© 2012 Natural Wellness®. All rights reserved.

These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease. Natural Wellness® has developed certain nutritional supplements to meet the specified needs of our customers. These products are not intended to diagnose, treat, cure, or prevent a disease, but rather are dietary supplements intended solely for nutritional support. These statements have not been evaluated by the Food and Drug Administration. Testimonials reflect the personal experience of each person quoted. Individual results may vary. the information provided on this site is not intended as a substitute for advice from your physician or other health care professional or any information contained on or in any product label or packaging. Please consult with a healthcare professional before starting any diet, exercise or supplementation program, before taking any medication, or if you have or suspect you might have a health problem.

The wait for the shingles vaccine continues, and figures to get even longer, as word spreads that the Food and Drug Administration has approved its use in 50- to 59-year-olds.

The Centers for Disease Control and Prevention has not yet incorporated the FDA’s March 24 announcement into its recommendations. the Advisory Committee on Immunization Practices, which makes vaccine recommendations to the CDC, is expected to discuss the topic next month.

Many facilities and insurance companies say they will wait for CDC approval to make the vaccine available to the 50-59 age group. the vaccine costs $180 to $220. Medicare part D covers it, but some insurance companies do not.

An estimated 1 million Americans a year — 200,000 of them between the ages of 50 and 59 — battle the painful, blistering condition known as shingles. It is a disease caused by the varicella-zoster virus, which is part of the herpes family and is the same virus that causes chickenpox.

After an attack of chickenpox, the virus lies dormant in certain nerves in the body. for reasons not fully understood, the virus can reappear in the form of shingles, “more commonly in people with weakened immune systems and with aging” the FDA stated in a March 24 media release.

”the likelihood of shingles increases with age,” said Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research. “the availability of Zostavax to a younger age group provides an additional opportunity to prevent this often painful and debilitating disease.”

”We get calls every day for it,” said Kristin Campbell, office manager at Lima’s Pharmacy in McKinleyville. “It’s back-ordered until June.”

Campbell said she has 25 people on her waiting list and 20 vaccines due to arrive next month.

Costco pharmacist Derby McLaughlin said his list numbers 119.

”We’ve been out of it for maybe four or five months,” he said. “We just got it back in stock now — maybe 40 vaccinations — and we are constantly trying to re-order.”

Cloney’s pharmacist Richard Spini said more than 200 names dotted his waitlist last fall.

”the 20 vaccines we just got is a release from about four months ago,” he said. “That’s how far behind Merck is. We have orders in, but they tell me they aren’t going to fill them for another four months.”

”Manufacturing issues” is the reason Merck gave for the backlog, according to other news reports.

Since 2006, a vaccine called Zostavax has been available to people age 60 and older. It was credited with a 55 percent reduction of people developing shingles and a 67 percent reduction in pain at the site of the rash that can persist for weeks, months or years.

”now that they’ve lowered the age, a lot more people are eligible and it is apparently more effective when given at a younger age,” Spini said.

The FDA announcement to lower the age of approval was based on a multi-center study of 22,000 people ages 50 to 59 conducted in the United States and four other countries. Half the group received Zostavax and half a placebo. Participants were monitored for at least one year to see if they developed shingles.

”Compared with the placebo, Zostavax reduced the risk of developing shingles by approximately 70 percent,” the FDA stated.

Shingles is characterized by a rash of blisters that tend to develop in a strip around one side of the body, usually in the upper quadrant of the head, along the shoulder and upper back or around the abdomen.

Pain, or in some cases a burning sensation or itch, usually appears one to five days before the blistering rash. other symptoms include upset stomach, fever, headache or chills.

The rash scabs over in 10 days and clears up within two to four weeks, but one in five people will develop serious, long-term pain known as postherpetic neuralgia.

Other complications may include blindness, skin infections and neurological problems associated with hearing, balance, facial paralysis or brain inflammation.

”I’ve known people whose lives were destroyed by it,” Dr. Alan Glaseroff told Tri-City Weekly in a story posted online March 1.

In younger people, Glaseroff said, it tends to be “the rash, a couple of weeks of pain, the memory of it and then it’s over. in old people, it can be a lifetime of pain.”

The CDC reports one out of every three people in the United States will develop shingles.

Half of all shingles cases occur in men and women age 60 and older and half of all people living to age 85 will ultimately deal with it, the CDC says. yet only 10 percent of the over-60 age group took advantage of the vaccine in 2009.

