* Trials show Afrezza better than injected insulin, oral
* Company to submit trial data to FDA in 4th qtr
* Shares rise as much as 27 pct
(Adds analyst comment; updates stock movement)
By Esha Dey
Aug 14 An inhaled insulin device made by
MannKind Corp proved more effective than injected and
oral treatments in trials, potentially improving the quality of
life for millions of diabetics and creating a multi-billion
dollar opportunity for the company.
MannKind shares rose as much as 27 percent in morning trade.
The product, Afrezza, is a whistle-sized inhaler that
delivers powdered insulin to adults with Type 1 and Type 2
diabetes. Given the ease of use compared with regular insulin
shots, it has the potential to capture a big share of the global
The number of diabetics worldwide is projected to cross half
a billion by 2030. According to a July report by Transparency
Market Research, the global insulin market is expected to reach
$32 billion in 2018.
MLV & Co analyst Graig Suvannavejh expects Afrezza to get
regulatory approval, but said the bigger question is whether the
company can successfully commercialize the product.
"I think it really will depend on who the exact partner is,
as this product is going to require a lot of education, a lot of
heavy lifting," Suvannavejh said.
He estimates U.S. and European sales of about $3 billion for
Afrezza by 2025.
The inhaled insulin market has seen high-profile commercial
failure in the past. Pfizer Inc withdrew Exubera in 2007
due to poor sales. The large size of the device and a high price
were blamed for its failure.
Suvannavejh said a potential partner for MannKind could come
from among such major diabetes players as Denmark's Novo Nordisk
, French drugmaker Sanofi, Bristol-Myers
Squibb, Merck & Co Inc, Eli Lilly & Co
and Johnson & Johnson.
Afrezza is a flagship product for MannKind, whose shares
have risen nearly 50 percent over the past three months in
anticipation of positive data from the two trials.
Results from the two studies included a reduction in fasting
blood glucose levels and lower incidences of hypoglycemia - a
side-effect of taking insulin that leads to dangerously low
MannKind said it expects to submit data from the trials to
the U.S. Food and Drug Administration in the fourth quarter
The FDA rejected Afrezza in early 2011 and asked the company
to conduct two clinical trials to prove that the
second-generation of the device was equivalent to its
MannKind had initially filed for approval based on data from
the first-generation device, before updating the application to
the newer device.
The first trial, named Study 171, compared Afrezza with Novo
Nordisk's injected insulin NovoLog, and showed that
the second-generation device was comparable to the
The second trial, named Study 175, showed Afrezza was better
in reducing patients' A1C levels - a measure of blood glucose
control - compared to oral therapy.
Diabetics typically start out on oral medicine but often
need to move on to insulin shots to regulate blood-sugar levels.
The company has another experimental diabetes therapy -
called MKC253 - in development, along with two potential cancer
MannKind shares were trading up 15 percent at $7.91 on the
Nasdaq on Wednesday.
(Reporting by Esha Dey and Pallavi Ail in Bangalore; Editing by
Maju Samuel and Saumyadeb Chakrabarty)