HEALTH

MannKind has dip in profit, flat sales

BY Alaric DeArment

VALENCIA, Calif. A drug company focused on developing drugs for diabetes and cancer reported a reduction in operating, research and development and general and administrative expenses of more than $32 million in its first quarter 2009 financial results Monday.

MannKind Corp. said the decrease in research and development expenses, by $15.6 million, was primarily due to decreased costs associated with the clinical development of the fast-acting insulin Afresa.

Cash, cash equivalents and marketable securities were $30.2 million as of March 31, compared with $46.5 million on Dec. 31 and $269.1 million on March 31, 2008.

“This past quarter was extremely busy for MannKind, culminating in our submission to the FDA of a new drug application for Afresa.” chairman and CEO Alfred Mann said in a statement. “With this milestone accomplished, we are now turning our attention to commercial readiness activities.”

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HHS releases television, radio PSAs on swine flu

BY Michael Johnsen

WASHINGTON The U.S. Department of Health and Human Services on Friday announced the availability of television and radio public service announcements on steps people can take against 2009 H1N1 influenza, also known as the swine flu.

The TV PSA, a 60-second spot featuring Acting Surgeon General Steven Galson, will be satellite fed 2 p.m. on Friday. The feed will be handled by the National Association of Broadcasters.

The NAB has posted a broadcast quality download at this site: https://download.yousendit.com/WnBSMFhqQ0M5RlpMWEE9PQ.

Three 30-second radio PSAs in English and another three in Spanish are available for download at a site hosted by the Centers for Disease Control and Prevention. The spots are in MP3 format and are accompanied by matching live-read scripts.

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FDA warns consumers about Hydroxycut

BY Michael Johnsen

ROCKVILLE, Md. The Food and Drug Administration on Friday warned consumers to immediately stop using Hydroxycut products by Iovate Health Sciences based on a possible association with a number of serious liver injuries.

Iovate has agreed to recall Hydroxycut products from the market.

“Iovate Health Sciences is strongly committed to product safety and welcomes balanced regulation for the dietary supplement industry,” the company stated Friday. “The number of adverse event reports described by the FDA in its advisory is small relative to the many millions of people who have used Hydroxycut products over the past seven years. Iovate’s own assessment of the potential risk associated with the use of these products differs from that expressed by the FDA. Every product marketed by Iovate is evaluated during its development for the safety of its individual ingredients,” the company noted.

Steve Mister, president and CEO for the Council for Responsible Nutrition, stated that, “both the Food and Drug Administration, as well as the manufacturer of the Hydroxycut products in question, took appropriate action today. We commend FDA for warning consumers of a potential safety problem associated with these products, and were encouraged to see that the company — Iovate Health Sciences — agreed to recall the products from the market until further determinations can be made.”

Hydroxycut is the leading dietary supplement diet aid in food, drug and mass markets, generating $36.8 million in sales across food, drug and mass (minus Walmart) outlets for the 52 weeks ended Oct. 5, 2008, according to Information Resources Inc. data. According to FDA officials, Hydroxycut reported it had sold more than 9 million units in the calendar year of 2008.

“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk,” stated Linda Katz, interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition. During a press conference with reporters Friday morning, the identification of the possible link between liver adverse events and Hydroxycut was made possible in part by the mandatory reporting of adverse events associated with dietary supplements.

The FDA has received 23 reports of serious health problems, ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

The death occurred in the fall of 2007 and was reported to the agency in March, 2009, FDA stated. “[However], the 2007 death referenced by the FDA was not caused by Hydroxycut,” the company noted.

Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching and loss of appetite.

Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids and for water loss under the Iovate and MuscleTech brand names. The list of products being recalled by Iovate currently includes:

  • Hydroxycut Regular Rapid Release Caplets
  • Hydroxycut Caffeine-Free Rapid Release Caplets
  • Hydroxycut Hardcore Liquid Caplets
  • Hydroxycut Max Liquid Caplets
  • Hydroxycut Regular Drink Packets
  • Hydroxycut Caffeine-Free Drink Packets
  • Hydroxycut Hardcore Drink Packets (Ignition Stix)
  • Hydroxycut Max Drink Packets
  • Hydroxycut Liquid Shots
  • Hydroxycut Hardcore RTDs (Ready-to-Drink)
  • Hydroxycut Max Aqua Shed
  • Hydroxycut 24
  • Hydroxycut Carb Control
  • Hydroxycut Natural

Although the FDA has not received reports of serious liver-related adverse reactions for all Hydroxycut products, Iovate has agreed to recall all the products listed above. Hydroxycut Cleanse and Hoodia products are not affected by the recall.

KelloggsDRSNhttp://www.centerstoregrowth.com

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