St. Louis Cardinals manager Tony La Russa wasn’t among them. the 66-year-old was reportedly diagnosed with shingles by the Mayo Clinic early in may. the appearance of his right eye and head — and the obvious pain and discomfort visible at press conferences — raised awareness of the disease in the Midwest and may help some determine the wisdom of vaccination.

”in the case of shingles, a picture is indeed worth a thousand words,” said Cindy Denbo, executive director of Area 1 Agency on Aging.

——

Carol Harrison is a freelance journalist commissioned by Area 1 Agency on Aging to produce this column twice a month.

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CORRECTIONRegarding the article “Protect yourself from HPV” that ran Feb. 14, Dr. Yolanda Reid-Chassiakos, director of Klotz Student Health Center, said “The HPV vaccine Gardisil provides immunity to four different strains of HPV, strains that can cause warts and increase the risk of cervical cancer. to date, vaccine testing for FDA approval has only included those ages 9-26, but further testing may expand this age recommendation in the future. The good news is Gardisil is recommended for women and man who have had unprotected sex and even have had HPV. That’s because even if you’ve been infected with one or two strains of HPV, you can still be protected from the others.”

Your palms are sweaty, you’re rocking back and forth in the chair staring aimlessly at the floor and you can’t seem to make your left leg stop shaking. It’s been two weeks since your last visit to the doctor. You’re there because you got a call saying your results were in and they needed to talk to you.

It could have been your last relationship or maybe it was that drunken night over the summer when you didn’t use protection that has put you in this position.  Maybe they had something they didn’t know about or maybe they just didn’t tell you.

That’s the case for millions of people in the United States when it comes to Human Papillomavirus, also known as HPV. according to the American Social Health Association, about 5.5 million new cases of sexually transmitted HPV infections are reported every year, but they estimate that roughly 6.2 million actually occur.

Even with such a prolific disease on our hands and one that can possibly lead to cervical cancer in women, we have not found a way to stem the tide.

The National Institutes of Health reports HPV is the most common STD today.  There are about 100 different types and about 30 types put women at risk for cancer.  Other types put both men and women at risk for genital warts.

According to the Center of Disease Control and Prevention, 50 percent of men and women will have genital HPV at some point in their lives. but even though 90 percent of strains will clear themselves over two years, there are basically no symptoms.  a lot of sexually active Americans have it and don’t even know it.

So how do you find out and do you tell people once you know you have it?

In 2008, an Iowa court found Dr. Alan Evans guilty of negligent transmission of the sexually transmitted disease HPV.  The case has undergone the appeal process once but the verdict still stands.

Evans, a dentist, argued that although he and his then-partner, Karly Rossiter, discussed whether or not they had any STDs before having sex, he was not aware he was carrying the virus.

Rossiter’s strain of HPV later developed into cervical cancer. She sued Evans and was awarded $1.5 million in punitive damages. The court found that whether or not Evans knew he had the virus or not was not the problem, but rather the fact that he had led her to believe he was disease-free and monogamous.

The court also argued that he should have known that he had HPV and genital warts.

However, according to the CDC there is no test for HVP other than to screen for cervical cancer. and what guy can get tested for cervical cancer when he doesn’t have the equipment?

So being there is no test, how does one know?

Well, you’ll know if you wake up one morning with a pasture of mini cauliflowers on your genitals, but many people never will.  More often than not, people will not know they are carrying it and are unwittingly transferring the disease to their partners meaning the only thing you can do is protect yourself.

There are vaccinations available for both males and females, available and effective only for people between 9 and 26 years old. The vaccination will not work if you currently have a strain of HPV at the time of the injection series, so the younger the better. one vaccine called Gardasil protects from cervical cancer and most strains of genital warts.

But if it’s too late for you, meaning you’ve already had unprotected sex or you’re older than 26, the only thing you can do is wrap it up or close your legs. Condoms don’t completely protect you from all strains of HPV, but according to the CDC, it protects you from most.

And the best protection is no intercourse at all until one is checked completely for the virus.

The U.S. Food & Drug Administration (FDA) has set up a website for metal-on-metal hip implants, which among other things, details the potential risks posed by these devices. the new website comes months after DePuy Orthopaedics, a subsidiary of Johnson & Johnson, issued a worldwide recall of two ASR hip implants, which were metal-on-metal hip components.

