Friday, November 2, 2012

Wockhardt may further rise on Biosimilar Insulin Newsflow

Wockhardt has a major lead in biosimilar insulins development. Over the next six months, three Phase 3 studies evaluating Wockhardt Biosimilar insulin are likely to be completed.  The Phase 3 studies are evaluating Wockhardt's biosimilar versions of Lantus ($6b growing at 18%), Humalog ($2.5b) and Novolin (Human insulin by Novo Nordisk, sales not reported). 

The potential market size is huge as indicated by the growth and sales of these products, but the potential  for biosimilars products will be limited by Device complexity, reimbursement isssues and non
 interchangeability.  Assuming a conservative 2% market share for Wockhardt's biosimilars, the potential sales opportuntiy translates  close to about $150million. Emerging markets where there is hihger out of pocket spend will constitute a more attractive market for biosimilars than the developed markets. 

Ongoing Clinical trials evaluating Wockhardt's Biosimilar versions of Lantus, Humalog and Novolin
  • An open label, randomized, parallel group comparison of the immunogenicity safety of Wockhardt's recombinant insulin analog Glargine (Glaritus®) and Sanofi-Aventis' recombinant insulin analog Glargine (Lantus®) in Type 1 diabetics.
    There are two phases of the study, which are as follows:
    1.Phase 1 is a comparative phase in which there will be 2 arms (Lantus® arm and the Glaritus® arm)
    2.Phase 2 is a follow up phase only applicable to the Glaritus® Arm.
    The study will last for 54 weeks for the patients enrolled in the Glaritus arm and approximately 28 weeks for the patients enrolled in the comparator arm.  Study will complete in January 2013

  • An open-label, randomized, parallel group comparison of the immunogenicity safety of Wockhardt's Insulin analogue (Lispro) basal bolus regimen (Listro™ with Listro Mix® 75/25 / Listro Mix® 50/50) with Eli Lilly's Insulin analogue (Lispro) basal bolus regimen (Humalog® with Humalog® Mix75/25TM/ Humalog® Mix50/50TM) in patients with Type 1 Diabetes Mellitus
           There are two phases of the study:
          1.  Phase 1 is a comparative phase of 6 months duration in which there will be 2 arms(Listro™ 
             arm and Humalog® arm).
          2.  Phase 2 is a follow up phase (another 6 months) only applicable to Arm 1 i.e. Listro™ Arm.

        The study will last approximately 54 weeks for the patients enrolled in Listro™ arm and
        approximately 28 weeks for the patients enrolled in the comparator arm.  242 will be enrolled 
        considering an estimated dropout rate of 12% for a sample size of approximately 108 patients   
        per arm. Study  is expected to be complete by May 2013.



  • This is an open label, randomized, parallel group comparison of the immunogenicity safety of Wockhardt's human insulin and isophane insulin compared with the Novo Nordisk's yeast based human insulin products (marketed in USA) in type 1 diabetics.
         There are two phases of the study, which are as follows:
         1.   Phase 1 is a comparative phase in which there will be 2 arms (which are described in the 
               section below).
         2.  Phase 2 is a follow up phase only applicable to Wosulin Arm.

The study will last for 54 weeks for the patients enrolled in Wosulin arm and approximately 28 weeks for   the patients enrolled in the comparator arm. Two hundred and forty two patients will be enrolled considering an estimated dropout rate of 15% for a sample size of approximately 105 evaluable patients per arm. The total planned enrollment period for this study is approximately 3 months (90 days). Study was scheduled to complete in October this year and hence we might see data from this study anytime in the coming few months.





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