MannKind and Sanofi are set to launch their inhalable insulin product. Approved earlier this year by the FDA, Afrezza is a fast-acting insulin to be taken at mealtimes. The drug is effective for both Type 1 and Type 2 diabetes.
Seven years ago, Pfizer launched Exubera, another inhalable insulin. When Exubera was introduced, it was believed to be a blockbuster product. However, Pfizer abandoned it because the product proved to be clumsy, inconvenient and very expensive. Moreover, the drug that it delivered was less efficient when compared to the injected rapid acting analogs. Pfizer stopped manufacturing the product in 2007, and in the process suffered a financial loss of $2.8 billion. Not only was the drug unable to gain both patient and physician acceptance, there was also an increased risk of lung cancer among its users.
MannKind and Sanofi are confident that Afrezza will not see the same fate. They believe that the two products cannot be compared; Afrezza claims to be different. The product has been produced using a Technosphere formulation technology platform that encompasses the excipient fumaryl diketopiperazine (FDKP). It has a pH of 6.0 and thus aids drug delivery.
It is interesting to note that Sanofi was the company that originally sold Exubera to Pfizer. Now, it has signed a $150 million marketing and commercialising deal with MannKind. The logic behind this step is that Sanofi already knows about Exubera and is in a better position to assess and judge that Afrezza is different from it.
Afrezza is small and elegant and has a PK profile that closely mimics the natural prandial insulin response. While the product may not replace injections, it can still prove to be an alternate way to give diabetics insulin therapy faster.
One surprising aspect of this deal between Sanofi and MannKind is the fact that Sanofi retains 65 percent of all profits while MannKind gets a mere 35 percent, despite putting in years of investment in researching and developing the product. However, since Sanofi will now bear the cost of any additional development and commercialisation. Also, since MannKind is a fairly small company as compared to Sanofi, the partnership may enable it to reach a wider target audience.
The product is expected to be launched in the first quarter of 2015.
Source: In-Pharma Technologist
Image Credit: Wikimedia Commons