A metal-on-metal hip implant is made of chromium and cobalt, and consists of a cup that’s implanted into the hip with a ball joint that connects to the leg. according to a New York Times report published in March 2010, metal-on-metal hip implants have been used in about one-third of the approximately 250,000 hip replacements performed annually in this country. However, many of the nation’s leading orthopedic surgeons have reduced or stopped use of these devices because of concerns that they can cause severe tissue and bone damage.

According to the FDA metal-on-metal hip implant site, because the metal ball and the metal cup on these device slide against each other during walking or running, some tiny metal particles may wear off of the device and enter into the space around the implant. some of the metal ions from the metal implant or from the metal particles may even get into the bloodstream. it is known that over time, the metal particles around some implants can cause damage to bone and/or tissue surrounding the implant and joint. This is sometimes referred to as an “adverse local tissue reaction (ALTR)” or an “adverse reaction to metal debris (ARMD).” such a reaction may cause the implant to become loose or cause pain. Ultimately this can require a revision surgery where the old device is removed and replaced with another one, the FDA said.

The FDA advises that recipients of metal-on-metal hip implants be aware of potential symptoms which may occur after surgery and indicate that their device is not functioning properly. Common symptoms may include:

• Pain in the groin, hip or leg• Swelling at or near the hip joint• A limp or change in walking ability

Metal-on-metal hip implant patients should also pay close attention to changes in their general health or new symptoms outside their hip including symptoms related to their:

• Heart (chest pain, shortness of breath)• Nerves (numbness, weakness, change in vision or hearing)• Thyroid (fatigue, feeling cold, weight gain)• Kidney (change in urination habits

The FDA website also details recalls involving metal-on-metal hip implants, including the DePuy ASR hip implant recall, as well as the recall of the Zimmer Durom® Acetabular Component (”Durom Cup”) issued in 2008.

© 2010 Natural Wellness®. all rights reserved.

These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease. Natural Wellness has developed certain nutritional supplements to meet the specified needs of our customers. these products are not intended to diagnose, treat, cure, or prevent a disease, but rather are dietary supplements intended solely for nutritional support. these statements have not been evaluated by the Food and Drug Administration. Testimonials reflect the personal experience of each person quoted. Individual results may vary. the information provided on this site is not intended as a substitute for advice from your physician or other health care professional or any information contained on or in any product label or packaging. Please consult with a healthcare professional before starting any diet, exercise or supplementation program, before taking any medication, or if you have or suspect you might have a health problem.

Posted on: Tuesday, 25 January 2011, 12:23 CST

BRIDGEWATER, N.J. and CHATTANOOGA, Tenn., Jan. 25, 2011 /PRNewswire/ — Sanofi-aventis U.S., and its U.S. Consumer Healthcare Division, Chattem, inc., announced today that the U.S. Food and Drug Administration (FDA) has approved the Allegra(®) family of allergy medication products for over-the-counter (OTC) use in adults and children two years of age and older. Additionally, Allegra-D(®), which also relieves nasal congestion and sinus pressure, will be available without a prescription at the pharmacy counter for use in adults and children 12 years of age and older. Allegra(®) and Allegra-D(® )will be available in March 2011 in their original prescription strengths without a prescription.

“As an allergist, I’m often addressing my patients’ concerns about treating their allergy symptoms with a medicine that can relieve their symptoms quickly and doesn’t make them tired or groggy,” said Eli Meltzer, MD, Co-director Allergy & Asthma Medical Group and Research Center, San Diego, CA. “The availability of the Allegra(®) family of products over the counter will provide my patients with the same effective relief they’ve received from prescription Allegra for many years, now without a prescription.”

Over 40 million adults suffer from indoor and outdoor allergies in the United States. Allegra(®) offers fast, non-drowsy, 24-hour relief of allergy symptoms: sneezing; runny nose; itchy, watery eyes; and itchy nose or throat. Allegra(®) has provided allergy sufferers with relief of symptoms for nearly 15 years.

“Leveraging our U.S. Consumer Healthcare platform to convert prescription medicines to OTC products is a key growth driver for sanofi-aventis to become a diversified healthcare company also in the United States,” said Hanspeter Spek, President, Global Operations, sanofi-aventis. “The approval of Allegra(®) for OTC use further validates our vision to increase our presence in the U.S. consumer healthcare market.”

“We’re pleased to provide U.S. consumer access to Allegra(®), the number one U.S.-prescribed allergy treatment, allowing allergy sufferers to conveniently obtain a safe and effective medication without a prescription,” said Zan Guerry, Chief Executive Officer, Chattem.

