Novartis reaches agreement to develop and commercialize glaucoma treatment with novel mechanism of action
In-licensing deal provides Novartis with entry into key glaucoma market
Basel, November 9, 2005 - Novartis announced today that it has signed a global (excluding Japan) development and commercialization agreement with Senju Pharmaceutical Co., Ltd., for Y39983, a Rho Kinase inhibitor for topical treatment of glaucoma, under the sub-license rights granted by Mitsubishi Pharma Corporation to Senju.
Novartis will be responsible for developing and commercializing Y39983 in its territories. Y39983, which has entered Phase I development in Japan, is a specific and highly potent Rho Kinase inhibitor with a new mechanism of action that regulates pressure inside the eye.
“This agreement will allow us to better leverage our well-established leadership and expertise in the treatment of back-of-the-eye diseases, such as ’wet’ age-related macular degeneration (AMD), to offer patients a novel treatment for glaucoma,” said Nicholas Franco, President of Novartis Ophthalmics. “A significant unmet medical need remains to help patients with glaucoma, and Novartis has taken the lead in the development of a next-generation treatment with Y39983. We believe this compound could become the leading treatment for patients with glaucoma.”
Under terms of the agreement, Senju will receive an initial payment and additional milestone payments based on the achievement of agreed clinical, regulatory and commercialization targets, with royalties to be paid on the marketed product.
Glaucoma is a group of diseases of the eye that may cause vision loss and blindness due to damage to the optic nerve. Damage is caused by intraocular pressure (IOP), which is caused by a blockage in the normal outflow of aqueous humor (fluid in the eye). There are several types of glaucoma, and most varieties are chronic and require life-long control after diagnosis. Glaucoma is one of the leading causes of adult blindness, with prevalence estimates in adults 40 years and over varying from 1.3 - 4.7 percent, with significant differences in racial sub-populations.
Glaucoma, valued at USD 3.7 billion in 2005, represents the largest portion of the ophthalmics market. The glaucoma market grows at an estimated 4 percent per year and is currently dominated by Intra Ocular Pressure (IOP) lowering prostaglandin (PG) analogues.
The foregoing press release contains certain forward-looking statements that can be identified by terminology such as “will be”, “will allow” “has taken the lead in the development of a next-generation treatment”, “we believe . could become”, “will receive”, or similar expressions, or by express or implied discussions regarding potential development and commercialization of Y39983. 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 the agreement that is the subject of this release will lead to commercialization of Y39983 in any market. In particular, management’s expectations relating to Y39983 could be affected by, among other things, uncertainties relating to product development and 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.
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.
 Tiesch et al, JAMA (1991) 266; 3: 369-374 - The Baltimore Eye Survey (US)
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