Results from two clin­i­cal trials (ELOQUENT-2 & CA204-009), each combining Empliciti with a dif­fer­en­t standard of care regi­men in­cluded in the sub­mission

Empliciti is poised to be the first-in-class SLAMF7-directed immunostimulatory anti­body

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) and AbbVie (NYSE:ABBV) to­day an­nounced the Euro­pean Medicines Agency (EMA) val­i­dated for review the Marketing Authori­za­tion Appli­ca­tion (MAA) for Empliciti, an inves­ti­ga­tional Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory anti­body, for the treat­ment of mul­ti­ple myeloma as com­bi­na­tion ther­apy in adult patients who have re­ceived one or more prior ther­a­pies. The appli­ca­tion was granted ac­cel­er­ated assess­ment by the EMA’s Com­mit­tee for Medicinal Products for Human Use (CHMP).

“We be­lieve the CHMP’s ac­ceptance for an ac­cel­er­ated assess­ment reflects the need for a new treat­ment op­tion for mul­ti­ple myeloma, a largely incurable dis­ease. We are proud to be one step closer to bringing Empliciti to patients with re­lapsed or re­frac­tory mul­ti­ple myeloma in Europe.”

Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with Bristol-Myers Squibb solely responsible for com­mer­cial ac­­tiv­i­ties. Bristol-Myers Squibb has proposed the name Empliciti which, if approved by health author­i­ties, will serve as the trade name for elotuzumab.

“The MAA val­i­da­tion marks a sig­nif­i­cant mile­stone in Bristol-Myers Squibb’s mis­sion to ad­vance the science and im­pact the treat­ment of hema­to­logic malig­nan­cies through our Immuno-Oncology leadership,” said Michael Giordano, MD, senior vice pres­i­dent, head of Oncology De­vel­op­ment, Bristol-Myers Squibb. “We be­lieve the CHMP’s ac­ceptance for an ac­cel­er­ated assess­ment reflects the need for a new treat­ment op­tion for mul­ti­ple myeloma, a largely incurable dis­ease. We are proud to be one step closer to bringing Empliciti to patients with re­lapsed or re­frac­tory mul­ti­ple myeloma in Europe.”

The MAA is primarily sup­ported by data from two ran­dom­ized clin­i­cal trials, each combining Empliciti with a dif­fer­en­t standard of care regi­men for mul­ti­ple myeloma. ELOQUENT-2, a Phase 3, ran­dom­ized, open-label study, 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, a Phase 2, ran­dom­ized, open-label study (Study CA004-009) 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).

Empliciti pre­vi­ously obtained orphan drug desig­na­tion in the Euro­pean Union (EU). An orphan medicinal prod­uct must be in­tended for the treat­ment, prevention or diag­nosis of a dis­ease that is life threatening and chronically debilitating; the prev­a­lence in the EU must not be more than five in 10,000. The med­i­cine must be of sig­nif­i­cant ben­e­fit to those affected by the con­di­tion. If main­tained, orphan drug desig­na­tion allows spon­sors to access a num­ber of incentives in­­clud­ing protocol assistance and re­ceive mar­ket exclusivity for a ten-year period fol­low­ing ap­prov­al.

About Empliciti

Empliciti 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 Empliciti have not been eval­u­ated by the FDA or any other health authority.

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, only 45% of patients have a ten-year sur­vival rate. 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.

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 http://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 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, 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/A, 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.