Profile: Valeant Pharmaceuticals International Inc (VRX.N)
9 Dec 2013
Valeant Pharmaceuticals International, Inc., formerly Biovail Corporation, is a multinational, specialty pharmaceutical company that develops, manufactures and markets a range of pharmaceutical products. The Company operates in five business segments: U.S. Neurology and Other, U.S. Dermatology, Canada and Australia, Branded Generics - Europe and Branded Generics -Latin America. Within its U.S. Dermatology segment and Branded Generic - Europe segment the Company generates service revenue from contract services in the areas of dermatology and topical medication. On December 12, 2011, it acquired assets of the Ortho Dermatologics division of Janssen Pharmaceuticals, Inc. (Janssen). On December 16, 2011, it acquired the dermatology business, Dermik, of Sanofi. On December 21, 2011, it acquired iNova, from Archer Capital, Ironbridge Capital and other minority management shareholders. On February 1, 2012, it acquired Probiotica Laboratorios Ltda (Probiotica). On February 3, 2012, the Company completed the divestiture of 1% clindamycin and 5% benzoyl peroxide gel (IDP-111), a generic version of Benzaclin, and 5% fluorouracil cream, (5-FU), an authorized generic of Efudex, to Mylan Inc. On March 12, 2012, it acquired a 19.9% minority equity investment in Pele Nova Biotecnologia S.A. In September 2012, the Company acquired Visudyne, which is used to treat abnormal growth of leaky blood vessels in the eye caused by wet age-related macular degeneration. On December 7, 2012, the Company acquired Medicis Pharmaceutical Corporation. In February 2013, it acquired Natur Produkt International, JSC. In April 2013, Valeant Pharmaceuticals International Inc acquired the entire share capital of Obagi Medical Products Inc. In June 2013, Hyperion Therapeutics Inc announced that the completion of its acquisition of BUPHENYL (sodium phenylbutyrate) Tablets and Powder from Ucyclyd Pharma Inc., a subsidiary of Valeant Pharmaceuticals International, Inc. In August 2013, Valeant Pharmaceuticals International Inc completed the acquisition of Bausch + Lomb Holdings Incorporated.
On February 7, 2011, the Company entered into an agreement to license the Canadian rights to ACZONE Gel 5%, a topical formulation of dapsone used in the treatment of acne vulgaris, from Allergan, Inc. On February 9, 2011, it acquired the Canadian rights to Lodalis (colesevelam hydrochloride), an oral bile acid sequestrant for hypercholesterolemia, from Genzyme Corporation (Genzyme). On February 22, 2011 and March 25, 2011, the Company acquired the United States and Canadian rights, respectively, to non-ophthalmic topical formulations of Zovirax from GlaxoSmithKline LLC and the entities within The Glaxo Group of Companies (GSK). On August 19, 2011, the Company acquired AB Sanitas. On March 10, 2011, the Company acquired PharmaSwiss S.A. (PharmaSwiss). On October 29, 2010, the Company acquired the intellectual property, trademarks and inventory related to the Hamilton skin care brand in Australia. On October 17, 2011, the Company acquired 73.8% of the outstanding common shares of Afexa Life Sciences Inc. (Afexa). During the year ended December 31, 2011, the Company acquired Ganehill Pty Limited (Ganehill).
The Company’s specialty pharmaceutical and over-the-counter (OTC) products are marketed under brand names and are sold in the United States, Canada, Australia and New Zealand. The Company focuses on products in the dermatology and neurology therapeutic classes. It also has branded generic, branded, and OTC operations in Europe, Latin America, South East Asia and South Africa. As of December 31, 2011, its product portfolio consists of approximately 900 products, with approximately 4,100 stock keeping units (SKUs). As of December 31, 2011, the Company operated in five new territories: Malaysia, Philippines, Thailand, Hong Kong and South Africa, with a distribution business in Vietnam, Indonesia and Singapore.
U.S. Neurology and Other
The U.S. Neurology and Other segment generates product revenues from pharmaceutical products. These pharmaceutical products are marketed and sold primarily through wholesalers. Its principal Neurology and Other products are Wellbutrin XL, which is an extended-release formulation of bupropion indicated for the treatment of major depressive disorder in adults. Xenazine is indicated for the treatment of chorea associated with Huntington's disease. In the United States, Xenazine is distributed for the Company by Lundbeck Inc. under an exclusive marketing, distribution and supply agreement for an initial term of 15 years. The Company generates alliance revenue from the licensing of various products it developed or acquired.
