In 2010 Afrezza was subject to a Complete Response Letters (CRL) from the US Food and Drug Administration (FDA), which demanded more performance and safety data after the firm switched administration method from its MedTone inhaler to its Dreamboat inhaler.
Now the company has released positive data from Phase III clinical trials signifying hope for Type 1 diabetes sufferers looking for an alternative to insulin injections.
In a conference call to discuss Mannkind’s Q2 2013 figures - postponed to coincide with the release of Afrezza’s results – CEO Alfred Mann said the trials had addressed the key issues in the CRL, opening “the door for an effective review by the agency.”
He said: “We have had a number of correspondences back and forth to the agency to ensure that we understood where they wanted information from the CRLs and we are comfortable that the info we generated on the device will satisfy the reviewing decision.”
Breath of fresh air for diabetics?
The inhaled insulin market was heavily deflated in 2007 when Pfizer pulled its drug Exubera at a cost of $2.8bn, due to disappointing sales and warnings it could increase the risk of lung cancer.
Other inhalable insulin (produced by Eli Lilly and Novo Nordisk) tumbled on the back of Exubera, but Mannkind’s latest results have led them to look to Big Pharma as a partner to bring Afrezza to market.
“Our goal is to secure a partner who has the right capability, right approach to diabetes therapy to make Afrezza the commercial success we know that it can be,” said Mannkind’s President Hakan Edstrom.
He told stakeholders Mannkind is searching for a “global partner to help launch the product and position the product on a global basis,” though is looking to keep some of the rights in the US market with a co-promotion deal.
Having partnered with advisory firm Greenhill & Co., Mannkind is undergoing a formal process of speaking to a number of companies, including those who have worked with Mannkind in the past, Edstrom added.
Test Results
Afrezza was found to be comparable to Novo Nordisk’s fast acting insulin analog, Novolog, said Mann, “with the additional benefits of lower fasting blood glucose levels, lower risk of hyperglycaemia and no weight gain.”
The Dreamboat inhaler too was deemed equivalent to the previously developed MedTone, with a wealth of previously developed safety and performance data to draw on.
“This is a compelling story,” said Mann. “We’ve been telling it for a while, but that story becomes even more compelling now that we have demonstrated these advantages with the Dreamboat inhaler.”