Avanir Drug Garners Priority Status From FDA

San Diego’s Avanir Pharmaceuticals, Inc. has received priority review from the Food and Drug Administration for its drug Neurodex, which could be used to treat an involuntary emotional expression disorder called pseudobulbar affect.

The disease is found in Alzheimer’s or Parkinson’s patients and affects more than a million people in the United States, according to Avanir.

The company faced some criticism from stockholders last year over whether Avanir’s management was being forthright about the drug’s chances for priority review.

Nearly a year and a half ago, then-Avanir Chief Executive Officer Gerald Yakatan prematurely announced at a conference in New York that the company had priority review status for Neurodex. A press release from that month announcing the priority review remained on the Avanir Web site late last year.

Now, Avanir, in fact, does have the priority review, and expects to hear some form of response from the FDA at the end of July. Priority review status means a drug could be approved or denied within six months from the date of acceptance, according to the FDA. The normal time period is 10 months.

The company’s shares, which trade on the American Stock Exchange under the ticker symbol AVN-R, closed at $15.13 the day of the announcement, April 4. The high trade that day was $15.80, with volume of trading about eight times what it normally garners.

Avanir also announced this month that it has been approved for trading on the Nasdaq stock exchange under the symbol AVNR beginning April 11.

Ultimately, if Neurodex is approved, the priority review status , since it is granted only for therapies for which there is no approved treatment , would allow Avanir to pitch Neurodex to doctors as the only approved treatment.

Avanir has one drug on the market already, Abreva, which treats cold sores, marketed by North Carolina-based GlaxoSmithKline.

Avanir reported a net loss of $30.6 million for the 2005 fiscal year, ending Sept. 30, compared with a net loss of $28.2 million for the year before. The current loss amounts to a drop of about 30 cents per share.

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County Seeks Health Workers’ Input:

The San Diego County Health and Human Services Agency is asking health care employees and other members of the public to be interviewed for a study on the county’s health needs for the next 20 years in relation to the uninsured and under-insured.

One in five residents of the county are uninsured, according to a local nonprofit, the Alliance Healthcare Foundation. Estimates for the state are 7 million.

The “safety net” study is being conducted by Walnut Creek-based emergency services consulting firm Abaris Group, which has a San Diego location.

The study will cost $634,000, said Rene Santiago, deputy director of San Diego County’s Health and Human Services Agency. The county will pay half, and the California Endowment, which funds health care research and other projects, will cover the other half.

Researchers want to gather information through one-on-one interviews with the public, including health care employees and patients. The group has begun holding town hall meetings as a means of gathering participants. For meeting dates, see www.abarisgroup.com, and click on “project sites.”

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New Company Helps Kids Get Fit:

A company started this year to help children lose weight or stay fit, Healthy Kids’ Catalog, has launched a Web site to assist parents in finding fitness products for youths.

Around 16 percent of American children ages 6-19 are overweight, according to the Centers for Disease Control and Prevention.

Co-founder of the San Diego company Marilee Kern is author of the fictional children’s book “It’s Not Your Fault That You’re Overweight , A Story of Enlightenment, Empowerment and Accomplishment for Overweight and Obese Kids.”

The new Web site, www.healthykidscatalog.com, features the ability to search for products by category, nutritional and educational materials and a free monthly e-newsletter, Weight-Wise Kids, that offers health advice, news and resources.

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Novatron Goes To Washington:

San Diego-based Novatron, Inc. is getting a little defensive.

That’s because the Pentagon is using the company’s air sterilization system in its heating and cooling system.

The U.S. government is evaluating BioProtector, along with other such systems, as part of the Pentagon Shield II Exercise.

The system, which treats 60,000 cubic feet of air per minute, could be installed permanently in the Pentagon, the company said.

In addition to ensuring air is safe to breathe in the event of a bioterrorism attack, the system can be used in treating air at hospitals during surgery, pharmaceutical production plants or commercial buildings to kill mold, Novatron reported.

The small private company was founded in 2000.

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Amylin Elects Director:

San Diego-based Qualcomm Inc. President Steven Altman has been elected to the Amylin Pharmaceuticals, Inc. board of directors.

Altman will donate the compensation he receives for the role to diabetes charities.

Altman also is a member of the board of trustees at the Salk Institute, and a past member of the board for the San Diego chapter of the Juvenile Diabetes Research Foundation.

Altman began his career with the San Diego law firm of Gray, Cary, Ware