Orphan designation qualifies the sponsor of the drug for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemption and seven-year marketing exclusivity upon FDA approval.
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| [22-January-2018] |
| BOSTON, Jan. 22, 2018 /PRNewswire/ -- BERG, a Boston-based biopharmaceutical company that merges biology with technology to map the nature of diseases, today announced the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to the Company’s leading product candidate BPM31510, for the treatment of pancreatic cancer. “The FDA’s orphan-drug designation marks an important milestone for BERG,” said Niven R. Narain, BERG President and Chief Executive Officer. “We look forward to working closely with the FDA and other regulatory authorities to advance the clinical development of this therapeutic and map out the most effective match for treatment of pancreatic cancer,” continued Narain. The FDA’s orphan-drug designation program provides orphan status to drugs defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the United States. Orphan designation qualifies the sponsor of the drug for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemption and seven-year marketing exclusivity upon FDA approval. After completion of a Phase 1 clinical trial establishing safety, BERG initiated a Precision Medicine driven Phase 2 clinical trial design for BPM31510-IV alone and in combination with gemcitabine to evaluate the efficacy in patients with advanced pancreatic cancer in the US and Europe. As part of this Phase 2 trial, the Company is driving towards identification and validation of molecular profiles representative of BPM31510 mediated outcomes, which could lead to a diagnostic panel for patient stratification. About Pancreatic Cancer About BPM31510 Cancer cells alter metabolism to generate energy from non-mitochondrial pathways to support uncontrolled growth. This allows the cancer cells to escape molecular mechanisms controlling cell death. BPM31510 is a first in class molecule that specifically targets the dysregulated metabolism observed in cancer. BPM31510, by targeting metabolism in cancer cells, re-engages the mitochondria to generate energy, shifting metabolism to that observed in the normal cell. The effect of BPM31510 on metabolism results in the reactivation of pathways that detect cell damage, triggering apoptosis or programmed cell death. About BERG BERG is a clinical-stage company disrupting and re-defining the approach to drug discovery, research and development through its Interrogative Biology® platform. The platform identifies therapies and biomarkers by applying the algorithm and probability-based artificial intelligence to analyze large numbers of patients’ genotypic, phenotypic and other characteristics. BERG’s platform operates at the intersection of biology, technology and artificial intelligence analytics, integrating many data characteristics regarding patients’ lifestyles, demographics, and biology. The platform aids in understanding patients’ disease profiles and consequently, identifying and revealing molecular signatures to guide and accelerate product candidate selection and development. By identifying biomarkers and patient characteristics that are unique to the disease state, BERG has the potential to determine novel therapeutic product candidates and develop companion diagnostics to enhance specificity in its drug development process. BERG has leveraged its Interrogative Biology® platform to develop a robust pipeline of therapeutic product candidates and diagnostics in cancer, diabetes and neurology. BERG’s Interrogative Biology® platform uses bAIcis® artificial intelligence for data-driven analysis of high throughput molecular and clinical information. It is a proven methodology in extracting actionable insights from disparate and unmanageably large (by conventional standards) data sets. As an innovator in precision medicine, BERG has been employing AI in its work towards the discovery of novel predictive and prognostic biomarkers in oncology and neurology. For additional information, please visit http://www.berghealth.com/. 1. American Cancer Society, Key Statistics for Pancreatic Cancer. https://www.cancer.org/cancer/pancreatic-cancer/about/key-statistics.html 2. Global Data: Pancreatic Cancer - Epidemiology Forecast to 2022 (July 2013). Media Contact: View original content:http://www.prnewswire.com/news-releases/berg-announces-fda-orphan-drug-designation-of-bpm31510-for-the-treatment-of-pancreatic-cancer-300585793.html SOURCE BERG |
