`Genentech, Inc. Submits Biologics License Application For FDA Review Of Lucentis(TM) In Wet Age-Related Macular Degeneration | BioS…
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`Genentech, Inc.
`Submits Biologics
`License Application For
`FDA Review Of
`Lucentis(TM) In Wet
`Age-Related Macular
`Degeneration
`
`Published: Dec 30, 2005
`
`SOUTH SAN FRANCISCO, Calif., Dec. 30
`/PRNewswire-FirstCall/ -- Genentech, Inc.
`announced today that it has submitted a
`Biologics License Application (BLA) to the U.S.
`Food and Drug Administration (FDA) for the
`use of Lucentis(TM) (ranibizumab) in the
`treatment of neovascular wet age-related
`macular degeneration (AMD). Lucentis is the
`first therapy for wet AMD to have shown
`improved vision in two pivotal Phase III trials
`and demonstrated a clinical benefit over
`verteporfin (Visudyne(R)) photodynamic
`therapy (PDT) in a head-to-head clinical trial. As
`part of the Lucentis BLA submission,
`Genentech has requested a Priority Review
`designation from the FDA, which, if granted,
`would give the FDA six months from the
`
`https://www.biospace.com/article/releases/genentech-inc-submits-biologics-license-application-for-fda-review-of-lucentis-tm-in-wet-age-related-macul… 1/11
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2084 Page 1
`
`
`
`2/3/2022
`
`Genentech, Inc. Submits Biologics License Application For FDA Review Of Lucentis(TM) In Wet Age-Related Macular Degeneration | BioS…
`Agency's receipt of the submission to take
`action on the application.
`
`The BLA submission is based on one-year
`clinical data on the efficacy and safety of
`Lucentis from two pivotal Phase III trials,
`ANCHOR and MARINA, as well as one-year
`clinical data from the Phase I/II FOCUS trial. In
`addition to these registrational studies,
`Genentech is currently enrolling patients with
`wet AMD in a Phase IIIb safety study called
`SAILOR. Data from the Phase IIIb PIER study
`evaluating a less frequent dosing regimen for
`Lucentis are anticipated in the first half of
`2006.
`
`"This application represents a summary of data
`from more than six years of rigorous clinical
`study and the dedication of thousands of
`patients and physicians hoping to improve
`outcomes for those with this devastating
`disease," said Hal Barron, M.D., Genentech's
`senior vice president of Development and chief
`medical officer. "We look forward to working
`with the FDA in our efforts to bring this
`potential therapy to patients quickly as it may
`offer benefit to patients with all types of wet
`AMD."
`
`ANCHOR
`
`In November 2005, Genentech announced
`positive preliminary data from the pivotal
`
`https://www.biospace.com/article/releases/genentech-inc-submits-biologics-license-application-for-fda-review-of-lucentis-tm-in-wet-age-related-macul… 2/11
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2084 Page 2
`
`
`
`2/3/2022
`
`Genentech, Inc. Submits Biologics License Application For FDA Review Of Lucentis(TM) In Wet Age-Related Macular Degeneration | BioS…
`Phase III ANCHOR study (ANti-VEGF Antibody
`for the Treatment of Predominantly Classic
`CHORoidal Neovascularization in AMD), a
`randomized, two-year, multi-center, double-
`masked, active-treatment controlled study
`comparing two different doses of Lucentis to
`PDT in 423 patients with predominantly classic
`wet AMD. Approximately 94 percent of patients
`treated with 0.3 mg of Lucentis and 96 percent
`of those treated with 0.5 mg of Lucentis
`maintained (defined as a loss of less than 15
`letters in visual acuity) or improved vision
`(defined as a gain of 15 letters or more)
`compared to approximately 64 percent of
`those treated with PDT alone [p<0.0001]
`during the first year of the two-year study. The
`Lucentis treatment groups further showed a
`statistically significant difference from the
`control arm in an important secondary
`endpoint: mean change in visual acuity (VA)
`from baseline to month 12. On average, VA
`among patients treated with Lucentis
`improved, while VA among patients treated
`with PDT declined. Based on these results,
`patients in the PDT-alone arm of the study will
`have access to Lucentis for the remainder of
`the study. One-year data from the ANCHOR
`study will be presented at the Macula 2006
`meeting in New York in January.
