Healthcare Industry News:  Pharmacyclics 

Biopharmaceuticals Oncology Regulatory

 News Release - July 27, 2015

European Medicines Agency Validates and Grants Accelerated Assessment of Marketing Authorization Application for Empliciti (elotuzumab) For the Treatment of Multiple Myeloma in Patients Who Have Received One or More Prior Therapies

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, N.J.--(Healthcare Sales & Marketing Network)--Bristol-Myers Squibb Company (BMY) and AbbVie (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).

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 or follow us on Twitter at

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 innovation 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 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

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