Sage Represents Cancer Prevention Pharmaceuticals: A Late Stage, $Billion Orphan Product Opportunity
Sage’s client, Cancer Prevention Pharmaceuticals (“CPP”; www.canprevent.com),is a late clinical stage company developing a unique, oral, fixed dose combination drug (CPP-1X/sul) to treat Familial Adenomatous Polyposis (FAP), an inherited disorder characterized by cancer of the large intestine (colon) and rectum. People with the classic type of FAP may begin to develop multiple noncancerous (benign) growths (polyps) in the colon as early as their teenage years. Unless the colon and associated parts of the GI tract are resected, these polyps will become malignant (cancerous). The average age at which an individual develops colon cancer, without constant surveillance and surgical intervention, in classic FAP is historically in the late 30s.
This is an opportunity that every pharmaceutical executive seeks. It is a late stage product with an NDA/MAA soon-to-be-filed on two major continents. FAP is a disease with a high unmet medical need, offering premium pricing potential with orphan protection, and a potential market of hundreds-of-millions of dollars. This is a valuable opportunity, and there is a story that needs to be understood to fully appreciate the value of CPP and CPP-1X/sul.
CPP believes that CPP-1X/sul can be launched in US in 1H 2021 and Europe in 2H2021 and has engaged The Sage Group to secure a global or regional partner for the further development and commercialization of CPP-1X/sul.
CPP-1X/sul is a novel combination drug comprised of Eflornithine, a potent, enzyme-activated, irreversible inhibitor of the enzyme ornithine decarboxylase the first and rate-limiting enzyme in the biosynthesis of polyamines, and Sulindac which effects both cyclooxygenases and non-cyclooxygenase as well as prostaglandin metabolism. Eflornithine has never been marketed as an oral formulation in any systemic form, and is a mediator of polyamine synthesis, and regulation of inflammation and the immune system.
CPP’s Pivotal Phase 3 Trial of CPP-1X/sul (FAP-310) achieved highly statistically significant results (p = 0.005-0.02) in delaying the clinically relevant surgical and interventional events in the “lower GI” tract (despite missing a pre-specified composite endpoint - never tried before, but recommended by the regulators to define clinical benefit in a challenging orphan disease). Based on the unmet need, the intriguing subgroup analysis, the excellent safety profile, and the “totality of evidence”, the FDA appears open to reviewing an NDA for CPP-1X/sul based on a formal pre-NDA meeting held in the 4Q of 2019. Based on two pre-MAA meetings, EMA is also open to reviewing an MAA based on the same information.
CPP-1X/sul has been granted “Fast Track” and “Orphan Drug” designation from FDA in the US and “Orphan Drug” designation from EMA in Europe. CPP has IP protection until at least 2028 extendable to 2033 covering formulation and use of CPP-1X/sul.
CPP is managed by a highly competent team supported by a very experienced Board of Directors, clinical and regulatory advisors, and key opinion leading clinicians, as well as numerous peer-reviewed publications. The Company is exploring potential partnerships and licensing arrangements to support the approval and commercialization of CPP-1X/sul.
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