This ac­ceptance for review marks the first in the U.S. for a SLAMF7-directed immunostimulatory anti­body

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) and AbbVie (NYSE:ABBV) to­day an­nounced the U.S. Food and Drug Admin­istra­tion (FDA) has ac­cepted for priority review the Biologics License Appli­ca­tion (BLA) for Empliciti (elo­tuzu­mab), an inves­ti­ga­tional Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory anti­body, for the treat­ment of mul­ti­ple myeloma as com­bi­nation ther­apy in patients who have re­ceived one or more prior ther­a­pies. Empliciti was pre­vi­ously granted Break­through Therapy Desig­na­tion, which ac­cord­ing to the FDA, is in­tended to expedite the devel­op­ment and review of drugs for serious or life-threatening con­di­tions. The Euro­pean Medicines Agency (EMA) also recently val­i­dated for review the Marketing Authori­za­tion Appli­ca­tion for Empliciti, granting it ac­cel­er­ated assess­ment.

Bristol-Myers Squibb has proposed the name Empliciti which, if approved by health author­i­ties, will serve as the brand name for elotuzumab.

“Bristol-Myers Squibb is delighted by the ap­proach both agencies have taken to review the Empliciti ap­pli­ca­tions as it underscores the unmet med­i­cal need in the treat­ment of mul­ti­ple myeloma and the role Immuno-Oncology may play,” said Michael Giordano, M.D., senior vice pres­i­dent, Head of Oncology Devel­op­ment, Bristol-Myers Squibb. “The ac­ceptance of our appli­ca­tions by the FDA and EMA brings Bristol-Myers Squibb’s Immuno-Oncology science a step closer to helping patients with hema­to­logic malig­nan­cies.”

The filing ac­ceptance is primarily sup­ported by data from the ELOQUENT-2 trial, a Phase 3, ran­dom­ized, open-label study, which eval­u­ated Empliciti in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone versus lena­lido­mide and dexa­meth­a­sone alone. The re­­sults of this trial were pub­lished in The New England Journal of Medicine on June 2. Addi­tionally, the filing was sup­ported by data from study CA204-009, a Phase 2, ran­dom­ized, open-label study which eval­u­ated Empliciti with bor­tez­o­mib and dexa­meth­a­sone versus bor­tez­o­mib and dexa­meth­a­sone alone. These Phase 2 re­­sults were pre­sented in an oral session (Abstract #S103) at the 20th Congress of the Euro­pean He­ma­tol­ogy Asso­ci­a­tion (EHA).

“AbbVie is en­cour­aged by the FDA’s de­ci­sion to award priority review to this appli­ca­tion,” said Gary Gordon, M.D., vice pres­i­dent, on­col­ogy clin­i­cal devel­op­ment, AbbVie. “AbbVie is com­mit­ted to the devel­op­ment of novel treat­ment op­tions for people affected by cancer.”

About Empliciti

Bristol-Myers Squibb has proposed the name Empliciti which, if approved by health author­i­ties, will serve as the brand name for elotuzumab. Elotuzumab is an inves­ti­ga­tional immunostimulatory anti­body targeted against SLAMF7, a cell-surface glycoprotein that is highly and uni­formly ex­pressed on myeloma cells and Natural Killer (NK) cells, but is not detected on nor­mal solid tissues or on hema­to­poietic stem cells. The safety and ef­fi­cacy of elotuzumab have not been eval­u­ated by the FDA or any other health authority.

Bristol-Myers Squibb and AbbVie are co-developing elotuzumab, with Bristol-Myers Squibb solely re­spon­sible for com­mer­cial ac­­tiv­i­ties.

About Multiple Myeloma

Multiple myeloma is a hema­to­logic, or blood, cancer that de­vel­ops in the bone mar­row. It oc­curs when a plasma cell, a type of cell in the soft center of bone mar­row, be­comes can­cer­ous and multiplies un­con­trolla­bly. Despite ad­vances in mul­ti­ple myeloma treat­ment over the last decade, it remains a largely incurable dis­ease with only 45% of patients sur­viving five years after diag­nosis. A common char­ac­ter­istic for many patients is that they ex­peri­ence a cycle of remission and relapse, in which they stop treat­ment for a short time, but even­tu­ally return to a treat­ment shortly after. Following relapse, less than 20% of patients are alive after five years. It is esti­mated that annually more than 114,200 new cases of mul­ti­ple myeloma are diag­nosed globally and annually more than 79,000 people die from the dis­ease globally.

Immuno-Oncology at Bristol-Myers Squibb

Surgery, radi­a­tion, cytotoxic or targeted ther­a­pies have rep­re­sented the mainstay of cancer treat­ment over the last sev­er­al decades, but long-term sur­vival and a pos­i­tive quality of life have remained elusive for many patients with ad­vanced dis­ease.

To address this unmet med­i­cal need, Bristol-Myers Squibb is lead­ing re­search in an inno­va­tive field of cancer re­search and treat­ment known as Immuno-Oncology, which in­volves agents whose pri­mary mech­a­nism is to work directly with the body’s im­mune sys­tem to fight cancer. The com­pany is exploring a va­ri­e­ty of com­­pounds and immuno­thera­peutic ap­proaches for patients with dif­fer­en­t types of cancer, in­clud­ing re­search­ing the poten­tial of combining Immuno-Oncology agents that target dif­fer­en­t path­ways in the treat­ment of cancer.