The Allegra(®) family of OTC products will be available without a prescription for allergy sufferers in drug, grocery, mass merchandiser and club stores nationwide. This includes Allegra(®) 24-Hour and 12-Hour Tablets for adults and children 12 years of age and older; Children’s Allegra(® )12-Hour Tablets for six years of age and older, and Liquid for use in two years of age and older; Children’s Allegra(® )12-Hour Orally Disintegrating Tablets for use in six years of age and older; and Allegra-D(®) 24-Hour and 12-Hour Allergy and Congestion Extended Release Tablets (with a decongestant) for use in children 12 years of age and older.

People can visit Allegra.com for more information. if allergy sufferers have additional questions, they should talk to their allergist, pharmacist or other healthcare provider.

About Allergies

Millions of Americans suffer from allergies. Allergies are caused when a person’s body overreacts to substances called “allergens.” these substances are often referred to as triggers. People can experience allergy triggers anytime throughout the year. Symptoms may include sneezing; runny nose; itchy; watery eyes; and itchy nose or throat. with proper management and patient education, allergy symptoms can be relieved.

About sanofi-aventis

Sanofi-aventis U.S. is an affiliate of sanofi-aventis, a leading global pharmaceutical company that discovers, develops and distributes therapeutic solutions to help improve the lives of patients. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). for more information, sanofi-aventis.us or sanofi-aventis.com

About Chattem

In March 2010, Chattem, inc. became a wholly-owned subsidiary of the sanofi-aventis Group; as the consumer healthcare division of sanofi-aventis in the U.S. Chattem is approximately 130 years old and is a leading manufacturer and marketer of branded consumer healthcare products, toiletries and dietary supplements across niche market segments in the United States. for more information, please visit Chattem’s website at chattem.com.

Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. these statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans” and similar expressions. Although sanofi-aventis’ management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. these risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities as well as those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under “Risk Factors” and “Cautionary Statement regarding Forward-Looking Statements” in sanofi-aventis’ annual report on Form 20-F for the year ended December 31, 2009. other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

U.S. Media Contact —————— Susan Brooks 908.981.6566

SOURCE sanofi-aventis

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Illuminating Alzheimer’s: Physicians can detect signs of Alzheimer’s in the living human brain thanks to a new imaging tool. High levels of amyloid plaques, a hallmark of the disease, are marked in red. Credit: Avid Radiopharmaceuticals.

An advisory panel for the U.S. Food and Drug Administration gave conditional approval on Thursday for a new imaging agent that could aid in early detection of Alzheimer’s. if the FDA follows the panel’s recommendation, as it usually does, it will be the first such tool available to physicians to detect amyloid plaques, the neurological hallmark of the disease, in the living human brain.

As I noted in a story we posted yesterday on the technology, experts say the tracer will be especially useful in future research studies testing drugs designed to prevent the brain damage that causes Alzheimer’s, as well as in diagnosing difficult and atypical cases of the disease.

The tracer, developed by Avid Radiopharmaceuticals (recently acquired by Eli Lilly) binds to amyloid plaques in the brain and is detected via position emission tomography (PET) scans. Previously, the only definitive way to detect amyloid in the brain, and hence definitely diagnose the disease, was via an autopsy.

The approval is conditional on the development of standards that make reading the scans consistent between radiologists and a doctor-training program. According to a report from the New York Times,

The question about interpreting the scans arose because in the Avid study, radiologists did not establish a firm cutoff point that would say whether a person had significant amounts of plaque. Instead they did a graded analysis. What is needed in practice is a set level that would say yes or no, and distinguish significant plaque accumulation from insignificant amounts. and the company must show that its cutoff points are accurate and that different radiologists assess the same scan in the same way.

Some people have plaque without having Alzheimer’s, so if a scan shows plaque, doctors will have to use their clinical judgment, taking into account a patient’s symptoms, in deciding what the scan results mean, noted Dr. P. Murali Doraiswamy, an Alzheimer’s researcher at Duke University and a clinical investigator in the Avid trial. but if a scan shows no plaque, the situation is simpler, Dr. Doraiswamy said. It means the doctor should focus on other causes for the symptoms.

Posted on: Friday, 7 January 2011, 18:40 CST

New findings could lead to new treatments for the 95 percent of Parkinson’s cases with no known cause

Just 5 percent of Parkinson’s disease cases can be explained by genetic mutation, while the rest have no known cause. but a new discovery by researchers at the University of Texas Health Science Center may begin to explain why the vast majority of Parkinson’s patients develop the progressive neurodegenerative disease.

