Sanofi signs $925 million inhaled insulin deal
pharmafile | August 13, 2014 | News story | Sales and Marketing | Afrezza, French, Sanofi, diabetes, fad, insulin
Sanofi could pay out as much as $925 million for global rights to the world’s only approved inhaled insulin just months after the drug received a regulatory nod in the US for its manufacturer MannKind.
The French firm, already a major player in the diabetes market, will pay $150 million up front and as much as $775 million if Afrezza (insulin human) Inhalation Powder meets certain sales and development targets.
Sanofi says in a statement that it will take 65% of profit or loss related to Afrezza, and will also advance California-based MannKind as much as $175 million in expenses.
“We are so very pleased and honoured that Sanofi has joined with MannKind to bring Afrezza to patients with diabetes worldwide,” says Alfred Mann, MannKind’s chairman and chief executive.
“Sanofi is the ideal partner given their complementary product portfolio, their vast insulin market presence and a leading global commercial infrastructure.
“Our profit-sharing agreement aligns the interests of MannKind and Sanofi to optimise development, commercialisation and manufacturing costs.”
The FDA approved Afrezza in June, and the drug works as a rapid-acting inhaled insulin which is taken at the beginning of each meal, or within 20 minutes of starting to eat.
It was far from an easy path to approval however, as the license application for Afrezza was twice rejected by the US regulator, most recently in 2011 when it told MannKind it had to produce more clinical trial data to assess its safety.
As part of the eventual approval this year, MannKind must also carry out various post-marketing studies as a condition of FDA approval.
Forecasts for peak annual sales for the treatment have not reached blockbuster heights however, with analysts typically landing on the $600 million mark.
Afrezza is a drug-device combination product, consisting of Afrezza inhalation powder delivered using an inhaler. The powder dissolves immediately upon inhalation into the lungs and the delivers insulin into the bloodstream in around 12 to 15 minutes.
This is compared to the 45 to 90 minutes for injected rapid acting insulin analogs and 90 to 150 minutes for injected regular human insulin, according to the firm.
Holy Grail?
Inhaled insulin was once seen as the Holy Grail for pharma, but has been met with much difficulty over the years.
Pfizer’s Exubera (insulin human [rDNA origin]) inhalation powder was the first such treatment to reach the market, but was later withdrawn in mid-2007 after it failed to catch on with doctors.
Lilly’s AIR insulin product suffered a similar setback in 2008 when it cancelled Phase III trials of its drug due to the “increasing uncertainties in the regulatory environment”, which looked to be the end of inhaled insulin.
MannKind has remained dedicated to producing an inhaled insulin product however, and even acquired Pfizer’s Exubera manufacturing facility – remaining confident that Afrezza will make it to market.
This latest deal will be set up less as a major revenue driver for Sanofi, but rather a step towards dipping its toe into this emerging, difficult market, whilst also adding to its own diabetes pipeline of drugs that includes the big-selling insulin Lantus, which makes around $8 billion a year in sales.
Ben Adams
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