Forest Laboratories, Inc.
) 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
) 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
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.
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
), which carries a Zacks Rank #1 (Strong Buy), looks more
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