The U.S. Dermatology segment generates product revenues from pharmaceutical and OTC products. These pharmaceutical products are marketed and sold primarily through wholesalers and to a lesser extent through retail and direct-to-physician channels. Zovirax Ointment is a topical formulation of a synthetic nucleoside analogue, which is active against herpes viruses. Each gram of Zovirax Ointment contains 50 milligram of acyclovir in a polyethylene glycol base. This product is indicated for the management of initial genital herpes and in limited non-life threatening mucocutaneous herpes simplex infections in immuno-compromised patients. Xerese (acyclovir and hydrocortisone cream) is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and adolescents (12 years of age and older). Xerese contains acyclovir, a synthetic nucleoside analogue active against herpes viruses, and hydrocortisone, an anti-inflammatory corticosteroid, combined in a cream for topical administration.
Elidel is a topical formulation used to treat mild to moderate atopic dermatitis, a form of eczema. Each gram of Elidel Cream 1% contains 10 milligram of pimecrolimus in a whitish cream base of benzyl alcohol, cetyl alcohol, citric acid, mono- and di-glycerides, oleyl alcohol, propylene glycol, sodium cetostearyl sulphate, sodium hydroxide, stearyl alcohol, triglycerides, and water. Elidel (pimecrolimus) Cream 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in nonimmunocompromised adults and children 2 years of age and older, who have failed to respond to other topical prescription treatments, or when those treatments are not advisable. Acanya gel is a fixed-combination clindamycin phosphate (1.2%)/benzoyl peroxide (2.5%) aqueous gel approved for the once daily treatment of acne vulgaris in patients 12 years and older.
Atralin gel is an aqueous gel containing micronized tretinoin (0.05%) approved for once daily treatment of acne vulgaris in patients 10 years and older. Atralin reduces both inflammatory and non-inflammatory acne lesions and contains ingredients (hyaluronic acid, collagen and glycerin) known to moisturize and hydrate the skin. The Company markets the prescription brand Retin-A Micro. The Company markets Sculptra and Sculptra Aesthetic, which is an injectable implant containing microparticles of poly-L-lactic acid (PLLA), a biocompatible, biodegradable, synthetic polymer from the alpha-hydroxy-acid family, carboxymethylcellulose (USP), non-pyrogenic mannitol (USP) and sterile water for injection (USP). Principal OTC products include CeraVe and Kinerase.
CeraVe is a range of OTC products with ceramides and other skin-nourishing and skin-moisturizing ingredients (humectants and emollients) combined with a Multivesicular Emulsion (MVE) delivery technology that, together, work to rebuild and repair the skin barrier. CeraVe formulations incorporate ceramides, cholesterol and fatty acids, all of which are essential for skin barrier repair and are used as adjunct therapy in the management of various skin conditions. Kinerase is a range of OTC and prescription cosmetic products. Kinerase contains the synthetic plant growth factor N6-furfuryladenine which has been shown to slow the changes that occur in the cell aging process in plants and in skin cells.
The Company generates alliance revenue and service revenue from the licensing of dermatological products and from contract services in the areas of dermatology and topical medication. Alliance revenue within its U.S. Dermatology segment included payments from the sale of a 1% clindamycin and 5% benzoyl peroxide gel product (IDP-111) by Mylan Pharmaceuticals, Inc. (Mylan). Contract services are primarily focused on contract research for external development and clinical research in areas such as formulations development, in vitro drug penetration studies, analytical sciences and consulting in the areas of labeling and regulatory affairs.
Canada and Australia
The Canada and Australia segment generates product revenues from pharmaceutical and OTC products. These pharmaceutical products are marketed and sold primarily through wholesalers and to a lesser extent through retail and direct-to-physician channels. Cesamet is a synthetic cannabinoid. It is indicated for the management of severe nausea and vomiting associated with cancer chemotherapy. Tiazac XC is a calcium channel blocker (CCB) used in the treatment of hypertension and angina. Tiazac XC is a once-daily formulation of diltiazem that delivers smooth blood pressure control over a 24-hour period. Its generic version of Tiazac XC is distributed in Canada by Teva Canada.
Wellbutrin XL is a once-daily formulation of bupropion developed by Biovail that is approved for the treatment of major depressive illness and the prevention of seasonal major depressive illness. Sublinox (zolpidem tartrate) is indicated for the short-term treatment and symptomatic relief of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. The product is commercialized by the joint venture between Meda AB and Valeant Canada Limited (Meda Valeant Pharma Canada Inc.) and was launched, in September 2011. Lodalis (colesevelam hydrochloride) is an oral bile acid sequestrant for hypercholesterolemia. Lodalis was launched in Canada, in February 2012.
