
`
`
`Genetics Home Reference related topics: X-linked juvenile retinoschisis
`MedlinePlus related topics: Macular Degeneration
`Drug Information available for: Ranibizumab Aflibercept
`U.S. FDA Resources
`
`Further study details as provided by Regeneron Pharmaceuticals:
`
`Primary Outcome Measures:
`« The proportion of subjects who maintain vision at Week 52, where a subject is classified as maintaining visionif the subject has lost fewer than 15 letters on the ETDRS
`chart compared to baseline (i.e. prevention of moderatevision loss) [ Time Frame: Week 52 ][ Designated as safety issue: Yes |
`
`Secondary Outcome Measures:
`+ Mean change from baseline in BCVA as measured by ETDRSletter score at Week 52 [ Time Frame: Week 52 ] | Designated as safety issue: Yes |
`« The proportion of subjects who gain atleast 15 letters of vision at Week 52 [ Time Frame: Week 52 ][ Designated as safety issue: No |
`+ Mean changefrom baseline in total NEI VFQ-25 score at Week 52 [ Time Frame: Week 52 | [ Designated as safety issue: No |
`« Mean changefrom baseline in CNV area at Week 52 [ Time Frame: Week 52 | [ Designated as safety issue: Yes ]
`
`1200
`Estimated Enrollment:
`August 2007
`Study Start Date:
`December 2011
`Estimated Study Completion Date:
`Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
`
`jars|Assigned Interventions
`1:
`Drug: VEGF Trap-Eye
`Experimental
`0.5 mg VEGF Trap-Eye administered every 4 weeks during thefirst year. Thereafter a dose may be administered as frequently as every 4 weeks, but
`no less frequently than every 12 weeks.
`Drug: VEGF Trap-Eye
`2.0 mg VEGF Trap-Eye administered every 4 weeks during thefirst year. Thereafter a dose may be administered as frequently as every 4 weeks, but
`no less frequently than every 12 weeks.
`
`2:
`Experimental
`
`3:
`Experimental
`
`Drug: VEGF Trap-Eye
`2.0 mg VEGF Trap-Eye administered every 8 weeks (including one additional 2.0 mg dose at week 4) duringthefirst year. Thereafter a dose may be
`administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
`
`4: Active
`Comparator
`
`Drug: Ranibizumab
`0.5 mg administered every 4 weeks during the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently
`
`than every 12 weeks.
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00880
`Page 12
`Joining Petitioner: Apotex
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00880
`Page 12
`
`