This week in the Journal of Neuroscience, the researchers demystified a process that leads to the death of brain cells – or neurons – in Parkinson’s patients. When researchers blocked the process, the neurons survived.

The findings could lead to an effective treatment to slow the progression of Parkinson’s disease, rather than simply address symptoms that include tremors, slowed movement, muscle stiffness and impaired balance. further studies could lead to a diagnostic test that could screen for Parkinson’s years before symptoms develop, said Syed Z. Imam, Ph.D., adjunct assistant professor at the UT Health Science Center.

Parkinson’s disease, which usually is not diagnosed until age 60 or later, affects an estimated half-million people in the United States.

Dr. Imam joined the U.S. Food and Drug Administration (FDA) after the research was conducted. Co-authors are from the Health Science Center’s Barshop Institute for Longevity and Aging Studies; the South Texas Veterans Health Care system; and the Hertie Institute for Clinical Brain Research in Tübingen, Germany.

The mechanism

After analyzing cells and post-mortem brain tissue from animals and humans, researchers noted that oxidative stress – a known culprit in neuron death – activated a protein called tyrosine kinase c-Abl in the nigra-striatum area of the brain. Neurons in this part of the brain are particularly vulnerable to Parkinson’s injury.

Activation of this protein led to changes in another protein called parkin, which is known to be mutated in hereditary Parkinson’s. the altered parkin lacked the capacity to break down other proteins, leading to harmful clumps of unprocessed protein in the neuron. the scientists believe this accumulation leads to progressive neuron death, resulting in Parkinson’s symptoms that worsen over time.

Implications

“When we blocked tyrosine kinase c-Abl activation, parkin function was preserved and neurons were spared,” Dr. Imam said. “We believe these studies provide sound rationale for moving forward with a preclinical trial of tyrosine kinase c-Abl inhibitors, with the goal of developing a potent therapeutic drug for slowing the progression of Parkinson’s.”

If preclinical trials in animal models of Parkinson’s disease yield positive results, the next step would be clinical trials in human patients, Dr. Imam said.

Tyrosine kinase c-Abl inhibitors are approved by the FDA for treating myeloid leukemia and gastrointestinal tumors. This could speed approval of the drug for Parkinson’s and its translation from bench research to clinical practice.

“The race is on to understand the mechanism of the 95 percent of Parkinson’s cases with no known cause, and our finding certainly is a building block,” Dr. Imam said. “We have found a specific signaling mechanism that is only turned on by oxidative stress and is selective only to Parkinson’s-affected neurons of the nigra-striatum, which is the area that sends signals for balance to the cerebellum.”

Acknowledgements

Co-authors from the UT Health Science Center San Antonio are Senlin Li, M.D., senior author; Qing Zhou, Ph.D.; Anthony J. Valente, Ph.D.; Mona C. Bains, Ph.D.; Robert a. Clark, M.D.; and James L. Roberts, Ph.D., whose primary appointment is now at Trinity University in San Antonio. Co-authors represent the School of Medicine and the Graduate School of Biomedical Sciences as well as the Barshop Institute.

The National Institutes of Health, Michael J. Fox Foundation, American Parkinson’s Disease Association, Parkinson’s Disease Foundation, San Antonio Area Foundation and Health Science Center Presidential Research Enhancement Fund supported the research.

On the Net:

• HSC News
• The Journal of Neuroscience

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EWING, N.J.–(BUSINESS WIRE)–Antares Pharma, inc. (NYSE Amex: AIS) today announced the filing of a new Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Anturol® Gel in patients with overactive bladder (OAB).

“the NDA submission for Anturol represents a significant accomplishment for the Company in 2010. the dedicated efforts of the Antares team allowed us to achieve our goal of submitting the NDA prior to year end and we are pleased with this achievement”

the NDA submission was supported by a Phase 3 clinical trial, which demonstrated a statistically significant reduction in urinary incontinence episodes for both doses studied (56 mg daily or 84 mg daily). the trial was conducted under a Special Protocol Assessment (SPA) with the FDA. in addition, an Open Label Extension study, evaluating long-term safety has been successfully completed.

“The NDA submission for Anturol represents a significant accomplishment for the Company in 2010. the dedicated efforts of the Antares team allowed us to achieve our goal of submitting the NDA prior to year end and we are pleased with this achievement,” said Paul K. Wotton Ph.D., President and Chief Executive Officer.