`
`MARINA
`
`https://www.biospace.com/article/releases/genentech-inc-submits-biologics-license-application-for-fda-review-of-lucentis-tm-in-wet-age-related-macul… 3/11
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2084 Page 3
`
`
`
`2/3/2022
`
`Genentech, Inc. Submits Biologics License Application For FDA Review Of Lucentis(TM) In Wet Age-Related Macular Degeneration | BioS…
`In July 2005, Genentech presented positive
`preliminary one-year results from the pivotal
`Phase III MARINA study (Minimally
`classic/occult trial of the Anti-VEGF antibody
`Ranibizumab In the treatment of Neovascular
`AMD), a randomized, two-year, multi-center,
`double-masked, sham-injection controlled
`study evaluating the safety and efficacy of two
`different doses of Lucentis in 716 patients with
`minimally classic or occult wet AMD. Nearly 95
`percent of patients treated with Lucentis
`maintained or improved vision at 12 months.
`Additional one-year results include:
`
`-- Twenty five percent (59/238) of patients
`treated with 0.3 mg of Lucentis and 34 percent
`(81/240) treated with 0.5 mg of Lucentis
`improved vision by a gain of 15 letters or more
`compared to approximately 5 percent (11/238)
`of patients in the control group as measured
`by the ETDRS eye chart. -- Nearly 40 percent
`(188/478) of Lucentis-treated patients (38.7
`percent in the 0.3 mg group and 40 percent in
`the 0.5 mg group) achieved a visual acuity
`score of 20/40 or better compared to 11
`percent (26/238) in the control group. --
`Patients treated with Lucentis gained an
`average of approximately seven letters in visual
`acuity (6.5 letters in the 0.3 mg group and 7.2
`letters in the 0.5 mg group) compared to study
`entry, while those in the control group lost an
`average of 10.5 letters. -- The majority of
`
`https://www.biospace.com/article/releases/genentech-inc-submits-biologics-license-application-for-fda-review-of-lucentis-tm-in-wet-age-related-macul… 4/11
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2084 Page 4
`
`
`
`2/3/2022
`
`Genentech, Inc. Submits Biologics License Application For FDA Review Of Lucentis(TM) In Wet Age-Related Macular Degeneration | BioS…
`patients treated with Lucentis (349/478) (74.8
`percent in the 0.3 mg group and 71.3 percent
`in the 0.5 mg group) experienced a letter
`improvement of zero or more compared to
`28.6 percent (68/238) in the sham group.
`
`In October 2005, Genentech announced that
`patients still in the sham arm of the MARINA
`study would be crossed over to active
`treatment with Lucentis.
`
`FOCUS
`
`The FOCUS trial (RhuFab V2 Ocular Treatment
`Combining the Use of Visudyne(R) to Evaluate
`Safety) is a randomized, two-year, multi-center,
`single-masked study evaluating the safety,
`tolerability and efficacy of Lucentis in
`combination with PDT compared to PDT alone
`in 162 patients with predominantly classic
`subfoveal wet AMD. Preliminary one-year data
`were presented in July 2005 and showed that
`approximately 90 percent of patients
`maintained or improved vision when treated
`with the combination of Lucentis and PDT
`compared to approximately 68 percent of
`those treated with PDT alone (p = 0.0003).
`
`Lucentis Safety Profile
`
`In clinical trials to date, the most common side
`effects that occurred more frequently in the
`Lucentis arms (0.3 mg and 0.5 mg) than in the
`control arms were mild to moderate and
`
`https://www.biospace.com/article/releases/genentech-inc-submits-biologics-license-application-for-fda-review-of-lucentis-tm-in-wet-age-related-macul… 5/11
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2084 Page 5
`
`
`
`2/3/2022
`
`Genentech, Inc. Submits Biologics License Application For FDA Review Of Lucentis(TM) In Wet Age-Related Macular Degeneration | BioS…
`included: conjunctival hemorrhage, eye pain,
`increased intraocular pressure and vitreous
`floaters.
