Page 1 of 2 12 LastLast
Results 1 to 10 of 13

Thread: Copaxone 3 times a week might be delayed

  1. #1
    Distinguished Community Member agate's Avatar
    Join Date
    Oct 2006
    Location
    USA
    Posts
    6,718
    Blog Entries
    11

    Default Copaxone 3 times a week might be delayed

    Teva Pharmaceuticals has been trying to launch its new version of Copaxone but is running into some snags. The article indicates that the new 3-times-a-week dosage is "higher" but actually the patient would get a total of 20 mg less of Copaxone every week with the new dosage of 40 mg 3 times a week.

    Each dose of Copaxone injected would be higher, however--40 mg compared to the current 20 mg.

    From www.bloomberg.com, July 29, 2013:

    Teva Plan to Safeguard $4 Billion Drug Endangered by Ruling

    By David Wainer

    Teva Pharmaceutical Industries Ltd. (TEVA)’s plan to switch patients to a longer-acting version of its Copaxone treatment suffered a setback as a U.S. court ruling gave the $4 billion drug less than a year of patent protection.

    Teva wants to move as many as half of the multiple-sclerosis patients taking daily Copaxone injections to a three-times-weekly version of the medicine. The U.S. Court of Appeals decision to invalidate a 2015 patent may allow generic competitors such as Cambridge, Massachusetts-based Momenta Pharmaceuticals Inc. (MNTA) to lure away patients with cheaper copies as early as next year, said Marc Goodman, an analyst at UBS AG.

    “This not only moves up the potential generic Copaxone launch into 2014 but it also doesn’t give Teva much time to convert patients,” said Goodman, who is based in New York. The analyst said he changed his earnings forecast to reflect a generic competitor by 2014 and a 15 percent patient conversion instead of a previously forecast 30 percent.

    Teva, based in Petach Tikva, Israel, markets a 20-milligram Copaxone injection, which generates more than five times the revenue of its second-best-selling branded drug, Treanda.

    A longer-acting, 40-milligram dose of Copaxone was effective in lowering relapse rates in MS patients compared with a placebo in a late-stage trial last year.

    Extra Year

    Because Teva expects the U.S. Food and Drug Administration to approve the long-acting version by early 2014, the extra year without generic competition would be key to moving its patients to the higher dosage.

    “Teva wanted to switch a significant portion of its prescriptions to the 40-milligram dose but that will be de facto impossible if the market goes generic in May 2014,” said Ori Hershkovitz, a partner at Sphera Funds Management Ltd., a Tel Aviv-based health-care hedge fund.

    ...

    Switching Patients

    Teva expects 30 percent to 35 percent of its patients to switch, Jon Congleton, senior vice president at Teva’s Global Medicines Group, said in a first-quarter earnings conference call. Market research done by Teva showed as many as half of all Copaxone patients would transition to fewer weekly injections, Congleton said. The newer formulation would have patent protection through 2030.
    Generic-drug makers still face hurdles in getting their products to the market next year. Teva can seek a review before the U.S. Supreme Court and the company said it will appeal the decision. The FDA would need to approve copies of the drug and Teva says that the regulator should require lengthy clinical trials not typical for generic medicines because Copaxone is a complex molecule.
    “Since the generics did not receive FDA approval, nor is there any indication as to when, if at all, such approval would be received, it is too early to assess if there will be any impact on Copaxone, and specifically on our launch of Copaxone 40-milligram 3-times-a-week,” Teva said in an e-mailed statement.

    Momenta’s application with the FDA for a generic has been under review for five years and the regulatory pathway “remains murky,” said David Steinberg, a San Francisco-based analyst at Deutsche Bank AG. There is a real possibility that a generic to Copaxone may not emerge for a number of years, said Steinberg, who has a buy recommendation on Teva.

    A generic approval in 2014 is increasingly possible as the FDA demonstrates more willingness to approve complex drugs, said Ronny Gal, an analyst at Sanford C. Bernstein & Co. Gal estimated the chances of a generic entrant next year at 50 percent.

    ________________

    To contact the reporter on this story: David Wainer in Tel Aviv atdwainer3@bloomberg.net
    To contact the editor responsible for this story: Phil Serafino atpserafino@bloomberg.net


    The story can be seen in its entirety here.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

  2. #2
    Distinguished Community Member
    Join Date
    Oct 2006
    Location
    Red Sox Nation :D
    Posts
    2,282

    Default

    Thanks for the "leg work," Agate.

    I am concerned w skin reactions- ulcerations- not the itchy blobs. My neuro said, in passing, that there was a particularly "nasty one across the hall." That was on 20mg. This is my reason to let many go before me and try the 40mg if they want or need less shots a week.

    Watching & waiting,
    ANN
    There comes a time when silence is betrayal.- MLK

  3. #3
    Distinguished Community Member agate's Avatar
    Join Date
    Oct 2006
    Location
    USA
    Posts
    6,718
    Blog Entries
    11

    Default

    At first the idea of a shot 3 times a week, compared to every day, appealed to me, and after all the total amount of Copaxone I'd be getting every week would be less by 20 mg.

