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 Developed by Mannkind Corp, Afrezza will be the only inhalable
insulin on the U.S. market, where Sanofi competes with Eli Lilly and
Novo Nordisk for sales of traditional injectable insulin.
Inhalation promises to be faster acting and much more convenient
than injections, but an inhaled product has failed in the past and
there are concerns about the potential risks associated with
breathing powdered insulin.
Afrezza, which uses a whistle-sized inhaler and works to control
blood-sugar levels in both type 1 and type 2 diabetes, was developed
in the shadow of Pfizer's rival Exubera and approved by the U.S.
Food & Drug Administration in June.
Exubera was approved in 2006 with expectations of $2 billion a year
in sales but the inhaler was bulky, and patients were put off by the
need for periodic lung function tests. Eventually it was withdrawn.
In the Afrezza marketing deal struck last year, Mannkind won an
upfront payment of $150 million, potential further milestone
payments of up to $775 million and 35 percent of future profits.
Priced at $7.54 for a daily dose of 12 units, Afrezza will be
pricier than $3.14 Apidra, which is the injectable equivalent in
Sanofi's drugs stable.
Afrezza should not be used in patients with asthma, or those
suffering from certain complications, however. It is also not
recommended for smokers or recent ex-smokers.
Industry analysts have said they expect Afrezza to generate modest
sales of about $182 million a year by 2019 according to Thomson
Reuters Cortellis, given Exubera's problems and the restrictions on
use.
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Sanofi's diabetes division generates about $7 billion of sales
annually and around 30 percent of group profits, but the patent on
its Lantus insulin, the world's most prescribed, expires this year,
and it expects little or no sales growth through 2018.
A poor diabetes performance in 2014 was one of the reasons Sanofi
sacked chief executive Chris Viehbacher in October. The company is
now betting on products like Afrezza and an improved version of
Lantus called Toujeo.
Orally delivered insulin is difficult to develop because the protein
gets broken down in the stomach, but last year Danish group Novo
Nordisk completed a Phase I trial of an oral version.
(Reporting by Andrew Callus and Ben Hirschler; Editing by James
Regan)
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