We can ask ourselves questions…..??
“IDEALLY POSITIONED TO COMMERCIALIZE MASITINIB IN MASTOCYTOSIS”
Monday, November 10, 2014 at 8:49 a.m.
(BFM Bourse) – AB Science SA on Monday provided a summary of the key points of the web conference held on November 7, 2014 with opinion leaders on its lead product, masitinib, in the treatment of mastocytosis.
“Phase 3 results in severe systemic mastocytosis will be released any time in 2015,” the company says, noting that “the number of adult patients with severe systemic mastocytosis is estimated at 10,000 people in the United States and in the European Union”.
In the event of a positive result of this study, an application for registration will be filed with the FDA and the European Medicines Agency (EMA).
In order to expand its franchise on the mast cell, initiated with severe systemic mastocytosis in adults, AB Science decided to launch in 2015 two phase 3 studies in mast cell activation syndrome (MCAS – Mast Cell Activation Syndrome) and in pediatric forms of mastocytosis.
Mastocytosis gives rise to urticaria pigmentosa in children and is mainly due to c-kit mutations which are effectively inhibited by masitinib. The target population in children with mastocytosis is estimated at 20,000 in the United States and the European Union.
Mast cell activation syndrome (MCAS) affects a much larger population than mastocytosis. MCAS is a common disease caused by mast cell activation and is associated with the same symptoms as mastocytosis, including chronic fatigue, pain, depression, diarrhea, bowel inflammation, pruritus, flushes and anaphylaxis, but this pathology affects approximately 5 to 10% of the population.
MCAS could include a portion of patients with multiple sclerosis, Crohn’s disease, chronic bowel inflammation, Duchene disease, or chronic fatigue syndrome, those with clear signs of MCAS. `mast cell activation (such as increased blood tryptase or increased urine histamine or dermographism).
“As masitinib was designed to block mast cell activation (through its action on c-Kit, Lyn, and Fyn kinases), it is a natural candidate for development in MCAS”, underlines AB Science.
The pharmaceutical company says it is “ideally positioned to commercialize masitinib in mastocytosis if approved.”
“A network of medical specialists is already structured in Europe (as in the GISTs), with the ECNM (European Competence Network on Mastocytosis)”, explains the group. “Similarly, a patient network is already structured with national patient associations in the main countries, and the founders of AB Science are also founders of the French patient association AFIRMM with more than 2500 identified patients”.
Finally, “AB Science has developed close relationships with patient associations and opinion leaders over the past ten years. In addition, AB Science has not to date granted any license and retains 100% of the rights to masitinib “.
Intellectual property protects masitinib until 2028 and potentially until 2031 in mastocytosis and 2034 in MCAS. The patent covering masitinib has been obtained and the protection will be extended until 2028 by the patent extension system (PTE). Additional protection was also obtained until 2028 by a patent covering the synthesis of the molecule.