Novartis obtains rights from Otsuka to develop new treatment for dry eye

Main Category: Eye Health / Blindness
Article Date: 13 Feb 2005 - 8:00 PDT

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Novel mechanism of action expected to enhance tear secretion and increase mucin levels covering conjunctiva and cornea - Over 22 million patients visit ophthalmologists each year seeking treatment for symptoms of dry eye.

Novartis announced today that it has in-licensed rebamipide, an investigational treatment for dry eye, from Otsuka Pharmaceutical Company, Ltd. Currently being tested in two Phase III studies in the US, rebamipide is expected to demonstrate a novel mechanism of action to enhance tear secretion and increase the levels of mucin covering the conjunctiva and cornea of the eye.

Dry eye is a condition characterized by a patient's inability to produce enough tears or the appropriate quality of tears to keep the eye healthy and comfortable. There are currently 22 million patients who visit an ophthalmologist worldwide for dry eye symptoms and many more who self-treat or do not treat their condition at all.

"As dry eye can have many causes and affects a large and growing patient population, there is a high unmet medical need and opportunities exist for several new pharmacological treatment approaches," said Flemming Ornskov, MD, President of Novartis Ophthalmics. "We expect rebamipide to provide distinct advantages to patients over currently available products."

Dysfunction in the delicate balance in the tear film may develop from aging, systemic inflammatory diseases, ocular surface diseases, or different medications. Palliative treatments for dry eye include artificial tears, which patients can self-administer four or more times per day. Unlike artificial tears, which simply lubricate the eyes and help maintain moisture1, rebamipide provides a new and unique pharmacologic approach to treatment of dry eye by increasing mucin secretion. It is expected to increase tear quality and may improve corneal health.

"Novartis sees promise in rebamipide's novel ability to treat dry eye," said Ornskov. "With this in-license agreement, we expect to be able to offer general ophthalmologists a well-rounded dry eye product portfolio that we hope will elevate the standard of treatment worldwide."

Under the agreement, Novartis will obtain an exclusive license with the right to sub-license the compound globally, excluding Japan and selected Asian countries. Novartis will pay an upfront fee and annual royalties. The terms of the agreement were not disclosed.

The foregoing press release contains certain forward-looking statements that can be identified by terminology such as "will," "expected to increase," "expect to provide," "may improve," "opportunities exist," "sees promise," "expect to be able," or similar expressions, or by express or implied discussions regarding the potential that rebamipide will be approved for marketing, or regarding any potential revenues from rebamipide. 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. In particular, management's expectations relating to rebamipide 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

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 a net income of USD 5.8 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 81 400 people and operate in over 140 countries around the world. For further information please consult
http://www.novartis.com.

References
1 American Academy of Ophthalmology. Dry Eye. 2003

Contacts

Laurie Wooding
Novartis Ophthalmics
Tel +41 61 697 9879 (CH)
or +1 862 778 2104 (USA)
mailto:laurie.wooding@pharma.novartis.com

Lisa Richert
Novartis Global Media Relations
Tel + 41 61 324 3543
or +41 61 324 2200
mailto:lisa.richert@group.novartis.com

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