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AbbVie (ABBV)'s Brain Tumor Drug Gets U.S., EU Orphan Designation


8/4/2014 7:33:50 AM

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AbbVie Receives EMA and FDA Orphan Drug Designation for Investigational Compound ABT-414 in the Treatment of Glioblastoma Multiforme

Results From Phase I Program In Glioblastoma Multiforme Presented At ASCO Earlier This Year

NORTH CHICAGO, Ill., Aug. 4, 2014 /PRNewswire/ -- AbbVie (ABBV) today announced the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have granted orphan drug designation to AbbVie's investigational compound ABT-414, an anti-epidermal growth factor receptor antibody drug conjugate, which is being evaluated for safety and efficacy in patients with glioblastoma multiforme.1 Glioblastoma multiforme is the most common and most aggressive type of malignant primary brain tumor. Each year in the U.S. and Europe, two to three out of every 100,000 people are diagnosed with glioblastoma multiforme, which has a five year survival rate of approximately four percent.2

"The orphan drug designation is an important regulatory advancement as we further our development in recurrent glioblastoma multiforme, a disease that is uniformly fatal with limited treatment options," said Gary Gordon, M.D., vice president, oncology clinical development, AbbVie. "We are pleased to continue developing ABT-414 in Phase II trials in patients with glioblastoma multiforme based on the results of our Phase I program."

Results from the Phase I clinical program evaluating ABT-414 in patients with recurrent or unresectable glioblastoma multiforme were presented at the 50th American Society of Clinical Oncology (ASCO) meeting in Chicago earlier this year.3

About Orphan Drug Designation
Orphan drug designation is a status assigned to a medicine intended for use in rare diseases.4 In the U.S., the Orphan Drug Designation program provides orphan status to medicines intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. or that are not expected to recover the costs of developing and marketing a treatment.5 In Europe, a medicine must meet similar criteria to be granted orphan status. The criteria include that the medicine must be intended for the treatment, prevention or diagnosis of a disease that is life threatening and has a prevalence in the EU of up to five in 10,000, and the intended medicine must aim to provide significant benefit to those affected by the condition.4 Orphan status provides sponsors with development and commercial incentives for designated compounds and medicines.

The approval of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval for an investigational use. Sponsors must establish safety and efficacy of a compound in the treatment of a disease through adequate and well-controlled studies.

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. AbbVie employs approximately 25,000 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.

About ABT-414
ABT-414 is an investigational anti-EGFR (epidermal growth factor receptor) monoclonal antibody drug conjugate (ADC) being evaluated for the treatment of patients with various cancer and tumor types. As an ADC, ABT-414 is designed to be stable in the bloodstream and only release the potent cytotoxic agent once inside targeted cancer cells. Developed by AbbVie researchers with components in-licensed from Life Science Pharmaceuticals, Inc. and Seattle Genetics, ABT-414 is currently being investigated for the treatment of glioblastoma multiforme, the most common and most aggressive malignant primary brain tumor. ABT-414 is also in clinical trials for the treatment of patients with squamous cell tumors. ABT-414 is an investigational compound and its efficacy and safety have not been established by the FDA.

About Glioblastoma Multiforme
Glioblastoma multiforme is the most common and most aggressive type of malignant primary brain tumor. Prior to diagnosis, most patients experience a serious symptom of glioblastoma multiforme, such as a seizure.6 Typically patients succumb to the disease approximately 15 months after diagnosis.2,6 Treatment for glioblastoma multiforme remains challenging and no long-term treatments are currently available. Standard treatment is surgical resection, radiotherapy and concomitant adjunctive chemotherapy.2

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, we are breaking ground in some of the most widespread and difficult-to-treat cancers, including multiple myeloma and chronic lymphocytic leukemia. Our 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 and our oncology portfolio, please visit http://oncology.abbvie.com.

1 http://clinicaltrials.gov/ct2/show/NCT01800695?term=ABT-414&rank=1
2 National Brain Tumor Society web site. "Tumor Types." http://www.braintumor.org/brain-tumor-information/understanding-brain-tumors/tumor-types/#glioblastoma-multiforme. Accessed April 22, 2014. 3 http://abstracts.asco.org/144/AbstView_144_133972.html
4 European Medicines Agency web site. "Orphan Designation." http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000029.jsp&mid=WC0b01ac05800240ce. Accessed June 5, 2014.
5 U.S. Food and Drug Administration web site. "Regulatory Information: Orphan Drug Act." http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/significantamendmentstothefdcact/orphandrugact/default.htm. Accessed June 11, 2014.
6 American Brain Tumor Association. (2012) "Glioblastoma and Malignant Astrocytoma." http://www.abta.org/secure/glioblastoma-brochure.pdf Accessed March 6, 2014.

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