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Antares Pharma, Inc. (ATRS-NASDAQ)
January 16, 2014
Antares Pharma focuses on patient self-administered parenteral (injectable)
pharmaceutical products
and topical gel-based medicines.
The Company has received marketing approval from the U.S. Food and Drug
Administration for OTREXUP™ (methotrexate) injection for the treatment of adults
with severe active rheumatoid arthritis, children with active polyarticular juvenile
idiopathic arthritis and adults with severe recalcitrant psoriasis.
Antares Pharma is also developing VIBEX® QS T for testosterone replacement
The Company's technology platforms include:
· VIBEX® disposable Medi-Jet, disposable multi-use pen injectors
· Accepts standard pre-fil ed syringes including BD, Schott and others· Fast jet-injection—1/2 ml in less than 1 second· Shallow 2.5 mm needle penetration assures subcutaneous injection· Hidden needle significantly reduces patient apprehension and provides a · Quickly ejects even highly viscous drug products· Retracting collar with lock-out to avoid accidental needle-sticks
· Vision™ reusable needle-free injectors marketed as Tjet® and Zomajet® by
Teva Pharmaceutical Industries, Ltd and Ferring
Pharmaceuticals (Ferring), respectively.
Their novel Medi-Jector is offered by Teva as the Tjet for patients taking TEV-
TROPIN® brand human growth hormone, making injections easier and more
Antares Pharma has a multi-product deal with Teva that includes:
· Tev-Tropin® [somatropin (rDNA origin) for injection] human growth hormone
· VIBEX® epinephrine and several other products.
Antares Pharma’s partnership with Ferring includes
· Zomacton® hGH (somatropin) injection.
In the U.S. Antares has received FDA approval for Gelnique 3%™ (oxybutynin) gel,
an anti-cholinergic drug used as treatment for overactive bladder that is marketed
by Actavis. Oral oxybutynin can cause dry mouth, but the topical gel avoids “first
pass metabolism” (i.e.: avoids passage through the liver before entering the blood
stream). This minimizes the creation of a metabolite that causes undesirable side
effects, like dry mouth.
Several large population studies have reported that overactive bladder (OAB) affects
approximately 16% of adults and that the incidence increases with age. It is believed
that around 100 mil ion people worldwide experience symptoms of OAB, with women
being affected more than men. Urinary incontinence in the elderly is a particular
problem with up to 50% of the inhabitants in US nursing homes suffering from
Elestrin® (estradiol gel) is FDA approved for the treatment of moderate-to-severe
vasomotor symptoms associated with menopause, and is marketed in the U.S. by
Meda Pharma.
Antares Pharma has two facilities in the U.S.
· The Parenteral Products Group located in Minneapolis, Minnesota directs the
manufacturing and marketing of the Company’s reusable needle-free injection
devices and related disposables, and develops its disposable pressure-assisted
Medi-Jet and pen injector systems
· The Company’s corporate office and Product Development and Commercial
Groups are located in Ewing, New Jersey.

Abbreviated New Drug Application (ANDA)
An Abbreviated New Drug Application (ANDA) contains data that, when submitted to
FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides
for the review and ultimate approval of a generic drug product. Generic drug
applications are called "abbreviated" because they are generally not required to
include preclinical (animal) and clinical (human) data to establish safety and
effectiveness. Instead, a generic applicant must scientifically demonstrate that its
product is bioequivalent (i.e., performs in the same manner as the innovator drug).
Once approved, an applicant may manufacture and market the generic drug product
to provide a safe, effective, low cost alternative to the American public.
New Drug Application (NDA)
When the sponsor of a new drug believes that enough evidence on the drug's safety
and effectiveness has been obtained to meet FDA's requirements for marketing
approval, the sponsor submits to FDA a new drug application (NDA). The application
must contain data from specific technical viewpoints for review, including chemistry,
pharmacology, medical, biopharmaceutics, and statistics. If the NDA is approved, the
product may be marketed in the United States. For internal tracking purposes, al
NDA's are assigned an NDA number.
Supplement Number/Supplement New Drug Application (sNDA)
A supplement number is associated with an existing FDA New Drug Application
(NDA) number. Companies are allowed to make changes to drugs or their labels
after they have been approved. To change a label, market a new dosage or strength
of a drug, or change the way it manufactures a drug, a company must submit a
supplemental new drug application (sNDA).
The stock has performed better than market expectations in recent months
and should continue to do well as current products continue to expand their markets
and the pipeline products get approved and marketed.
Antares Pharma is a well-run company that manufactures its own products
and partners with other companies that utilize Antares’ patented, patient friendly,
injectable and topical delivery systems. The company has 5 products that are
currently being marketed that are partnered and 10 products in its pipeline in various
stages of approval, including three of its own and seven that are partnered. Its stock
has been doing well in recent months and should continue to do so for the
foreseeable future.
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Source: http://stocksthatmove.com/dr_corner/ATRS.pdf


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