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Jul 9, 2014

Baxter Buys AesRx, Adding Phase II Sickle Cell Compound

  • Baxter International said today it acquired orphan drug developer AesRx, whose lead product is the Phase II prophylactic treatment for sickle cell disease Aes-103.

    The price was not disclosed. Baxter did say that it made an initial payment to acquire the company, and may make additional future payments based on undisclosed development, regulatory and commercial milestones.

    ''With this acquisition, we gain a compound that has the potential to address an extremely high unmet clinical need in a community with inadequate treatment options and no recent major clinical developments,'' Ludwig Hantson, Ph.D., president of Baxter BioScience, said in a statement. ''This program is complementary to our established experience in hemophilia and supports our goals to raise the bar for care of patients with a range of blood-related disorders.''

    Added Stephen Seiler, AesRx' Founder and former CEO: ''By becoming a part of Baxter's organization, we believe this will provide Aes-103 the needed resources and expertise to complete a robust development and commercialization program.”

    Aes-103 is a first-in-class, oral, small molecule compound (5-hydroxymethylfurfural) designed to bind to hemoglobin, changing its structure, and increase oxygen affinity and stabilization, thereby reducing the sickling of red blood cells. That process, in turn, is intended to reduce sickling-related outcomes such as vaso-occlusive crisis, pain, severe anemia, and fatigue.

    Aes-103 is currently in a Phase II clinical trial as part of an ongoing collaboration with the NIH's National Center for Advancing Translational Sciences (NCATS), through its Therapeutics for Rare and Neglected Diseases (TRND) program.

    TRND researchers signed a collaborative agreement with AesRx in 2010, and established a project team consisting of NCATS and AesRx investigators, as well as a leading sickle cell disease clinical researcher at the National Heart, Lung, and Blood Institute (NHLBI). Other key project collaborators received support through NHLBI grants, the NIH Clinical Center and its pharmacy, and NCATS’ Bridging Interventional Development Gaps program.

    Aes-103 was licensed by AesRx from Virginia Commonwealth University, Richmond, which discovered the compound through its Institute for Structural Biology and Drug Discovery. Baxter’s acquisition of AesRx marks the first time a company has acquired a drug candidate developed through TRND. “This is a wonderful example of why NCATS was created,” NIH Director Francis S. Collins, M.D., Ph.D. stated.

    Aes-103 has received an orphan designation from the FDA, and is eligible for orphan designation in Europe.

    Currently, the only drug approved by the FDA to treat sickle cell disease is hydroxyurea, a drug initially developed to treat cancer. However, many individuals with sickle cell disease either do not respond to the drug, or they may experience undesirable side effects.

    The Baxter acquisition has enabled privately held AesRx to repay early, with interest, a $750,000 loan it received in 2011 through the Accelerator program of the Massachusetts Life Sciences Center (MLSC), the quasi-public agency that oversees the commonwealth’s 10-year, $1 billion Life Sciences Initiative. AesRx’ repayment amount totaled $1.024 million.

    “The MLSC Accelerator loan was critical in helping us make it across the biotech ‘valley of death’ and bringing us closer to an important new treatment for patients in an area of enormous unmet medical need,” Seiler added.


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