Earlier this year, the US Food and Drug Administration (FDA) approved the drug Afrezza for use as a fast-acting insulin for at mealtimes for those with Type 1 and Type 2 diabetes. The validation came seven years after Pfizer abandoned its once toted blockbuster Exubera, also an inhalable insulin, but in a conference call last week MannKind said it is confident Afrezza will be a success.
“It’s hard to really try to compare Afrezza to Exubera because they are totally different products,” President and COO Hakan Edstrom told investors.
“They are [both] truly powders, so both companies - Pfizer and MannKind - decided to deliver by inhalation. But the difference is that Exubera had a very huge clumsy inconvenient and very expensive device, and delivered a powder that was clinically less efficient and ineffective than injected rapid acting analogs.”
Pfizer stopped manufacturing its device in 2007, taking a financial hit of $2.8bn (€2.2bn), after admitting the drug and device failed to gain patient and physician acceptance. The following year, warnings of increased lung cancer risk among users contributed further to Exubera’s downfall.
Afrezza uses the firm’s Technosphere formulation technology platform, encompassing the excipient fumaryl diketopiperazine (FDKP) which aids delivery due to its high solublity at pH 6.0, the prevailing pH in the lungs.
Further confidence in the product came via Sanofi which signed a $150m marketing and commercialising deal with MannKind in August, with former CEO Christopher Viehbacher saying last week Sanofi’s knowledge of Exubera – having originally sold the product to Pfizer - played a key part in this deal.
“Because we knew of Exubera, we also were able to I think assess why Afrezza is different,” he told investors (see transcript here). “One of the first [differences with Afrezza] is the small elegant device that is there, and the other is that this has a PK profile that really can mimic the natural prandial insulin response.”
Viehbacher, who resigned from Sanofi the day after this conference call, added that though Afrezza may not necessarily replace injection, it “could be an interesting way to get people on insulin therapy a little bit faster.”
35-65% split
MannKind will receive a 35% share of profits with Sanofi picking up the remainder, and founder and CEO Alfred Mann said on the call that the company has received some criticism of what may be deemed a “disproportionately low reward” for years of investment in R&D.
“However, it is important to recognize that this 'blip' provides very attractive returns to both companies and that Sanofi will bear the brunt of remaining development and commercialization costs.”
He added “Sanofi will be able to serve a larger diabetic population in the wider market then MannKind could ever do on its own,” and not just on the sales and marketing side of operations.
“Our MannKind factory in Denver, even fully equipped, will be able to serve only a small portion of the people worldwide with diabetes. As our partnership relation with Sanofi grows we should also be working together on multiple aspects of this supply chain such as insulin and other materials.”
For the third quarter 2014, the company received no revenue (since its inception in 1991, MannKind has received a cumulative total of $3.2m) with operational expenses standing at $38m, slightly less than the same period last year.
Sanofi and MannKind are aiming to launch Afrezza in the first quarter 2015.