NVS » Topics » Ophthalmics, Dermatology, Gastrointestinal & Urinary (ODGU)

This excerpt taken from the NVS 20-F filed Jan 31, 2007.

Ophthalmics, Dermatology, Gastrointestinal & Urinary (ODGU)

        In ophthalmics, our research and development is focused on treatments for "Back of the Eye" diseases as well as on "Dry Eye" conditions and glaucoma. These areas are characterized by high growth

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and significant unmet medical need. The key area of focus within "Back of the Eye" is "wet" age-related macular degeneration (AMD), a leading cause of blindness in people over age 50. Our ophthalmics business has built a leadership position in wet AMD with its flagship product Visudyne. We are now in the launch phase for Lucentis, a revolutionary product which is the first to show improved vision in patients with wet AMD. Lucentis was approved in Switzerland in August 2006, and approval is expected in the EU in January 2007.

        Our focus in dermatology is on the treatment of two very common diseases—the inflamed skin condition known as atopic dermatitis, or eczema, and fungal nail infections. Elidel was the first non-steroid cream approved for eczema, a disease that affects about 10% of children in the US, while Lamisil tablets are the most frequently prescribed treatment worldwide for fungal nail infection.

        We have established Novartis in the gastrointestinal market with the launch of Zelnorm/Zelmac for the treatment of irritable bowel syndrome with constipation (IBS-C), a motility and sensory disorder characterized by abdominal pain, bloating and constipation. More than 30 million people in the US are estimated to suffer from IBS-C, and Zelnorm/Zelmac is the first and only medication approved by major health authorities to treat this condition. Zelnorm/Zelmac is also approved for the treatment of chronic idiopathic constipation in the US and several other countries including Canada, Mexico and Turkey.

    Key Marketed Products

    Elidel (pimecrolimus) was the first non-steroid cream approved for the treatment of atopic dermatitis, a skin condition commonly known as eczema, in adults and children. It is one of the first new eczema treatments introduced since the 1950s, when topical corticosteroids—historically the mainstay of therapy—became available. First launched in 2002 in the US, Elidel is now registered in approximately 90 countries, including many EU markets. Following discussions with the FDA and EMEA, prescribing information for Elidel (dispensed only as a topical cream) was updated in February and May 2006. In the US, a boxed warning and medication guide make clear that no causal link has been established between the use of Elidel and rare post-marketing reports of malignancy. In the EU, a similar warning was also added to the prescribing information. The concern of the health authorities for a potential risk for malignancies exists based on the use of oral calcineurin inhibitors at high doses. A similar change in labeling has been made to the other product in this class. While we believe this action is not substantiated by scientific or clinical evidence, we agreed to make the requested changes and will continue to communicate them to physicians and patients so that they can continue to use Elidel as labeled to effectively manage eczema. We are confident in the safety and efficacy of Elidel, which is one of the most thoroughly researched dermatology products in the world and continues to be supported with significant ongoing clinical trials.

    Enablex/Emselex (darifenacin) is a once-daily, oral, selective M3 receptor antagonist for the treatment of Overactive Bladder. Enablex is the trade-name in the US, Canada, Latin America, Australia and South Africa, while Emselex is the trade-name in Europe and most other countries. This product was approved in the EU in October 2004 and approved in the US in December 2004. It is now available in over 10 countries, including the US, Germany and the UK. Enablex/Emselex has been shown to reduce the number of weekly urge urinary incontinence episodes by up to 83% versus placebo.

    Lamisil (terbinafine) is the leading therapy for onychomycosis, also known as fungal nail infection. Lamisil tablets kill the fungus that causes the infection at its source, working through the patient's bloodstream. This product was first launched in 1991 and is now available in more than 90 countries, with the US the leading market. Lamisil tablets are also approved for treating athlete's foot (tinea pedis) and fungal infection of the scalp (tinea capitis) in some countries, though not yet in the US. Our Consumer Health Division's OTC Business Unit markets over-the-counter cream formulations of Lamisil for use in treating athlete's foot in many markets, including the US.

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      Generic forms of terbinafine were launched in a number of European markets in 2005, with generic competition expected in the US in July 2007 following the expiration of exclusivity.

    Lucentis (ranibizumab) is a recombinant humanized high affinity antibody fragment that binds to vascular endothelial growth factors. It is designed to penetrate the retina to decrease permeability and inhibit the formation of choroidal neovascularization, which leads to blindness in AMD patients. Lucentis is the first approved drug for wet AMD patients that has been shown in Phase III studies to improve vision and return the ability to do life-affirming everyday activities such as reading. Lucentis was approved by the US FDA in June 2006, in Switzerland in August 2006, and in the EU in January 2007. Lucentis is developed in collaboration with Genentech, which holds the rights to market the product in the US.

