Nycomed
In January 2008, Sepracor and Nycomed announced an exclusive development, marketing and commercialization agreement for ciclesonide in the U.S. Ciclesonide is the active ingredient in ALVESCO® HFA Inhalation Aerosol for asthma and OMNARIS AQ Nasal Spray for allergic rhinitis. ALVESCO HFA and OMNARIS AQ are approved by the U.S. Food and Drug Administration (FDA), and Sepracor is targeting launch of OMNARIS AQ in April 2008 and ALVESCO HFA in the second half of 2008. Under the agreement, Sepracor has obtained development rights to several line extensions. These programs include OMNARIS HFA MDI, a Phase II candidate; ALVESCO Inhalation Solution, a preclinical candidate; and ALVESCO in combination with a long-acting beta-agonist, an early clinical candidate. Nycomed will receive an upfront payment and is entitled to receive subsequent payments upon accomplishment of various development and sales milestones. Nycomed will also receive compensation for providing finished product, and royalties on sales of ciclesonide products.
Bial Portela & Company S.A.
In December 2007, Sepracor and Bial entered into an exclusive licensing agreement for the development and commercialization of Bial’s anti-epileptic compound BIA 2-093 in the United States and Canada. Under the terms of the agreement, Sepracor will be responsible for filing the U.S. New Drug Application (NDA) and seeking marketing approval from the FDA, and contingent on obtaining regulatory approval, commercialization of the product in the U.S. In exchange, Bial received an upfront payment and is entitled to receive subsequent payments upon accomplishment of various development and regulatory milestones. Bial will also receive compensation for providing finished product and milestone payments upon FDA approval of additional indications, if any.
GlaxoSmithKline
In September 2007, Sepracor and GlaxoSmithKline (GSK) announced an agreement for the commercialization of Sepracor's eszopiclone product for all markets worldwide (excluding the U.S., Canada, Mexico and Japan). Sepracor's eszopiclone product will be marketed by GSK in these areas as LUNIVIA® for the treatment of insomnia. Under the agreement, Sepracor received an initial payment of $20 million and is entitled to receive subsequent payments upon accomplishment of various milestones as well as double-digit royalties that escalate upon increased product sales and compensation for supplying the product to GSK.
LUNIVIA is currently under European Medicines Agency (EMEA) review for marketing approval under the Centralized Procedure. This procedure provides for the EMEA to conduct a single, coordinated scientific evaluation on behalf of all EU member states, using experts from national regulatory authorities as lead reviewers. Approval of the MAA would authorize the marketing of LUNIVIA for insomnia in EU member countries, subject to national pricing and reimbursement approvals.
Eisai Co. Ltd.
In July 2007, Sepracor announced an agreement with Eisai Co. Ltd. for the development and commercialization of Sepracor's eszopiclone product for the Japanese market. Under the agreement, Eisai will be 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 exchange, Sepracor received an initial milestone payment and is entitled to subsequent payments upon accomplishment of various development, regulatory and pricing milestones, as well as royalties on product sales and compensation for providing the product's active ingredient.
Schering-Plough Corporation
In December 1997, Schering-Plough Corporation and Sepracor announced a licensing agreement giving Schering-Plough exclusive worldwide
rights to our 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). We earn royalties on sales
of CLARINEX in the U.S. and other countries where we hold patents relating to desloratadine.
Rhone-Poulenc Rorer SA, Now sanofi-aventis
In October 1999, Sepracor entered into an agreement with Rhone-Poulenc Rorer SA (RPR), a unit of Rhone-Poulenc SA, now sanofi-aventis,
whereby Sepracor 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 RPR under the brand
names of IMOVANE® and AMOBAN® for the treatment of insomnia, is available in approximately 80 countries worldwide but has never been
registered for the U.S. market.
Subject to the successful completion of the proposed business combination between Aventis and Sanofi-Synthelabo, Sepracor and sanofi-aventis agreed to amend their existing agreement relating to eszopiclone. Under the amended agreement, Sepracor 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 Sepracor the foreign counterparts to the U.S. patent covering eszopiclone and its therapeutic use. In exchange, we permitted sanofi-aventis to assign our obligation to pay a royalty on sales of eszopiclone in the U.S. to a third party.
UCB Pharma
In June 1999, Sepracor entered into a licensing agreement with UCB Pharma, an affiliate of UCB, relating to levocetirizine, an isomer
of ZYRTEC® (cetirizine), for the treatment of allergies. Under the agreement, Sepracor has exclusively licensed to UCB all of Sepracor's issued patents and pending patent applications
regarding levocetirizine in Europe and other countries. Sepracor currently earns royalties from UCB on sales of levocetirizine in
European countries where the product is sold. Levocetirizine (XYZAL®/XUSAL™) has been marketed in the E.U. since 2001. Sepracor announced a separate licensing agreement with UCB in February
2006, relating to levocetirizine. Under this agreement, Sepracor exclusively licensed to UCB all of Sepracor's patents and patent
applications in the U.S. regarding levocetirizine. Sepracor is entitled to receive royalties upon product sales of levocetirizine in
the U.S. Sepracor has retained its rights to this compound in Japan.
sanofi-aventis
Sepracor earns royalties from sanofi-aventis on sales of ALLEGRA® brand fexofenadine HCl, a nonsedating antihistamine for the
treatment of allergic rhinitis, in countries outside the U.S. where Sepracor holds patents relating to fexofenadine (including Japan,
Europe, Canada, and Australia). In December 1993, Sepracor licensed its U.S. patent relating to use of fexofenadine to Hoechst Marion
Roussel, Inc. (HMRI). HMRI developed the drug and launched it in late 1996 as ALLEGRA brand fexofenadine hydrochloride. In August
1999, HMRI and Sepracor amended their existing business arrangement related to fexofenadine. As a result, Sepracor has licensed or assigned
its related patents worldwide to HMRI, now sanofi-aventis.
