In a little more than two months' time, the U.S. Food and Drug Administration is all set to announce its decision on whether or not to approve Antares Pharma Inc.'s (AIS) Anturol gel for the management of overactive bladder.
Overactive Bladder , or OAB for short, is a urological condition that causes a sudden and unstoppable need to urinate, even if only a small amount of urine is present in the bladder. More than 30 million Americans have OAB, and the annual OAB prescription market in the United States is valued at about $2.0 billion by pharmaceutical market research firm IMS Health Inc.
According to a report by Global Industry Analysts Inc., over 200 million people worldwide are estimated to be affected by overactive bladder. The global market for overactive bladder drug therapies is projected to be in excess of $4.0 billion by the year 2017.
Some of the FDA-approved drugs for overactive bladder include, Novartis' (NVS) Darifenacin, marketed under the brand name Enablex; Pfizer Inc.'s (PFE) Fesoterodine marketed under the trade name Toviaz; Watson Pharmaceuticals Inc.'s (WPI) Oxybutynin marketed under the brand names Ditropan, Ditropan XL, Oxytrol and a topical gel called Gelnique; Astellas Pharma Inc.'s Solifenacin sold under the brand name Vesicare; Pfizer's Tolterodine sold under the brand names Detrol, Detrol LA; and Trospium sold under brand names Sanctura and Sanctura XR.
Anturol delivers the FDA-approved oxybutynin gel using Antares Pharma's ATD (advanced transdermal delivery) Gel technology platform, which allows the oxybutynin gel to be systemically absorbed through the skin in a controlled manner.
Antares filed its New Drug Application with the FDA for Anturol Gel in patients with overactive bladder late last year. The NDA submission was based on a phase 3 clinical trial, which demonstrated a statistically significant reduction in urinary incontinence episodes for two doses namely, 56 mg daily or 84 mg daily. The trial was conducted under a Special Protocol Assessment with the FDA.
The regulatory agency would decide on whether to approve Anturol Gel on December 8, 2011.
Anturol gel is licensed to Watson Pharma, which has exclusive rights in the U.S. and Canada to commercialize the product. Under a license agreement signed in July of 2011, Watson will make milestone payments based on the achievement of regulatory approval and certain sales levels to Antares, and also be responsible for certain manufacturing start-up activities. Upon launch of the product, Antares will receive escalating royalties based on product sales in the U.S. and Canada. Additional details on the agreement are not known.
Antares has a rich pipeline composed of two types of products namely, injectable products and gel products, in various stages of development.
Two of the company's products are set to advance to NDA submission in 2012 and they are VIBEX MTX, an auto-injection system that is being developed to treat patients suffering from rheumatoid arthritis and several other autoimmune diseases and LibiGel, a testosterone gel for the treatment of women who suffer from female sexual dysfunction.
Antares has a partnership with BioSante Pharmaceuticals Inc. (BPAX) for LibiGel and is seeking a licensing partner for VIBEX MTX, for territories outside of the U.S. and Canada.
Antares also has a partnership with Israeli drug giant Teva Pharmaceuticals Industries Ltd. (TEVA). Teva's Tjet injector system, which delivers Tev-Tropin brand human growth hormone, uses Antares' needle-free device to administer the human growth hormone. This needle-free injection was approved by FDA in 2009.
VIBEX Epinephrine, VIBEX 2, Pen 1 and Pen 2 are the other injectable products in Antares Pharma's pipeline that are being developed in partnership with Teva.
The first FDA approved gel product of Antares is Elestrin, approved in 2006, for the treatment of hot flashes associated with menopause. Elestrin was developed in partnership with BioSante. In 2008, a privately-held company Azur Pharma Ltd. acquired U.S. rights to Elestrin from BioSante.
Founded in 1979, Antares was formerly known as Medi-Ject Corp. The company went public in October 1996, offering its shares at a price of $5.50 each. It was in January 2001 that Medi-Ject changed its name to Antares Pharma Inc.
From inception through June 30, 2011, Antares has accumulated aggregate net losses of $139.9 million. The company's revenue stream includes product sales, development revenue, licensing revenue and royalties.
In the second quarter ended June 30, 2011, the company incurred a net loss of $1.55 million or $0.02 per share, unchanged from the year-ago quarter. Total quarterly revenues were $3.5 million, an increase of 16 percent from the comparable quarter of 2010.
Antares ended the second quarter of 2011 with $33.3 million in cash, compared to approximately $9.8 million at December 31, 2010. The increase in cash was due to the public offering of 14,375,000 shares of common stock at $1.60 per share in May.
Shares of Antares have gained more than 40 percent year to date and trade over $2. As the FDA decision date approaches, it's time to keep an eye on AIS.
by RTT Staff Writer
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