EX-US: First Oral Approved for PWMS: Cladribine approved in RUSSIA

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that the Russian Federal Service on Surveillance in Healthcare and Social Development has become the first [...]

• Caroline says: The Russian approval of Merck's cladribine marks approval of the FIRST oral MS drug in the world. The Russian Federal Service on Surveillance in Healthcare and Social Development (Russia's FDA) has approved Cladribine for RRMS. It will be marketed under the brand name Movectro and Russian launch is expected in early 2011.
   

• Related Links:
• http://www.prnewswire.co.uk/cgi/news/release?id=291909…

• Merck Refiles Cladribine for US Approval

  FRANKFURT (Dow Jones)–German pharmaceutical and chemicals company Merck KGaA (MRK.XE) said Tuesday it resubmitted its application for U.S. regulatory approval of oral multiple sclerosis treatment cladribine–seven months [...]

  • Caroline says: After the FDA refused to file their initial application in November 2009, Merck has re-filed their oral MS drug cladribine in June 2010.
     
  • Related Links:
  • http://www.reuters.com/article/idUSLDE62O0CG20100608…
  
  

  • Merck KGaA Submits Application For Cladribine Tablets In US

    Germany’s Merck KGaA has made further progress in its bid to be the first company to market an oral multiple sclerosis treatment by filing cladribine in the [...]

    • Caroline says: The oral race continues and Merck has pulled ahead just a little bit...this US filing comes a day after Novartis announced positive Phase III data for fingolimod.
       
    
    

    • Hot off the ECTRIMS Press…Cladribine Reduces Disease Activity in a Big Way

      Darmstadt, Germany, September 11, 2009 – Merck KGaA announced today new data from a post-hoc analysis of the two-year (96-week) placebo-controlled CLARITY(1) Phase III trial using a [...]

      • Caroline says: These data are significant! Two-year data were released at ECTRIMS showing that 44% of patients treated with cladribine had no disease activity compared with 16% on placebo. Merck submitted their EMEA approval application in July 2009 and will file it in other countries, including the US, in Q3...meaning the end of this month, I believe.
         
      
      

      • Merck Sumbits Cladribine Application for EU Approval

        July 23, 2009 — 9:05am ET | By John Carroll Racing to beat Novartis to the world’s biggest drug markets with a new oral therapy for multiple sclerosis, [...]

        • Caroline says: Merck has submitted their Cladribine application in the EU today. They will submit their US application later this quarter. They filed just ahead of Novartis (FTY-720). The orals are not too far away from market approval!
           
        
        

        • Hot off the ENS Press: Cladribine Is Safe Overall in Patients With Multiple Sclerosis

          MILAN, Italy — June 24, 2009 — According to a safety analysis of a study presented here at the 19th Meeting of the European Neurological Society (ENS), [...]

          • Caroline says: This is good news for people who are excited about orals. Cladribine seems to be the safer option out of the ones that are coming out soon. Incidence of treatment-emergent AE's in the trial of 1326 RRMS patients were comparable between 2 doses of cladribine and placebo. As expected based on the MOA of cladribine, lymphopenia (low white blood cells) occurred with the highest incidence in patients receiving the higher dose of the drug.
             
          
          

          • Hot off the AAN Press: Cladribine Reduces Relapses, Disability, Disease Progression

            April 29, 2009 Merck KGaA on Wednesday presented detailed results from a previously announced Phase III study of investigational oral multiple sclerosis drug cladribine at the American [...]

            • Caroline says: 1326 patients received cladribine or placebo in a 2-year study. According to Merck, the findings demonstrated that annual short-course treatment with cladribine significantly reduced the rate of clinical relapses, disability progression and brain lesions in patients with relapsing-remitting MS, and also led to a significant increase in the proportion of patients who remained relapse-free. And it's an oral...
               
            
            

            • LATE BREAKING: New Phase III Data for Cladribine to be Presented at AAN

              CLARITY (CLAdRIbine tablets Treating MS OrallY) Study Data to be Presented as Late-Breaking Oral Presentation By: PR Newswire Mar. 30, 2009 08:01 AM // GENEVA, Switzerland, March [...]

              • Caroline says: AAN has accepted a late-breaking oral presentation on Merck/Serono's oral cladribine Phase III results. Most medical conferences decide what abstracts and subject matter they're approving months before the actual congress. So, this means that the investigator of this study has some potentially new and riveting findings for us. The abstract is embargoed until AAN, but this could be big news for all you oral fans...
                 
              
              

              • 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…
                
                
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