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Allergan Inc. Reports Operating Results (10-K)
Posted by: gurufocus (IP Logged)
Date: March 1, 2011 07:24AM
Allergan Inc. (AGN) filed Annual Report for the period ended 2010-12-31.
Highlight of Business Operations:
The largest segment of the market for ophthalmic prescription drugs is for the treatment of glaucoma, a sight-threatening disease typically characterized by elevated intraocular pressure leading to optic nerve damage. Glaucoma is currently the worlds second leading cause of blindness, and we estimate that over 70 million people worldwide have glaucoma. According to IMS Health Incorporated, our products for the treatment of glaucoma, including Lumigan® (bimatoprost ophthalmic solution) 0.03%, Lumigan® 0.01%, Ganfort (bimatoprost/timolol maleate ophthalmic solution), Alphagan® (brimonidine tartrate ophthalmic solution) 0.2%, or Alphagan®, Alphagan® P 0.15%, Alphagan® P 0.1% and Combigan® (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, captured approximately 26.2% of worldwide market sales in their product categories for first nine months of 2010.
Lumigan® 0.03% and Lumigan® 0.01% are topical treatments indicated for the reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension. Lumigan® 0.01% is an improved reformulation of Lumigan® 0.03%. We currently sell Lumigan® 0.01% and Lumigan® 0.03% in the United States and over 75 countries worldwide and, together, they are our second best selling eye care products. According to IMS Health Incorporated, Lumigan® 0.01% and Lumigan® 0.03% were amongst the best selling glaucoma products in the world for the first nine months of 2010. In 2002, the European Commission approved Lumigan®
0.03%. In 2004, the European Unions Committee for Proprietary Medicinal Products approved Lumigan® 0.03% as a first-line therapy for the reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension. In 2006, the U.S. Food and Drug Administration, or the FDA, approved Lumigan® 0.03% as a first-line therapy. We are party to an exclusive licensing agreement with Senju Pharmaceutical Co., Ltd., or Senju, under which Senju became responsible for the development and commercialization of Lumigan® 0.03% in Japan. In 2009, Senju received approval of Lumigan® 0.03% in Japan. Also in 2009, Lumigan® 0.01% was approved by Health Canada. In the first quarter of 2010, the European Commission granted a Marketing Authorization for Lumigan® 0.01% in the European Union member states. During the third quarter of 2010, the FDA approved Lumigan® 0.01% as a first-line therapy indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. In 2006, we received a license from the European Commission to market Ganfort in the European Union. Ganfort is now sold in over 37 countries outside the United States. Combined sales of Lumigan® 0.03%, Lumigan® 0.01% and Ganfort represented approximately 11%, 10% and 10% of our total consolidated product net sales in 2010, 2009 and 2008, respectively.
Our third best selling eye care products are the ophthalmic solutions Alphagan®, Alphagan® P 0.15% and Alphagan® P 0.1%. These products lower intraocular pressure by reducing aqueous humor production and increasing uveoscleral outflow. Alphagan® P 0.15% and Alphagan® P 0.1% are improved reformulations of Alphagan® containing brimonidine, the active ingredient in Alphagan®, preserved with Purite®. We currently market Alphagan®, Alphagan® P 0.15% and Alphagan® P 0.1% in over 70 countries worldwide. In 2002, based on the acceptance of Alphagan® P 0.15%, we discontinued the U.S. distribution of Alphagan®. We are party to an exclusive licensing agreement with Senju, under which Senju is responsible for the development and commercialization of Alphagan® and Alphagan® P 0.15% in Japan. The marketing exclusivity period for Alphagan® P 0.1% expired in 2008 and Alphagan® P 0.15 % now faces generic competition in the United States, although we have a number of patents covering the Alphagan® P 0.1% and Alphagan® P 0.15% technology that extend to 2022 in the United States. In 2003, the FDA approved the first generic of Alphagan®. Additionally, a generic form of Alphagan® is sold in a limited number of other countries, including Canada, Mexico, India, Brazil, Colombia, Argentina and in the European Union.
We also developed the ophthalmic solution Combigan®, a brimonidine and timolol combination designed to treat glaucoma and ocular hypertension in patients who are not responsive to treatment with only one medication and are considered appropriate candidates for combination therapy. In 2005, we received positive opinions for Combigan® from 20 concerned member states included in the Combigan® Mutual Recognition Procedure for the European Union, and we launched Combigan® in the European Union during 2006. In 2007, the FDA approved Combigan® and we launched Combigan® in the United States. Combigan® is now sold in 67 countries worldwide. Combined sales of Alphagan®, Alphagan® P 0.15% and Alphagan® P 0.1% and Combigan® represented approximately 8%, 9% and 9% of our total consolidated product net sales in 2010, 2009 and 2008, respectively.
Our ophthalmic anti-inflammatory product Acuvail® (ketorolac tromethamine ophthalmic solution) 0.45%, an advanced unit-dose preservative-free formulation of ketorolac for the treatment of pain and inflammation following cataract surgery, was approved by the FDA in 2009. Our ophthalmic anti-inflammatory product Acular LS® (ketorolac ophthalmic solution) 0.4% is a version of Acular® that has been reformulated for the reduction of ocular pain, burning and stinging following corneal refractive surgery. Acular® PF was the first preservative-free topical non-steroidal anti-inflammatory drug in the United States. Acular® PF is indicated for the reduction of ocular pain and photophobia following incisional refractive surgery. In 2009, the FDA approved seven Abbreviated New Drug Applications, or ANDAs, for ketorolac tromethamine ophthalmic solution 0.5%, a generic version of Acular® and Acular LS®. Acular® and Acular LS® now face generic competition. Our ophthalmic anti-inflammatory product Pred Forte® remains a leading topical steroid worldwide based on 2010 sales. Pred Forte® has no patent protection or marketing exclusivity and faces generic competition.