Forest Labs Fights Back, VNDA Gets Thumbs Up From FDA, IntelGenx Awaits Decision

(RTTNews) - Forest Laboratories Inc. (FRX) has filed a patent infringement lawsuit against Sun Pharma Global FZE, Teva Pharmaceuticals USA, Inc., Wockhardt Bio AG, and related companies and subsidiaries which have sought approval to market a generic version of NAMENDA XR before the expiration of some or all of the patents.

Forest Labs' NAMENDA XR, a once-daily extended-release version of the company's immediate release formulation of NAMENDA, is indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Though approved by FDA in 2010, NAMENDA XR was launched only in June 2013.

Since its launch in June 2013 through Dec.2013, NAMENDA XR has raked in sales of $63.3 million.

The FDA is scheduled to announce its decision on RHB-103, an anti-migraine VersaFilm oral film product, co-developed by IntelGenx Technologies Corp. (IGXT.OB) and partner RedHill Biopharma Ltd. (RDHL), on February 3, 2014.

RHB-103 is a proprietary oral fast dissolving thin film formulation of Rizatriptan, the active drug in Merck's headache medicine Maxalt-MLT orally disintegrating tablets.

The approval for VersaFilm is being sought under 505(b)(2) regulatory pathway that allows a company to rely, at least in part, on the FDA's findings of safety and/or effectiveness for a previously approved drug.

IntelGenx, which licensed the VersaFilm oral film product to RedHill Biopharma in June 2011, is eligible to receive up to 50% of all proceeds including, but not limited to, all sales milestones and income from the product world-wide, upon commercialization of RHB-103.

IGXT.OB closed Friday's trading at $0.98, up 9.44%.

Vanda Pharmaceuticals Inc. (VNDA) has received FDA approval for HETLIOZ 20mg capsules for the treatment of Non-24-Hour Sleep-Wake Disorder, which is highly prevalent among the totally blind.

The Non-24-Hour Sleep-Wake Disorder is a chronic, circadian rhythm disorder resulting from the misalignment of the endogenous master body clock to the 24-hour day, disrupting the sleep-wake cycle, and is estimated to affect approximately 80,000 Americans.

HETLIOZ is expected to be commercially available in the second quarter of 2014.

VNDA closed Friday's trading 1.30% higher at $13.23. In after-hours, the stock gained another 1.28% to $13.40.