Canada Approves Forest's Bystolic - Analyst Blog
January 22 2013 - 11:30AM
Zacks
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.
FOREST LABS A (FRX): Free Stock Analysis Report
NOVARTIS AG-ADR (NVS): Free Stock Analysis Report
VALEANT PHARMA (VRX): Free Stock Analysis Report
WATSON PHARMA (WPI): Free Stock Analysis Report
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