Anturol Phase 3 Trial

the NDA submission, subject to acceptance by FDA, was supported by a Phase 3 trial conducted under a Special Protocol Assessment (SPA) with FDA. the trial was a double blind, randomized, parallel placebo-controlled multi-center study that evaluated the efficacy and safety of Anturol in 600 subjects with overactive bladder. the primary objective of the study was to demonstrate that daily treatment of 56mg or 84mg dose of oxybutynin applied in the ATDTM Gel technology for 12 weeks was superior to placebo for the relief of OAB symptoms. the study met its primary endpoint of a statistically significant reduction in urinary incontinence episodes for both doses studied (56 mg daily or 84 mg daily, p=0.028 and 0.033 respectively).

Secondary end points included changes from baseline in average daily urinary frequency, void volume, patient perceptions, as well as safety and tolerability including skin irritation. although not the basis for approval, the 84 mg dose provided highly statistically significant results for the secondary end points of urinary frequency and volume while the 56 mg dose did not reach statistical significance. Additionally, Anturol which uses the proprietary ATD Gel technology was well tolerated in the study. No serious adverse events related to the treatment were reported. Anticholinergic side effects such as dry mouth and constipation were low and no CNS side effects were seen compared to placebo. Treatment-related adverse events that resulted in study discontinuation during the double-blind period were low and similar for both the treatment and placebo groups.

About Overactive Bladder

OAB, also called urge incontinence, is a condition marked by a sudden need to urinate that can happen at any time whether or not the bladder is full. OAB is typically caused when the smooth muscle of the bladder undergoes involuntary contractions and may result in uncontrolled leakage. OAB is defined as urgency, with or without urge incontinence and usually includes frequency and nocturia (waking up one or more times during the night to urinate). According to published reports it is estimated that more than 30 million Americans have OAB, and while it can happen at any age is more prevalent among older individuals. It is more common than both diabetes and asthma. According to IMS the annual OAB prescription market in the United States is valued at approximately $2.0 billion.

About Anturol®

Anturol is oxybutynin gel based on the ATD Gel technology platform which is a clear, odorless, hydroalcoholic gel that provides for delivery of oxybutynin in a non-patch transdermal form. the ATD technology is also used in Elestrin®, an FDA approved product for hormone replacement therapy in postmenopausal women. It has been well recognized that transdermal delivery of drugs including oxybutynin is a safe and effective way of delivering certain drugs that undergo first pass metabolism. by delivering oxybutynin transdermally, first-pass gastric and hepatic metabolism is avoided, which is believed to result in lower anticholinergic side effects such as dry mouth and constipation compared to orally administered treatments. these side effects account for a significant level of patient non-compliance among existing oral OAB treatments.

About Antares Pharma

Antares Pharma focuses on self-injection pharmaceutical products and topical gel-based medicines. the Company’s subcutaneous and intramuscular injection technology platforms include VIBEXTM disposable pressure-assisted auto injectors, ValeoTM/VisionTM reusable needle-free injectors, and disposable multi-use pen injectors. in the injector area, Antares Pharma has a multi-product deal with Teva Pharmaceutical Industries, Ltd that includes Tev-Tropin® human growth hormone and a partnership with Ferring Pharmaceuticals. in the gel-based area, the Company’s lead product candidate is Anturol®, an oxybutynin ATD™ gel that has completed Phase 3 studies for the treatment of OAB (overactive bladder). Antares also has a partnership with BioSante that includes LibiGel® (transdermal testosterone gel) in Phase 3 clinical development for the treatment of female sexual dysfunction (FSD), and Elestrin® (estradiol gel) indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and currently marketed in the U.S. Antares Pharma has corporate headquarters in Ewing, new Jersey, with subsidiaries performing research, development and product commercialization activities in Minneapolis, Minnesota and Muttenz, Switzerland.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements related to the potential success or failure of the Anturol NDA and the impact of Phase 3 trials on the NDA. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. these risks and uncertainties include, among others, difficulties or delays in the initiation, progress, or completion of product development, clinical trials, difficulties or delays in the progress or completion of Anturol’s product development or in the success of the NDA and whether or not the Company’s application for marketing approval is accepted for review or at all by the FDA or any other regulatory authority. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2009, and in the Company’s other periodic reports and filings with the Securities and Exchange Commission. the Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.