The Company’s principal OTC products in Canada are Cold-FX. Cold-FX is a ChemBioPrint product derived from the roots of North American ginseng (Panax quinquefolius). Each capsule contains 200 milligram or 300 milligram of CVT-E002 a extract of polysaccharides. The Company’s principal products sold in the Australian market are Duromine/Metermine, Difflam and Duro-Tuss. Duromine/Metermine is a prescription weight loss drugs that act through appetite suppression. Duromine/Metermine contains the active ingredient, phentermine, in a once daily formulation. The Company markets a range of OTC products that relieve painful conditions of the mouth and throat and also a range of products that provide relief of dry and chesty coughs sold under the brand names Difflam, Duro-Tuss and Rikodeine, respectively.
Difflam is a market product range of lozenges, sprays and gargles for the treatment of sore throats and other painful mouth conditions. Duro-Tuss and Rikodeine are products consisting of lozenges and syrups for the treatment of dry and chesty cough. Its principal OTC skin products in Australia are Dr. Lewinn's, Dermaveen, Invisible Zinc and Hamilton products. Dr. Lewinn's is a range of anti-aging skincare products, which caters to individual skin-types. Dermaveen is a therapeutic skincare range for dry, itchy or sensitive skin using colloidal oatmeal. Invisible Zinc is a skincare product that provides sun protection using zinc-oxide. Hamilton products are a range of sun and therapeutic skincare products.
Branded Generics - Europe
The Branded Generics - Europe segment generates revenues in more than 20 countries in Central and Eastern Europe from branded generic pharmaceutical products, OTC products and from agency/in-licensing arrangements with other research-based pharmaceutical companies (where it distributes and markets branded, patented products under long-term, renewable contracts). Products are sold primarily in Poland, Serbia, Hungary, Croatia and Russia. Its PharmaSwiss S.A. (PharmaSwiss), is a privately-owned branded generics and OTC pharmaceutical company with a product portfolio in seven therapeutic areas and operations in 19 countries throughout Central and Eastern Europe. AB Sanitas (Sanitas) is a specialty pharmaceutical company. Sanitas has a branded generics product portfolio consisting of 390 products in nine countries. Sanitas has in-house development capabilities in dermatology, hospital injectables and ophthalmology.
The Company’s European products are sold under the Valeant umbrella brand. Its combined European branded generics business covers a range of treatments, including antibiotics, treatments for cardiovascular and neurological diseases, antifungal medications and diabetic therapies among many others. The Company’s product is Bisocard, which is a Beta-blocker that is indicated to treat hypertension and angina pectoris. From PharmaSwiss, it has acquired products, including Monopril (fosinopril), Diclo Duo (an NSAID) and Cardiopirin (an enteric coated low dose OTC aspirin). From Sanitas, the Companu has acquired products, including Flucinar, a corticosteroid ointment, and Sachol, a gel product for mouth ulcers.
Branded Generics - Latin America
The Branded Generics - Latin America segment generates revenues from branded generic pharmaceutical products and OTC products in Mexico and Brazil and exports out of Mexico to other Latin American markets. Its branded generic products in Mexico are primarily marketed in this region to physicians and pharmacies through approximately 500 sales professionals under the Grossman and Tecnofarma brands. Our Tecnofarma generic portfolio is primarily sold through Mexico's Government Health Care System. The Company’s portfolio covers a range of therapeutic classes, including vitamin deficiency, antibacterials and dermatology. Its product in this market is Bedoyecta, a brand of vitamin B complex (B1, B6 and B12 vitamins) products. Bedoyecta products act as energy improvement agents for fatigue related to age or chronic diseases, and as nervous system maintenance agents to treat neurotic pain and neuropathy. Bedoyecta is sold in an injectable form, as well as in a tablet form in Mexico. Its M.V.I. multi-vitamin infusion, is a hospital dietary supplement used in treating trauma and burns.
In Brazil, the Company’s primary products include Tandene, which contains acetaminophen used in treating fever, headaches, and other minor aches and pains and also Melleril, an anti-psychotic product used in treating anxiety, depression, and other related disorders. Its branded generic products in Brazil are primarily marketed to pharmacies and wholesalers through approximately 200 sales professionals.
The Company competes with Sun Pharmaceuticals, Actavis, Inc. (Actavis), Janssen, Spear Pharmaceuticals, Inc. (Spear).
Valeant Pharmaceuticals International Inc
2150 St. Elzear Blvd. West
LAVAL QC H7L 4A8