Oryx Pharmaceuticals Inc. (Oryx)
In June 2008, Sunovion acquired Oryx Pharmaceuticals Inc., a specialty pharmaceutical company based in Canada and affiliated with the Arrow Group, which was subsequently renamed Sunovion Pharmaceuticals Canada Inc. (SPI). SPI’s portfolio consists of 14 specialized products including NIASPAN®, ADVICOR®, ANGIOMAX®, NAPRELAN®, CUBICIN®, TRILEPTAL® and RESTORIL®. This acquisition creates a commercial platform for Sunovion in the Canadian specialty pharmaceutical market.
Nycomed GmbH (Nycomed)
In January 2008, Sunovion and Nycomed entered into an exclusive development, marketing and commercialization agreement for ciclesonide in the U.S. Ciclesonide is the active ingredient in ALVESCO® HFA Inhalation Aerosol for the treatment of asthma and OMNARIS® (ciclesonide) Nasal Spray for the treatment of allergic rhinitis. Sunovion commercially launched OMNARIS Nasal Spray in the U.S. in April 2008. In September 2008, Sunovion commercially introduced ALVESCO HFA through a staged launch that was initially targeted primarily to specialists. In early 2009, Sunovion expanded its sales and marketing efforts to include a broader group of physicians. Under the agreement, Sunovion has obtained development rights to several line extensions. These programs include OMNARIS HFA MDI, a Phase III candidate; ALVESCO Inhalation Solution, a preclinical candidate; and ALVESCO in combination with a long-acting beta-agonist, an early clinical candidate.
BIAL-Portela & Ca, S.A. (BIAL)
In December 2007, Sunovion and BIAL entered into an exclusive licensing agreement for the development and commercialization of BIAL’s antiepileptic compound, eslicarbazepine acetate, in the U.S. and Canada. Pursuant to the terms of the agreement, Sunovion submitted the U.S. New Drug Application (NDA) for this compound in March 2009 and is seeking marketing approval from the FDA. In August 2009, Sunovion's Canadian subsidiary, Sepracor Pharmaceuticals, Inc., submitted an application to the Therapeutic Products Directorate of Health Canada. Sunovion plans to market and sell this product under the brand name STEDESA™ in the U.S. and Canada, if and when approved.
Eisai Co. Ltd.
In July 2007, Sunovion entered into an agreement with Eisai Co. Ltd. (Eisai), for the development and commercialization of Sunovion's eszopiclone product for the Japanese market. Under the agreement, Eisai is responsible for completing the remaining clinical trials necessary for attaining marketing approval from the Japanese regulatory authorities, and contingent on regulatory approval, commercialization of the product in Japan.
In December 1997, Schering-Plough Corporation and Sunovion entered into a licensing agreement granting Schering-Plough exclusive worldwide rights to Sunovion’s patents relating to desloratadine. In January 2002, Schering-Plough launched CLARINEX® (desloratadine) 5 mg tablets in the U.S. for the treatment of seasonal allergic rhinitis (SAR) in patients 12 years of age and older. In February 2002, Schering received FDA approval for CLARINEX tablets for the treatment of chronic idiopathic urticaria (CIU), or hives of unknown cause, and for the treatment of allergic rhinitis (AR), which encompasses both SAR and perennial allergic rhinitis (PAR).
sanofi-aventis (formerly Rhone-Poulenc Rorer SA)
In October 1999, Sunovion entered into an agreement with Rhone-Poulenc Rorer SA (RPR), a unit of Rhone-Poulenc SA, now sanofi-aventis, whereby Sunovion exclusively licensed RPR's preclinical, clinical and post-marketing surveillance data package relating to zopiclone, its isomers and metabolites, to develop, make, use and sell eszopiclone in the United States. Zopiclone, marketed by sanofi-aventis under the brand names of IMOVANE® and AMOBAN® for the treatment of insomnia, is available in approximately 80 countries worldwide but is not registered for use in the U.S. market.
Sunovion has the right to read and reference sanofi-aventis' regulatory filings related to zopiclone outside of the United States for the purpose of development and regulatory registration of eszopiclone outside of the U.S., and sanofi-aventis has assigned to Sunovion the foreign counterparts to the U.S. patent covering eszopiclone and its therapeutic use.
sanofi-aventis (formerly Hoechst Marion Roussel, Inc.)
Sunovion earns royalties from sanofi-aventis on sales of ALLEGRA® brand fexofenadine HCl, a nonsedating antihistamine for the treatment of allergic rhinitis, where Sunovion holds patents relating to fexofenadine (including Japan, Europe, Canada and Australia).