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BioCentury Extra
As published Friday, March 06, 2015 6:23 PM PST

  • FDA approves Zarxio, first biosimilar in U.S.

    FDA approved Zarxio filgrastim-sndz from the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) for the same indications as its reference product, Neupogen filgrastim methionyl human G-CSF from Amgen Inc. (NASDAQ:AMGN). The agency said filgrastim-sndz is a "placeholder nonproprietary name," noting that it is not reflective of the agency's biosimilar naming policy. FDA intends to issue draft guidance on biosimilar naming, though it has not disclosed a timeline.

    Sandoz said it will not discuss Zarxio's price until its launch. Zarxio's launch date depends on pending litigation between Sandoz and Amgen, which has alleged that Sandoz refused to comply with the Biologics Price Competition and Innovation Act of 2009 when it filed its BLA for Zarxio. The U.S. District Court for the Northern District of California plans to hear the case on March 13.

    Sandoz has agreed not to launch Zarxio in the U.S. until the earlier of April 10 or a ruling in favor of Sandoz. In the latter scenario, Sandoz would provide Amgen five days' notice before launching Zarxio (see BioCentury Extra, Feb. 27).

    Sandoz declined to say whether it will seek approval of interchangeability for Zarxio, but said FDA has "signaled a two-step approach toward interchangeability, with granting biosimilar approval first followed by interchangeability."

    Neupogen, a recombinant methionyl human granulocyte colony-stimulating factor, is approved to treat cancer patients receiving myelosuppressive chemotherapy; patients with acute myelogenous leukemia (AML) receiving induction or consolidation chemotherapy; cancer patients receiving bone marrow transplant; patients undergoing peripheral blood progenitor cell collection and therapy; and patients with severe chronic neutropenia.

    FDA has four disclosed biosimilar applications under review, including another biosimilar of Neupogen and a biosimilar of Amgen's Neulasta pegfilgrastim, both from Apotex Inc. (Toronto, Ontario). Hospira Inc. (NYSE:HSP) has submitted an application for Retacrit, a biosimilar of Amgen's anemia drug Epogen epoetin alfa and Procrit epoetin alfa from the Janssen Biotech unit of Johnson & Johnson (NYSE:JNJ). Celltrion Inc. (KOSDAQ:068270) is seeking approval of CT-P13, a biosimilar of autoimmune therapy Remicade infliximab from J&J and Merck & Co. Inc. (NYSE:MRK). Hospira has exclusive rights to market CT-P13 in the U.S., Canada and other undisclosed territories (see BioCentury Extra, Feb. 12).

  • Orexigen falls following FDA comments

    Orexigen Therapeutics Inc. (NASDAQ:OREX) fell $0.91 (11%) to $7.10 on Friday after media reports said John Jenkins, director of FDA's office of new drugs, said the company could face penalties as a result of its premature disclosure of data from the LIGHT cardiovascular outcomes trial of obesity drug Contrave naltrexone/bupropion.

    The interim data, disclosed Tuesday in a patent and a subsequent regulatory filing, were part of Orexigen's December 2013 NDA resubmission for Contrave. Last year, the agency voiced concern that Orexigen had disclosed the interim analysis to too many people, potentially biasing the trial. FDA required a second CV outcomes trial when it approved Contrave last September (see BioCentury, Sept. 22, 2014).

    The Food, Drug, and Cosmetic Act gives FDA the authority to take enforcement action, including civil monetary penalties, seizure and injunction, against a company that fails to comply with postmarketing requirements. FDA also has the option to withdraw a product approval.

    FDA spokesperson Eric Pahon declined to comment on specific enforcement actions the agency may pursue regarding Contrave, noting that FDA does not yet know whether Orexigen will be able to meet its postmarketing requirements.

    The second CV outcomes trial is slated to start this year, with data expected in 2022. Orexigen declined to comment on how the disclosure of interim data from the LIGHT study might affect enrollment in the new trial (see BioCentury Extra, March 4).

  • FDA approves antifungal Cresemba

    FDA approved an NDA from Astellas Pharma Inc. (Tokyo:4503) for oral and IV Cresemba isavuconazonium sulfate to treat adults with invasive aspergillosis and mucormycosis. The broad-spectrum water-soluble azole antifungal was under Priority Review, and has Qualified Infectious Disease Product (QIDP) and Orphan Drug status for both indications. Astellas declined to discuss launch plans.