`

`® Eligibility
`
`Ages Eligible for Study:
`GendersEligible for Study:
`Accepts Healthy Volunteers:
`Criteria
`
`50 Years and older
`Both
`No
`
`nopown
`
`Key Inclusion Criteria:
`1. Signed Informed Consent.
`. Men and women 2 50 years of age.
`. Active primary or recurrent subfoveal CNV lesions secondary to AMD,including juxtafoveal lesions that affect the fovea as evidenced by FAin the study eye.
`. ETDRSbest-correctedvisualacuity of: 20/40 to 20/320(letter score of 73 to 25) in the study eye.
`. Willing, committed, and able to return for ALLclinic visits and complete all study-related procedures.
`. Able to read, (or, if unable to read dueto visual impairment, be read to verbatim by the person administering the informed consentor a family member. See Appendix J.4)
`understand and willing to sign the informed consentform.
`Key Exclusion Criteria:
`1. Any prior ocular(in the study eye) or systemic treatment or surgery for neovascular AMD except dietary supplementsor vitamins.
`. Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye, except dietary supplementsor vitamins.
`. Any prior treatment with anti-VEGF agentsin the study eye.
`. Total lesion size > 12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by FA in the study eye.
`. Subretinal hemorrhagethatis either 50% or more of the total lesion area,orif the blood is under the fovea and is 1 or more disc areas in size in the study eye. (If the blood
`is under the fovea, then the fovea must be surrounded 270 degreesbyvisible CNV.)
`. Scar or fibrosis, making up > 50% of total lesion in the study eye.
`. Scar, fibrosis, or atrophy involving the centerof the fovea.
`. Presence of retinal pigmentepithelial tears or rips involving the macula in the study eye.
`9. History of any vitreous hemorrhage within 4 weeksprior to Visit 1 in the study eye.
`10. Presence of other causes of CNV in the study eye.
`11. History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina,other than AMD, in either eye.
`12. Prior vitrectomyin the study eye.
`13. History of retinal detachmentor treatmentor surgery for retinal detachmentin the study eye.
`14. Any history of macular hole of stage 2 and abovein the study eye.
`15. Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, exceptlid surgery, which may not have taken place within 1 month of day 1, as long asits
`unlikely to interfere with the injection.
`
`onfeowPM
`anaoa
`
`® Contacts and Locations
`
`Please refer to this study byits ClinicalTrials.gov identifier: NCTO0509795
`
`Contacts
`Contact: Regeneron
`
`866-549-8439 VIEW 1study@rtp.ppdi.com
`
`=}| Show 191 Study Locations
`Sponsors and Collaborators
`Regeneron Pharmaceuticals
`Bayer
`Investigators
`Study Director: Avner Ingerman, MD Regeneron Pharmaceuticals
`
`® More Information
`
`No publications provided
`
`Regeneron Pharmaceuticals ( Dr. Avner Ingerman)
`Responsible Party:
`VGFT-OD-0605
`Study ID Numbers:
`July 31, 2007
`Study First Received:
`April 28, 2009
`Last Updated:
`ClinicalTrials.gov Identifier: NCTO0509795—_History of Changes
`Health Authority:
`United States: Food and Drug Administration; Canada: Health Canada
`
`Study placed in the following topic categories:
`Eye Diseases
`Mitogens
`Retinal Degeneration
`Additional relevant MeSH terms:
`Growth Substances
`Eye Diseases
`Physiological Effects of Drugs
`Retinal Degeneration
`
`ClinicalTrials.gov processedthis record on September 11, 2009
`
`Macular Degeneration
`Endothelial Growth Factors
`Retinal Diseases
`
`Macular Degeneration
`Endothelial Growth Factors
`Pharmacologic Actions
`Retinal Diseases
`
`Gontact Help Desk
`Lister Hill National Genterfor Biomedical Gommunications, U.S. National Library of Medicine,
`U.S. NationalInstitutes of Health, U.S. Deparment of Health & Human Services,
`USA.gov, Gopyright, Privacy, Accessibility, Freedom of Information Act
`
`Space
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`8
`aay
`eas INO
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`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00880
`Page 13
`Joining Petitioner: Apotex
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00880
`Page 13
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`

`

` JURAT
`
`State/Commonwealth of _____________________
`
` City County of ______________________
`
`)
`)
`)
`
`On __________________, before me, _________________________________________ ,
`Date
`Notary Name
` the foregoing instrument was subscribed and sworn (or affirmed) before me by:
`
`________________________________________________________________________.
`Name of Affiant(s)
` Personally known to me -- OR --
`
` Proved to me on the basis of the oath of _____________________________ -- OR --
`Name of Credible Witness
` Proved to me on the basis of satisfactory evidence: ________________________________
`Type of ID Presented
`
`WITNESS my hand and official seal.
`
`Notary Public Signature: _________________________
`
`Notary Name:__________________________________
`Notary Commission Number:______________________
`Notary Commission Expires:______________________
`Notarized online using audio-video communication
`
`DESCRIPTION OF ATTACHED DOCUMENT
`
`Title or Type of Document: ____________________________________________________
`
`Document Date: ________________________________
`
`Number of Pages (including notarial certificate): _____________
`
`VIRGINIA
`
`Virginia Beach
`
`01/20/2021
`
`William Scott
`
`Duncan D Hall
`
`driver_license
`
`William Scott
`7897791
`01/31/2024
`
`Affidavit of Authenticity
`
`01/20/2021
`
`14
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00880
`Page 14
`
`