Drugmaker Chooses Lone Wolf Strategy

Posted by: Arlene Weintraub on October 7, 2009

AlMann.jpgOn October 6, shares of pharmaceutical startup MannKind Corp. plummeted 30% to $6.30, when the company predicted it wouldn’t sign a partnership deal with a well-capitalized Big Pharma company until after its experimental drug is approved. Here’s the twist: MannKind’s experimental drug is inhaled insulin—a product that was left for dead by drug companies and investors long ago. CEO Alfred Mann says his company has plenty of cash to make it well into 2011. Nevertheless, investors are clearly worried.

With good reason. When Mann—an 83-year-old serial entrepreneur—started started working on inhaled insulin early in the decade, it seemed like a good idea. If people with diabetes could breathe in their insulin instead of injecting it, they would save themselves a lot of hassle and pain, drugmakers thought. In fact, a lot of major pharmaceutical companies were interested: Pfizer, Eli Lilly and Novo Nordisk were all developing inhaled-insulin products of their own.

But Pfizer’s product, Exubera, flopped. It brought in just $12 million in sales in its first nine months on the market, prompting Pfizer to drop the product in 2007. Patients didn’t like the clumsy inhaler, and doctors balked at the requirement that they test patients to make sure their lungs were working properly before prescribing Exubera to them. Soon Lilly and Novo Nordisk abandoned the idea, too.

AFRESA.jpgMann thinks his product, Afresa, is different. He told Reuters that patients in his clinical trials have not suffered any lung problems. And he enjoys carrying a prototype around to investment conferences to show off how much smaller and less obtrusive Afresa is compared to Exubera.

Investors know better than to count Mann out completely. In the 1980s, his company MiniMed invented an insulin pump that delivered a steady stream of the drug to diabetics through a tube implanted in their skin. Companies including Lilly and Novo Nordisk pulled out of the market for insulin pumps, but not Mann. He succeeded, and in 2001, Medtronic bought MiniMed for $4 billion.

Will Mann pull off the same feat with Afresa? The U.S. Food & Drug Administration is expected to deliver a verdict in January.

Reader Comments

Ellen

October 7, 2009 3:36 PM

I wish Al Mann had invested his money in curing type 1 diabetes - that would have been money well spent. How about encapsulated porcine islets (i.e. Living Cell Technology in New Zealand) - a potential true insulin replacement without immunosuppression to restore normoglycemia.

I will NEVER encourage a single person to use inhaled insulin. I predicted Pfizer's would go down the tubes and now this one will follow. What a waste of precious dollars.

Inhaled insulin is far too dangerous down the road - long term. My now 21 year old son was diagnosed with type 1 diabetes 20 years ago. He doesn't need another mode of insulin delivery. He needs a cure for diabetes or a way to restore euglycemia. What a waste of more billions. Al Mann used to be a visionary. I think this is a wasted pipe dream. RIP Afresa.

Wasn't it interesting when all the people with type 2 who were afraid of using an injection to take insulin, suddenly got over their fear of injection when Byetta was found to help with weight loss? If doctors would empower patients to take insulin, instead of holding it over their heads as if it's a punishment for not being compliant - more patients would learn how the injection/needle part of insulin administration is the least of insulin therapy problems.

PLEASE support a CURE for all types of diabetes.

David Smithson

October 7, 2009 4:04 PM

Al Mann is one of the greatest inventors of my time. I believe his inhaler is the wave of the future, and that many theraputic drugs will benefit from this easy to use method. Mr Mann, you are THE MAN...you are a GENIUS!!!!!!

sean

October 7, 2009 4:14 PM

The problem with inhaled meds is that it's very difficult to control dosage. For insulin, in particular, small dosage differences can have an enormous impact on blood glucose. Plus, if you have to do expensive tests (spirometry, etc) then it's just not cost effective.

sg

October 7, 2009 4:43 PM

Sorry to Ellen, but I promise you that if these guys launch an effective insulin breather needles will become quickly obsolete. No one, short of crack addicts, like to stick themselves with needles on a daily basis. Have you seen the scars over years of use?!

