HOT off the AAN 2011 Press: 23% Lower Relapse Rate For MS Patients On Laquinimod

Multiple sclerosis patients on laquinimod experienced a 23% reduction in annual relapse rate compared to those on a placebo during a two year Phase III clinical trial [...]

• Caroline says: Another oral on the horizon...Teva's laquinimod showed statistically significant Phase III results. According to lead authors in the study, laquinimod is shown to be well tolerated and safe -- elevated liver enzymes are "transient and reversible". Teva anticipates US and EU regulatory filing after the second Phase III trial results are available in Q3 2011.
   

• Related Links:
• http://www.medicalnewstoday.com/articles/222016.php…

• Teva says FDA won’t approve new version of Copaxone

  The Jerusalem-based company received a complete response letter, which means the FDA informed the company it is not willing to approve the drug at this time. Teva [...]

  • Caroline says: The FDA has declined to approve a new formulation of Copaxone for RRMS. The currently approved injectable dose is 20 mg of glatiramer acetate in one milliliter of solution, and Teva is trying for 20 mg of glatiramer acetate in half a milliliter of solution (read: more side effects). Teva may need to run an additional clinical trial showing the new version works as well as the old version.
     
  • Related Links:
  • http://www.bloomberg.com/news/2010-12-23/teva-says-fda-won-t-approve-new-version…
  
  

  • HOT off the ECTRIMS Press: Copaxone after CIS delays MS onset

    The study reached both its primary and secondary clinical and MRI endpoints, all of which were significantly positive. Earlier initiation of treatment with Copaxone significantly slowed the [...]

    • Caroline says: Most of the CRABS have now been approved to treat a CIS (clinically isolated syndrome). The data are compelling that early initiation after a first incidence of possible MS can delay disease onset.
       
    • Related Links:
    • http://www.marketwatch.com/story/early-initiation-of-treatment-with-copaxone-r-p…
    
    

    • Newly Published Data Show Copaxone Promoted Remyelination of Damaged Axons

      The purpose of this study was to examine the effect of glatiramer acetate on oligodendrogenesis (the formation of myelin-producing glial cells in the central nervous system) and [...]

      
      

      • Teva Sues Mylan Over MS Drug Copaxone

        Teva Pharmaceutical Industries Ltd. issued a press release last week discussing the abbreviated new drug application (ANDA) containing a Paragraph IV certification for COPAXONE® (glatiramer acetate injection), [...]

        • Caroline says: Not long ago, I posted a similar article about Biogen blocking the generic equivalent of Avonex and now it appears Teva is doing the same thing with Copaxone. The company is saying that Copaxone is so complex that only they can develop it...I'm not kidding. Read the article. This is the logic behind their litigation. Once again we see pharma putting profits over patients...shame on you, Teva.
           
        
        

        • Copaxone Used for First-Episode/CIS Halves MS Risk

          PARIS — Early treatment with a key drug to fight multiple sclerosis (MS) nearly halves the risk of progression to the full-blown disease, according to a study [...]

          • Caroline says: Copaxone was studied in first-episode/clinically isolated syndrome "CIS"/possible MS patients and it was found to reduce the risk of clinically definite MS by 45%. That's serious.
             
          
          

          • Teva completes enrollment in second Phase III trial

            Jun 26, 2009 (Datamonitor via COMTEX) — Teva Pharmaceutical Industries, an Israeli generic pharmaceutical company, and Active Biotech, a Swedish pharmaceutical company, have completed patient enrollment for [...]

            • Caroline says: Laquinimod is a pipeline oral MS drug. Teva and Active Biotech have completed pt enrollment for the 2nd pivotal Phase III clinical trial, Bravo, evaluating the oral once-daily immunomodulating compound, laquinimod, for the treatment of RRMS. Bravo is a global clinical trial designed to evaluate the efficacy, safety and tolerability of laquinimod compared to placebo, and to provide risk-benefit data for laquinimod compared to a currently available injectable treatment, Avonex.
               
            
            

            • Hot off the AAN Press: Laquinimod, New Data, Novel MOA

              New Data Illustrate Novel Mechanism OF Action of Laquinimod, an Oral Compound for the Treatment of Multiple Sclerosis -Researchers Demonstrate Immunomodulatory Effects of Laquinimod on Disease Activity [...]

              • Caroline says: Teva/Active Biotech presented data on their oral RRMS drug laquinimod-- and it's novel MOA, which modulates the immune system, suggesting immunomodulating effects within the CNS. A Phase IIb study in 306 patients found that an oral 0.6 mg dose of laquinimod QD significantly reduced MRI disease activity by a median of 60%. So far this is the only oral in the pipeline that I can see with no significant side effects. Good news.
                 
              
              

              • Hot off the AAN Press: Study Suggests Copaxone has Protective Effects

                Long-Term Study with COPAXONE® Indicated Protective Effect on Brain Tissue in Multiple Sclerosis Patients – New Data Presented at 61st Annual Meeting of the American Academy of [...]

                • Caroline says: Data from a 6-year study suggests that Copaxone may have neuroprotective effect in RRMS. It was the largest and longest study of its kind to date.
                   
                
                

                • The Age of Orals: Who Will Win the Race to the Market?

                  Jan 23, 2009 Oral Cladribine Reduces MS Relapses in Phase 3 Clinical Trial Oral cladribine (EMD Serono) reduced the relapse rate significantly more than inactive placebo in [...]

                  • Caroline says: OK, OK I know I said I am not excited about orals, and I'm not. HOWEVER, I respect the fact that MANY, MANY of you are and will therefore continue to post fresh updates about their introduction. First-to-market advantage is not a trivial matter! Cladribine has fast track FDA status, Serono anticipates approval in mid-2009 (that's just a few months away). Teva's Laquinimod also has fast track status and is in Phase III trials. Novartis' FTY720 (fingolimod) also plans to file in mid-2009. Who will win?? It's getting...dare I say...exciting!!
                     
                  • Related Links:
                  • http://www.fiercepharma.com/story/tevas-oral-laquinimod-ms-gets-fast-tracked/200…