Bristol-Myers Squibb is com­mit­ted to ad­vanc­ing the science of Immuno-Oncology, with the goal of changing sur­vival ex­pec­ta­tions and the way patients live with cancer.

Oncology at AbbVie

AbbVie's on­col­ogy re­search is focused on the discovery and devel­op­ment of targeted ther­a­pies that work against the processes cancers need to sur­vive. By investing in new tech­nolo­gies and ap­proaches, AbbVie is breaking ground in some of the most widespread and dif­fi­cult-to-treat cancers, in­­clud­ing glio­blas­toma mul­ti­forme, mul­ti­ple myeloma and chronic lym­pho­cytic leukemia. AbbVie's on­col­ogy pipe­line in­cludes mul­ti­ple new mol­e­cules in clin­i­cal trials being studied in more than 15 dif­fer­en­t cancers and tumor types. For more in­­for­ma­tion on AbbVie Oncology, please visit http://oncology.abbvie.com.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global bio­pharma­ceu­tical com­pany whose mis­sion is to discover, de­vel­op and de­liver inno­va­tive med­i­cines that help patients prevail over serious dis­eases. For more in­­for­ma­tion about Bristol-Myers Squibb, visit www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

About AbbVie

AbbVie is a global, re­search-based bio­pharma­ceu­tical com­pany formed in 2013 fol­low­ing separation from Abbott Laboratories. The com­pany’s mis­sion is to use its ex­per­tise, ded­i­cated people and unique ap­proach to inno­va­t to de­vel­op and mar­ket ad­vanced ther­a­pies that address some of the world’s most complex and serious dis­eases. Together with its wholly-owned sub­sid­i­ary, Pharmacyclics, AbbVie employs more than 28,000 people world­wide and mar­kets med­i­cines in more than 170 countries. For fur­ther in­­for­ma­tion on the com­pany and its people, port­folio and com­mitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Face­book or LinkedIn page.

Bristol-Myers Squibb Forward-Looking State­ment

This press re­lease con­tains "forward-looking state­ments" as that term is defined in the Private Se­cu­ri­ties Lit­i­ga­tion Reform Act of 1995 re­gard­ing the re­search, devel­op­ment and com­mer­cial­iza­tion of pharma­ceu­tical prod­ucts. Such for­ward-looking state­ments are based on cur­rent ex­pec­ta­tions and in­volve in­her­ent risks and un­cer­tain­ties, in­­clud­ing factors that could delay, divert or change any of them, and could cause actual out­comes and re­­sults to differ ma­teri­ally from cur­rent ex­pec­ta­tions. No for­ward-looking state­ment can be guar­an­teed. Among other risks, there can be no guar­an­tee that elotuzumab will re­ceive regu­la­tory ap­prov­al for one or more indi­ca­tions or, if approved, that it will be­come a com­mer­cially suc­cess­ful prod­uct. Forward-looking state­ments in this press re­lease should be eval­u­ated to­geth­er with the many un­cer­tain­ties that affect Bristol-Myers Squibb's business, par­tic­u­larly those identified in the cautionary factors dis­cus­sion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended De­cem­ber 31, 2014 in our Quar­ter­ly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb under­takes no obli­ga­tion to pub­licly up­date any for­ward-looking state­ment, whether as a re­­sult of new in­­for­ma­tion, future events or other­wise.

AbbVie Forward-Looking State­ments

Some state­ments in this news re­lease may be for­ward-looking state­ments for pur­poses of the Private Se­cu­ri­ties Lit­i­ga­tion Reform Act of 1995. The words "be­lieve," "expect," "antic­i­pate," "project" and similar ex­pres­sions, among others, generally identify for­ward-looking state­ments. AbbVie cautions that these for­ward-looking state­ments are subject to risks and un­cer­tain­ties that may cause actual re­­sults to differ ma­teri­ally from those in­di­cated in the for­ward-looking state­ments. Such risks and un­cer­tain­ties in­clude, but are not lim­ited to, the like­li­hood that the trans­­action is consummated, the ex­pec­ted ben­e­fits of the trans­­action, chal­lenges to in­tel­lec­tual property, com­pe­ti­tion from other prod­ucts, dif­fi­culties in­her­ent in the re­search and devel­op­ment process, adverse lit­i­ga­tion or gov­ern­ment action, and changes to laws and reg­u­la­tions ap­pli­ca­ble to our industry. Addi­tional in­­for­ma­tion about the economic, competitive, gov­ern­mental, tech­no­log­i­cal and other factors that may affect AbbVie's op­er­a­tions is set forth in Item 1A, "Risk Factors," in AbbVie's 2014 Annual Report on Form 10-K, which has been filed with the Se­cu­ri­ties and Ex­change Com­mis­sion. AbbVie under­takes no obli­ga­tion to re­lease pub­licly any revisions to for­ward-looking state­ments as a re­­sult of sub­se­quent events or devel­op­ments, except as re­quired by law.

Source: Bristol-Myers Squibb.