IBJNews

Would-be Lilly foe wins U.S. panel backing for inhaled insulin

Back to TopCommentsE-mailPrintBookmark and Share

MannKind Corp.’s inhaled diabetes treatment won the backing of a panel of U.S. regulatory advisers, boosting the company’s long-running effort to get its first product on the market. Shares more than doubled in extended trading Tuesday after the panel’s recommendation.

Advisers to the Food and Drug Administration voted 13-1 and 14-0 that the drug, Afrezza, should be approved for Type 1 and Type 2 diabetes, respectively. The FDA doesn’t have to follow the panel’s recommendation. FDA staff raised concerns in a report March 28 that the drug may affect lung function and about missing data from a study on Type 1 diabetes patients.

Afrezza would compete with Indianapolis-based Eli Lilly and Co.’s Humalog and Novo Nordisk A/S’s Novolog, both injected insulins. Novolog generated $3 billion in sales last year and Humalog brought in $2.6 billion, according to data compiled by Bloomberg. Many diabetics begin treatment on an older drug called metformin, a pill which can lose effectiveness over time.

MannKind has spent more than seven years trying to gain approval. The FDA rejected the drug twice, most recently in 2011, after the Valencia, Calif.-based company decided to switch inhalers during the review process.

While some panel members who recommended approval expressed reservations about potential safety risks, they said MannKind demonstrated the drug works. The advisers also said the benefit of an alternative to insulin injections outweighed their concerns or could be addressed in the medicine’s labeling

If approved, Afrezza may generate $534 million in 2018, according to the average estimate of three analysts compiled by Bloomberg. The FDA is expected to decide whether to clear the drug for sale by April 15.

MannKind shares more than doubled, to $9.31 each, in after-market trading after being halted during the day for the panel’s meeting. The company declined five straight days leading to the meeting, including a 17-percent drop Monday, to $4.02, the biggest single-day fall since October 2012, as investors were concerned the panel may react negatively to the drug.

“We are pleased with the advisory committee’s approval recommendation in support of Afrezza, and we appreciate the thoroughness of their review,” Alfred Mann, chairman and CEO, said in a prepared statement. “Diabetes is a major health problem in the United States, and we are committed to bring Afrezza to the many patients who might benefit from this novel product.”

About 26 million people in the U.S. had diabetes in 2010, or 8.3 percent of the population, according to the Centers for Disease Control and Prevention. The condition, which is caused when the body doesn’t use insulin properly or doesn’t make the hormone, is the seventh-leading cause of death in the U.S. Insulin is a hormone secreted by the pancreas that helps the body control blood sugar. Type 2 accounts for 90 percent to 95 percent of diabetes cases in the U.S.

Pfizer Inc. made the only other inhaled insulin, Exubera, approved in 2006. The New York-based drugmaker pulled the product after sales were lower than expected, according to the FDA staff report. The drug was associated with a higher risk of lung cancer because insulin is directly deposited in the lungs and the drug is a growth factor. FDA staff said this may be a concern with Afrezza as well.

FDA staff suggested two post-market studies to evaluate lung-cancer risk.

Lilly tried to produce an inhaled insulin of its own, but abandoned the effort in 2008 after spending tens of millions of dollars on the effort.

Lilly shares fell 11 cents in after-market trading, to $58.71 each, after dropping 4 cents Tuesday during regular market hours.

ADVERTISEMENT

Post a comment to this story

COMMENTS POLICY
We reserve the right to remove any post that we feel is obscene, profane, vulgar, racist, sexually explicit, abusive, or hateful.
 
You are legally responsible for what you post and your anonymity is not guaranteed.
 
Posts that insult, defame, threaten, harass or abuse other readers or people mentioned in IBJ editorial content are also subject to removal. Please respect the privacy of individuals and refrain from posting personal information.
 
No solicitations, spamming or advertisements are allowed. Readers may post links to other informational websites that are relevant to the topic at hand, but please do not link to objectionable material.
 
We may remove messages that are unrelated to the topic, encourage illegal activity, use all capital letters or are unreadable.
 

Messages that are flagged by readers as objectionable will be reviewed and may or may not be removed. Please do not flag a post simply because you disagree with it.

Sponsored by
ADVERTISEMENT

facebook - twitter on Facebook & Twitter

Follow on TwitterFollow IBJ on Facebook:
Follow on TwitterFollow IBJ's Tweets on these topics:
 
Subscribe to IBJ
  1. President Obama has referred to the ACA as "Obamacare" any number of times; one thing it is not, if you don't qualify for a subsidy, is "affordable".

  2. One important correction, Indiana does not have an ag-gag law, it was soundly defeated, or at least changed. It was stripped of everything to do with undercover pictures and video on farms. There is NO WAY on earth that ag gag laws will survive a constitutional challenge. None. Period. Also, the reason they are trying to keep you out, isn't so we don't show the blatant abuse like slamming pigs heads into the ground, it's show we don't show you the legal stuf... the anal electroctions, the cutting off of genitals without anesthesia, the tail docking, the cutting off of beaks, the baby male chicks getting thrown alive into a grinder, the deplorable conditions, downed animals, animals sitting in their own excrement, the throat slitting, the bolt guns. It is all deplorable behavior that doesn't belong in a civilized society. The meat, dairy and egg industries are running scared right now, which is why they are trying to pass these ridiculous laws. What a losing battle.

  3. Eating there years ago the food was decent, nothing to write home about. Weird thing was Javier tried to pass off the story the way he ended up in Indy was he took a bus he thought was going to Minneapolis. This seems to be the same story from the founder of Acapulco Joe's. Stopped going as I never really did trust him after that or the quality of what being served.

  4. Indianapolis...the city of cricket, chains, crime and call centers!

  5. "In real life, a farmer wants his livestock as happy and health as possible. Such treatment give the best financial return." I have to disagree. What's in the farmer's best interest is to raise as many animals as possible as quickly as possible as cheaply as possible. There is a reason grass-fed beef is more expensive than corn-fed beef: it costs more to raise. Since consumers often want more food for lower prices, the incentive is for farmers to maximize their production while minimizing their costs. Obviously, having very sick or dead animals does not help the farmer, however, so there is a line somewhere. Where that line is drawn is the question.

ADVERTISEMENT