UCB's Kremers Urban Pharmaceuticals Inc. receives FDA approval for extended release methylphenidate hydrochloride

 UCB's Kremers Urban Pharmaceuticals Inc. receives FDA approval for extended
                    release methylphenidate hydrochloride

-- Extended release methylphenidate hydrochloride product is bioequivalent to
Concerta QD®

-- 18mg and 27mg extended release methylphenidate hydrochloride product

-- Tentative approval for the 36mg and 54mg

PR Newswire

BRUSSELS and PRINCETON, N.J., July 10, 2013

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 existingALZA 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.


Website: http://www.ucb.com
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