Basel, Switzerland and Irvine, Calif., USA, 8 January 2003 - Novartis Ophthalmics, the eye health unit of Novartis, and Valley Forge Pharmaceuticals, Inc., announced today that they have entered into a licensing agreement for a novel eye medication for the treatment of myopia (nearsightedness). The compound Pirenzepine is currently in Phase II clinical trials. Upon successful completion of Phase III clinical trials and regulatory approvals, Novartis Ophthalmics will market the compound worldwide.
In Phase II clinical trials Pirenzepine has been shown to reduce the progression of the disease by at least 50% in the first 12 months of therapy in children who suffer from myopia.
Financial terms of the transaction were not disclosed.
"This novel compound significantly strengthens our development pipeline by addressing myopia, one of the most important unmet needs in ophthalmics," said Dr. Flemming Ørnskov, Head of Novartis Ophthalmics. "It could set new standards for the treatment of this eye disorder, since there is no pharmacological therapy available today."
Paul A. Lopez, CEO of Valley Forge, commented, "We are very excited about this agreement and securing such a strong partner as Novartis Ophthalmics. The licensing of our lead product, Pirenzepine ophthalmic gel, is an important milestone for Valley Forge Pharmaceuticals, Inc. We look forward to a productive collaboration."
Pirenzepine ophthalmic gel is a completely new therapeutic approach to myopia - a relatively selective muscarinic M1 receptor antagonist administered as an eye gel twice a day, which is expected to reduce the progression of myopia (near-sightedness) by up to 50%.
About Myopia
Myopia (nearsightedness) is a very common eye disorder, with onset occurring mainly during childhood. It affects approximately 50 million young people (age 5 - 19 years) in industrialized countries. Severe myopia (myopia higher than 6 diopter) and pathologic myopia (myopia higher than 12 diopter) are associated with an elevated risk of ocular complications later in life. Additionally, lesser degrees of myopia may also represent a risk factor for future ocular disorders.
The foregoing press release contains forward-looking statements that can be identified by terminology such as "upon successful completion", "could set new standards", "Novartis Ophthalmics will market", "is expected to advance" or similar expressions. 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. Such factors include, but are not limited to: risks associated with the development and commercialization of the treatment, including uncertainties relating to manufacturing, clinical trials, registration, pricing and reimbursement; patient and physician demand for the treatment; competition; any uncertainty regarding patents and proprietary rights; product liability claims and insurance; government regulation; dependence on corporate relationships; volatility of share prices as well as factors discussed in the Company's Form 20-F filed 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.
Background on Novartis Ophthalmics
With worldwide headquarters in Bulach, Switzerland, Novartis Ophthalmics is a global leader in research, development and manufacturing of leading ophthalmic pharmaceuticals that assist in the treatment of glaucoma, age-related macular degeneration, eye inflammation, 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 are based in Atlanta, Georgia. Novartis Ophthalmics products are made in Switzerland, France and Canada. For further information please consult www.novartisophthalmics.com or www.novartisophthalmics.com/us.
Background on Novartis
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2001, the Group's businesses achieved sales of CHF 32.0 billion (USD 19.1 billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 74,000 people and operate in over 140 countries around the world. For further information please consult www.novartis.com.
Background on Valley Forge
Valley Forge Pharmaceuticals Inc, is an early stage ophthalmic pharmaceutical company located in Irvine, California. The Company's key focus is the development of anti-myopia drugs. Valley Forge Pharmaceuticals Inc. has secured an extensive world wide patent estate related to their areas of development and the company will continue to evaluate new and innovative compounds for ophthalmic use. For further information please consult www.valleyforgepharmaceuticals.com.
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