Mylan Announces Amendment to Bystolic(TM) (Nebivolol) Agreement
February 27 2008 - 4:20PM
PR Newswire (US)
PITTSBURGH, Feb. 27 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE:MYL)
announced today that it and Forest Laboratories Holdings, Ltd., a
wholly owned subsidiary of Forest Laboratories, Inc. (NYSE:FRX)
have amended their January 2006 agreement to commercialize, develop
and distribute the novel beta blocker Bystolic(TM) (nebivolol),
which is currently approved in the United States for the treatment
of hypertension. The companies have agreed that Forest will assume
Mylan's commercial rights for Bystolic in the U.S. and Canada
including, but not limited to, the elimination of Mylan's option to
co-promote the product. Forest will be responsible for all future
Bystolic development expenses as well as all sales and marketing
expenses for the product. Under the terms of this amendment, Forest
Laboratories Holdings, Ltd. (Ireland) will make a one-time cash
payment of $370 million to Mylan. Forest will continue to pay Mylan
its contractual royalties for three years, through calendar 2010.
Robert J. Coury, Vice Chairman and CEO of Mylan, commented: "We are
very proud of the role Mylan has played to date in Bystolic's
development and commercialization in the U.S. and believe that
today's agreement with Forest is evidence of the value we have
created through this product. Today's announcement is just one of
the many initiatives we have announced to enhance our strategic
focus and ensure we are ideally positioned to maximize the
significant opportunities of our world leading generics assets."
About Bystolic Bystolic (nebivolol) is a novel beta blocker that
was approved by the FDA in December 2007 and is approved and
marketed in more than 65 countries outside of North America. Mylan
licensed the U.S. and Canadian rights to Bystolic from Janssen
Pharmaceutical N.V. in 2001, and obtained Janssen's consent to
sub-license Bystolic to Forest Laboratories in those territories in
an initial agreement completed in January 2006. Bystolic is a
cardio-selective beta-1 blocker, with vasodilation properties and a
favorable tolerability profile. Upon FDA approval, Bystolic has
received five years of marketing exclusivity under the Hatch Waxman
legislation. In addition there is an issued U.S. pharmaceutical
composition of matter patent that expires in 2021, which may offer
additional exclusivity. About Mylan Mylan Inc. is one of the
world's leading quality generic and specialty pharmaceutical
companies. The Company offers one of the industry's broadest and
highest quality product portfolios, a robust product pipeline and a
global commercial footprint through operations in more than 90
countries. Through its controlling interest in Matrix Laboratories
Limited, Mylan has direct access to one of the largest active
pharmaceutical ingredient (API) manufacturers in the world. Dey,
L.P., Mylan's fully integrated specialty business, provides the
Company with innovative and diversified opportunities in the
respiratory and allergy therapeutic areas. For more information
about Mylan, please visit http://www.mylan.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, including with regard to
the future value of the product and the anticipated economic impact
of the transaction. These statements involve a number of risks and
uncertainties, including regulatory matters outside of the
companies' control, the acceptance and demand for Bystolic, the
impact of competitive products and pricing, and the risk factors
listed from time to time in Mylan Inc.'s Annual Reports on Form
10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC
filings. DATASOURCE: Mylan Inc. CONTACT: Mike Laffin (Media), or
Kris King (Investors), +1-724-514-1813, both of Mylan Inc. Web
site: http://www.mylan.com/
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