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    Ligand Partner Melinta Therapeutics Submits Baxdela New Drug Application for Hospital-Treated Skin Infections

    Chelsea Pratt
    Oct. 24, 2016 07:13AM PST
    Biotech Investing

    Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) partner Melinta Therapeutics announced today that it has submitted New Drug Applications to the U.S. Food and Drug Administration for approval of IV and oral Baxdela.

    Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) partner Melinta Therapeutics, a privately held company developing novel antibiotics to treat serious bacterial infections, announced today that it has submitted New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) for approval of IV and oral Baxdela™ (delafloxacin) for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI).
    Baxdela is an investigational anionic fluoroquinolone with a broad spectrum of antimicrobial activity,
    including activity against methicillin-resistant Staphylococcus aureus (MRSA). Melinta’s NDAs are based on the results of two Phase 3 studies (NCT01811732 and NCT01984684),
    in both of which Baxdela met the primary endpoint of non-inferiority to
    a combination regimen of vancomycin plus aztreonam in reducing lesion
    size at the primary infection site at 48-to-72 hours. In addition,
    Baxdela met the primary endpoint, the investigator assessment of
    clinical cure, for the European Medicines Agency (EMA) in both studies.
    Baxdela was shown to be well-tolerated among Phase 3 study participants,
    with less than 1% of patients discontinuing for treatment-related
    adverse events. With the submission, Ligand has earned a $1.5 million
    milestone payment. If approved, Ligand is entitled to receive a 2.5%
    royalty on net sales of the IV formulation of Baxdela and an additional
    $1.5 million approval milestone payment.
    “Baxdela, if approved, represents a potentially attractive treatment
    option for the nearly 3 million patients hospitalized annually in the
    U.S. with serious skin infections,” stated Eugene Sun, M.D., Melinta’s
    Chief Executive Officer. “These patients have a high rate of treatment
    failure, and frequently have underlying medical conditions that pose
    challenges to the choice of antibiotic. Baxdela has been tested in over
    2,600 patients to date, and was well-tolerated with fewer than 1% of
    Baxdela-treated patients discontinuing due to treatment-related adverse
    events.”
    Baxdela has been designated a Qualified Infectious Disease Product
    (QIDP) by the U.S. FDA, which provides for priority review. According to
    Melinta’s press release, Melinta could receive a regulatory decision by
    mid-year 2017 consistent with Prescription Drug User Fee Act (PDUFA)
    priority review timelines.
    “Baxdela has demonstrated in clinical trials a broad spectrum of
    activity and the ability to treat patients with serious co-morbidities,
    both of which are compelling characteristics sought by physicians
    according to our market research. We believe that Baxdela’s ability to
    treat challenging patients in hospitals will be a major driver of
    adoption,” concluded John Temperato, Melinta’s President and Chief
    Operating Officer. “If approved, we plan to support the introduction of
    Baxdela for the treatment of ABSSSI with a focused acute-care hospital
    sales force. We believe we can further leverage the resources of such a
    sales team in the future as we seek to complete clinical studies and
    file applications to market Baxdela in additional indications such as
    community-acquired bacterial pneumonia and complicated urinary tract
    infections.”
    About Baxdela
    Baxdela (delafloxacin) is an investigational anionic fluoroquinolone
    antibiotic for hospital-treated skin infections, known as acute
    bacterial skin and skin structure infections (ABSSSI). Baxdela has
    robust in-vitro antimicrobial activity, including activity against
    methicillin-resistant Staphylococcus aureus (MRSA), a major cause
    of hospital-treated skin infections, a favorable tolerability profile,
    and both intravenous and oral dosage forms, which may facilitate
    hospital discharge. The studies (studies 302 and 303) were Phase 3,
    multicenter, randomized, double-blind, active-controlled trials to
    evaluate IV and oral Baxdela compared with vancomycin plus aztreonam for
    the treatment of patients with ABSSSI. Both studies met the primary
    endpoints for efficacy.
    Overall adverse event rates were similar between treatment arms in the
    Phase 3 studies, which enrolled over 1,500 individuals. The most common
    treatment-emergent adverse events in the Phase 3 studies on Baxdela were
    diarrhea and nausea, which were generally mild and did not lead to
    treatment discontinuation. The treatment discontinuation rate due to
    treatment-related adverse events for patients treated with Baxdela in
    the Phase 3 trials was 0.8%. Unlike some other quinolones, Baxdela has
    not shown any potential for QT prolongation or phototoxicity in
    definitive clinical studies. In addition, there were no elevated rates
    of liver or glucose abnormalities compared to vancomycin plus aztreonam
    in the clinical studies conducted to date.
    The 450 mg tablet has been shown to have bioequivalent exposure (area
    under the curve) to the 300 mg IV dose, and can be dosed without regard
    to food. There are no anticipated drug-drug interactions with
    delafloxacin other than co-administration with chelating agents.
    Melinta is also assessing Baxdela in a clinical trial in patients with
    hospital-treated community-acquired bacterial pneumonia (CABP) and
    planning to initiate a clinical trial in complicated urinary tract
    infections (cUTI) in the near future. Baxdela has been designated a
    Qualified Infectious Disease Product (QIDP) and has been granted fast
    track designation for community-acquired bacterial pneumonia by the U.S.
    Food and Drug Administration.
    About Ligand Pharmaceuticals
    Ligand is a biopharmaceutical company focused on developing or acquiring
    technologies that help pharmaceutical companies discover and develop
    medicines. Our business model creates value for stockholders by
    providing a diversified portfolio of biotech and pharmaceutical product
    revenue streams that are supported by an efficient and low corporate
    cost structure. Our goal is to offer investors an opportunity to
    participate in the promise of the biotech industry in a profitable,
    diversified and lower-risk business than a typical biotech company. Our
    business model is based on doing what we do best: drug discovery,
    early-stage drug development, product reformulation and partnering. We
    partner with other pharmaceutical companies to leverage what they do
    best (late-stage development, regulatory management and
    commercialization) to ultimately generate our revenue. Ligand’s Captisol®
    platform technology is a patent-protected, chemically modified
    cyclodextrin with a structure designed to optimize the solubility and
    stability of drugs. OmniAb® is a patent-protected transgenic
    animal platform used in the discovery of fully human mono- and
    bispecific therapeutic antibodies. Ligand has established multiple
    alliances, licenses and other business relationships with the world’s
    leading pharmaceutical companies, including Novartis, Amgen, Merck,
    Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly.
    Follow Ligand on Twitter @Ligand_LGND.
    Forward-Looking Statements

