• Bristol Myers Squibb to buy out its ex-U.S. mile­stone and royalty obli­ga­tions to bluebird bio for $200 million
• Bristol Myers Squibb assumes re­spon­si­bil­ity­ for vector manu­fac­tur­ing in ex-US territories
• bluebird to hold conference call and webcast to­day, May 11, 2020 at 8:00AM ET

Cambridge, MA (Press Release) – bluebird bio, Inc. (NASDAQ: BLUE) to­day an­nounced that it has amended its existing co-promotion / co-development agree­ment with Bristol Myers Squibb (BMS) to enable the com­pa­nies to focus their efforts on efficient com­mer­cial­iza­tion of idecabtagene vicleucel (ide-cel; bb2121) in the U.S., the com­pa­nies’ lead inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA)-directed chi­meric an­ti­gen re­cep­tor (CAR) T cell immuno­therapy, cur­rent in review with the FDA.

“Under our amended col­lab­o­ration, we and BMS are redoubling our com­mitment to ide-cel and op­ti­miz­ing the rela­tion­ship as we work to­geth­er to bring this crit­i­cal treat­ment to patients in the com­mer­cial setting,” said Joanne Smith-Farrell, PhD, Chief Business Officer and Oncology Franchise Leader, bluebird bio. “With bluebird exiting the passive par­tic­i­pa­tion as supplier outside the U.S., we and BMS are taking steps to ensure an efficient and robust supply chain for this pro­gram. This, to­geth­er with the monetization of our ex-U.S. royalties and mile­stones will allow bluebird to con­tinue to par­tic­i­pate in co-developing and co-commercializing ide-cel within the U.S. and to refocus resources on our in­ternal pro­grams and pipe­line.”

“Our col­lab­o­ration with bluebird has resulted in the first CAR T cell ther­apy sub­mitted for regu­la­tory ap­prov­al to target the B-cell maturation an­ti­gen and for mul­ti­ple myeloma,” said Krishnan Viswanadhan, Pharm.D., Senior Vice Pres­i­dent, Global Cell Therapy Franchise Lead for Bristol Myers Squibb. “This amended part­ner­ship allows Bristol Myers Squibb to leverage our global manu­fac­tur­ing capabilities and consolidate all responsibilities outside the United States.”

The com­pa­nies will con­tinue to share equally profits and losses in the U.S. Under the terms of the amended agree­ment, BMS will buy out its obli­ga­tions to pay bluebird bio future ex-U.S. mile­stone and royalty pay­ments for ide-cel and bb21217, the com­pa­nies’ sec­ond BCMA-directed CAR T immuno­therapy, for a one-time up­front pay­ment of $200 million. bluebird bio is cur­rent in the process of build­ing out and qualifying its wholly-owned manu­fac­tur­ing facility in Durham, North Carolina for the pro­duc­tion of lentiviral vector (LVV) to sup­port the U.S. com­mer­cial mar­ket for ide-cel and for bluebird bio’s pipe­line. Over time, BMS will assume re­spon­si­bil­ity­ for manu­fac­tur­ing of LVV outside the U.S.

About bluebird bio, Inc.

bluebird bio is pioneering gene ther­apy with pur­pose. From our Cambridge, Mass., headquarters, we’re devel­op­ing gene ther­a­pies for severe ge­netic dis­eases and cancer, with the goal that people facing poten­tially fatal con­di­tions with limited treat­ment op­tions can live their lives fully. Beyond our labs, we’re work­ing to pos­i­tively disrupt the health­care sys­tem to create access, transparency and education so that gene ther­apy can be­come avail­able to all those who can benefit.

bluebird bio is a human com­pany powered by human stories. We’re putting our care and ex­per­tise to work across a spectrum of disorders in­clud­ing cerebral adrenoleukodystrophy, sickle cell dis­ease, β-thalassemia and mul­ti­ple myeloma, using three gene ther­apy tech­nolo­gies: gene addi­tion, cell ther­apy and (megaTAL-enabled) gene edit­ing.

bluebird bio has addi­tional nests in Seattle, Wash.; Durham, N.C.; and Zug, Switzerland. For more in­for­ma­tion, visit bluebirdbio.com.

Follow bluebird bio on social media: @bluebirdbio, LinkedIn, Insta­gram and YouTube.

bluebird bio is a trademark of bluebird bio, Inc.

Forward-Looking State­ment

This press release con­tains “forward-looking state­ments” within the meaning of the Private Se­cu­ri­ties Lit­i­ga­tion Reform Act of 1995 re­gard­ing, among other things, the re­search, de­vel­op­ment and com­mer­cial­iza­tion of pharma­ceu­tical prod­ucts. All state­ments that are not state­ments of historical facts are, or may be deemed to be, for­ward-looking state­ments. Such for­ward-looking state­ments are based on historical per­for­mance and current ex­pec­ta­tions and pro­jec­tions about our future fi­nan­cial results, goals, plans and objectives and in­volve­ in­her­ent risks, assump­tions and un­cer­tainties, in­clud­ing in­ternal or ex­ternal factors that could delay, divert or change any of them in the next several years, that are dif­fi­cult to predict, may be beyond our con­trol and could cause our future fi­nan­cial results, goals, plans and objectives to differ ma­teri­ally from those ex­pressed in, or im­plied by, the state­ments. These risks, assump­tions, un­cer­tainties and other factors in­clude, among others, the possibility of un­fa­vor­able results from addi­tional clin­i­cal trials of ide-cel, that ide-cel may not re­ceive regu­la­tory ap­prov­al and, if approved, whether such prod­uct can­di­date for such in­di­ca­tion described in this release will be com­mer­cially suc­cess­ful, and that the col­lab­o­ration with Bristol Myers Squibb may not con­tinue or be suc­cess­ful. No for­ward-looking state­ment can be guar­an­teed. Forward-looking state­ments in this press release should be eval­u­ated to­geth­er with the many risks and un­cer­tainties that affect bluebird bio’s business, par­tic­u­larly those identified in the risk factors dis­cus­sion in bluebird bio’s Annual Report on Form 10-K for the year ended De­cem­ber 31, 2019, as up­dated by our sub­se­quent Quar­ter­ly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Se­cu­ri­ties and Ex­change Com­mis­sion. The for­ward-looking state­ments in­cluded in this doc­u­ment are made only as of the date of this doc­u­ment and except as other­wise re­quired by appli­cable law, bluebird bio under­takes no obli­ga­tion to pub­licly up­date or revise any for­ward-looking state­ment, whether as a result of new in­for­ma­tion, future events, changed cir­cum­stances or other­wise.

Source: bluebird bio.