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Halozyme Therapeutics, Inc. Message Board

  • fezziwig2008 fezziwig2008 Feb 23, 2013 2:25 PM Flag

    Inv Bus Daily- 1. Herceptin soon to be generic- ENTER HERCEPTIN SQ_ also T-DMI Approved for AFTER Herceptin

    The Whoie Reason for Subcut Herceptin is that Regular Herceptin is soon going to be knocked off by
    Generic Drug Makers- The SameReason Pfizer Partnered- To Extend the Life of Soon to be Generic Biotherapeutic Agents-

    Inv Bus Daily 2/22/13-
    "The Food and Drug Administration specifically OK'd Kadcyla for patients with metastatic breast cancer who'd previously been treated with Herceptin, the blockbuster also owned by Roche through its Genentech subsidiary. The product's underlying technology involves linking Herceptin's antibody with ImmunoGen chemotherapy agent DM1. Both companies are optimistic this model can be expanded.
    "We currently have more than 25 antibody-drug conjugates in our pipeline and hope this promising approach will help us deliver more medicines to fight other cancers in the future," Genentech's chief medical officer, Hal Barron, said in a press release.

    For Roche, the approval should help shore up its breast-cancer dominance, which was one important thing it acquired in its $46.8 billion buyout of Genentech in 2009.
    The franchise took a blow in 2011 when the FDA revoked the breast-cancer indication of Avastin, but Herceptin retains 90% market share in first-line treatment of cancer involving HER2 cell receptors, which make up 20% to 30% of breast cancers. It's generally used in combination with chemotherapy agents such as Roche's own Xeloda, Bristol-Myers Squibb's (BMY) Taxol and Celgene's (CELG) Abraxane. In advanced cancers it faces competition from GlaxoSmithKline 's (GSK) Tykerb, but in clinical trials Kadcyla came out ahead against a Tykerb-Xeloda combo treatment.
    Herceptin, however, is likely to face cheaper competition soon. As an antibody, it can't be copied directly by generic drugmakers at lower cost. But the recent arrival of biosimilar medicines in Europe, and the FDA's new procedure for approving biosimilars drawn up last year, opens the door for close-enough imitations of the drug. Morningstar analyst Karen Andersen told IBD that Herceptin biosimilars could arrive as early as 2015 in Europe and 2019 in the U.S.
    "Overall, we think T-DM1 should effectively blunt any negative impact from biosimilar Herceptin," she said.
    This will be especially true if, as expected, Kadcyla also wins approval as a first-line treatment. Roche is conducting a clinical trial of that indication, with results due in the first quarter of next year. Analyst Yale Jen of Roth Capital estimates that if that approval goes through, peak annual Kadcyla sales could reach $3.5 billion.
    The question, Jen says, is how much payers will be willing to reimburse the cost. Herceptin's $70,000-a-year price tag in the U.S. was already controversial, and Kadcyla is expected to go for as much as $94,000. Jen says the drug's impressive trial results should strengthen its case."

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