AMD is leading cause of blindness for people over age 50
Basel, November 7, 2005 - Novartis announced today that a second Phase III clinical study of the investigational drug Lucentis® (ranibizumab) met its one-year primary efficacy endpoint of maintaining vision in patients with wet age-related macular degeneration (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 vision (defined as a loss of less than 15 letters in visual acuity), or improved vision, compared to approximately 64 percent of those treated with verteporfin (Visudyne®) photodynamic therapy (PDT) (p<0.0001) during the first year of the two-year study.
Patients treated with Lucentis had, on average, a significant improvement in visual acuity compared to their visual acuity at study entry, an important secondary endpoint. Data from this Phase III trial along with those of MARINA will be submitted to the health authorities in 2006. One-year data from the ANCHOR study will be presented at an upcoming medical meeting.
"The outstanding results of this second Phase III study demonstrate Lucentis' potential to improve vision in patients with all subtypes of wet AMD," said Nicholas Franco, President of Novartis Ophthalmics. "With Lucentis, we hope to be the only pharmaceutical company to provide wet AMD patients with two effective treatments, Lucentis and Visudyne, with different and potentially complementary modes of action."
ANti-VEGF Antibody for the Treatment of Predominantly Classic CHORoidal Neovascularization in AMD (ANCHOR) is a Phase III randomized, multi-center, double-masked, active-treatment controlled study comparing two different doses of Lucentis to PDT in 423 patients with predominantly classic wet AMD. Patients were randomized 2:1 to receive intravitreal Lucentis injections (0.3 mg or 0.5 mg dose) once a month or PDT every three months for two years. Exclusion criteria included prior subfoveal laser treatment, PDT or experimental treatments for wet AMD. Visual acuity was measured using the Early Treatment of Diabetic Retinopathy (ETDRS) chart, the standard method of quantifying visual acuity. The study is ongoing in the United States, Europe and Australia.
Preliminary safety findings were consistent with those observed in the other Phase III pivotal study of Lucentis, MARINA. Common ocular adverse side effects that occurred more frequently in the Lucentis arms than in the control group were mild to moderate and 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 (approximately 1 percent). Among non-ocular serious adverse events, the frequency of cerebral vascular events was equal across all three arms. The frequency of myocardial infarctions was slightly higher in patients treated with 0.5 mg of Lucentis than in the other two arms, although this difference was not statistically significant.
About MARINA
Earlier this year, Novartis announced positive preliminary one-year Phase III data on Lucentis from this study of 716 patients with wet AMD. In addition to meeting the study's primary efficacy endpoint of maintaining vision in patients with wet AMD,
25 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 sham control group as measured by the ETDRS eye chart.
Nearly 40 percent (188/478) of Lucentis-treated patients achieved a visual acuity score of 20/40 or better at 12 months compared to 11 percent (26/238) in the control group.
At 12 months, patients treated with Lucentis gained an average of seven letters in visual acuity compared to study entry, while those in the control group lost an average of 10.5 letters.
The majority of patients treated with Lucentis (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 at one year compared to 28.6 percent in the sham control group.
An analysis of the one-year data showed that adverse events were similar to those seen in earlier trials of Lucentis. Common side effects occurring more frequently in the Lucentis arms than in the control group were mild to moderate and included conjunctival hemorrhage, eye pain and vitreous floaters. Serious ocular adverse events occurring more frequently in Lucentis-treated patients were uncommon (<1 percent) and included uveitis and endophthalmitis. There appeared to be no imbalance in serious non-ocular adverse events.
About Lucentis
Lucentis (ranibizumab) is a humanized monoclonal antibody fragment 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). Consequently Lucentis blocks new blood vessel growth and leakiness which leads to wet AMD disease progression and vision loss.
Lucentis is being developed by Genentech and the Novartis Ophthalmics Business Unit. Genentech retains commercial rights for Lucentis in North America (United States, Canada and Mexico). Novartis has exclusive commercialization rights for the rest of the world.
About Visudyne
Visudyne therapy is a two-step procedure involving the intravenous administration of the drug into the patient's arm. A non-thermal laser light is then shone into the patient's eye to activate the drug. Once activated, Visudyne affects abnormal blood vessels, resulting in a cessation of growth of blood vessels in the eye and a stabilization of the corresponding vision loss. Visudyne therapy does not appear to damage normal retinal vessels.
About AMD
AMD is a major cause of painless central visual loss and is a leading cause of blindness for people over the age of 50. It affects over 25 million people worldwide. AMD occurs in two forms: dry and wet. The dry form is associated with atrophy of the central retina or macula, that 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 macula. These changes result in a deterioration of sight over a period of months to years.
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 protein plays 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.
The foregoing press release contains certain forward-looking statements that can be identified by terminology such as "investigational", "preliminary", "ongoing", "will be", "potential to improve", "hope to be", "potentially", or similar expressions, or by express or implied discussions regarding potential marketing approvals of Lucentis , or regarding any potential revenues from Lucentis. Such forward-looking statements involve known and unknown risks, uncertainties or other factors that may cause the actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. There can be no guarantee that Lucentis will be approved for sale in any market or that it will reach any particular sales levels. In particular, management's expectations relating to Lucentis could be affected by, among other things, uncertainties relating to clinical trials; 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; government, industry and general public pricing pressures; as well as factors discussed in the Company's Form 20-F filed 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 Ophthalmics
With worldwide headquarters in Basel, Switzerland, the Novartis Ophthalmics Business Unit 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. Novartis Ophthalmics products are made in Switzerland, France, the United States and Canada. For more information, visit
www.novartisophthalmics.com or
www.us.novartisophthalmics.com.
About Novartis
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Group's businesses achieved sales of USD 28.2 billion and pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.1 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 91,700 people and operate in over 140 countries around the world. For further information please consult
http://www.novartis.com.
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