    Astellas obtained rights to Cresemba in the U.S. and Canada from originator Basilea Pharmaceutica AG (SIX:BSLN), which retains rights elsewhere under an amended 2010 deal.

    FDA based its approval to treat aspergillosis on results of the Phase III SECURE trial, in which Cresemba met the primary endpoint of non-inferiority to voriconazole in the rate of all-cause mortality through day 42 (18.6% vs. 20.2%). The mucormycosis approval was based on results from a 37-patient subgroup in the open-label Phase III VITAL trial along with matched historical data.

    In January, FDA's Anti-Infective Drugs Advisory Committee backed Cresemba's approval in both indications (see BioCentury Extra, Jan. 22).

    FDA approved Cresemba after market close. Basilea, which filed an MAA to EMA for the drug and expects a decision by YE15, gained CHF1.90 to CHF120.90 on Friday.

  • Merck disbands discovery team at Cubist subsidiary

    Merck & Co. Inc. (NYSE:MRK) has cut about 120 jobs at its Cubist Pharmaceuticals Inc. subsidiary in Lexington, Mass., ending discovery and non-clinical operations at the site.

    Merck spokesperson Lainie Keller said the company intends to develop some of Cubist's early stage projects at Merck's other facilities, but declined to provide details. She said the cuts would not affect development of later stage candidates at the site.

    Merck acquired Cubist in December for $9.5 billion. At the time, Merck said it would operate Cubist as part of the pharma, rather than a subsidiary, but that it did not yet have a plan for integrating Cubist's teams (see BioCentury Extra, Dec. 8, 2014).

  • Management tracks

    Acceleron Pharma Inc. (NASDAQ:XLRN) promoted Steven Ertel to EVP and COO from SVP and CBO and Matthew Sherman to EVP and CMO from SVP and CMO.

    Adocia S.A. (Euronext:ADOC) named Simon Bruce CMO of Adocia Inc., its new U.S. subsidiary. Bruce was previously executive medical director at Halozyme Therapeutics Inc. (NASDAQ:HALO).

  • China issues guidance on biosimilars

    China FDA's Center for Drug Evaluation has issued long-awaited biosimilars guidance that lays out basic principles for reviewing biosimilars in China.

    The Chinese-language guidelines, which are effective immediately, are similar to draft guidance released in November, with a few notable changes, according to a note issued Friday by Ropes & Gray to clients (see BioCentury Extra, Nov. 10).

    Most importantly, the guideline clarifies that while biosimilars will be reviewed according to different technical criteria, they are subject to the same new drug approval pathway as innovative biologics. China's approach differs from that in Europe and the U.S., which have both established independent regulatory pathways.

    This distinction means it is "unclear if the time to market for biosimilars will be substantially reduced," wrote Ropes & Gray Partner Katherine Wang in the note. Given that innovative biologics can take at least five to six years to reach market in China, industry should seek further clarification, she said.

    The final guidance also provides somewhat looser definitions for both biosimilars and reference products than the draft guidance.

    The guidelines stipulate that a biosimilar be "similar to a reference product approved in China or elsewhere in quality, safety and efficacy" and that the biosimilar should "in principle have the same amino acid sequence as the reference product," according to Ropes' translation.

    The reference product must be approved in China or elsewhere during a biosimilar's analytical and preclinical studies. The reference product must be approved in China before clinical trials of the biosimilar begin.

    In contrast, the draft guidance had said that the reference product should be registered in China at all stages of the biosimilar's clinical development. It had also said a biosimilar should have the same amino acid sequence as the reference product.

    The final guidance also clarifies that a reference product is usually, but not always, the originator product, although CFDA says that a biosimilar itself cannot serve as a reference product.

    In a statement, BIO SVP of International Affairs Joseph Damond said China's development of biosimilar guidelines "are generally consistent with WHO, U.S. FDA and EMA," but he said some areas still need clarification.

    "BIO hopes that its comments on reference products, R&D and evaluation, immunogenicity, multiple indications, and interchangeability continue to be considered as CFDA implements their new guidelines," he said.

    BIO submitted detailed comments to CFDA in December (see BioCentury Extra, Dec. 9, 2014).

  • Antibiotic-resistant bacteria is a growing threat

    Experts agree: antibiotic-resistant bacteria is a growing threat but the pipeline for novel antibiotics has virtually dried up. What's holding back new treatments to combat these infections? Jonathan Kfoury offers solutions to unleash a new wave of antibiotic development by fixing a broken pricing and reimbursement model in L.E.K.'s Executive Insights.

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