Commercial Opportunities

About Us

Commercial Opportunities

Today, the current drug lV busulfan is approved for the pretreatment of stem cell transplants for CML patients in the United States. However, it is reported that there is substantial “off-label” use in other disease conditions, especially AML. After our drug Bulanta ™ is approved in the USA for CML, we plan to
investigate the use of Bulanta ™ in these other disease conditions:

Current Uses of IV Busulfan
Acute Myeloid Leukemia (AML)
Sickle Cell Anemia
Acute Lymphocytic Leukemia (ALL)
Multiple Myeloma (MM)
Aplastic Anemia
Chronic Myeloid Leukemia (CML)
Myelodysplastic Leukemia (MDS)
Hodgkin's Lymphoma (HL)
Non-Hodgkin's Lymphoma (NHL)

Market Size

Estimates of the market for busulfan range from $225 million to $1 billion today. According to drug manufacturers, the worldwide market for the busulfan active ingredient is more than 15 kilograms, which translates to approximately a $225 million market, the lower limit of our estimates. The
upper limit is based on market studies by third parties

We believe Bulanta ™ has the potential to substantially replace the current IV busulfan products due to the removal of the solvent DMA. 

The stem cell transplant market is growing by 6% per year. The largest producer of the active pharmaceutical ingredient (API) stated busulfan sales are increasing 5 to 10 percent per year.

Regulatory Strategy

GreenJay intends to submit for regulatory approval for its lead drug, Bulanta ™, through the 505(b)(2) regulatory pathway for CML. GreenJay has conducted a pre-IND meeting with the FDA that has provided guidance relating to our development plan.

The 505(b)(2) New Drug Application (NDA) is a streamlined process in which the applicant relies on one or more investigations conducted by a company other than the applicant and for which the applicant has not obtained right of reference. The 505(b)(2) pathway enables investigators and/or manufacturers
to apply for approval without the need to repeat all the drug development work performed for an innovator drug.

To show comparability with the marketed IV busulfan products, GreenJay intends to conduct PK studies in rodents.

Other IV busulfan products

Currently, IV busulfan is sold by Otsuka (Busulfex) and nine generic manufacturers. All of these products contain DMA as an excipient. GreenJay believes that an IV busulfan without DMA could supplant a substantial portion of sales.