If it dropped 20% based on this there is something seriously...

If it dropped 20% based on this there is something seriously wrong in the world of investment. Such guidance should be deemed a positive.


FDA Provides Clarity to Isis Regarding the Development Path for Mipomersen
Isis to Host Conference Call Today at 8 a.m. EDT
CARLSBAD, Calif. and CAMBRIDGE, Mass., April 25, 2008 /PRNewswire via COMTEX News Network/ -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) and Genzyme Corp. (Nasdaq: GENZ) announced today that the FDA has provided guidance regarding approval requirements for mipomersen. The FDA has indicated that reduction of LDL-cholesterol is an acceptable surrogate endpoint for accelerated approval of mipomersen for use in patients with homozygous familial hypercholesterolemia (hoFH). The FDA will require data from two ongoing preclinical studies for carcinogenicity to be included in the hoFH filing, which is now anticipated to take place in 2010. A phase 3 study of mipomersen in hoFH is currently enrolling patients.
The companies plan to conduct an outcome trial to support full approval of mipomersen for hoFH and to expand its indication to include other patients with high cholesterol who are at high risk for cardiovascular events. In response to the FDA's guidance, the companies are revising the development plan for mipomersen to accelerate plans for an outcome study. Isis and Genzyme plan to communicate further details of the revised development plan as they are finalized.
"Because our development plan, and our joint plan with Genzyme, has always included outcome studies to maximize the profile and commercial potential of mipomersen, this FDA guidance accelerates these planned studies and simplifies the overall development path for mipomersen," said Dr Stan Crooke, Chairman and Chief Executive Officer of Isis. "Conducting an outcome study in parallel with our continued evaluation of the effects of mipomersen on atherogenic lipids will allow us to submit a much stronger NDA for high risk patients. We are confident that mipomersen will bring benefit to patients with high cholesterol and remain committed to its development and commercialization."
"We are pleased that the FDA has given clear direction on what will be required for the approval of mipomersen, and has acknowledged its potential to help high risk patients whose needs are not being met by current therapies," said Henri A. Termeer, Genzyme's chairman and chief executive officer. "Having outcome data earlier on in the development process will be important to patients and serve to enhance the value of this treatment. We plan to engage in discussions with regulatory agencies in Europe and the rest of the world, and look forward to receiving their feedback."
ABOUT MIPOMERSEN
In early 2008, Isis and Genzyme announced that they had entered into a strategic alliance in which Genzyme will develop and commercialize mipomersen. Final contracts are still being negotiated and are expected to be completed this quarter.
Mipomersen is a second-generation antisense drug that reduces the production of apoB-100, a protein critical to the synthesis and transport of "bad" cholesterol. Cholesterol can be carried in the bloodstream in a variety of forms, with high-density lipoprotein, or HDL-cholesterol, being the good form, and low-density lipoproteins, or LDL-cholesterol, and very low-density lipoproteins, or VLDL-cholesterol, being bad forms directly involved in heart disease. Collectively lowering LDL-cholesterol, VLDL-cholesterol, and other bad forms of cholesterol are a key component in the prevention and management of cardiovascular disease.
Mipomersen is currently in phase 3 development for patients with homozygous familial hypercholesterolemia, a disease which creates a greatly increased risk of premature cardiovascular disease (CVD) and CVD-related death. In phase 2 studies, mipomersen, a weekly injectable therapeutic, was observed to reduce cholesterol and other atherogenic lipids beyond reductions achieved with standard lipid-lowering drugs.