• bluebird and Celgene will share 50% of U.S. costs and profits
• bluebird to re­ceive mile­stones and royalties on ex-U.S. sales

Cambridge, MA and Summit, NJ (Press Release) – bluebird bio, Inc. (Nasdaq: BLUE) and Celgene Corpo­ra­tion (Nasdaq: CELG) to­day an­nounced that the com­pa­nies have entered into an agree­ment to co-develop and co-promote bb2121, an inves­ti­ga­tional anti-B-cell maturation an­ti­gen (BCMA) chi­meric an­ti­gen re­cep­tor (CAR) T cell ther­apy for the poten­tial treat­ment of patients with re­lapsed/refractory mul­ti­ple myeloma in the United States.

“Entering into this co-development and co-promotion part­ner­ship with Celgene is a sig­nif­i­cant step for­ward in build­ing a fully integrated on­col­ogy fran­chise for bluebird and to­geth­er, we are com­mit­ted to rapidly ad­vanc­ing devel­op­ment of bb2121 for patients,” said Joanne Smith-Farrell, Ph.D., on­col­ogy fran­chise leader and senior vice pres­i­dent, corporate devel­op­ment and strat­e­gy, bluebird bio. “The col­lab­o­ra­tion builds upon our extensive re­search and devel­op­ment capabilities in on­col­ogy and is a testament to the strong part­ner­ship that exists be­tween our two com­pa­nies.”

The com­pa­nies originally entered into a broad, global stra­te­gic re­search col­lab­o­ra­tion in 2013 to discover, de­vel­op and com­mer­cial­ize novel ther­a­pies in on­col­ogy, which in­cluded bb2121.

“We are extremely pleased to ad­vance our col­lab­o­ra­tion with bluebird on bb2121 and we be­lieve this ther­apy has the poten­tial to sig­nif­i­cantly impact the treat­ment ap­proach and out­comes for patients with mul­ti­ple myeloma,” said Nadim Ahmed, Pres­i­dent, He­ma­tol­ogy and Oncology for Celgene.

About the bluebird bio-Celgene Collaboration

bluebird bio and Celgene are col­lab­o­rating to de­vel­op CAR T cell ther­a­pies targeting BCMA. The col­lab­o­ra­tion’s lead on­col­ogy pro­gram, bb2121, is cur­rently being studied for the treat­ment of re­lapsed and re­frac­tory mul­ti­ple myeloma. For bb2121, bluebird and Celgene have joint re­spon­si­bil­ity­ for devel­op­ment, manu­fac­tur­ing and com­mer­cial­iza­tion in the United States. Celgene will assume sole re­spon­si­bil­ity­ for drug prod­uct manu­fac­tur­ing and com­mer­cial­iza­tion outside the United States.

bluebird bio and Celgene are also work­ing to­geth­er on a sec­ond clin­i­cal-stage anti-BCMA CAR T pro­gram, bb21217.

About bluebird bio, Inc.

With its lentiviral-based gene ther­a­pies, T cell immuno­therapy ex­per­tise and gene edit­ing capabilities, bluebird bio has built an integrated prod­uct plat­form with broad poten­tial appli­ca­tion to severe ge­netic dis­eases and cancer. bluebird bio's gene ther­apy clin­i­cal pro­grams in­clude its Lenti-D™ prod­uct can­di­date for the treat­ment of cerebral adrenoleukodystrophy, and its LentiGlobin® prod­uct can­di­date for the treat­ment of transfusion-dependent β-thalassemia, also known as β-thalassemia major, and severe sickle cell dis­ease. bluebird bio's on­col­ogy pipe­line is built upon the com­pany's leadership in lentiviral gene de­livery and T cell engi­neer­ing, with a focus on devel­op­ing novel T cell-based immuno­therapies, in­­clud­ing chi­meric an­ti­gen re­cep­tor (CAR T) and T cell re­cep­tor (TCR) ther­a­pies. bluebird bio's lead on­col­ogy pro­grams, bb2121 and bb21217, are anti-BCMA CAR T pro­grams part­nered with Celgene. bluebird bio also has discovery re­search pro­grams uti­liz­ing megaTAL/homing endonuclease gene edit­ing tech­nolo­gies with the poten­tial for use across the com­pany's pipe­line.

bluebird bio has op­er­a­tions in Cambridge, Massachusetts, Seattle, Washington, Durham, North Carolina and Zug, Switzerland.

LentiGlobin and Lenti-D are trademarks of bluebird bio, Inc..

About Celgene

Celgene Corpo­ra­tion, headquartered in Summit, New Jersey, is an integrated global bio­pharma­ceu­tical com­pany engaged primarily in the discovery, devel­op­ment and com­mer­cial­iza­tion of inno­va­tive ther­a­pies for the treat­ment of cancer and in­flam­ma­tory dis­eases through next-gener­a­tion solu­tions in pro­tein homeo­stasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more in­­for­ma­tion, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Face­book and YouTube.

Forward-Looking State­ments

This press release con­tains “forward-looking state­ments” within the meaning of the Private Se­cu­ri­ties Lit­i­ga­tion Reform Act of 1995, in­­clud­ing state­ments re­gard­ing the poten­tial benefits of, and plans relating to the col­lab­o­ra­tion be­tween bluebird bio and Celgene; the poten­tial of bb2121 as a thera­peutic drug; and the benefit of each com­pany’s stra­te­gic plans and focus. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “would,” “could,” “potential,” “possible,” “hope” and similar ex­pres­sions are in­tended to identify for­ward-looking state­ments, although not all for­ward-looking state­ments con­tain these identifying words. Any for­ward-looking state­ments are based on man­agement’s current ex­pec­ta­tions of future events and are subject to a number of risks and un­cer­tain­ties that could cause actual results to differ ma­teri­ally and adversely from those set forth in or im­plied by such for­ward-looking state­ments. These risks and un­cer­tain­ties in­clude, but are not limited to, risks that the pre­lim­i­nary results from our clin­i­cal trials of bb2121 will not con­tinue or be repeated in on­go­ing or planned clin­i­cal trials of bb2121, the risk of cessation or delay of any of the on­go­ing or planned clin­i­cal stud­ies and/or our devel­op­ment of the bb2121 or bb21217 prod­uct can­di­dates, risks that the current or planned clin­i­cal trials of the bb2121 prod­uct can­di­date will be insufficient to sup­port regu­la­tory sub­missions or mar­ket­ing ap­prov­al in the United States, Euro­pean Union or other countries, the risk that our col­lab­o­ra­tion with Celgene will not con­tinue or will not be suc­cess­ful, and the risk that the bb2121 prod­uct can­di­date will not be suc­cess­fully com­mer­cial­ized. These and other risks are described in greater detail under the caption "Risk Factors" in­cluded in each com­pany’s pub­lic filings with the Se­cu­ri­ties and Ex­change Com­mis­sion. Any for­ward-looking state­ments con­tained in this press release speak only as of the date hereof, and neither com­pany has any obli­ga­tion to up­date any for­ward-looking state­ments, whether as a result of new in­­for­ma­tion, future events or other­wise, except as may be re­quired by law.

Hyperlinks are provided as a con­ve­nience and for in­­for­ma­tional pur­poses only. Neither Celgene nor bluebird bio bears re­spon­si­bil­ity­ for the se­cu­ri­ty or content of ex­ternal websites or websites outside of their re­spec­tive­ con­trol.

Source: bluebird bio and Celgene.