    Visudyne (verteporfin) is a light-activated drug used in a two-step procedure that can be performed in a doctor's office. First, the drug is injected intravenously into the patient's arm. A low-energy laser light is then shone into the patient's eye to activate the drug. First launched in 2000, Visudyne is commercially available in over 75 countries for the treatment of predominantly classic subfoveal choroidal neovascularization (CNV), a major cause of vision loss caused by AMD. It is also approved in over 40 countries other than the US for the treatment of occult subfoveal CNV secondary to AMD, including the EU, where it gained approval in 2002. In addition, Visudyne is approved in over 45 countries, including the EU, US and Canada, for the treatment of subfoveal CNV due to pathologic myopia (severe near-sightedness). In Japan, Visudyne is approved for all types of subfoveal CNV secondary to AMD. Further geographic expansion is planned, including in China.

    Zaditor/Zaditen (ketotifen fumarate) is an eye drop that provides fast and lasting relief of symptoms in patients suffering from ocular allergy. This product, which is known as Zaditor in the US and Zaditen in other markets, works through multiple mechanisms of action to provide relief within minutes and a duration of action of up to 12 hours. Zaditor/Zaditen was first launched in Japan and has been approved in more than 60 countries, including the US and the EU. Zaditor was recently approved by the FDA for over-the-counter use. It will be available OTC beginning in January 2007.

    Zelnorm/Zelmac (tegaserod) is the first in a new class of medicines known as serotonin-4 (5-HT4) receptor selective agonists approved for the treatment of the multiple symptoms associated with irritable bowel syndrome with constipation (IBS-C) in women. This product, which is known as Zelnorm in North America and South Africa and as Zelmac in other markets, acts by decreasing the visceral sensitivity of the intestinal tract, increasing intestinal secretion, and increasing gastrointestinal motility. This reduces the impact of symptoms such as abdominal pain, bloating and constipation. In 2004, Zelnorm received US approval to become the first treatment approved for chronic idiopathic constipation in men and women under age 65. First launched in 2001 in Mexico, this product has now been approved in more than 55 countries. Zelnorm is also approved for the treatment of chronic idiopathic constipation in more than 25 countries including the US, Canada and Mexico.

    New Indications in Development

    Lamisil (terbinafine) has been under development for the treatment of ringworm of the scalp (tinea capitis). Product registration files have been submitted in the US. In addition, a topical formulation of Lamisil (nail lacquer) is in development for the treatment of onychomycosis. Lamisil lacquer entered Phase III trials in December 2006, with US filing expected in early 2009.

    Zelnorm/Zelmac (tegaserod maleate/tegaserod) received a negative opinion from EMEA in May 2006 for the treatment of irritable bowel syndrome with constipation in women. Novartis will pursue regulatory options with positive EU countries in 2007. In addition, Zelnorm/Zelmac has finalized Phase III studies for the treatment of functional dyspepsia and we are in discussion with FDA concerning the submission of this data.

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    Elidel (pimecrolimus) is in Phase III development for atopic dermatitis in infants under two years old. In addition, it is in Phase II development for the treatment of dry eye in a novel drops formulation.

    Lucentis (ranimizumab) is in Phase II development for the treatment of Diabetic Macular Edema.

    Sandostatin LAR (diabetic retinopathy) and Visudyne (predominant occult AMD) have been terminated.

    Compounds in Development

    OPC759 (rebamipide) is a selective mucin secretagogue, currently in Phase III studies for the treatment of dry eye. This compound was in-licensed from Otsuka Pharmaceuticals Corporation, Japan.

    PTK787 (vatalanib) is currently in development for the treatment of age-related macular degeneration (all forms of wet AMD) and is in Phase II. We are jointly developing PTK787 with Schering AG for certain oncology indications. We have entered into an agreement with Schering granting us exclusive rights to develop and commercialize PTK787 for the treatment of ophthalmic conditions.

    AEB071 is a PKC inhibitor currently in Phase I for the treatment of psoriasis.

    AHT956 is a PKC inhibitor currently in Phase I for the treatment of psoriasis.

    RKI983 is a Rho kinase inhibitor, currently in Phase I and investigated for topical treatment of glaucoma. This compound was in-licensed from Senju Pharmaceutical Co, Japan, and is under the sub-license rights granted by Mitsubishi Pharma Corporation to Senju.
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