Forest Settles with Glenmark - Analyst Blog
January 09 2013 - 12:00PM
Zacks
Forest Laboratories, Inc. (FRX) recently
entered into a settlement agreement with Glenmark Pharmaceuticals
Ltd., relating to its patent infringement litigation for Bystolic
(nebivolol).
Glenmark 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 versions of Bystolic subject to certain
conditions.
Glenmark will be allowed to launch its generic version three
months ahead of the expiration of US Patent No. 6,545,040
(including any extensions and/or pediatric exclusivities) or on
gaining final FDA approval of its abbreviated new drug application
(ANDA), whichever occurs later. However, Glenmark could
launch its generic version earlier in certain circumstances.
We note that 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
against Amerigen Pharmaceuticals Ltd. and Watson
Pharmaceuticals Inc. (WPI), and related companies pending
in the court.
Forest Labs has a strong presence in the cardiovascular
disease market. Forest Labs’ cardiovascular products include
hypertension drug Benicar/HCT and Bystolic, a long-acting,
cardio-selective beta-blocker. 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. Bystolic turned in sales
of $347.8 million in fiscal 2012, up 31.6%. Bystolic has $500
million potential in its current indication.
Forest Labs is looking to drive Bystolic's growth by providing
additional data on the appropriate use of the product. The company
is also working on extending the product’s lifecycle by conducting
a phase III study with a fixed dose combination of Bystolic and
valsartan (the market leader) for hypertension. A fixed dose
combination product would expand the patient population for
Bystolic.
We currently have a Neutral recommendation on Forest Labs
which carries a Zacks Rank #3 (Hold). Forest is facing tough times
with Lexapro losing patent protection.
Moreover, the company lowered its guidance for Namenda, which
is currently the main contributor to the company’s top line. The
performance of new products, especially Teflaro, has also been
below expectations. However, we remain encouraged by the company’s
progress with its pipeline candidates.
Pharma stocks which currently look attractive are
Ironwood Pharmaceuticals (IRWD) and
Valeant Pharmaceuticals (VRX), which carry a Zacks
Rank #1 (Strong Buy).
FOREST LABS A (FRX): Free Stock Analysis Report
IRONWOOD PHARMA (IRWD): Free Stock Analysis Report
VALEANT PHARMA (VRX): Free Stock Analysis Report
WATSON PHARMA (WPI): Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research
Watson (NYSE:WPI)
Historical Stock Chart
From Mar 2024 to Apr 2024
Watson (NYSE:WPI)
Historical Stock Chart
From Apr 2023 to Apr 2024