Canada Approves Forest's Bystolic

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Forest Laboratories, Inc. (FRX) recently announced the Canadian approval of its hypertension treatment, Bystolic (nebivolol). The company expects to launch Bystolic, a long-acting, cardio-selective beta-blocker, in Canada in the second quarter of calendar 2013.

Bystolic, which is already approved and marketed in the US, posted sales of $347.8 million in fiscal 2012, up 31.6%. Forest Labs is working on extending Bystolic’s lifecycle and is conducting a phase III study with a fixed dose combination of Bystolic and Novartis’ (NVS) Diovan (valsartan), the market leader for hypertension. A fixed dose combination product would expand the patient population for Bystolic. Top-line data should be out in the second quarter of calendar 2013.

We note that the company has also been entering into settlement agreements with generic companies that have been looking to launch their generic version of the product. Earlier this month, Forest Labs entered into a settlement agreement with Glenmark Pharmaceuticals Ltd., which was looking to launch its generic version of Bystolic. Under the terms of the settlement agreement, Forest Labs will provide a license to Glenmark allowing the latter to launch its generic version of Bystolic subject to certain conditions.

Apart from Glenmark, Forest Labs has already settled litigation with companies like Hetero Labs Ltd., Alkem Laboratories, Ltd., Indchemie Health Specialties Pvt. Ltd. and Torrent Pharmaceuticals Ltd. All these companies were looking to launch their generic versions of Bystolic.

However, Forest Labs still has patent infringement litigation pending against Amerigen Pharmaceuticals Ltd. and Watson Pharmaceuticals Inc. (WPI).

Forest Labs has a strong presence in the cardiovascular disease market. The company's cardiovascular products include hypertension drug Benicar/HCT and Bystolic. We believe that Bystolic’s unique characteristics such as its low side-effect profile could make it a multi-million dollar revenue generator. We continue to be encouraged by positive efficacy and tolerability data which we believe will help differentiate the drug from generic beta blockers in the market.

Forest Labs currently carries a Zacks Rank #3 (Hold). The company is facing tough times with Lexapro losing patent protection.

Currently, Valeant Pharma (VRX), which carries a Zacks Rank #1 (Strong Buy), looks more attractive.

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