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Isis Pharmaceuticals, Inc. Message Board

  • dinepat203 dinepat203 Nov 30, 2012 9:46 AM Flag

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

    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.

    Vitravene is approved by the FDA in 1998, is an antisense drug that we discovered and developed, to treat cytomegalovirus, or CMV retinitis in AIDS patients. Novartis Ophthalmics AG, our worldwide distribution partner for this drug, launched Vitravene in November 1998. New anti-HIV drugs, particularly protease inhibitors and combination treatment regimens, have prolonged survival in HIV-infected individuals. This has resulted in a decline in mortality from AIDS, accompanied by a decline in the incidence of many opportunistic infections, including CMV retinitis. As a result, Novartis no longer markets Vitravene. Vitravene demonstrates our ability to meet FDA and European regulatory requirements for safety and efficacy, and for the commercial manufacture of antisense drugs

    Genzyme plans to concentrate marketing and sales efforts on lipid specialists and physicians who refer patients to these specialists to quickly reach the initial patient populations for KYNAMRO in the United States and Europe. Genzyme has also established the foundation for market access and reimbursement in the United States and Europe to accelerate market penetration after launch. Genzyme is planning to launch KYNAMRO with a prefilled syringe that will provide a convenient form of administration. We believe that Genzyme has the commercial infrastructure and aptitude to successfully commercialize KYNAMRO worldwide making the drug available for patients in need by end of 2012.

    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 ...

      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.

    • system_architect_enterprise system_architect_enterprise Dec 3, 2012 2:01 PM Flag

      The problem is the EU didn't make their own deadline, which means the decision sits in limbo with no motivating factor for its resolution. That really leaves ISIS hanging out to dry.

    • Fomivirsen (Vitravene was a total useless drug) Darkout told us in 1998 that there will be not one dime to the bottom line. Darkster was right as usual. "Not one proven antisense drug in 20 years".

      Want to learn something, check out darkoutonights last 15 years of information exposing ans.

      • 1 Reply to dnastheway
      • 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

    • If they have no plan, they will be acquired.

      • 1 Reply to therewillbegas
      • Or go broke when there expected FDA approval for Kynamro is not forthcoming. Or the FDA approval is so narrowly defined when Kynamro can be used as to render the approval meaningless. Played this game with Genta 5 yrs ago. Did not turn out well....There is a lot of farts and feathers in the antisense arena....Make sure this is your Las Vegas money you are playing with......

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