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Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.
The partnership will focus on the development of CAR T-cell therapies and other programs related to T-cell technology.
Celgene and Juno Therapeutics will enter into a decade-long partnership to develop and commercialize immunotherapies for the treatment of cancer and autoimmune diseases, both companies announced on June 29, 2015. The total payment of $1 billion includes an upfront payment of $150 million and the purchase of approximately 9.1 million shares of Juno's stock for $93.00 per share.
Under terms of the agreement, Celgene has the option to be the commercialization partner in North America for all of Juno’s product candidates, including Juno’s CD19 and CD22 chimeric antigen receptor T cell (CAR-T) product candidates. Celgene, however, may not initially select the CD19 or CD22 programs for its global profit sharing agreement, and must choose among Juno’s other projects-such as its L1CAM program for neuroblastoma, its MUC16 and IL16 program for ovarian indications, or its ROR-1 program for CLL or solid tumors, for example-and will have the option to select a third program for global co-promotion that will be “subject to additional obligations,” according to a Celgene press release.
Juno will gain the right to co-develop and co-promote select Celgene programs involving T cells, and both companies will share global costs and profits for these programs. Juno will retain commercialization and R&D in North America. Celgene also will be able to purchase additional equity in Juno with the option to own up to 30% of Juno’s stock.
Celgene’s B-cell Maturation Antigen (BCMA) for the treatment of multiple myeloma is excluded as a target in this collaboration, as Celgene is working with Juno rival bluebird bio on this candidate. When Celgene and bluebird initially teamed up in 2013, Celgene had an option to exclusive rights to any CAR-T therapies for cancer to come from the collaboration-but the companies amended their agreement in June 2015, and now those rights will be restricted to BCMA-related programs. AstraZeneca and Juno's CAR-T cell candidate paired with antibody MEDI4736 and Celgene’s other next-generation immunomodulatory candidates are also exempt from the deal, according to a note from Evercore ISI’s Mark Schoenebaum.
"This unique collaboration is designed to catalyze and create tremendous ongoing scientific and product development synergy by leveraging each company's strengths and assets,” said Hans Bishop, CEO of Juno, in a statement. "In addition to its established global presence and commercial reach, Celgene has leading small molecule and protein capabilities that complement Juno's advanced engineered T cell capabilities."
When it comes to intellectual property, Juno will retain the freedom to operate as it relates to the Celgene deal. Intellectual property issues associated with the development of T-cell therapies have been a hot-button issue in the past. As a result of a patent litigation settlement in April 2015, Juno will collect an initial payment of $12.25 million, future milestone payments, and mid-single digit royalties from Novartis from US net sales of product candidates related to disputed contract and patent claims, as well as a percentage of the royalties Novartis pays to The University of Pennsylvania for global net sales for said product candidates.
Juno is also in collaborations with the Fred Hutchinson Cancer Research Center, the Seattle Children’s Research Institute, and the Memorial Sloan Kettering Cancer Center in New York. The company also has collaboration agreements with Editas Medicine surrounding genome editing technologies and partnerships with Sanofi, Five Prime Therapeutics, and Sutro Biopharma, among others.