Kangen specializes in working with pharmaceutical companies outside the US through co-development or licensing arrangements to develop their drugs in the US. Through these agreements we obtain exclusive distribution rights, or co-marketing rights for the North American market. We offer a unique perspective on how to develop drugs utilizing various regulatory strategies & platforms with our core team that has decades of experience in developing niche and Orphan Drugs worldwide. Our primary territory is Japan, though we also have partners in other parts of Southeast Asia as well as Europe that desire to bring their products into the North American market.
We oversee development for our partners from IND and NDA preclinical development through phase 3 studies, to approval. We provide expertise in the overall regulatory strategy to identify the quickest method to market, by identifying potential regulatory options such as Orphan Drug Designation, Breakthrough Designation, Accelerated Approval, and Fast Track programs.
For many companies we work with the drug may be off patent in their country, or soon to be off patent but was never approved in the US. By bringing these drugs into the US as New Chemical Entities (NCEs) for approval, we can extend the life cycle and sales of these products for our partners through exclusivity gained from various regulatory strategies, particularly for diseases that currently have no treatment options in the US. Once the drug is approved in the US we will begin to work with our partners on life-cycle planning during the exclusivity period to determine how we can continue to gain future exclusivity with new formulations and increased sales revenue.
Additionally, Kangen has the capability to develop generic drugs via an Abbreviated New Drug Application (ANDA) under special circumstances, such as a new dosage formulation—505(b)2, or a cytotoxic compound requiring an IND for bioequilivance study to be conducted in patients (vs. healthy volunteers).
We closely work with our global partners to review their portfolios & pipelines, and identify products that meet unmet indications within the US; as well as, identify patent issues, and file US patents and PCT applications for nationalization.
We act as our partners US Agent and handle all communication electronically with FDA, including pre-IND meeting requests, protocol development, briefing packets, IND submissions, end of phase 2 meetings and NDA submissions.
From a sales and revenue prospective, we provide current market conditions and predictions of future market trends. We can conduct pharmacovigilance studies; as well as, assisting in the brand naming of the drug.
Regulatory Strategies & Platforms We Manage:
Development of FDA briefing documents
Orphan Drug Designation
Orphan Drug grants
Patent & PCT filings