(Adds background, analyst comment; update shares)
April 2 MannKind Corp's shares doubled
on Wednesday, after an advisory committee to the U.S. health
regulator recommended approval of the drug developer's inhaled
Analysts said the drug, Afrezza, is likely to win approval
in its third attempt, but noted that MannKind would still have
to conduct postmarket studies to demonstrate its long-term
"If approved, Afrezza will require quite extensive
post-marketing surveillance to monitor lung cancer and pulmonary
function. Given the costs involved, this could keep some
(potential partners) at bay," MLV & Co analyst Graig Suvannavejh
said in a note.
The advisory panel on Tuesday voted 13-1 to recommend the
drug's approval for patients with type 1 diabetes and
unanimously backed it for those with type 2, but said
longer-term studies would be required to gauge the risk of lung
cancer and other potential side-effects.
The U.S. Food and Drug Administration is not obligated to
follow the panel's recommendations, but typically does so.
If launched, Afrezza, will be the first inhaled insulin
product in the United States since 2006, when the FDA approved
Pfizer Inc's Exubera. Pfizer discontinued the product a
year later due to weak sales attributed primarily to the
bulkiness of its delivery device.
It is expected that whistle-sized inhaler used in Afrezza
will make it more acceptable to needle-phobic diabetics and the
The advisory panel said it accounted for Exubera's history
of a potential link to lung cancer when the committee suggested
additional safety studies for Afrezza. Earlier, FDA staff
reviewers had pointed to four cases of lung cancer in patients
enrolled in Afrezza's latest trials.
"Afrezza appears likely to enter the market with less
attractive labeling than (Exubera), which became arguably the
biggest commercial flop in industry history," Guggenheim
Securities analysts said in a note, adding that the MannKind
label would likely include a reference to potential cancer risk.
The panel had also raised concerns that the drug did not
work any better than traditional insulin in patients with type 1
diabetes, but said it offered a convenient alternative to
Given the efficacy and safety concerns, the FDA's decision
on the treatment, scheduled for April 15, is likely to be
delayed, analysts noted.
MLV's Suvannavejh said a three-month delay seemed "very
reasonable" in this case.
MannKind's shares were up about 83 percent at $7.41 in heavy
early trading on the Nasdaq. They touched a high of $8.08.
(Reporting by Natalie Grover and Vrinda Manocha in Bangalore;
Editing by Saumyadeb Chakrabarty and Maju Samuel)