`
`Serious ocular adverse events that occurred
`more frequently in the Lucentis-treated arms
`were uncommon and included
`endophthalmitis and intraocular inflammation
`(less than 1 percent for each). Among non-
`ocular serious adverse events, cerebral
`vascular events and myocardial infarctions
`were observed in all three arms of both the
`Phase III MARINA and ANCHOR studies; in each
`study the combined rate of these events was
`similar in the control and the 0.3 mg Lucentis
`arms and slightly higher in the 0.5 mg Lucentis
`arm. Cerebral vascular events and myocardial
`infarctions were also seen in the Phase I/II
`study of Lucentis 0.5 mg in combination with
`Visudyne PDT (FOCUS), although the combined
`frequency of these events was approximately
`equal in both treatment arms.
`
`Additional Phase III Studies
`
`SAILOR
`
`In November 2005, Genentech began
`enrollment in a Phase IIIb study, SAILOR, to
`make Lucentis available to eligible patients.
`SAILOR (Safety Assessment of Intravitreal
`Lucentis fOR AMD) is a Phase IIIb clinical study
`of Lucentis for patients with all types of new or
`
`https://www.biospace.com/article/releases/genentech-inc-submits-biologics-license-application-for-fda-review-of-lucentis-tm-in-wet-age-related-macul… 6/11
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2084 Page 6
`
`
`
`2/3/2022
`
`Genentech, Inc. Submits Biologics License Application For FDA Review Of Lucentis(TM) In Wet Age-Related Macular Degeneration | BioS…
`recurrent active subfoveal wet AMD. It is a one-
`year study designed to evaluate the safety of
`two different doses (0.3 mg and 0.5 mg) of
`Lucentis administered once a month for three
`months and thereafter as needed based on
`retreatment criteria. The study will be
`conducted at more than 100 sites in the
`United States and will enroll up to 5,000
`patients. Those interested in additional
`information about the study can call toll-free 1-
`888-662-6728.
`
`PIER
`
`Genentech is also conducting PIER (A Phase
`IIIb, Multi-center, Randomized, Double-Masked,
`Sham Injection-Controlled Study of the Efficacy
`and Safety of Ranibizumab in Subjects with
`Subfoveal Choroidal Neovascularization with or
`without Classic CNV Secondary to Age-Related
`Macular Degeneration) with 184 patients in the
`United States. In this trial, Lucentis is
`administered once per month for the first
`three months followed thereafter by doses
`once every three months for a total of 24
`months. Enrollment in this study is complete
`and preliminary results are expected in the
`first half of 2006.
`
`About AMD
`
`AMD is a major cause of painless central visual
`loss and is the leading cause of blindness for
`
`https://www.biospace.com/article/releases/genentech-inc-submits-biologics-license-application-for-fda-review-of-lucentis-tm-in-wet-age-related-macul… 7/11
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2084 Page 7
`
`
`
`2/3/2022
`
`Genentech, Inc. Submits Biologics License Application For FDA Review Of Lucentis(TM) In Wet Age-Related Macular Degeneration | BioS…
`people over the age of 60. The National Eye
`Institute estimates that there are 1.6 million
`people with AMD in the United States alone
`and that this prevalence will grow to 2.95
`million by 2020. AMD occurs in two forms: dry
`and wet.
`
`The dry form is associated with atrophic cell
`death of the central retina or macula, which is
`required for fine vision used for activities such
`as reading, driving or recognizing faces. The
`wet form is caused by growth of abnormal
`blood vessels also known as choroidal
`neovascularization (CNV) or ocular
`angiogenesis under the macula. These vessels
`leak fluid and blood and cause scar tissue that
`destroys the central retina. This results in a
`deterioration of sight over a period of months
`to years.
`
`About Lucentis
`
`Lucentis(TM) (ranibizumab) is a humanized
`therapeutic antibody fragment developed at
`Genentech and designed to bind and inhibit
`VEGF-A, a protein that is believed to play a
`critical role in angiogenesis (the formation of
`new blood vessels). Lucentis is designed to
`block new blood vessel growth and leakiness,
`which lead to wet AMD disease progression
`and vision loss.
