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Taxus Cardium Pharmaceuticals Group, Inc. Message Board

  • hearth2hearth2 hearth2hearth2 Nov 12, 2011 8:26 AM Flag

    Regranex history for newbies

    Regranex is no longer owned by J&J, they have sold it long time ago.
    Here’s little history on this situation;

    SOMERVILLE, N.J., Dec. 1 /PRNewswire/ -- ETHICON, Inc., a Johnson & Johnson company, announced today that it has completed the divestiture of its Professional Wound Care business to One Equity Partners. Financial terms of the transaction are not being disclosed.
    Under the terms of the transaction, One Equity Partners has acquired the Professional Wound Care product portfolio, which contains such advanced wound care brands as PROMOGRAN Matrix Wound Dressing, TIELLE Hydropolymer Dressing and REGRANEX (becaplermin) Gel 0.01%, a prescription treatment for lower extremity diabetic ulcers, as well as a portfolio of general wound care products. Also included in the transaction is the transfer of the R&D and manufacturing facility in Gargrave, England. The Professional Wound Care business generated annual net sales of approximately $270 million in 2007.
    The professional wound care product portfolio will be marketed and distributed by Systagenix Wound Management, a new company created by One Equity Partners. Approximately 700 employees/contractors supporting the business will transfer to the new company.

    And latest news;

    Maybe the boys at One Equity Partners know something?

    One Equity Partners SYSTAGENIX have sold Regranex® Gel to Healthpoint Biotherapeutics.

    Healthpoint Biotherapeutics Acquires Regranex® Gel

    <FORT WORTH, Texas, June 2, 2011 /PRNewswire/ -- Healthpoint Biotherapeutics today announced that it has acquired Regranex® Gel, along with the corresponding intellectual property (including patents), from Systagenix. Terms of the deal were not disclosed.

    "This acquisition is aligned with our strategic focus on building a portfolio of novel biopharmaceuticals for wound healing and tissue regeneration," said Travis E. Baugh, President and Chief Operating Officer of Healthpoint Biotherapeutics. "Moreover, Regranex® Gel is a good fit for our commercial organization, which has a well established record of successfully marketing biologics for wound care."

    Regranex® Gel (0.01% Becaplermin) is a recombinant human platelet-derived growth factor (rhPDGF) and was the first biotechnology product approved for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond, and have adequate blood supply.>

    <Regranex® Gel should not be used in patients with skin tumors at the site of application.

    People who use 3 or more tubes of Regranex® Gel may have an increased risk of death from cancer.

    You should talk with your doctor about the possible benefits and risks to you if you use more than 3 tubes of Regranex® Gel.

    If you already have cancer, you and your doctor should carefully consider whether you will use Regranex® Gel.

    If you decide to use Regranex® Gel, your healthcare provider will tell you how to use Regranex® Gel.>

    <It is estimated that 7% or 20.8 million people have diabetes in the Unites States alone, and the incidence is expected to increase some 14% annually. Of those diagnosed with diabetes, up to 15% will develop a diabetic foot ulcer in their lifetime, and up to 59% will have recurrence of their foot ulcers, leading to over 82,000 amputations annually. The total annual direct cost of non-infected diabetic ulcer treatment has been estimated at over $6 billion.>

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    • J&J buyout ???
      Regranex history for newbies

    • sell order @ $10

    • huge volume today

    • Okay, this is all very exciting...but does CXM have the money to get their products into the market place. I'm encouraged this has moved up from .37...but what catalyst needs to occur to drive this past a buck!?

    • oldie but worth reading for newbies;

      <That being said Excellagen does appear to produce very favorable results as the Phase IIb study showed the topical gel had complete wound closure by 12 weeks at 45%, significantly higher than the 34% produced by Regranex, the main product on the market today for the treatment of diabetic foot ulcers. Excellagen also appears to be safer than Regranex which carries with it a warning label concerning the risk to develop cancer. If Excellagen is able to make it to market and compete directly with Regranex then Cardium could be sitting on a goldmine.>

    • Excellagen vs. Regranex

      The only competition REGRANEX has this warning;

      An increased risk of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of REGRANEX Gel in a post-marketing retrospective cohort study. REGRANEX Gel should only be used when the benefits can be expected to outweigh the risks. REGRANEX should be used with caution in patients with known malignancy.”
      REGRANEX™ has been prescribed more than 750,000 times since it became available.
      The new warnings were issued after a retroactive epidemiological study of more than 4,400 patients showed those prescribed three or more tubes of REGRANEX™ were 5 times more likely to die of cancer.

      Regranex Gel has been linked to a substantially increased risk of death from cancer when three or more tubes are used within 20 months to treat severe foot or leg ulcers in diabetics. In June 2008, the FDA announced a “black box” warning about the risk of cancer death as a possible side effect of Regranex.

      STATUS OF REGRANEX LAWSUITS: Potential cases are being reviewed by lawyers on behalf of individuals who died from cancer after using three or more tubes of Regranex Gel

      From one user of Regranex;

      <*****Comment by Kerri on 29 September 2009:

      I have stage 3 breast cancer, and I was treated with Regranex and STILL had a toe amputated. not only did this crap not do what it was supposed to do, now it probably has caused the cancer that will kill me. Perhaps the drug companies someday will put people’s lives before PROFITS (but probably NOT in MY lifetime)*****>

      • 1 Reply to hearth2hearth2
      • Excellagen vs. Regranex

        "Regranex Topical Gel - first FDA-approved advanced care biologic topical agent for the treatment of patients with lower extremity neuropathic diabetic foot ulcers.

        Excellagen just approved by FDA is a highly purified, physiologically formulated fibrillar bovine Type I collagen-based topical gel (2.6% collagen) designed to support favorable wound care management. There are no other collagen-based wound care management dressings available for professional use in the United States that are considered comparable to Excellagen in terms of its overall formulation, fibrillar nature, and product format. Other professional-use collagen-based products include granulated collagens that require mixing prior to use, as well as a variety of sheet-based products.

        Regranex is patient administered, requires daily application followed by a daily cleansing 12 hours after the drug treatment over a 20-week period. As a result, during the prescribed 20-week treatment period, Regranex patients are required to undertake approximately 280 interventions (drug administrations and cleansings) to achieve the potential maximum healing effect.

        Excellagen requires one or two physician administered treatment regimen.

        Regranex - 50% of patients achieved complete wound closure in 20 weeks.

        Excellagen - 83% of patients achieved complete wound closure in 14 weeks.

        Regranex - Increase cancer risk in Patients

        Excellagen - appears to be both safe and well tolerated, with no serious adverse events attributable to the study product.

        The wound care market is projected to experience double digit growth over the next 3 to 5 years, with advanced wound care products comprising the fastest growing segment of the total wound care market. There are an estimated 91.3 million wounds in the U.S., which include 67.0 million surgical wounds, 17.6 million trauma wounds including burn injuries and amputations, 2.5 million pressure ulcers, 3.6 million diabetic ulcers and 3.3 million venous stasis and arterial ulcers. The ability to effectively address even a small proportion of these wounds would represent major new market opportunities for the Company's Excellagen.

        In other words Excellagen will be the Number 1 topical gel for wound care which equals..........


0.20+0.03(+14.63%)Sep 28 12:25 PMEDT