FDA-Approved CLARINEX(R) Reditabs(R) Disintegrate Without Water
EDEN PRAIRIE, Minn., Aug. 25 /PRNewswire-FirstCall/ -- CIMA LABS INC., a
Cephalon company (Nasdaq: CEPH), announced today that Schering-Plough
Corporation plans to market an orally disintegrating version of CLARINEX(R)
(desloratadine), its prescription antihistamine product using OraSolv(R), a
proprietary orally disintegrating drug delivery technology developed by CIMA
LABS.
Schering-Plough announced in July that the U.S. Food and Drug
Administration (FDA) approved a new formulation of CLARINEX Reditabs using
OraSolv(R). Schering-Plough expects to begin U.S. distribution of the
re-formulated CLARINEX Reditabs in September.
"CLARINEX Reditabs is a good example of CIMA LABS' drug delivery
innovation, enhancing medications for patients and creating value for our
partners," said Todd MacLaughlan, General Manager of CIMA LABS. "CLARINEX
Reditabs is our first product with Schering-Plough and the fifth partnered
product approved by the FDA this year using our technology."
With the addition of CLARINEX Reditabs, there are now 10 pharmaceutical
products approved for sale in the United States and in other countries
utilizing orally disintegrating drug delivery technologies developed by CIMA
LABS. OraSolv(R) tablets disintegrate on the tongue, without chewing or the
need for water, enabling convenient dosing and ease of swallowing.
About CIMA LABS
CIMA LABS INC. is a leading drug delivery technology company that develops
and manufactures prescription and over-the-counter pharmaceutical products
based on proprietary, orally disintegrating technologies. CIMA LABS' seven
prescription and three over-the-counter products are distributed globally by
its pharmaceutical partners and are based on OraSolv(R) and DuraSolv(R) orally
disintegrating tablet (ODT) technologies. The tablets disintegrate quickly in
the mouth without chewing or the need for water - making it easier for
patients to take medication. CIMA LABS also developed OraVescent(R), an oral
transmucosal technology. The first product candidate using OraVescent
technology is in Phase III clinical trials.
CIMA LABS, located in suburban Minneapolis, Minnesota, is a wholly-owned
subsidiary of Cephalon, Inc. and serves as one of Cephalon's U.S.
manufacturing sites. Cephalon, based in Frazer, Pennsylvania, is focused on
the discovery, development and marketing of innovative medicines to treat
sleep and neurological disorders, cancer and pain.
In addition to historical facts or statements of current condition, this
press release may contain forward-looking statements. Forward-looking
statements provide Cephalon's current expectations or forecasts of future
events. These may include statements regarding anticipated scientific
progress on its research programs, development of potential pharmaceutical
products, including future products utilizing the OraSolv and DuraSolv
technologies, interpretation of clinical results, prospects for regulatory
approval of product candidates, manufacturing development and capabilities,
market prospects for its products, sales and earnings guidance, and other
statements regarding matters that are not historical facts. You may identify
some of these forward-looking statements by the use of words in the statements
such as "anticipate," "estimate," "expect," "project," "intend," "plan,"
"believe" or other words and terms of similar meaning. Cephalon's performance
and financial results could differ materially from those reflected in these
forward-looking statements due to general financial, economic, regulatory and
political conditions affecting the biotechnology and pharmaceutical industries
as well as more specific risks and uncertainties facing Cephalon such as those
set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S.
Securities and Exchange Commission. Given these risks and uncertainties, any
or all of these forward-looking statements may prove to be incorrect.
Therefore, you should not rely on any such factors or forward-looking
statements. Furthermore, Cephalon does not intend to update publicly any
forward-looking statement, except as required by law. The Private Securities
Litigation Reform Act of 1995 permits this discussion.
SOURCE CIMA LABS INC.
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Related links:
http://www.cimalabs.com
http://www.cephalon.com
Company News On-Call:
http://www.prnewswire.com/comp/134563.html
CONTACT:
Media: Lisa McCue, CIMA LABS INC.,
+1-952-983-8043, lisa.mccue@cimalabs.com; or Investors: Chip
Merritt, Cephalon, Inc., +1-610-738-6376, cmerritt@cephalon.com
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