Businessweek

ption. Allegra/Telfast is marketed in approximately 80 countries. Depakine Depakine (sodium valproate) is a spectrum anti-epileptic. Depakine remains a reference treatment for epilepsy worldwide. Depakine is also a mood stabilizer, registered in the treatment of manic episodes associated with bipolar disorder and, in numerous countries, in the prevention of mood episodes. The company provides a range of formulations of Depakine enabling it to be adapted to most types of patients: syrup, oral solution, injection, enteric-coated tablets, Depakine Chrono (a sustained release formulation in tablets) and Depakine Chronosphere (sustained release formulation of Depakine packaged in stick packs, facilitating its use by children, the elderly and adults with difficulties swallowing). Depakine is marketed in approximately 100 countries, and is generally subject to generic competition. Auvi-Q In January 2013, Sanofi launched Auvi-Q (epinephrine injection, USP) in the U.S. Auvi-Q is the first-and-only epinephrine auto-injector with audio and visual cues for the emergency treatment of life-threatening allergic reactions in people who are at risk for or have a history of anaphylaxis. Sanofi US licensed the North American commercialization rights to Auvi-Q from Intelliject, Inc. Main compounds in Phase II or III clinical development: In the Metabolic field: Phase II results for SAR236553, co-developed with Regeneron (REGN727: anti-PCSK9 mAb), have been obtained confirming a significant reduction in mean LDL-C by 40% to 72% over 8 to 12 weeks in patients with elevated LDL-C in patients on stable dose of statins. In the Ophthalmology field: Sanofi started establishing its footprint in ophthalmology through the acquisition of Fovea, a French ophthalmology specialist, the ophthalmology assets of Genzyme, and a collaboration agreement with Oxford BioMedica that led to the exercise of two opt-in options in August 2012. In the Thrombosis and Cardiovascular field: Otamixaban (direct factor Xa inhibitor, interventional cardiology; Phase III). Otamixaban is an injectable, selective direct inhibitor of coagulation factor Xa. In the Internal Medicine field: Sarilumab (SAR153191), a monoclonal antibody against the Interleukin-6 Receptor (anti IL-6R mAb) derived from the company’s alliance with Regeneron, is in Phase III in adult patients with moderate to severe rheumatoid arthritis (RA). The SARIL-RA phase III program is underway. Dupilumab (SAR231893), a monoclonal antibody against the Interleukin-4 alpha Receptor (anti IL-4R alpha) derived from the company’s alliance with Regeneron, is being developed in two indications. Dupilumab modulates signaling of both IL-4 and IL-13 pathways. Consumer Health Care (CHC) In 2011, the Allegra family of allergy medication products was commercially launched in the U.S. for OTC use in adults and children two years of age and older. The Allegra family of OTC products is available in drug, grocery, mass merchandiser, and club stores nationwide. In 2012, Sanofi launched Allegra OTC in Japan, for patients suffering allergic rhinitis (15 years and older). CHC sales are also supported by the company’s legacy CHC brands, which provide it with a strong presence in the fever & pain and digestive health areas. Doliprane is a range of paracetamol formulas to fight pain and fever. Doliprane is sold mainly in France and in some African countries. NoSpa is a product containing drotaverine hydrochloride. NoSpa is indicated in abdominal spastic pain, such as intestinal spasm, menstrual pain, or vesical spasm. NoSpa is sold mainly in Russia and Eastern Europe. Enterogermina is composed of two billion Bacillus clausii spores in a ready-to-drink oral suspension in vials of 5ml and in capsules. Enterogermina is indicated in the prevention and the treatment of intestinal imbalance during acute or chronic intestinal disorders (from babies to adults). Enterogermina is sold mainly in Europe and has been enjoying strong growth in Latin America, India and Central Asia. Essentiale is a herbal preparation for liver therapy, made of highly purified essential phospholipids extracted from soybeans