Paris, 20 May 2014 : Hybrigenics (ALHYG), a bio-pharmaceutical group listed on the Alternext market of Euronext in Paris, with a focus on research and development of new treatments

against proliferative diseases, today announces the orphan drug designation by the American Food and Drug Administration of inecalcitol for the treatment of chronic lymphocytic leukemia

(CLL) in the United States. Orphan designation qualifies the sponsor of the drug for various development incentives of the Orphan Drug Act, including tax credits for qualified clinical

testing. A marketing application for a prescription drug product that has received orphan designation is not subject to a prescription drug user fee unless the application includes an

indication for other than the rare disease or condition for which the drug was designated.

 

“Already designated in Europe earlier this year, the orphan drug status of inecalcitol for the

treatement of CLL is now recognized in the US. This achievement broadens the geographical

scope of the clinical development and partnering opportunities that inecalcitol may generate,”

said Remi Delansorne, Hybrigenics’ CEO.

 

About Chronic Lymphocytic Leukemia (CLL)

CLL is the most frequent form of leukemia (cancerous proliferative disease of circulating blood cells) and accounts for about 35% of all leukemic patients. Annual estimates of newly diagnosed CLL cases amount to close to 15,000 in the United States (American Leukemia Lymphoma Society, Facts 2013), 14,000 in Europe and 130,000 world-wide (Globocan 2008). CLL is designated as an orphan disease in the United States, Europe and Japan.

 

People with CLL produce too many lymphocytes (mononuclear white blood cells) of one single abnormal “family” (monoclonal) which are not fully developed (immature). Over time, these circulating CLL cells (monoclonal immature lymphocytes) in excess build up in the lymphatic system and cause large, swollen lymph nodes. They may also fill the bone marrow, reducing the number of normal white cells, red cells and platelets that can be made, thereby lowering their blood counts. There is no definitive cure for CLL.

 

About Hybrigenics

Hybrigenics (www.hybrigenics.com) is a bio-pharmaceutical group listed (ALHYG) on the Alternext market of Euronext in Paris, focusing its internal R&D programs on innovative targets and therapies for the treatment of proliferative diseases and providing cutting-edge proteomic and genomic scientific services. Hybrigenics’ current development program is based on inecalcitol, a vitamin D receptor agonist active by oral administration. Oral inecalcitol has shown excellent tolerance and strong presumption of efficacy for the first-line treatment of metastastic castrate-resistant prostate cancer in combination with Taxotere®, which is the current gold-standard chemotherapeutic treatment for this indication. Oral inecalcitol is currently being tested in chronic lymphocytic leukemia patients, an indication for which inecalcitol has received orphan drug status in Europe and the United States.

Hybrigenics has a research collaboration with Servier on deubiquitinating enzymes and their inhibitors in oncology, neurology, psychiatry, rheumatology, ophthalmology, diabetes and cardiovascular diseases. Hybrigenics continues to build on its pioneer research position in the field of ubiquitin-specific proteases by exploring their role in other areas of particular relevance, such as inflammation and virology. 
 

Hybrigenics Services (www.hybrigenics-services.com) is the market leader in Yeast Two-Hybrid (Y2H) and related services to identify, validate and inhibit protein interactions for researchers in all areas of life sciences, using its ISO 9001-certified high-throughput Y2H screening platform.

Helixio (www.helixio.eu), Hybrigenics’ genomic branch, provides state-of-the-art services specialized in DNA chips, DNA or RNA target enrichment and next generation sequencing.

Hybrigenics Corp., based in Cambridge, Mass., is the American subsidiary of Hybrigenics.