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`Novartis International AG
`Novartis Communications
`CH-4002 Basel
`Switzerland
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`Tel + 41 61 324 2200
`Fax + 41 61 324 3300
`Internet address:
`http://www.novartis.com
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`MEDIA RELEASE • COMMUNIQUE AUX MEDIAS • MEDIENMITTEILUNG
`
`
`Novartis Ophthalmics and Genentech announce development and
`commercialization agreement for age-related macular degeneration
`treatment, Lucentis™
`
`Basel, 25 June 2003 – Novartis Ophthalmics, the eye health unit of Novartis AG and
`Genentech, Inc. today announced that they have entered into an agreement under which
`Novartis Ophthalmics will receive an exclusive license to develop and market Lucentis(cid:212)
`
`(ranibizumab), formerly known as rhuFab V2, an anti-VEGF (vascular endothelial growth
`factor) antibody fragment, outside of North America for indications related to diseases of the
`eye. Lucentis is currently in Phase III clinical trials for the treatment of the wet form of age-
`related macular degeneration (AMD) in the United States.
`
`Under the terms of the agreement, Genentech and Novartis will share certain global
`development costs. Genentech will receive an upfront fee, payments for achievement of clinical
`development milestones, and royalties on net sales of Lucentis products outside North
`America. Genentech will retain marketing rights for Lucentis in North America (United States,
`Canada and Mexico). Novartis Ophthalmics will receive exclusive commercialization rights for
`the rest of the world.
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`“This is a landmark accomplishment in our continued commitment as leaders in the
`development of drug therapies for diseases affecting the back of the eye. We are excited to have
`this opportunity to further strengthen our portfolio with another innovative product for
`AMD,” said Flemming Ornskov, MD, MPH, Head of Novartis Ophthalmics. “Lucentis will be
`a strong addition to our ophthalmology franchise, which includes Visudyne® (verteporfin), the
`only approved drug treatment for a prevalent form of this disease.”
`
`“This strategic collaboration provides Genentech with a strong development and marketing
`collaborator for Lucentis outside of North America,” said Joseph McCracken, D.V.M, Vice
`President, Business and Commercial Development. “Novartis Ophthalmics’ experience and
`proven success in the retinal disease market will allow Lucentis, if approved, to compete
`effectively on a global basis.”
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`About Lucentis
`Lucentis (ranibizumab) is a humanized, therapeutic antibody fragment developed at Genentech
`to bind and inhibit VEGF, a protein that plays a critical role in angiogenesis (the formation of
`new blood vessels). Lucentis is designed to block new blood vessel growth and leakiness, which
`are thought to lead to wet AMD disease progression.
`
`On October 1, 2002, Genentech announced positive preliminary data from a Phase Ib/II
`randomized, single-agent study with Lucentis for patients with the wet form of AMD. In that
`study, sixty-four patients were enrolled in a single-agent, multi-center trial. Patients were
`treated in one eye every four weeks for four doses (either 300 or 500 micrograms) of Lucentis
`(n=53) or were treated with standard of care (no Lucentis) (n=11). Three different groups of
`subjects were enrolled in the study based on disease pattern and prior treatment: minimally
`classic, predominantly classic (both refer to particular patterns of leakiness and lesion
`characteristics seen on an angiogram), and patients previously treated with photodynamic
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`1/3
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`Regeneron Exhibit 1178.001
`Regeneron v. Novartis
`IPR2021-00816
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`therapy (PDT).
`
`Patients were monitored for safety and visual acuity. Visual acuity is defined as the total
`number of letters read correctly on the Early Diabetic Retinopathy Study [ETDRS] chart. Of
`the 53 patients treated with Lucentis, 50 patients (94 percent) had stable or improved vision
`compared with the baseline, of which 14 patients (26 percent) improved 15 letters or more on
`the ETDRS chart, and 36 patients (68 percent) had stable vision at day 98. Stable vision is
`defined as losing or gaining fewer than 15 letters on the ETDRS chart compared with the
`baseline.
