AbbVie's Venetoclax Wins 3rd Breakthrough Tag from the FDA

NORTH CHICAGO, Ill., Jan. 28, 2016 /PRNewswire/ -- AbbVie (NYSE:ABBV), a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the investigational agent venetoclax in combination with hypomethylating agents (HMAs) for the treatment of patients with untreated (treatment-naïve) acute myeloid leukemia (AML) who are ineligible to receive standard induction therapy (high-dose chemotherapy). Venetoclax is an inhibitor of the B-cell lymphoma-2 (BCL-2) protein being developed by AbbVie in partnership with Genentech and Roche.

"Acute myeloid leukemia is an aggressive and life- threatening cancer. Unfortunately, for many AML patients, intensive therapy is not an option, causing a high need for new, effective, and alternative treatments," said Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. "This third Breakthrough Therapy Designation for venetoclax highlights our efforts to pursue the significant and broad potential of this therapy."

AML is characterized by the body producing too many of a specific type of white blood cell (myeloblast) which can crowd out healthy blood cells.¹ In the U.S. specifically, it was estimated that more than 20,000 people would be diagnosed with AML in 2015.¹ AML is the most common type of acute leukemia among adults.³ The average age of a patient with AML is about 67 years.¹

The Breakthrough Therapy Designation is supported by data from untreated patients, 65 years or older with AML and reported in one investigational study. AML is typically treated with chemotherapy and the intensity of chemotherapy depends on a person's age and health.² However, no single standard of care exists for older patients with AML, as there are no FDA- approved therapies for patients not eligible to receive standard induction therapy/intensive chemotherapy. Because induction-therapy-related mortality for patients 55 years of age or older has been estimated at 15 to 20 percent, these patients are best managed with non-intensive approaches.³ HMAs are currently used as monotherapy for treatment of AML in the United States, as low-intensity therapy which may be appropriate for elderly patients, or those with comorbidities who cannot tolerate standard induction therapy. HMAs, alone or in combination with the investigational agent venetoclax is not approved for the treatment of AML.

In April 2015, the FDA granted Breakthrough Therapy Designation to single agent venetoclax for the treatment of CLL in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation. In January 2016, AbbVie announced that the FDA granted priority review for the single agent NDA application, and granted a second Breakthrough Therapy Designation for venetoclax supported by the investigational study in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL). According to the FDA, Breakthrough Therapy Designation is intended to expedite the development and review of therapies for serious or life-threatening conditions.

Additional information regarding the venetoclax clinical trials is available on www.clinicaltrials.gov.

About AbbVie Oncology
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 Acute Myeloid Leukemia (AML)
Acute myeloid leukemia (AML) is a rapidly progressing cancer of the blood and bone marrow and is the most common type of acute leukemia among adults.³ In AML, the body produces too many of a specific type of white blood cell (myeloblast), which can crowd out healthy blood cells.³ In the U.S. specifically, it is estimated that more than 20,000 people will be diagnosed with AML this year.¹

About Venetoclax
Venetoclax is an investigational oral B-cell lymphoma-2 (BCL-2) inhibitor being evaluated for the treatment of patients with various cancer types. The BCL-2 protein prevents apoptosis (programmed cell death) of some cells, including lymphocytes, and can be over expressed in some cancer types. Venetoclax is designed to selectively inhibit the function of the BCL-2 protein. Venetoclax is being developed in collaboration with Genentech and Roche. Together, the companies are committed to BCL-2 research with venetoclax, which is currently being evaluated in Phase 3 clinical trials for the treatment of relapsed/refractory CLL, along with studies in several other cancers. Venetoclax is an investigational compound and its safety and efficacy have not been evaluated by the FDA or any other health authority.

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 www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

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, 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.

¹ MedlinePlus, U.S. National Library of Medicine (2015). "Acute Myeloid Leukemia." https://www.nlm.nih.gov/medlineplus/acutemyeloidleukemia.html. Accessed January 21, 2016.
² American Cancer Society (2014). "Leukemia Acute Myeloid (Myelogenous)" http://www.cancer.org/acs/groups/cid/documents/webcontent/003110-pdf.pdf. Accessed January 21, 2016.
³ Erba, H.P. Finding the optimal combination therapy for the treatment of newly diagnosed AML in older patients unfit for intensive therapy. Leuk Res. 2015;39(2):183-91.

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