Subscribe

  • How Can We Help You?

    Global Problem Solving from Covington: Deal with Complex Problems Anywhere in the World

Needles_Sara_1000x714_ENV

Sara A. Needles

Of Counsel

Washington +1 202 662 5634

  • About
  • Representative Matters
  • Credentials
  • About

    Sara Needles advises pharmaceutical and biotechnology clients on transactional matters across the full life cycle of their drug products, biologics, medical devices and technologies. Her work spans discovery and early research collaborations, complex licensing arrangements, acquisitions and divestitures and other clinical and commercial transactions in the life sciences industry.

    Sara regularly counsels clients on transactions in the companion diagnostic, cell and gene therapy, digital health and authorized generic spaces across a variety of therapeutic areas.

    Sara’s clients range from early-stage ventures still in stealth mode to leading global companies marketing mature products. Her expertise includes structuring, drafting and negotiating:

    • license and collaboration agreements
    • manufacturing, supply and distribution agreements
    • clinical trial and investigator-sponsored study agreements
    • co-development, co-commercialization and co-promotion agreements
    • consulting and services agreements
    • termination and transition agreements

    Areas of Expertise

  • Practices and Industries
  • Representative Matters
    • AbbVie in:
      • a collaboration and option agreement with Capsida Biotherapeutics to develop tissue-targeted gene therapies for CNS disease targets using Capsida’s AAV engineering and screening platform with AbbVie’s cargo therapeutic technologies; and
      • a research and license agreement with Pure MHC to discover and validate peptide targets for use with T-cell receptor therapeutics in several types of cancers.
    • Arcellx, Inc., a clinical-stage biopharmaceutical company developing adaptive and controllable cell therapies for the treatment of cancers and autoimmune diseases, on various research, clinical, manufacturing services and supply transactions and other commercial matters.
    • Bristol-Myers Squibb in a drug discovery collaboration with Schrödinger, Inc. to use Schrödinger’s physics-based software platform to advance small molecule therapeutics for targets in oncology, immunology and neurological disorders, with a total deal value of up to $2.7 billion plus royalties.
    • AstraZeneca in:
      • the restructuring of its collaboration agreement with Ironwood Pharmaceuticals, Inc., giving AstraZeneca full responsibility for developing, manufacturing and commercializing Linzess (linaclotide) in China;
      • a worldwide out-license agreement with PhaseBio Pharmaceuticals, Inc. for PB2452 (formerly MEDI2452), a reversal agent for ticagrelor;
      • numerous distribution agreements for authorized generic versions of marketed AstraZeneca products, including Nexium® and Symbicort®;
      • its $325 million divestiture of Myalept® to Aegerion Pharmaceuticals;
      • its divestiture of worldwide rights to Ethyol® to Clinigen Group plc; and
      • its divestiture of rights to 17 formerly marketed injectable products to IGI Laboratories, Inc.

    • MedImmune, AstraZeneca’s biologics arm, in:
      • the sale of U.S. rights to Synagis and the right to participate in U.S. profits and losses for MEDI8897 to Swedish Orphan Biovitrum AB (publ) for upfront consideration of $1.5 billion plus further contingent payments; and
      • its acquisition of Amplimmune for $225 million upfront and additional potential milestone payments.
    • Takeda in a collaboration and licensing arrangement with ImmunoGen, Inc. to develop and commercialize targeted anticancer therapeutics using ImmunoGen’s proprietary antibody-drug conjugate technology.
    • Regeneron in:
      • the restructuring of its antibody collaboration with Sanofi for Praluent® (alirocumab) to simplify the arrangement between the companies, increasing efficiency and streamlining operations; and
      • its global collaboration with Teva Pharmaceuticals to develop and commercialize fasinumab, with an upfront payment of $250 million, as well as ongoing research and development costs of approximately $1 billion.
    • Asuragen, Inc., a privately held molecular diagnostics company, in:
      • various clinical study, development and licensing transactions; and
      • the sale of Asuragen’s miRInform Thyroid and Pancreas laboratory-developed cancer tests to Interpace Diagnostics, a subsidiary of PDI, Inc.
    • Actelion Ltd. in its acquisition of Ceptaris Therapeutics for $250 million upfront and additional royalty and potential milestone payments.
    • Eisai Inc. in its divestiture of US rights to Gliadel® Wafer to Arbor Pharmaceuticals.
    • Numerous emerging and leading biopharmaceutical, diagnostic and medical device companies in the U.S. rollout of Phase 1, 2 and 3 clinical trials and the management of investigator-sponsored study programs.

    Areas of Expertise

  • Credentials
    Education
    • University of North Carolina School of Law, J.D., 2010
        • with high honors
        • Order of the Coif
        • North Carolina Law Review, Executive Articles Editor
    • Cambridge University, M.Phil., 2005
    • University of Pittsburgh, B.A., 2002
        • summa cum laude
        • Phi Beta Kappa
    Bar Admissions
    • District of Columbia
    • Virginia
    Pro Bono
    • Advising several Washington, DC-area non-profit organizations on corporate formation, restructuring, governance matters and commercial real estate transactions.
    • Providing analysis and advice to governmental bodies on State practice relating to witness and victim protection mechanisms and war crimes prosecution.
    Previous Experience
    • Oxford University Press, Production Editor
    • Cambridge University Press, Project Manager

    Areas of Expertise

News and Insights

Events