- +9% growth of Hybrigenics’ operating revenues
- 60% biological response rate of chronic lymphocytic leukemia patients to oral inecalcitol
- US Patent protection for high dose inecalcitol until 2031
Paris, 22 October 2013 – Hybrigenics (ALHYG), a bio-pharmaceutical company listed on Alternext (NYSE-Euronext) in Paris, with a focus on research and development of new treatments against proliferative diseases and specialised in protein interactions, today presents its consolidated accounts for the first half of 2013 and gives an update on the development status of inecalcitol.
2013 first-half results
| EUR (million) | H1 2013 | H1 2012 | Change (%) |
| Operating revenues | 2.3 | 2.1 | +9% |
| Operating costs | 4.2 | 4.6 | -9% |
| Operating loss | -1.9 | 2.5 | -24% |
| Exceptional revenue | --- | 1.0 | --- |
| Net loss | -1.5 | 1.5 | 0% |
| Net cash position (end of period) | 2.1 | 4.1 | -49% |
Hybrigenics’ consolidated operating revenues grew by 9% and operating costs decreased by 9%. As a result, operating loss decreased by 24% from €2.5 to €1.9 million. Despite a nonrecurring favorable accounting impact of €0.96 million on the net loss of H1 2012 due to the conversion of a loan into a subsidy by the French Ministry of Industry (cf. Hybrigenics’ pressrelease of August 28th, 2012), the net loss of H1 2013 has been contained to the same level of €1.5 million.
Hybrigenics’ cash position on June 30th, 2013 amounted to €2.1 million compared to €3.5 million on December 31st, 2012, and €4.1 million on June 30th, 2012. During H1 2013, a total of €1.1 million has been raised from drawings on the equity line agreement with the American fund Yorkville Global Advisors; €6.5 million were still available on this line as of June 30th, 2013.
Update on the clinical study of inecalcitol in chronic lymphocytic leukemia (CLL) and orphan drug application to the European Medicines Agency (EMA)
Out of 15 patients treated long enough by oral inecalcitol at 2 mg/day to get a reliable biological response on their blood lymphocytes counts (BLC), one patient achieved a -90% decrease in BLC after 10 months of treatment. The BLC of eight other patients stopped growing when treatment was initiated, and have remained stable for at least 6 months. Six patients did not show any biological response at any time point, and among them two patients dropped out of the study to receive chemotherapy after 4 or 5 months of treatment. One responder whose disease resumed progression at 9 months after at least 6 months of stabilization will also undertake chemotherapy.
An application for Orphan Medicinal Product Designation of inecalcitol in CLL has been filed to the EMA. This application has been accepted as valid by the EMA, which should give its official opinion in January 2014, after the usual 90-day procedure.
Patent protection for high dose inecalcitol until 2031 in the United States (US)
The patent on the therapeutic use of inecalcitol at high oral doses has been definitively granted in the US. Under the Patent Term Adjustment Act, it will benefit from 308 additional days of patent protection on top of the usual 20 years from the date of patent application. In practice, treatments with inecalcitol doses higher than one milligram per day will remain Hybrigenics’ exclusive intellectual property for any therapeutic indications until March 22, 2031 in the US.
“CLL disease progression has been halted for at least 6 months in 60% of the patients treated by oral inecalcitol alone. These intermediate results encouraged us to file an EMA application for the orphan drug designation of inecalcitol to facilitate further potential clinical development in this orphan disease,” said Dr. Jean-François Dufour-Lamartinie, Hybrigenics’ Head of clinical R&D.
“Hybrigenics’ operations have earned more and spent less in the first half of 2013 than of 2012, while continuing to invest in the clinical development of inecalcitol in CLL, with encouraging results so far, and in its successful patent protection worldwide,” said Remi Delansorne, Hybrigenics’ CEO.
About Hybrigenics
Hybrigenics (www.hybrigenics.com) is a bio-pharmaceutical company listed (ALHYG) on Alternext (NYSEEuronext) in Paris, focusing its internal R&D programs on innovative targets and therapies for the treatment of proliferative cancerous or non-cancerous diseases.
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.
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), a fully-owned subsidiary, 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, its sophisticated bioinformatics tools and extensive database, along with its chemical library and chemical screening platform. Hybrigenics also provides state-of-the-art genomic services specialized in DNA chips, DNA or RNA target enrichment and next generation sequencing. « back to overview