Posted on August 20th, 2014
by Nevan Elam
I was thrilled to see MannKind and Sanofi’s announcement regarding their licensing agreement to bring Afrezza to market. As Brian recently highlighted in his blog post, it is easy to envision a future insulin replacement regimen consisting of Afrezza as a meal-time insulin and AB101 as a basal insulin. In this scenario, the injection burden for patients would lessen from several injections per day to as little as one injection per week.
The terms of the partnership include $150 million of upfront and $775 million of milestone payments to Mannkind, as well as profit sharing of 65% Sanofi/35% MannKind. While MannKind will manufacture Afrezza, Sanofi will be responsible for all of the drug’s commercial, regulatory and development work globally. This is a great indicator of how large pharmaceutical companies are willing to offer a premium for a novel therapy like Afrezza. I think the announcement of this partnership bodes extremely well for AntriaBio as it highlights a renewed focus on novel insulin therapies that reduce the injection burden for patients. It is also an excellent example of big pharma looking outside its four walls to smaller biotech companies to identify and pursue licensing opportunities that are complementary to their existing product portfolios. Whereas Afrezza plays in the rapid acting insulin market with too many existing competing therapies to list, AB101 has a much larger opportunity in the ~$10 billion basal insulin market with only two existing therapies – Lantus and Levemir.
One of the first questions I almost always get when telling our story is, “When does AntriaBio plan to partner with a large pharma company on AB101?”
The response is simple. We will consider forming a development and commercialization partnership once we have validated AB101’s true clinical potential. We know AB101 will generate more value the longer we hold on to it. Given how disruptive this technology is, we could explore the option to partner now or possibly early next year once we complete our animal studies. However, planning for success, we envision ideally forming a partnership well after demonstrating clinical efficacy. We are gearing up to initiate phase 1/2a clinical trials in type 1 and type 2 diabetes patients in the second half of 2015. These will be single and repeat ascending dose studies investigating the safety and time-action profile (PK-PD) to establish our proposed once-weekly dosing regimen. Given our unique formulation, we are very optimistic.
Please feel free to share your comments and questions below, as I would love to hear them. Onward and upward…
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