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Isis Pharmaceuticals, Inc. Message Board

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  • dinepat203 dinepat203 Dec 3, 2012 10:40 AM Flag

    ISIS awaits 2 approvals from EMA by 2012 End - Vitravene (CIBA Novartis) & KYNAMRO (Genzyme-Sanofi)

    Nov. 9 /PRNewswire/ -- CIBA Vision Corporation, the eye care unit of Novartis AG, today announced the launch of Vitravene (fomivirsen sodium intravitreal injectable), for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS. The announcement was made at the American Academy of Ophthalmology Annual Meeting in New Orleans. Vitravene is the first in a class of novel therapeutics based on an antisense mechanism to be approved for marketing in the U.S. Vitravene is indicated for the local treatment of CMV retinitis in patients with AIDS who are intolerant of or have a contraindication to other treatments for CMV retinitis or who were insufficiently responsive to previous treatments for CMV retinitis. A Marketing Authorization Application (MAA) submitted by CIBA Vision is currently under review with the European Agency for the Evaluation of Medicinal Products (EMEA) for the marketing of Vitravene in Europe. CIBA Vision's partner in the discovery and development of Vitravene is Isis Pharmaceuticals (Nasdaq: ISIP), Carlsbad, Calif. The recommended dose of Vitravene is 330 (micrograms). Treatment with Vitravene involves an induction and a maintenance phase. The induction dose for Vitravene should be one injection every other week for two doses. Subsequent maintenance doses should be administered once every four weeks after induction. Vitravene will be marketed directly to physicians and clinics. CIBA Vision will offer reimbursement support services to assist providers with claims submission, claims adjudication and reimbursement questions. Additionally, CIBA Vision has established the Vitravene Patient Assistance Program (PAP) to provide therapy to patients who meet the eligibility criteria. These services can be obtained by calling CIBA Vision Vitravene Support Services

    Sentiment: Strong Buy

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    • At first I thought you were the duck in disguise. No one has pointed out what I think is happening here. If you're pointing out that Vitravene recevied EMA approval, then you're right. Vitravene was approved in Europe in 1998.

      But I think you're pointing out that ISIS should receive Vitravene approval this year. That's just wrong. This is a Press Release from 14 years ago. In fact, Novartis recently pulled Vitravene off the market because no one is using it.

      I would recommend the duck's posts in general, but it's so hard to squeeze out his quackery. Vitravene is a commercial failure, but it has nothing to do with ISIS. Vitravene is a wonderful story of a horrible condition that big bad pharma has... solved... for eternity. I would like to send out a "you're welcome" to all of the vitriol-spewing, "occupy-something", do-nothing ingrates that criticize corporate America.

57.560.00(0.00%)Dec 21 4:00 PMEST