D-Day Nearing For Antares Pharma

(RTTNews) - Shares of Antares Pharma Inc. (ATRS) have lost nearly 7% of their value so far this month, as the company's regulatory catalyst draws closer.

Antares Pharma is a revenue-generating, specialty pharmaceutical company, focusing on self-injection pharmaceutical products and technologies, and topical gel-based products.

The immediate catalyst of Antares Pharma that is going to impact its share price is the FDA decision on the company's resubmitted NDA for Xyosted, proposed for the treatment of testosterone deficiency (hypogonadism).

Testosterone, often considered the "fountain of youth", is a major sex hormone in men. The level of this hormone naturally declines with aging. The condition in which the body doesn't produce enough testosterone is known as hypogonadism or simply, Low T, and is associated with specific signs and symptoms, including diminished sex drive and sense of vitality, erectile dysfunction, mood disturbances, fatigue, osteoporosis and difficulty in walking.

Testosterone replacement therapy (TRT) is often recommended to provide and maintain a normal level of testosterone. TRT is available in several forms like skin patch, gels, mouth patch, injections and subcutaneous implants.

AbbVie's AndroGel; Eli Lilly's Axiron; Pfizer's Depo-Testosterone; Actavis' Androderm; Valeant Pharmaceuticals' Android and Endo Pharmaceuticals' Fortesta are some of the leading prescription testosterone treatments.

Antares Pharma's Xyosted is a subcutaneous once-weekly testosterone enanthate delivered via the QuickShot auto injector.

The FDA declined to approve Xyosted last October, citing concerns of an increase in blood pressure and the occurrence of depression and suicidality.

The company resubmitted the Xyosted NDA in April of this year, and it was accepted for review by the FDA the following month, with a decision date set for September 29, 2018.

If approved, Antares Pharma plans to launch Xyosted next quarter.

The commercial products of Antares include Otrexup, prescribed for use in the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriasis; Elestrin, indicated for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) associated with menopause, and marketed in the U.S. by Meda Pharmaceuticals; Gelnique for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency, and marketed by Allergan; Vibex, a generic substitute of Mylan's branded product EpiPen, approved as recently as last month, and marketed by Teva; Sumatriptan Injection, the generic version of GlaxoSmithKline's Imitrex Injection, to treat migraines, and distributed by Teva, and Makena for the prevention of preterm birth in pregnant women, marketed by Amag Pharma.

Recent events:

On August 6, Antares Pharma entered into an agreement with Pfizer Inc. to develop a combination drug device rescue pen. This rescue pen will utilize the Antares QuickShot auto injector and an undisclosed Pfizer drug.

On August 7, the Company reported operating and financial results for the second quarter ended June 30, 2018.

Net loss was $4.5 million or $0.03 per share on total revenue of $14.2 million for the second quarter of 2018. This compared with a net loss of $2.8 million or $0.02 per share and total revenue of $13.4 million in the same period in 2017.

Antares Pharma ended June 30, 2018, with cash, cash equivalents and investments of $28.8 million.

Shares of Antares have traded in a range of $1.58 to $4.09 in the last 1 year. The stock closed Wednesday's trading at $3.30, down 1.79%.