Novartis Pharma AG announced that Visudyne® (verteporfin), currently the only treatment for some forms of “wet” Age-Related Macular Degeneration (AMD), was launched today in Japan. AMD is the leading cause of blindness in people over age 50. Visudyne was approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) in October 2003 for the “wet” form of age-related macular degeneration with all types of subfoveal choroidal neovascularization (CNV).
“We are very pleased that we are able to bring this drug to the Japanese marketplace,” said Flemming Ornskov, MD, President and Chief Executive Officer of Novartis Ophthalmics, the eye health unit of Novartis Pharma AG. “The progressive loss of central vision associated with AMD can have a devastating impact on a patient’s quality of life. Without this treatment a person on average may be legally blind after just two years from diagnosis”.
In Japan, the loss of vision is defined legally as the case when the corrected vision of both eyes are under 0.1 or when the corrected vision of first an eye is under 0.02 and with the vision of the second another eye being under 0.6.
Approval was based on the results of a well-designed 12-month clinical study conducted in Japan, which confirmed the efficacy and safety profile of Visudyne. In fact approximately 3 patients out of 4 participating in this study either maintained or improved their vision as a result of Visudyne therapy. Visudyne was evaluated in Japan as a therapeutic drug for the wet form of AMD following its designation as an orphan drug in June 1997.
AMD is the leading cause of legal blindness in 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.
Vision loss from 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.
Visudyne therapy is a two-step procedure. Following intravenous administration, Visudyne is activated by a non-thermal laser light. The process is known as photodynamic therapy. Visudyne selectively targets abnormal blood vessels under the retina, resulting in a reduction in their growth, without affecting normal/healthy retina tissue. This, in turn, stops the leakage associated with wet AMD. However, it is important for patients to be diagnosed and treated early if they are to gain maximal benefit from treatment with Visudyne.
Visudyne is the only drug approved for the treatment of some forms of wet AMD, the leading cause of blindness in people over the age of 50, and has been used in more than 250,000 patients worldwide. Visudyne is commercially available in more than 70 countries mainly for the treatment of predominantly classic subfoveal CNV and in over 40 countries for occult subfoveal CNV caused by AMD. It is also approved in more than 55 countries, including the EU, U.S. and Canada, for the treatment of subfoveal CNV due to pathologic myopia (severe near-sightedness). In some countries Visudyne is also approved for presumed ocular histoplasmosis or other macular diseases.
The foregoing press release contains forward-looking statements that can be identified by terminology such as “able to bring”, “may be “, or similar expressions, or by express or implied discussions regarding potential future sales of Visudyne.
Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the actual results and assumptions to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee regarding potential future sales of Visudyne.
In particular, management’s expectations regarding commercialization of Visudyne could be affected by, among other things, additional analysis of Visudyne clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the company’s 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 the Company’s current 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 anticipated, believed, estimated or expected. 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.
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.novartisophthalmics.com/us.
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2003, the Group’s businesses achieved sales of USD 24.9 billion and a net income of USD 5.0 billion . The Group invested approximately USD 3.8 billion, in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 78 500 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.