Novartis, Juno Settle CAR-T Litigation

Juno Therapeutics, Inc. has settled litigation with the trustees of the University of Pennsylvania (Penn) and Novartis Pharmaceuticals Corporation regarding a patent dispute involving chimeric antigen receptors (CAR) therapies, a promising anticancer therapy. Penn has an exclusive global agreement with Novartis to research, develop and commercialize personalized CAR T cell therapies for the treatment of cancers.

Juno became a party to the litigation after it entered into a December 2013 license agreement with St. Jude Children’s Research Hospital, also a party in the litigation, for patent rights owned by St. Jude. The litigation itself, which began in July 2012 in connection with a contract dispute between St. Jude and Penn, was broadened in March 2013 to include a dispute concerning St. Jude’s U.S. Patent No. 8,399,645, titled “Chimeric Receptors with 4-1BB Stimulatory Signaling Domain.”

Under the terms of the settlement, Novartis agreed to make payments to Juno including an initial payment of $12.25 million, future milestone payments, and mid-single digit royalties from US net sales of product candidates related to the disputed contract and patent claims as well as a low double-digit percentage of the royalties Novartis pays to Penn for global net sales for those product candidates. Payments received by Juno will be shared with St. Jude under the terms of the license agreement between Juno and St. Jude. The parties also agreed to dismiss all claims in the relevant legal proceedings.

In July 2014, Novartis received Breakthrough Therapy status from the US Food and Drug Administration (FDA) for CTL019, an investigational CAR T cell therapy for the treatment of pediatric and adult patients with relapsed/refractory acute lymphoblastic leukemia According to the FDA, Breakthrough Therapy designation is intended to expedite the development and review of new medicines that treat serious or life-threatening conditions if the therapy has demonstrated substantial improvement over an available therapy on at least one clinically significant endpoint. The designation includes all of the fast track program features, as well as more intensive FDA guidance.

Juno is developing cell-based cancer immunotherapies based on CAR and high-affinity T cell receptor technologies to genetically engineer T cells to recognize and kill cancer. Juno is developing multiple cell-based product candidates to treat a variety of B-cell malignancies as well as solid tumors.. The company is applying research from centers, such as the Fred Hutchinson Cancer Research Center, Memorial Sloan Kettering Cancer Center, Seattle Children’s Research Institute, and The National Cancer Institute.

Source: Juno Therapeutics

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