    But the more I thought about getting 40 mg each time instead of 20 mg, the less appealing the idea got. That's double the dose I was getting.

    I already have some lipoatrophy from my time on Copaxone. I'm at an age where a few lumps and dents in my skin don't matter much but people do run out of injection sites if they have enough lipoatrophy going on.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

  4. #4
    Distinguished Community Member renee's Avatar
    Join Date
    Oct 2006
    Location
    Up-upstate NY where it gets cooooold.
    Posts
    756

    Default

    I want to be a more compliant patient, really.
    So who is greasing whos palm?

  5. #5
    Distinguished Community Member SalpalSally's Avatar
    Join Date
    Oct 2006
    Location
    SWOhio
    Posts
    3,569

    Default

    We all know the answer to that, Renee..
    Last edited by SalpalSally; 09-09-2013 at 06:16 PM.
    Love, Sally


    "The best way out is always through". Robert Frost







  6. #6

    Default

    I know next to nothing about Copaxone. But I am curious. I have a question.

    It is not a given that an increase in the dose from 20 mg to 40 mg will mean the overall quantity of the liquid in each 40 mg injection will be larger than that contained in the 20 mg shot. They could use less dilutant with the 40 mg dose, or not double the amount of dilutant. Maybe someone knows what will be done in this regard and can tell me/us . . .

    Just curious,
    lawnerd

  7. #7
    Distinguished Community Member agate's Avatar
    Join Date
    Oct 2006
    Location
    USA
    Posts
    6,718
    Blog Entries
    11

    Default

    I don't know but this may make it clear:

    Teva Pharmaceutical Industries Ltd. ... announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s supplemental new drug application (sNDA) for COPAXONE® (glatiramer acetate injection) 40mg/ 1mL, a higher concentration dose of COPAXONE® that offers a less frequent three times a week dosing regimen administered subcutaneously for patients with relapsing-remitting multiple sclerosis (RRMS). Currently, the approved dose for COPAXONE® is 20 mg/ 1mL, which is a once a day subcutaneous injection.
    http://finance.yahoo.com/news/teva-announces-fda-acceptance-snda-120200934.html

    It sounds as if people taking Copaxone 3 times a week instead of every day will be getting double the dose of Copaxone compared to people taking it daily.
    Last edited by agate; 09-11-2013 at 05:46 PM.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

  8. #8
    Distinguished Community Member SalpalSally's Avatar
    Join Date
    Oct 2006
    Location
    SWOhio
    Posts
    3,569

    Default

    3 @ 40 or 6 @ 20...seems like 6 of one or half a dozen of the other...LOL
    I think they mean that your day dose will be double and IMO, that could
    double your side effects. I think they should just go to 3 per week @ 20!!!
    Save money and it will probably work just as well.??
    Last edited by SalpalSally; 09-11-2013 at 06:41 PM.
    Love, Sally


    "The best way out is always through". Robert Frost







  9. #9
    Distinguished Community Member agate's Avatar
    Join Date
    Oct 2006
    Location
    USA
    Posts
    6,718
    Blog Entries
    11

    Default

    Quote Originally Posted by SalpalSally View Post
    This quote is hidden because you are ignoring this member. Show Quote
    3 @ 40 or 6 @ 20...seems like 6 of one or half a dozen of the other...LOL
    I think they mean that your day dose will be double and IMO, that could
    double your side effects. I think they should just go to 3 per week @ 20!!!
    Save money and it will probably work just as well.??
    Actually it would be 3 x 40 = 120 or 7 x 20 = 140, the way I figure it. So the new dosage would give a person a bit less Copaxone, total, per week. Copaxone is taken 7 days a week even though I often wished for a day off.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

  10. #10

    Default

    Three times a week - why isn't it just every other day? You get a 30 day month supply now - well a month can be 28, 29 30, or 31 days!

Page 1 of 2 12 LastLast

Similar Threads

  1. Delayed sleep phase syndrome
    By ACC_gal in forum Sleep Disorders
    Replies: 6
    Last Post: 01-14-2014, 11:24 PM
  2. Replies: 12
    Last Post: 11-09-2012, 11:59 PM
  3. Long New York Times article on CCSVI
    By agate in forum Multiple Sclerosis
    Replies: 2
    Last Post: 10-28-2012, 11:07 AM
  4. Replies: 3
    Last Post: 10-03-2012, 02:07 PM
  5. Letter to the NY Times about Managing Care Online
    By Donna Thomson in forum Child Neurology
    Replies: 1
    Last Post: 06-11-2012, 04:55 PM

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •  


BTC Inc's Disclaimer and Privacy Policy

The material on this site is for information & support purposes only, and is not a substitute for medical advice provided by a licensed health care provider. Always consult your doctor before trying anything that you find online.