Top-line data are expected to be available in mid-2009, and thesubmission of a U.S. marketing application for this indication is anticipatedduring the second half of 2010. Genzyme continues to engage in discussions withregulatory authorities outside the U.S regarding the development path formipomersen. Data from the four new studies of mipomersen will continue to build the body ofclinical evidence around the treatments value in managing high-risk,high-cholesterol patients. Data are expected to be available before thecompanies begin an outcome study of mipomersen, and will help inform thattrials design. The study, anticipated to begin in mid-2010, is intended tosupport potential expansion of mipomersen's label to include a broader group ofat-risk, high cholesterol patients.
About MipomersenMipomersen is a first-in-class apo-B synthesis inhibitor currently in phase 3development. In phase 2 studies, mipomersen, a weekly injectabletherapeutic, was observed to reduce LDL-C beyond reductions achieved withstandard lipid-lowering drugs, enabling more patients to achieve LDL-C targets.It was also observed to reduce triglycerides, lipoprotein(a), and serum apo-B,all generally accepted risk factors for cardiovascular disease. In 2008 Genzymeand Isis completed a licensing agreement that provides Genzyme with exclusiveworldwide rights to mipomersen, which was discovered and initially developed byIsis. About GenzymeOne of the world's leading biotechnology companies, Genzyme is dedicated tomaking a major positive impact on the lives of people with serious diseases.Since 1981, the company has grown from a small start-up to a diversifiedenterprise with more than 10,000 employees in locations spanning the globe and2007 revenues of $3.8 billion.
The company's products and servicesare focused on rare inherited disorders, kidney disease, orthopaedics, cancer,transplant and immune disease, and diagnostic testing. Genzymes press releases and other company information are available at and by calling Genzymes investor information line at1-800-905-4369 within the United States or 1-678-999-4572 outside the UnitedStates. About Isis Pharmaceuticals, Inc.Isis is exploiting its expertise in RNA to discover and develop novel drugs forits product pipeline and for its partners. The Company has successfullycommercialized the world's first antisense drug and has 19 drugs in development.Isis drug development programs are focused on treating cardiovascular andmetabolic diseases. Isis partners are developing antisense drugs invented byIsis to treat a wide variety of diseases. Isis is a joint owner of RegulusTherapeutics Inc., a joint venture focused on the discovery, development andcommercialization of microRNA therapeutics.