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MannKind Nears End of Clinical Trial, Medical Breakthrough

Local biotech company hopes for approval of diabetes treatment, Afrezza, by next spring

Posted: July 23, 2013 1:00 p.m.
Updated: July 23, 2013 1:00 p.m.

Matthew Pfeffer of MannKind Corporation displays the Afrezza inhaler in the company's Valencia office.

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With luck, Santa Clarita’s MannKind Corporation hopes to have FDA approval by April of next year of its innovative diabetes treatment – Afrezza.

First conceived in 2011, and funded to a great extent by serial biomed and high tech entrepreneur Alfred Mann, MannKind is a publically traded company whose shares of stock have risen steadily as the company approached the end of its final clinical trials on June 17.

Treating diabetes with insulin, a very potent drug, is tricky, said Matthew Pfeffer, corporate vice president and CFO of the MannKind Corporation.

Using insulin requires a delicate balance of finger-pricking tests, measured doses and timing – making it hard for lay patients to treat themselves adequately. As a result, doctors will underprescribe insulin to patients to create a safety margin, Pfeffer said.

Afrezza, however, gives patients a tool that allows them to better control insulin levels in their body, he said. The rapid-acting insulin therapy involves a dry powder, contained inside a cartridge, which is inhaled through a small device that looks like a whistle, Pfeffer said.

People need a background level of insulin in the body at all times, he said. And they need a “big bowl” of it in response to a meal to keep blood sugar levels in check.

Diabetes, however, results when the body’s pancreas fails to produce insulin. If left untreated over time, blindness, amputation of limbs and organ failure can follow.

While there are two types of diabetes – Type I and Type II, the latter is self-inflicted, Pfeffer said, by poor diets and sedentary lifestyles. And its growth is explosive, he said.

As much as diabetes is a serious health problem in the United States, the problem is greater in other parts of the world.

Developing regions – like China, India and some Middle Eastern countries – where societies rapidly changed from a nomadic to very sedentary lifestyle within only a few generations have been the hardest hit by the disease.

“The U.S. is not even in the top 10 percent globally,” Pfeffer said. “More than one-third of the world has developed diabetes.”

When injecting insulin, a person must wait 60 to 90 minutes for it to reach peak performance, so people have to predict more or less what time they are going to eat or they could end up in trouble, he said.

Afrezza uses the same form of insulin that the pancreas produces, and by inhaling the dry powder, it can reach peak performance in 12 minutes.

“The lung is a very good mechanism to get things into your system very fast,” Pfeffer said. “It gets into the bloodstream quickly and can immediately go to work – similar to what a healthy pancreas does.”

On the backend, injected insulin lingers in the body for too long – up to seven hours. With Afrezza, it’s out of your system within two to three hours, he said.

The only thing different about testing in the latest clinical trial was the use of a new inhalation device, Pfeffer said.

MannKind expects to release the results of the next-generation inhaler later this summer. At the company’s first quarter conference call on May 9, Alfred Mann said the company plans to resubmit a new drug application with the Food and Drug Administration in early October.

At this point in the process of Afrezza’s development, company officials expect the FDA’s review to last only about six months.

Referring to diabetes as a pandemic, Mann said the need for treatment is so great that he believes Afrezza could “potentially become the most significant medical product ever.” Mann is such a strong believer, that of the $2 billion invested to date, about $930 million of it has come from his own pocket.

“You’d be hard pressed to find another CEO with that level of commitment,” Pfeffer said. “But that’s his history. If he believes in it, he’ll stick with it and pony up. And his track record of success has been a huge asset.”

And the newest round of financing, $160 million from New York-based Deerfield Management Company, reflects confidence the investment company has in the ultimate success of Afrezza, he said.

Although the funds will be released incrementally based on MannKind achieving certain milestones, Deerfield doesn’t get its money back until Afrezza gets on the market and starts making money.
Mostly for practical reasons, if the company gets FDA approval, Pfeffer said it’s more likely that MannKind will manufacture Afrezza but market it through an existing pharmaceutical company.

“Marketing Afrezza would entail a huge sales force, and trying to create one of those from scratch would be pretty daunting,” he said.



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