Friday, 7 November 2014

Pharma: Merck-Serono culls its plovamer acetate programme

Is Merck-Serono right to cull their plovamer acetate programme? #MSResarch #MSBlog

"Many of you are interested in the various development pipelines of Pharma. I received an email yesterday from Merck-Serono telling me that they are culling one of their development programmes (see below). I sincerely hope they are making the right decision. In view of the liberal EMA alemtuzumab license and the stunning results of the ORACLE study (cladribine in CIS), I suspect they regret their rather premature decision to cull their cladribine development programme; particularly as the drug already had licenses in Australia and Russia. When I was in Australia this year a large number of Australian neurologists were very disappointed that they had lost cladribine as a treatment option. We as a community need to get cladribine back; it has numerous advantages as it is relatively easy  to use as a drug."


After careful consideration, Merck Serono has reached the decision to terminate the Phase II development of our plovamer acetate development relapsing remitting multiple sclerosis (RRMS). Plovamer acetate, a second generation copolymer, did not meet the threshold for continuation. This was based on a number of considerations including the level of investment, probability of success, time to market and changing market dynamics. As a consequence, the ongoing plovamer acetate Pathway 1 (EMR 200575-001) study will be terminated early as we do not believe we can develop a differentiated product that improves patient care.

Study investigators have been informed of the study termination and requested to immediately stop screening and randomizing patients into the study. Each investigator will schedule early termination visits and transition to approved therapies for all patients within three (3) months of the announcement date. Additionally, a one (1) month safety follow-up will be conducted.

Discontinuing plovamer acetate frees up resources, including people that will be made available to strengthen other areas of our pipeline, with the goal to bring additional, meaningful products to people with MS and in other disease areas. We continue to invest in this area with the advancement of our MS pipeline, including ATX-MS-1467, an investigational therapy for RRMS, and imilecleucel-T, an investigational therapy for Secondary Progressive MS (SPMS), as well as internal research and business development activities to expand our portfolio. (Merck Serono has an option agreement for the development and commercial licensing of imilecleucel-T.)

Merck Serono remains committed to driving innovation in the field of MS and improving the lives of people living with the disease. Rebif® (interferon beta-1a) which has been used by patients for more than a decade and is registered in more than 90 countries around the world , our innovative devices with the launch of the new RebiSmart® and MSdialog™ and our patient-centered support programs have further enhanced our value proposition for people with MS, HCPs and payors.

We continue to pursue external collaborations such as the Fast Forward program with the National Multiple Sclerosis Society in the U.S. and the annual Grant for MS Innovation available to investigators worldwide. We are also investing in internal programs aimed at identifying and developing high-quality candidate molecules with the goal of making a real difference in the lives of people with MS.

Our promise and responsibility to the MS community remains strong and unwavering. As a physician and MS community leader, we know you dedicate every day to helping people with MS, while keeping an eye out for new treatment protocols that increase positive outcomes. In this light, we thank you for your understanding regarding this tough decision.

On behalf of the Merck Serono Global Neurology Team

CoI: multiple

6 comments:

  1. ProfG. says:

    "We as a community need to get cladribine back; it has numerous advantages as it is relatively easy to use as a drug."

    Is there any chance (remote or not) to get cladribine back?

    ReplyDelete
    Replies
    1. Re: "Is there any chance (remote or not) to get cladribine back?"

      Yes, if you read my post I am promoting it off-label.

      http://multiple-sclerosis-research.blogspot.com/2014/10/offlabel-cladribine.html

      Delete
  2. ProfG you have questioned whether immune treatments affect SPMS and whether T cells are the important targets for progression, so do you think imilecleucel-T will work?

    ReplyDelete
    Replies
    1. RE: "do you think imilecleucel-T will work?"

      No.

      Delete
  3. I have PPMS and sometimes my urine is expelled normally but other times it's like a broken showerhead that sprays everywhere. Is this a common occurrence in MS or is it just me? (I am a bloke, by the way.)

    ReplyDelete
    Replies
    1. Dr m&m says
      irregular flow is nor unusual but we think spraying is unusual I would suggest seeing a urologist. spraying is likely do to urine pressure.

      Delete

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