FDA approves inhalable diabetes drug Afrezza

WASHINGTON -- The Food and Drug Administration on Friday approved a long-delayed inhalable diabetes medication to help patients control their blood sugar levels during meals.

The FDA cleared MannKind Corp.'s Afrezza, a fast-acting form of insulin, for adults with the most common form of diabetes, which affects more than 25 million Americans. The approval decision comes more than three years after the agency first asked MannKind to run additional clinical studies on the drug.

Demand for diabetes treatments is surging globally as the prevalence of obesity explodes. According to the World Health Organization, roughly 347 million people worldwide have the disease, a chronic condition in which the body either does not make enough insulin to break down the sugar in foods or uses insulin inefficiently. It can lead to blindness, strokes, heart disease or death. In type 2 diabetes, the most common form of the disease, the body does not use insulin properly. Type 1 diabetes is usually diagnosed in children and young adults. In those cases, the body does not produce insulin.

Afrezza, an insulin powder, comes in a single-use cartridge and is designed to be inhaled at the start of a meal or within 20 minutes. MannKind has said that patients using the drug can achieve peak insulin levels within 12 to 15 minutes. That compares to a wait time of an hour and a half or more after patients inject insulin.

The FDA said in its approval announcement that Afrezza is not a substitute for long-acting insulin and is a new option for controlling insulin levels during meals. The agency approved Afrezza with a boxed warning — the strongest type — indicating that the drug should not be used in patients with chronic lung diseases, such as asthma and smoker's cough, due to reports of breathing spasms. The agency is also requiring several follow-up studies looking at the drug's long-term safety, including its impact on the heart and lungs.

Mannkind first submitted the drug to FDA in March 2009. The Valencia, California-based company has no other products on the market and lost more than $191 million last year.

Several other companies have failed to make inhaled insulin work commercially. In 2007, Pfizer Inc. discontinued its inhaled insulin Exubera after it failed to gain ground on the market. In 2008, Eli Lilly & Co. ended its development program, citing regulatory uncertainty.

MannKind shares fell 5.5 percent in regular trading after the FDA's approval announcement but rebounded 70 cents, or 7 percent, to $10.70 in after-hours trading Friday.

Michaels has tepid return to public markets

NEW YORK -- Michaels had a tepid return to the stock market Friday, its shares going back and forth between small gains and declines.

The arts and crafts store operator's shares closed up 2 cents to $17.02 in trading on the Nasdaq, after falling as much as 2 percent earlier.

The lackluster response shows investors are wary of retailing and the fragmented $30 billion arts and crafts industry. The last IPO from a major retailer was The Container Store Group Inc., which made its debut in November. Its shares have fallen 20 percent since then and closed at $29 Friday.

The IPO comes amid a market rush. It's the third-busiest week for IPOs since 2000, according to IPO investment adviser Renaissance Capital.

Michaels Cos. Inc., which also runs the Aaron Brothers chain, priced an initial public offering of 27.8 million shares at $17 each, at the low end of its predicted range.

The Irving, Texas, company raised $472 million from the offering.

Private equity firms Bain Capital LLC and The Blackstone Group LP bought Michaels in a $6 billion leveraged buyout in 2006.

Michaels' IPO was delayed two years after its then-CEO John Menzer resigned after a stroke.

Michaels, which was in a sweet spot during the Great Recession when homemade goods gained new currency as people tried to save money, has faced increasingly tough competition. That's coming from discounters — Wal-Mart Stores Inc., for example, recently brought back its fabric offerings — and online king Amazon.com.

Michaels has been late to the online party, launching its e-commerce business only this year.

In an interview with The Associated Press on Friday, Chuck Rubin, who was appointed CEO of Michaels in March 2013, dismissed the market's response. He said he's focusing on long-term opportunities, and that investors will be rewarded.

"This is a marathon, not a sprint," he added.

While there's not a lot of data available on the arts and crafts market, he said Michaels' sales have been growing faster than the industry's annual rate of low-single-digit increases, and it's been taking market share away from other traditional chains, though he declined to give names.

Rubin shrugged off competition from Amazon, saying e-commerce is not as much of a threat as it is to other industries.

"When you sell pieces and parts, we know customers want to come to the brick and mortar stores to see how things come together," he said.

He also noted the average price for an arts and crafts item is $3. "There's no easy showrooming in this industry," he added.

The big opportunity is personalization and taking advantage of social media sites like Pinterest, he says. Michaels wants to focus not only on the crafts enthusiasts but novices as well. Last year, more than 800,000 customers took classes at Michaels stores.

The company, founded in 1973 with one small store in Dallas, said in a regulatory filing that North America could potentially grow to 1,500 Michaels stores. It currently operates 1,263 Michaels stores and 118 Aaron Brothers stores.

Its original debut as a public company came in 2001 on the New York Stock Exchange. It's using the same ticker "MIK," but is now trading on the Nasdaq.

For its latest fiscal year, which ended on Feb. 1, sales rose nearly 4 percent to $4.6 billion. Net income rose to $243 million from $200 million.

The arts and crafts chain plans to use the IPO's proceeds to pay down its debt. It had $3.7 billion of debt as of May 3.

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AP Business Reporter Michelle Chapman contributed to this report in New York.

Wheat rises ahead of closely watched report

Wheat prices rose to their highest level in two weeks Friday as traders prepared for the release of a closely watched U.S. crop report Monday.

