This excerpt taken from the ACL 20-F filed Mar 15, 2005.
Our broad range of products represents one of the strongest portfolios in the ophthalmic industry, with high-quality and technologically advanced products across all major product categories. Our leadership position across most of our product categories enhances our ability to extend our product offerings, through the launch of new and innovative products, and to expand our geographic reach into ophthalmic markets worldwide. We manage our business through two business segments: Alcon United States and Alcon International. Our portfolio spans three key ophthalmic categories: pharmaceutical, surgical and consumer eye care products. See notes 9 and 10 to the consolidated financial statements for a three year history of our sales by segment and category.
Our Pharmaceutical Products
We are a global leader in ophthalmic pharmaceuticals. We develop, manufacture and market a broad offering of prescription ophthalmic pharmaceutical products.
The following table lists our principal pharmaceutical products:
In 2004, sales of our glaucoma products were $526.3 million, or 34.1% of our total pharmaceutical sales.
In 2001, we launched Travatan®, our entry into the prostaglandin analogue class of glaucoma treatments, in the United States. Prostaglandin analogues are the newest and most effective class of compounds currently available to reduce intraocular pressure, the primary characteristic of glaucoma. Travatan® contains the most potent prostaglandin analogue available today. Outside the United States, we have launched Travatan® in more than 95 countries.
In addition to Travatan®, we offer a complete line of glaucoma products, including Azopt® and Betoptic S® ophthalmic suspensions, both of which utilize other classes of compounds. Azopt®, a carbonic anhydrase inhibitor, has shown to be an excellent adjunct therapy when used with other glaucoma therapies, including prostaglandin analogues, to control intraocular pressure.
These products are important to our glaucoma franchise and currently make up a majority of our glaucoma sales. We expect these glaucoma products to continue to contribute to our sales growth.
Anti-infectives, Anti-inflammatories and Combination Therapies
We currently manufacture and market a broad range of drugs to treat bacterial, viral and fungal infections of the eye and to control ocular inflammation. In 2004, combined sales of our ocular anti-infectives, ocular anti-inflammatories and combination therapies were $572.7 million, or 37.1% of our total pharmaceutical sales.
Our leading ocular anti-infective product is Vigamox® ophthalmic solution utilizing moxifloxacin. Vigamox® is effective against a broad spectrum of bacteria, including strains resistant to more than one antibiotic. In April 2003, we launched Vigamox® in the U.S. for the treatment of bacterial conjunctivitis. Vigamox® became our leading topical antibiotic in the U.S. due to its broad spectrum, its ability to eradicate resistant bacteria, its ability to penetrate the surface of the eye and its three times a day dosing. During 2004, Vigamox® replaced Ciloxan® ophthalmic ointment and solution as our largest selling anti-infective.
Ciloxan® is offered in both ointment and solution form, providing options for treating ocular infection in a variety of patients. We currently sell Ciloxan® in more than 100 countries. The patents for Ciloxan® have expired in virtually all of the countries where it is marketed, including the U.S. in June 2004.
Our combination ocular anti-infective/anti-inflammatory product, TobraDex® ophthalmic suspension and ointment, is convenient because it combines a broad-spectrum antibiotic with a proven anti-inflammatory. TobraDex® is currently the only tobramycin/dexamethasone ophthalmic combination product in the U.S. market and has no generic equivalent. We currently sell TobraDex® in more than 90 countries.
We currently market and manufacture products for the treatment of ocular allergies. In 2004, sales of our ocular allergy pharmaceutical products were $321.4 million, or 20.8% of our total pharmaceutical sales. The allergy market is, by its nature, seasonal, peaking in the spring and again, but to a lesser extent, in the fall.
Patanol® ophthalmic solution was the first twice-daily ocular allergy product with a dual-action active ingredient, which acts as both an antihistamine and a mast-cell stabilizer. When we introduced Patanol® in 1997, we estimated the total topical ocular allergy market to be less than $100 million. Due in large part to the effectiveness of this drug, our related marketing efforts to physicians and direct-to-consumer advertising, the methods for treating ocular allergy have been expanded to include topical eye drops. This evolution in treatment methods has resulted in sales of topical ocular allergy products in the United States increasing to more than $400 million in 2004. In 2003, we launched a European version of Patanol® under the name Opatanol® ophthalmic solution, and we are also seeking approval of Patanol® in Japan. We currently sell Patanol® in more than 60 countries.
We also market combination anti-infective/anti-inflammatory products for ear infections. In 1998, we licensed Cipro® HC
Otic drops to treat otitis externa, commonly known as swimmers ear. Cipro® HC Otic currently is marketed in over 30 countries. Sales of this product are seasonal, with the majority of prescriptions written during the summer months.
In 2003 we strengthened our otic portfolio with the introduction of Ciprodex® otic suspension for the treatment of otitis media in the presence of tympanostomy tubes (AOMT) and of otitis externa. The AOMT indication allows us to compete in the market for patients who have middle ear infections and ear tubes. Clinical trials for Ciprodex® otic showed higher cure rates versus market-leading products. Ciprodex® currently is marketed in the U.S. and a small number of countries outside the U.S.
We established Falcon Pharmaceuticals in 1994 to manufacture and market generic ophthalmic and otic pharmaceutical products in the United States. Falcons sales in 2004 were $102.1 million, or 6.6% of our total global pharmaceutical sales.
Falcons main product is Timolol GFS, a patented gel forming solution used to treat glaucoma. Timolol GFS is currently the sole generic pharmaceutical approved by the FDA as an AB therapeutically equivalent substitute for Mercks Timoptic- XE® at the pharmacy. In 2004, Timolol GFS accounted for over 89% of the U.S. prescriptions written for gel formulated timolol. We expect Timolol GFSs status as the sole generic substitute for Timoptic-XE® to continue through September 2006, when Mercks patent protection expires.
Falcon currently manufactures and markets 28 generic pharmaceutical products. Falcons other principal generic products include Prednisolone Acetate 1% (which is a steroid used for the treatment of inflammation of the eye), Timolol Solution (for the treatment of glaucoma), Trifluridine (used to treat virus infections of the eye), Brimonidine 0.2% (introduced in 2003 for the treatment of glaucoma), and Neomycin and Polymyxin B Sulfates and Hydrocortisone otic and ophthalmic suspensions (sterile antibacterial and anti-inflammatory combination products for the treatment of bacterial infections in the ear and the eye, respectively).