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July 1, 2016

AstraZeneca Inks Tralokinumab, Brodalumab Licensing Deals with Leo Pharma

  • AstraZeneca has inked licensing agreements covering two of its drug candidates with Leo Pharma, giving it global rights to skin disease indications for tralokinumab as well as European rights to brodalumab for psoriasis, the companies said today.

    The licensing deal for tralokinumab alone could generate more than $1 billion for AstraZeneca, which has spent recent months unloading noncore assets to generate cash and focus more closely on treatments in its core therapeutic areas.

    Tralokinumab is an anti-interleukin-13 (IL-13) monoclonal antibody that has completed a Phase IIb trial for the treatment of patients with atopic dermatitis. Tralokinumab is also in Phase III development for patients with severe asthma.

    In return for gaining exclusive tralokinumab rights for dermatology indications, Leo Pharma agreed to pay AstraZeneca $115 million upfront, as well as up to $1 billion in payments tied to achieving commercial milestones, and up to mid-teen tiered percentage royalties on product sales.

    “This agreement allows us to concentrate our efforts on tralokinumab’s potential for patients with severe asthma, a priority area for AstraZeneca, while benefitting from Leo Pharma’s expertise in dermatology for the continued development and commercialization of tralokinumab in atopic dermatitis and other dermatology conditions,” Luke Miels, evp, global product and portfolio strategy for AstraZeneca, said in a statement.

    AstraZeneca said it will manufacture and supply tralokinumab to Leo Pharma and will retain all rights to the drug candidate in respiratory disease and any other indications outside of dermatology.

    AstraZeneca’s agreement with Leo Pharma for tralokinumab is subject to customary closing conditions and is expected to complete in the third quarter of 2016. The tralokinumab partnership expands Leo Pharma’s dermatology offerings to include biologics.

    “By expanding our portfolio to include both biologics and topicals, Leo Pharma is set to become the world dermatology leader, offering the most diverse range of treatment solutions to meet the individual needs of people with skin diseases,” added Leo President and CEO Gitte Aabo.

    AstraZeneca also signed a licensing deal giving Leo Pharma European rights to brodalumab, an IL-17 receptor monoclonal antibody under regulatory review for patients with moderate-to-severe plaque psoriasis, as well as for psoriatic arthritis.

    Those rights were part of a global up-to-$445 million licensing agreement for brodalumab that AstraZeneca signed last September with Valeant Pharmaceuticals International. AstraZeneca and Valeant have agreed to terminate the European rights portion of that agreement, while Valeant will continue to develop and commercialize brodalumab in the U.S. and other markets covered by the original deal.

    Leo Pharma agreed to license European rights to brodalumab under similar terms to those agreed with Valeant, AstraZeneca said, while Amgen will continue to receive a low single-digit inventor royalty.

    AstraZeneca said its agreements with Leo Pharma will not affect its 2016 financial guidance. The pharma giant has told investors it anticipates “low- to mid- single-digit percentage” declines in both total revenue and core earnings per share.

    AstraZeneca’s therapeutic areas are cardiovascular and metabolic disease, oncology, and respiratory, inflammation, and autoimmunity diseases. The company has reached numerous agreements this year to sell rights to noncore assets. Most recently earlier this month, AstraZeneca sold outside-the-U.S. rights to its portfolio of seven anesthetics to Aspen Global for up to $770 million-plus.

    Earlier this year, AstraZeneca inked an up-to-$265 million-plus licensing deal with Ironwood Pharmaceuticals for U.S. rights to the soon-to-launch gout-associated hyperuricemia treatment Zurampic® (lesinurad) to Ironwood Pharmaceuticals, and an up-to-$230 million-plus agreement with Grünenthal for European and Latin American rights to the drug.

    Also this year, AstraZeneca sold Chinese rights to partial rights to hypertension treatment Plendil (felodipine) and ex-U.S. rights to angina pectoris drug Imdur (isosorbide mononitrate) for a combined $500 million. AstraZeneca also sold rights to its opioid-induced constipation treatment Moventig (naloxegol) in the EU and four European nations to a subsidiary of Kyowa Hakko Kirin for a sum that included $70 million upfront.

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