February 14, 2011 09:00 AM Eastern Time 

EWING, N.J.–(BUSINESS WIRE)–Antares Pharma, Inc. (NYSE Amex: AIS) today announced the receipt from the U.S. Food and Drug Administration (FDA) of a waiver, on February 8, 2011, for the $1,500,000 New Drug Application (NDA) filing fee for Anturol® Gel for overactive bladder (OAB).

“We are pleased to have received the waiver for the NDA filing fee for the Anturol NDA. this waiver represents a significant accomplishment for the Company and helps maintain our strong cash position”

The waiver, requested by Antares in accordance with section 736(d)(1)(D) of the Federal Food, Drug and Cosmetic Act, is granted to a small business for the first human drug application that it submits to the FDA for review. To be considered for the waiver, a company must demonstrate it meets the size restrictions established by the Small Business Administration (SBA), which the SBA confirmed for Antares on January 14, 2011. The FDA will typically provide notice of acceptance of the NDA within 60 days of receipt of the waiver.

“We are pleased to have received the waiver for the NDA filing fee for the Anturol NDA. this waiver represents a significant accomplishment for the Company and helps maintain our strong cash position,” said Paul K. Wotton Ph.D., President and Chief Executive Officer.

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.

January 21st, 2011

It is customarily diagnosed in a younger era with a victims customarily in between a ages of 10 to twenty years aged as good as a many ordinarily diagnosed have been males. Bone Cancer Symptoms in HumansThere have been cases of immature kids removing Ewing’s Sarcoma from as immature as 3 or 4 years of age. it frequency is diagnosed or engaged past a age of thirty years old. it is in all diagnosed in Caucasians as good as not as mostly in African-Americans or Asians; in actuality it is really rare. it is a rarely virulent initial growth in a bone as good as is in all found in a Upper legs, hip as good as pelvis of a patient, nonetheless it can start anywhere in a body. This sort of cancer is found inside of a soothing hankie in a bone.

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Pain radiating from a limbs can be a single of a initial indicators upon bone cancer, generally Ewing’s Sarcoma. This suffering starts tiny as good as lifeless as good as escalates fast to a really heated feeling. Elevated LDH levels as good as weight detriment as good as anemia additionally attend with a symptoms of Ewing’s Sarcoma. Tender flourishing which is localized as good as has been strong for multiform weeks or months is an indicator which we should revisit your alloy for serve testing. A cat indicate or MRI will be means to diagnose your cancer as good as will be means to serve discuss it either or not it has widespread to alternative tools of your body, which will confirm a correct march of treatment. Generally, a operation is achieved to mislay a carcenogenic tumor. if a growth is intensely large, amputation might be a prerequisite in sequence to keep a cancer from swelling elsewhere. The operation is afterwards followed by an endless turn or rounds of deviation or chemotherapy.

Ewing’s Sarcoma is a many fatal as good as a second many usual carcenogenic or virulent growth found in a immature cancer patient. There is a presence rate of 5 years which is 70%-80% if a bone cancer is found early sufficient as good as has not metastasized, or widespread as good as has been treated with colour with chemotherapy. if a cancer has metastasized, a prolonged tenure presence rate plummets to around 10%-20%.

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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.

Cancer is a complex disease which is also called as malignant neoplasm. . Invading in adjacent tissues or spreading of uncontrolled growth of cells in the body from one part to another.this metastasis makes it even more dangerous.Diagnosis of cancer at an early stage is most important. Complete cure and easy treatment is possible in early stage and later stage becomes difficult.It is known to be one of the most dreaded diseases because of the high mortality and morbidity rates.

Carcinoma,Sarcoma, Leukemia and Lymphome are the four categories of cancer. Carcinoma is the malignant growth of the epithelial cells. Many parts of the body are effected by this like oesophagus, colon, nose, prostrate, urinary bladder, ureter etc.Parts which are affected, depends on the symptoms.the main symptoms are weight loss and dysphagia is in the case of esophageal carcinoma.

Sarcoma is the type of tumour which arise in bone, muscle, fat, fibrous tissue or cartilage. Sarcoma’s symptoms are pain, fever and swelling at effected site. Sarcomas common types are Kaposi and Ewing.

Blood’s cancer is the Leukemia.In this, there is especially white blood cells which are abnormal. Possibility of Normal functioning does not carry.Leukemia symptoms are fever, chills, weakness, loss of appetite, weight loss, petechiae under skin, bleeding gums, bone pain, sweating at night etc.

Lymphoma acts as the filter system of the body.the most common type of lymphoma is Hodgkin’s disease. the symptoms of this are fever, night sweats, painless swelling of lymph nodes, itching of skin, constant fatigue, weight loss, red patches on skin etc.

Breast cancer, colon cancer, lung cancer and prostrate cancer are the common cancers on the basis of body parts.Cancer in breast is common in females in the age group of 45-55years.the diagnosis of this is made on the basis of any change in the shape, color or texture of the breast or nipple. If anyone notices this, a physician should be contacted as early as possible. Itching, increases sensitivity, burning, pain etc in the breast are the common symptoms.

Colon cancer is also common which is mainly suspected when there is bleeding from the rectum. the position of the tumor in the colon, indicates the color of the blood. Heavy diarrohoea or constipation are the changes in the bowel habits. Fatigue, weakness, loss of appetite & weight, vomiting, nausea, morning sickness, pain in rectum etc are the other symptoms.

Males are affected commonly by lung cancer.Factors is high with cigarette smoking.the common symptoms of lung cancer are cough, bleeding with cough, pain in chest, difficulty in breathing, loss of weight, fatigue, hoarseness or loss of voice, respiratory infection like bronchitis,swelling of fingertips etc. Lung cancer is common by metasis. Bones, liver, adrenal gland etc are the parts which are more effected.

Also gather more details on cancer signs and lip cancer.

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