Forest Laboratories, Inc. Announces Buyout of Bystolic Royalties from Janssen Pharmaceutica NV
April 02 2012 - 8:00AM
Business Wire
Forest Laboratories, Inc. (NYSE: FRX) today announced that
Forest Laboratories Holdings Limited (Forest), its wholly owned
subsidiary, and Janssen Pharmaceutica NV (Janssen) entered into an
agreement under which Forest acquired all U.S. patents and other
U.S. and Canadian intellectual property for Bystolic® (nebivolol),
which is currently approved in the United States for the treatment
of hypertension, thereby eliminating all future royalties. The
acquisition was completed simultaneously with the execution of the
agreement on March 30.
Under the terms of this agreement, Forest made a one-time cash
payment of $357 million to Janssen, and Janssen assigned to Forest
all U.S. patents and other U.S. and Canadian know-how covering
Bystolic®, including the nebivolol composition of matter patent in
the U.S. Forest will amortize the one-time cash payment over the
remaining patent life of Bystolic.
In addition, contemporaneously with the closing of the
acquisition, Forest and Janssen terminated the licenses in Canada
for both Bystolic and Savella® (milnacipran) with Janssen
Pharmaceutica NV and Janssen Pharmaceutical, respectively. Forest
has now established its Canadian subsidiary, which will take over
the registration and commercialization of both products.
Howard Solomon, Chairman and Chief Executive Officer of Forest
Laboratories said, “We are pleased with the success of Bystolic and
we look forward to the product’s continued growth. Though it is the
only branded beta-blocker in the U.S. market, Bystolic now
represents over 4% of this very large class and it continues to
grow. Sales in the quarter ending December 31, 2011 grew 33% over
the same quarter last year. Forest will enjoy the fruits of its
further investment in the commercialization of Bystolic, as well as
in available lifecycle strategies.”
About Bystolic
Bystolic (nebivolol) was approved by the U.S. Food and Drug
Administration in 2007 for the treatment of hypertension (chronic
high blood pressure). Bystolic is a once-daily medication effective
at lowering blood pressure when taken alone or in combination with
other high blood pressure medications. It is available in 2.5 mg, 5
mg, 10 mg and 20 mg tablets. In clinical trials, the
discontinuation rate due to adverse events was 2.8% for Bystolic
versus 2.2% for placebo. Nebivolol is approved and marketed in 60
countries outside of North America.
About Forest Laboratories
Forest Laboratories’ (NYSE: FRX) longstanding global
partnerships and track record developing and marketing
pharmaceutical products in the United States have yielded its
well-established central nervous system and cardiovascular
franchises and innovations in anti-infective and respiratory
medicine. The Company’s pipeline, the most robust in its history,
includes product candidates in all stages of development across a
wide range of therapeutic areas. The Company is headquartered in
New York, NY. To learn more, visit www.FRX.com.
Except for the historical information contained herein, this
release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. These
statements involve a number of risks and uncertainties, including
the difficulty of predicting FDA approvals, the acceptance and
demand for new pharmaceutical products, the impact of competitive
products and pricing, the timely development and launch of new
products, and the risk factors listed from time to time in Forest
Laboratories’ Annual Report on Form 10-K, Quarterly Reports on Form
10-Q, and any subsequent SEC filings.
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