Bumpy Greens

October 7, 2009 4:59 PM

Al Mann has scored in many fieldsbut his medical achievements are almost biblical. He perfected the insulin pump. His cochlear implant allows the profoundly deaf to hear. The BBC did a program on a blind man whose sight was restored by SecondSight project this summer. Mann is chairman. In Mannkind's lab work is moving on a series of new cancer vaccines. And a cure for obesity!

Bumpy Greens

October 7, 2009 4:59 PM

Al Mann has scored in many fieldsbut his medical achievements are almost biblical. He perfected the insulin pump. His cochlear implant allows the profoundly deaf to hear. The BBC did a program on a blind man whose sight was restored by SecondSight project this summer. Mann is chairman. In Mannkind's lab work is moving on a series of new cancer vaccines. And a cure for obesity!

Jeff

October 7, 2009 5:17 PM

So many people focus on the point that Afresa is "inhaled", rather than the point that Afresa is simply a better form of insulin. It is a monomeric form of insulin that peaks in 12-14 minutes and doesn't have a tail like the current insulin treatments have. Sounds like a break-through treatment to me.

JP Marat

October 8, 2009 1:26 PM

As a type 1 diabetic, I have been injecting multiple insulin doses now for 43 years. We diabetics find that while insulin shots take some getting used to, after about the first week they are absolutely no problem at all. Because non-diabetics cannot comprehend that fact, they throw away billions of dollars answering the non-existent problem of insulin injections. These foolish ventures do give diabetics a good opportunity to sell the company's stock short and make some money, however.

Jay

October 8, 2009 6:22 PM

Sorry to all the syringe haters out there, but I've been diabetic for 23 years, and I'll tell you, the absolute LEAST irritating thing about being diabetic is giving insulin.

Retinopathy? Sucks. Blood Sugar Testing...sucks. Renal Failure? Sucks. 9 Billion other complications? They all suck.

Counting Carbs, avoiding high GI foods, adjusting for alcohol, higher insurance premiums...Those all suck too.

Insulin injections? Basically no big deal once you've done it a couple of dozen times.


Now, on the other hand, this is a wonderful invention for type 2 diabetics who don't feel like exercising or watching what they eat...but it's useless as a treatment for type 1. Too bad the news media mostly doesn't know the difference.

Russell

October 11, 2009 7:17 PM

Short of a cure, the future of diabetes treatment is sitting in Medtronic's closed loop system. Nothing better than knowing what your current glucose levels are AND having the most physiologically way to deliver insulin via the insulin pump. For you shot takers, say goodbye to hypoglycemia and 4-10 shots a day. Still cannot comprehend why anyone would prefer shots over a pump. Ignorance, I guess.

Tom

October 15, 2009 9:54 AM

As Jeff points out in his Oct 7 comment and none of the so called "experts" seem to note, you guys are all missing the point and looking at "inhaled" rather than monomeric. Al Mann and Mannkind are the ONLY ones who have been able to deliver insulin in a monomeric form instead of hexomeric. Read, study and listen to Al in his press conferences and take note. Because others fail such as Pfizer doesn't mean that MNKD will also. Ask a diabetic about losing weight and poking themselves with needles daily. Life for these millions will be so much brighter once this delivery system is approved. So easy to be negative ... all you have to do is be uneducated to the facts.

Dunny

October 19, 2009 2:42 PM

Ellen and the others out there that aren't getting this -- AFRESA WAS NOT CREATED AS AN ALTERNATIVE TO INJECTING INSULIN. It is a vastly superior product to the fast acting insulins you are currently using. Here are the facts about afresa...

- Reduces hypoglycemic episodes by 60%
- Most type 1's LOSE WEIGHT taking this product
- Significantly lowers fasting glucose levels
- Is almost instantly is disolved in the lungs = no residue = no pulminary issues 5 years of trialist data behind this.

Al has said this is the most important product he has ever worked on because he believes that with Afresa he is going to be able to manage patients at much lower fasting glucose levels, and thus significantly depress the incidence of the long term complications of the disease, that will, in long run save millions of lives and billions of dollars for the worldwide health care industry.

OXYGEN

March 27, 2010 4:34 PM

The problem with inhaled meds is that it's very difficult to control dosage.

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