http://finance.individual.com/display_news.asp?doc_id=CT2001275p3486&page=news
October 2, 2001 7:00am
KANSAS CITY, Mo., Oct 2, 2001 /PRNewswire
via COMTEX/ -- The Food and Drug Administration today granted an approvable
letter to Teva Pharmaceuticals USA for COPAXONE(R) (glatiramer acetate
injection) to be available in prefilled syringes. COPAXONE(R) is positioned
to become the first and only relapsing-remitting multiple sclerosis drug
therapy to offer its medication in a prefilled syringe approved in the
United States. Current injectable MS therapies require mixing and preparation
time.
The letter is one of the final steps
in the approval process. Teva is working closely with the FDA to answer
the remaining questions, and the company anticipates that the prefilled
glass syringes will become available in early 2002. The prefilled syringe
is expected to replace the previous mixable form of COPAXONE(R).
"Teva Neuroscience is dedicated to
continuous improvements in the way COPAXONE(R) is delivered. A prefilled
syringe should make traveling, working and maintaining an active lifestyle
more convenient for people living with MS," said Larry Downey, President
and CEO of Teva Neuroscience.
COPAXONE(R) is indicated for the
reduction of relapses in relapsing- remitting multiple sclerosis. The most
common side effects of COPAXONE(R) are redness, pain, swelling, itching,
or a lump at the site of injection, flushing, chest pain, weakness, infection,
pain, nausea, joint pain, anxiety, and muscle stiffness. These reactions
are usually mild and seldom require professional treatment. Patients should
tell their doctor about any side effects.
Some patients report a short-term
reaction right after injecting COPAXONE(R) (glatiramer acetate injection).
This reaction can involve flushing (feeling of warmth and/or redness),
chest tightness or pain with heart palpitations, anxiety, and trouble breathing.
These symptoms generally appear within minutes of an injection, last about
15 minutes, and go away by themselves without further problems.
Teva Pharmaceutical Industries Ltd.
(Nasdaq: TEVA), headquartered in Israel, is among the top 40 pharmaceutical
companies and among the largest generic pharmaceutical companies in the
world. Teva Pharmaceuticals USA is a subsidiary of Teva Pharmaceuticals
Industries Ltd. Over 80% of Teva's sales are in North America and Europe.
The Company develops, manufactures and markets generic and innovative human
pharmaceuticals and active pharmaceutical ingredients.
This report contains forward-looking
statements, which express the beliefs and expectations of management. Such
statements are based on current expectations and involve a number of known
and unknown risks and uncertainties that could cause the Company's future
results, performance or achievements to differ significantly from the results,
performance or achievements expressed or implied by such forward-looking
statements. Important factors that could cause or contribute to such differences
include the impact of pharmaceutical industry regulation, the difficulty
of predicting FDA and other regulatory authority approvals, the regulatory
environment and changes in the health policies and structure of various
countries, acceptance and demand for new pharmaceutical products and new
therapies, the impact of competitive products and pricing, the availability
and pricing of ingredients used in the manufacture of pharmaceutical products,
uncertainties regarding market acceptance of innovative products newly
launched, currently being sold or in development, the impact of restructuring
of clients, reliance on strategic alliances, fluctuations in currency,
exchange and interest rates, operating results, the impact of the year
2000 issue and other factors that are discussed in the Company's Annual
Report on Form 20-F and the Company's other filings with the U.S. Securities
and Exchange Commission.
Teva Neuroscience, Inc. is a subsidiary
of Teva Pharmaceutical Industries Ltd.
Call 1-800-887-8100 or log onto WWW.COPAXONE.COM
for more information about COPAXONE(R) (glatiramer acetate injection) or
multiple sclerosis. Teva Neuroscience, Inc. markets COPAXONE(R).
COPAXONE(R) is a registered trademark
of Teva Pharmaceutical Industries Ltd.
CONTACT: Aharon Schwartz of Teva
Pharmaceutical Industries Ltd., +1-011-972-392-67277, Aharon.Schwartz@teva.co.il
, Holly Gibson of Fleishman- Hillard, Inc., 816-512-2349, gibsonh@fleishman.com
, or Larry Downey of Teva Neuroscience, Inc., 816-508-5051, Larry.Downey@tevaneuro.com
For more information, please go to
http://www.copaxone.com/pi/index.html
SOURCE Teva Pharmaceuticals Industries
Ltd.
CONTACT: Aharon
Schwartz of Teva Pharmaceutical Industries Ltd.,
URL:
http://www.copaxone.com/
Copyright (C) 2001 PR Newswire
Source: PR Newswire
+1-011-972-392-67277, Aharon.Schwartz@teva.co.il , Holly Gibson of Fleishman-
Hillard, Inc., +1-816-512-2349, gibsonh@fleishman.com , or Larry Downey
of
Teva Neuroscience, Inc., +1-816-508-5051, Larry.Downey@tevaneuro.com