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`On average, patients treated with Lucentis gained 9.0 letters at day 98 compared to patients
`treated with standard of care who lost 4.9 letters. The most common side effects from
`treatment with Lucentis were mild transient, reversible inflammation.
`
`Based on this data, Genentech initiated a Phase III study in minimally classic and occult AMD
`in March 2003. Genentech this month began enrolling patients in a Phase III study in
`predominatly classic AMD.
`
`About AMD
`AMD (age-related macular degeneration) is a major cause of painless, central visual loss and is
`the leading cause of blindness for people over the age of 50. Its associated vision loss has been
`shown to significantly decrease quality of life. Everyday tasks such as driving and walking can
`be severely affected. Awareness of the condition and treatment in the initial stages of the
`disease are essential for patients to take the necessary steps that lead to diagnosis and early
`treatment to halt progression of AMD.
`
`AMD occurs in two forms: dry and wet. The dry form is associated with atrophic cell death of
`the central retina. The wet form is caused by growth of abnormal blood vessels (CNV) under
`the central part of the retina or 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.
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`The foregoing release contains “forward-looking statements” that can be identified by forward
`looking terminology such as “will,” “if approved,” or similar expressions, or by express or
`implied discussions regarding the potential that Lucentis will be approved for marketing, or
`regarding potential revenues from Lucentis. Such statements reflect the current views of
`Novartis with respect to future events and are subject to certain risks, uncertainties and
`assumptions. There can be no guarantee that Lucentis will be approved for sale in any market,
`or regarding potential revenues from Lucentis. In particular, management’s expectations could
`be affected by, among other things, new clinical data; unexpected clinical trial results;
`unexpected regulatory actions or delays or government regulation generally; the ability to
`obtain or maintain patent or other proprietary intellectual property protection; competition in
`general; increased government pricing pressures; and other risks and factors referred to in
`Novartis’ Form 20-F on file with the US Securities and Exchange Commission. Should one or
`more of these risks or uncertainties materialize, or should underlying assumptions prove
`incorrect, actual results may vary materially from those described herein as anticipated,
`believed, estimated or expected.
`
`About Novartis
`With its registered office in Hettlingen, Switzerland, Novartis Ophthalmics is a global leader in
`research, development and manufacturing of leading ophthalmic pharmaceuticals that assist in
`the treatment of age-related macular degeneration, eye inflammation, glaucoma, ocular
`allergies and other diseases and disorders of the eye. Novartis Ophthalmics products are
`available in more than 110 different countries. The North American headquarters is based in
`Atlanta, Georgia. Novartis Ophthalmics products are made in Switzerland, France and
`or
`www.novartisophthalmics.com
`Canada.
`For
`more
`information,
`visit
`www.novartisophthalmics.com/us.
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`2/3
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`Regeneron Exhibit 1178.002
`Regeneron v. Novartis
`IPR2021-00816
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`Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2002,
`the Group's businesses achieved sales of USD 20.9 billion and a net income of USD 4.7 billion.
`The Group invested approximately USD 2.8 billion in R&D. Headquartered in Basel,
`Switzerland, Novartis Group companies employ about 77 200 people and operate in over 140
`countries around the world. For further information please consult http://www.novartis.com.
`
`About Genentech
`Genentech is a leading biotechnology company that discovers, develops, manufactures and
`commercializes biotherapeutics for significant unmet medical needs. Sixteen of the currently
`approved biotechnology products originated from or are based on Genentech science.
`Genentech manufactures and commercializes eleven biotechnology products in the United
`States. The company has headquarters in South San Francisco, California and is traded on the
`New York Stock Exchange under the symbol DNA. For press releases and additional
`information about the company, please visit http://www.gene.com.
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`3/3
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`Regeneron Exhibit 1178.003
`Regeneron v. Novartis
`IPR2021-00816
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