Developing Zindol for chemotherapy-induced nausea and vomiting (CINV) and other nausea/vomiting-induced conditions caused by pregnancy, motion sickness, and medication
The market size of CINV drugs in the United States was more than $1.5 billion in 2005. The number of patients experiencing chemotherapy-induced nausea in the US is estimated to be 1.53 million in 2011. Based on four to eight chemotherapy cycles per patient, the number of cases of nausea per year is estimated to be 9.2 million. Based on the treatment cost of $100 per nausea case for an anti-emetic adjuvant therapy, the estimated market potential is approx. $1 billion. The US marketplace for Zindol for CINV and other indications such as post-operative nausea and vomiting (PONV), pregnancy-related nausea and vomiting (PRNV), motion sickness nausea and vomiting (MSNV) and medication-related nausea and vomiting (MRNV) could be as high as $3.3 billion. The worldwide market for Zindol is estimated to be a multiple larger.
Zindol will be initially commercialized as adjunctive therapy to 5-HT3 antagonists to alleviate nausea associated with, or in anticipation of, chemotherapy. It will be positioned as a natural anti-nausea alternative and/or adjunct, which has fewer side effects and can be taken orally, to other adjuvants such as Merck’s Emend and developing NK-1 antagonists.
Zindol will be marketed directly to oncology centers and oncologists with multinational partners with a strong anti-emetic or oncology capabilities and/or initially through a direct sales force such as Reliant Pharmaceuticals that launched Lovaza, the FDA-approved, purified omega-3 fatty acids for triglyceride management. Reliant boosted sales of Lovaza to $200 million in 2006 before being purchased by GSK for $1.6B. GSK sales for Lovaza in 2011 were ~ $1.5B.
We are currently raising capital to conduct a pivotal Phase III clinical trial of Zindol as an adjuvant to conventional 5-HT3 anti-emetics to treat CINV. In subsequent financings, which may include an IPO, we plan to raise additional capital to complete clinical development of Zindol, file an NDA with the FDA and commercialize Zindol.