    This news release contains forward-looking statements by Ligand that
    involve risks and uncertainties and reflect Ligand’s judgment as of the
    date of this release. These include statements regarding the timing of
    review and approval, if any, by the FDA of the Baxdela NDA; the timing
    of the $1.5 million payment payable to Ligand; the potential payments to
    Ligand upon approval of Baxdela; and the description of the side effects
    for Baxdela. Actual events or results may differ from our expectations.
    For example, there can be no assurances that the FDA will approve
    Baxdela or that, if approved, Melinta will successfully launch Baxdela;
    the side effects or efficacy of Baxdela may prove different or worse
    than the results from previous clinical trials; and Baxdela may not be
    accepted as a treatment option by doctors and other health
    professionals. In addition, there can be no assurance that Melinta will
    make the required milestone payment. The failure to meet expectations
    with respect to any of the foregoing matters may reduce Ligand’s stock
    price. Additional information concerning these and other important risk
    factors affecting Ligand can be found in Ligand’s prior press releases
    available at www.ligand.com
    as well as in Ligand’s public periodic filings with the Securities and
    Exchange Commission, available at www.sec.gov.
    Ligand disclaims any intent or obligation to update these
    forward-looking statements beyond the date of this press release, except
    as required by law. This caution is made under the safe harbor
    provisions of the Private Securities Litigation Reform Act of 1995.

    clinical trialsbaxter internationalclinical studieseli lilly
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