8/14/2019 MannKind Expects U.S. FDA to Approve Inhaled Insulin (Update3)

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MannKind Expects U.S. FDA to Approve Inhaled Insulin (Update3)

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By Rob Waters and Catherine Larkin

Jan. 6 (Bloomberg) -- MannKind Corp.’s President and Chief Operating Officer Hakan Edstrom said he

expects U.S. regulators to approve the company’s experimental inhaled insulin drug by Jan. 16,

challenging analysts who predicted a delay.

 “Based on our success so far I am bold enough to say we w ill see an approval,” Edstrom said yesterday

in a telephone interview. “There are no indications by the FDA that they w ill not be able to come out

with a final ruling by Jan. 16,” the scheduled date for a decision from the Food and Drug Administration.

MannKind, based in Valencia, California, was founded by billionaire inventor Alfred Mann, who lent the

company about $1 billion to finance clinical trials and get the drug, Afresa, on the market. New York-

based Pfizer Inc., the world’s largest drug company, abandoned its inhaled insulin product, Exubera,

after some patients developed lung cancer in clinical trials.

That history has complicated MannKind’s efforts and some analysts expect regulators will reject the

drug or delay the scheduled decision date by requiring an advisory panel review. Four of 10 analysts

who cover the company recommend selling its shares, according to data compiled by Bloomberg.

 “We continue to think that Afresa will not gain a near- term approval,” said Jon Lecroy, an analyst for

Hapoalim Securities in New York, in a note yesterday to investors. “Longer term, we do not think

MannKind will be able to find a partner for Afresa and, if approved, we do not think the market will

accept the product in a meaningful way.” 

Volatile Shares

MannKind gained 36 cents, or 4.6 percent, to $8.28 at 4 p.m. New York time in Nasdaq Stock Market

composite trading. The shares fell 12 percent yesterday, the most since Oct. 6 when the company said

it didn’t expect to find a marketing partner until after the FDA decision. Lecroy recommends selling the

stock and has a $1 target price.

Edstrom said the company is negotiating with the FDA about the drug’s official prescribing information

and a plan for managing Afresa’s risks. He also said MannKind is in discussions with “major

pharmaceutical companies that are capable of both U.S. and international distribution” to partner with

the company in marketing the treatment if it wins approval.

Simos Simeonidis, an analyst at Rodman & Renshaw, sees MannKind as a good pick for investors even

if Afresa is delayed until later this year.

 ‘Buying Opportunity’ 

 “We don’t see this outcome as a reason to sell,” the New York-based analyst said today in a note to

clients. “If the market reacts negatively on such a delay, we would see any dip as a buying

opportunity.” 

Simeonidis has a “market outperform” rating on MannKind and expects shares to rise to $18 within 12

months.

People with diabetes don’t produce enough insulin and take drugs or synthetic versions of the hormone

to control their blood su ar, called lucose. The number of diabetics will climb from 170 million eo le

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8/14/2019 MannKind Expects U.S. FDA to Approve Inhaled Insulin (Update3)

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worldwide to 366 million by 2030, according to the World Health Organization.

Before Exubera’s study results were released, inhaled insulin was seen as having blockbuster potential

because it allows patients to quickly control their glucose levels by sniffing the medicine through a tube

rather than injecting themselves with needles.

To contact the reporters on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net;

Catherine Larkin in Washington at clarkin4@bloomberg.net.

Last Updated: January 6, 2010 16:08 EST  

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