September wheat rose nine cents, or 1.5 percent, to $5.94 a bushel. That's the highest price since June 10.

The Department of Agriculture will release its quarterly grain stocks report on Monday. The report is expected to show wheat stocks declined as well as a modest decline in the amount of acres of wheat being grown in the U.S.

Corn rose 4 cents, or 1 percent, to $4.47 a bushel and soybeans fell 16 cents, or 1 percent, to $12.28 a bushel ahead of the report.

In other commodities, oil fell 10 cents, or 0.1 percent, to $105.74 a barrel. Wholesale gasoline rose 1.3 cents to close at $3.07 a gallon, natural gas fell 1.1 cents close at $4.39 per 1,000 cubic feet and heating oil fell 1.6 cents to close at $3 a gallon.

In metals, gold rose $3, or 0.2 percent, to $1,320 an ounce. Silver fell three cents, or 0.1 percent, to $21.08 an ounce. Platinum rose $8.40, or 0.6 percent, to $1,478.50 an ounce and palladium rose $7.05, or 0.8 percent, to $842.85 an ounce.

Hedge fund calls off plan for move to Stamford

WESTPORT, Conn. -- A Connecticut-based hedge fund says it is calling off a plan to build a $750 million corporate headquarters in Stamford.

Bridgewater Associates says it made the decision after considering the "challenges, time, energy, and resources" that would be involved in completing the project.

Two years ago Gov. Dannel P. Malloy announced that the state would provide up to $115 million in state aid to support the company's plan to build the new headquarters and create up to 1,000 jobs.

The Westport-based company said in its statement Friday that it is thankful to the governor for his support but it is now exploring other options.

Bridgewater manages about $150 billion in investments worldwide for a variety of clients, including pension funds, university endowments, charities, foreign governments and central banks.

How the Dow Jones industrial average did Friday

Summertime settled into Wall Street on Friday as major stock indexes drifted slightly higher going into the weekend. The listless day of trading left the stock market with a tiny loss for the week, its second this month. A handful of corporate results drove trading in some big names. Warnings of weaker earnings pushed DuPont down, while stronger results pushed Nike up. But the overall market was essentially flat.

The Dow Jones industrial average rose 5.71 points, less than 0.1 percent, to close at 16,851.84.

The Standard & Poor's 500 index rose 3.74 points, or 0.2 percent, to 1,960.96.

The Nasdaq composite index rose 18.88 points, or 0.4 percent, to 4,397.93.

For the week:

The Dow fell 95.24 points, or 0.6 percent.

The S&P 500 fell 1.91 points, or 0.1 percent.

The Nasdaq rose 29.89 points, or 0.7 percent.

For the year:

The Dow is up 275.18 points, or 1.7 percent.

The S&P 500 index is up 112.60 points, or 6.1 percent.

The Nasdaq is up 221.34 points, or 5.3 percent.

Board blocks demolition of Vicksburg building

VICKSBURG, Miss. -- A Vicksburg businessman's plans to demolish the two-story brick building he owns have been put on hold again by the Board of Architectural Review.

The Vicksburg Post reported (http://bit.ly/1nPQEje) that the board for a second time refused to give Robert Johnson approval to tear down the building at the corner of Speed and Washington streets to make way for a used-car lot. The board issued a five-month stay on demolition.

The building is in Vicksburg's historic district and board members say it is an important structure. In February, the board had issued a 4 and a half month stay for further consideration of the request.

Demolition stays are issued to give property owners in the district time to consider alternatives to taking them down, such as renovation.

Johnson said in February that he wanted to remove the building. Several board members recommended that Johnson renovate the building, including removing the top floor and remodeling and using its ground-floor portion.

Johnson, however, said he couldn't afford to repair the building.

Several board members also suggested Johnson sell the building, but he said the property's corner lot is a good fit for his proposed car business.

The building was home to a television and electronics repair shop from 1966 to 2009. It was built about 1910 by Lebanese immigrant Elias Bodron, who opened Bodron's Grocery on its first floor.

Sirens, phones sound erroneous alert in California

LOS ANGELES -- People in San Luis Obispo County received a series of unsettling, erroneous emergency alerts Friday as repairs were being made to a nuclear power plant's siren system, including a vague cellphone message that told them to "prepare for action."

The chain of mistaken alerts began arousing confusion and fear when a siren that's part of the Diablo Canyon Power Plant's warning system began wailing Friday afternoon for no apparent reason, county emergency services manager Ron Alsop said.

Earlier in the day, crews had upgraded the siren as part of a summer-long revamp of the emergency system by Pacific Gas & Electric Co.

To indicate there was no emergency, county officials issued an alert.

"Unbeknownst to us, with a new emergency alert system, it also triggered the new wireless alert cellphone system," Alsop said.

Across the county, people's cellphones buzzed with a special tone and a vague message that said there was a "civil emergency in this area" and people should "prepare for action."

The warning halted wine tasting at the Saucelito Canyon Vineyard & Winery in San Luis Obispo, manager Katherine Taylor said.

"I had 15 people here, looking at their phones and asking what to do," she said.

Nisse Noble, 27, was at her online apparel company's office when she received the message. The vague warning was "unsettling," leading her to think there was a mass shooting, a nuclear accident or a criminal at large in the area, she said.

"We didn't know where we should turn or what we should prepare for," Noble said.

When county officials realized the gaffe, they issued a final message stating that there was no cause for alarm.

"We're just glad we learned this before we had an actual emergency," Alsop said.