BRUSSELS and PRINCETON, N.J., July 10, 2013
/PRNewswire/ -- - regulated information - UCB announced
today that Kremers Urban Pharmaceuticals Inc. (KU), its U.S.
subsidiary focused on specialty generics, received approval from
the U.S. Food and Drug Administration (FDA) for 18mg and 27mg
extended release methylphenidate hydrochloride product, for which
Concerta® is the reference listed drug product. KU has
begun launch operations and supplying the US-market with the
product. KU also received tentative approval for the 36mg and 54mg.
KU will be eligible for final approval after exclusivity expiration
in September 2013.
KU's extended release methylphenidate hydrochloride product is
bioequivalent to Concerta QD® marketed by ALZA
Corporation (a unit of Johnson & Johnson). Each tablet is
designed to be effective for 12-hours.
In September 2011, KU announced
that it has reached a settlement dismissing all pending litigation
arising from its Abbreviated New Drug Application (ANDA) to market
an extended release methylphenidate hydrochloride product. The
settlement allows Kremers Urban to commercially launch its
methylphenidate ANDA product under the existing ALZA
Corporation patents.
The launch of KU's new generic product was already considered in
UCB's 2013 financial guidance.
For further information
Antje Witte, Investor
Relations, UCB
T +32 2 559 9414, antje.witte@ucb.com
Alexandra Deschner, Investor
Relations, UCB
T +32 2 559 9683, alexandra.deschner@ucb.com
France Nivelle, Global
Communications, UCB
T +32 2 559 9178, france.nivelle@ucb.com
Laurent Schots, Media
Relations, UCB
T +32.2.559.9264, laurent.schots@ucb.com
Kristie Madara, U.S. Corporate
Communications, UCB
T +1 770 970-8726,
kristie.madara@ucb.com
Notes to the editor
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global
biopharmaceutical company focused on the discovery and development
of innovative medicines and solutions to transform the lives of
people living with severe diseases of the immune system or of the
central nervous system. With more than 8 500 people in about 40
countries, the company generated revenue of EUR 3.4 billion in 2012. UCB is listed on
Euronext Brussels (symbol: UCB).
About Kremers Urban Pharmacuticals Inc.
(KU)
KU is the generic subsidiary of UCB in the US.
It is a specialty generic pharmaceutical company focused on
difficult, "high barrier" to entry generic products. To learn more
visit www.kremersurban.com.
UCB Forward-Looking Statement
This press
release contains forward-looking statements based on current plans,
estimates and beliefs of management. All statements, other than
statements of historical fact, are statements that could be deemed
forward-looking statements, including estimates of revenues,
operating margins, capital expenditures, cash, other financial
information, expected legal, political, regulatory or clinical
results and other such estimates and results. By their nature, such
forward-looking statements are not guarantees of future performance
and are subject to risks, uncertainties and assumptions which could
cause actual results to differ materially from those that may be
implied by such forward-looking statements contained in this press
release. Important factors that could result in such differences
include: changes in general economic, business and competitive
conditions, the inability to obtain necessary regulatory approvals
or to obtain them on acceptable terms, costs associated with
research and development, changes in the prospects for products in
the pipeline or under development by UCB, effects of future
judicial decisions or governmental investigations, product
liability claims, challenges to patent protection for products or
product candidates, changes in laws or regulations, exchange rate
fluctuations, changes or uncertainties in tax laws or the
administration of such laws and hiring and retention of its
employees. UCB is providing this information as of the date
of this press release and expressly disclaims any duty to update
any information contained in this press release, either to confirm
the actual results or to report a change in its
expectations.
There is no guarantee that new product candidates in the
pipeline will progress to product approval or that new indications
for existing products will be developed and approved. Products or
potential products which are the subject of partnerships, joint
ventures or licensing collaborations may be subject to differences
between the partners. Also, UCB or others could discover safety,
side effects or manufacturing problems with its products after they
are marketed.
Moreover, sales may be impacted by international and domestic
trends toward managed care and health care cost containment and the
reimbursement policies imposed by third-party payers as well as
legislation affecting biopharmaceutical pricing and
reimbursement.
SOURCE UCB