`
`https://www.biospace.com/article/releases/genentech-inc-submits-biologics-license-application-for-fda-review-of-lucentis-tm-in-wet-age-related-macul… 8/11
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2084 Page 8
`
`
`
`2/3/2022
`
`Genentech, Inc. Submits Biologics License Application For FDA Review Of Lucentis(TM) In Wet Age-Related Macular Degeneration | BioS…
`Lucentis is being developed by Genentech and
`the Novartis Ophthalmics Business Unit.
`Genentech retains commercial rights for
`Lucentis in North America. Novartis has
`exclusive commercialization rights for the rest
`of the world.
`
`About Angiogenesis
`
`Genentech is a leader in research and product
`development in the area of angiogenesis, the
`process by which new blood vessels are
`formed. In 1989 Napoleone Ferrara, M.D., and
`a team of scientists at Genentech conducted
`seminal work in the field, which resulted in the
`identification and cloning of a gene termed
`Vascular Endothelial Growth Factor (VEGF),
`now known as VEGF-A. The VEGF-A protein is
`believed to play a critical role in angiogenesis
`and serves as one of the key contributors to
`physiological or pathological conditions that
`can stimulate the formation of new blood
`vessels. The process of angiogenesis is
`normally regulated throughout development
`and adult life, and the uncontrolled growth of
`new blood vessels is an important contributor
`to a number of pathologic conditions, including
`wet AMD.
`
`About Genentech
`
`Genentech is a leading biotechnology
`company that discovers, develops,
`
`https://www.biospace.com/article/releases/genentech-inc-submits-biologics-license-application-for-fda-review-of-lucentis-tm-in-wet-age-related-macul… 9/11
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2084 Page 9
`
`
`
`2/3/2022
`
`Genentech, Inc. Submits Biologics License Application For FDA Review Of Lucentis(TM) In Wet Age-Related Macular Degeneration | BioS…
`manufactures and commercializes
`biotherapeutics for significant unmet medical
`needs. A considerable number of the currently
`approved biotechnology products originated
`from, or are based on, Genentech science.
`Genentech manufactures and commercializes
`multiple biotechnology products directly in the
`United States and licenses several additional
`products to other companies. The company
`has headquarters in South San Francisco,
`Calif., and is traded on the New York Stock
`Exchange under the symbol DNA. For
`additional information about the company,
`http://www.gene.com
`please visit
` .
`
`This press release contains forward-looking
`statements regarding Lucentis as a potential
`therapy and the expected time frame for the
`PIER trial results. Actual results could differ
`materially. Among other things, the time frame
`for the PIER results could be affected by
`unexpected safety or efficacy issues, additional
`time requirements to achieve study endpoints
`or for data analysis, or discussions with the
`FDA or FDA actions; and Lucentis as a potential
`therapy could be affected by certain of the
`forgoing and the failure to receive FDA
`approval, competition, pricing and the ability to
`supply product or a product withdrawal.
`Genentech disclaims any obligation and does
`not undertake to update or revise the forward-
`looking statements in this press release.
`
`https://www.biospace.com/article/releases/genentech-inc-submits-biologics-license-application-for-fda-review-of-lucentis-tm-in-wet-age-related-mac… 10/11
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2084 Page 10
`
`
`
`2/3/2022
`
`Genentech, Inc. Submits Biologics License Application For FDA Review Of Lucentis(TM) In Wet Age-Related Macular Degeneration | BioS…
`Media Contact: Dawn Kalmar 650-225-5873
`
`Investor Contact: Kathee Littrell 650-225-1034
`
`Patient Inquiries: 1-888-662-6728
`
`Genentech, Inc.
`CONTACT: media, Dawn Kalmar, +1-650-225-
`5873, or investors, KatheeLittrell, +1-650-225-
`1034, or patients, 1-888-662-6728, all of
`Genentech
`
`Web site: http://www.gene.com/
`
`Related links
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`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2084 Page 11
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