http://finance.individual.com/display_news.asp?doc_id=CT2001260b7712&page=news
September 17, 2001 6:02am
JERUSALEM, Sep 17, 2001 (BUSINESS
WIRE) -- Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced
that an interim analysis of its Coral (oral Copaxone) trial showed a trend
for a treatment effect in favor of the higher oral dose in patients who
were treated for more than a year, although the difference has not reached
statistical significance.
The independent Data Safety Monitoring
Committee (DSMC) that has been monitoring the trial has recommended continuing
the trial to its completion by October 2001. As previously reported by
Teva, the oral formulation could not be available for commercial use prior
to 2003.
Professor Henry McFarland the chairman
of the DSMC said, "We are deeply impressed by Teva's commitment to develop
the first oral therapy for relapsing remitting multiple sclerosis patients.
The trial should provide meaningful insight into the possible effect of
the oral treatment. The DSMC recommends that the trial continue to its
completion, although there is only a small likelihood that the final results
of the study will be different than the interim results."
Prof. Giancarlo Comi, the Chairman
of the Clinical Steering Committee said: "We have been very surprised by
the relatively few number of relapses during the trial compared to the
same patients' relapse rates in the prior year. This may compromise the
study's ability to detect a statistically significant effect. After all
the information will be analyzed and considering the favorable safety profile,
we may recommend to the company to conduct further trials."
Eli Hurvitz, President and CEO of
Teva said: "Our business is robust, and we expect to continue to fulfill
the market's expectations for the years 2001, 2002, 2003 and beyond. The
positive global market environment for generic pharmaceuticals and our
significant ANDA pipeline in the U.S. will continue to support our strong
growth objectives. While we are disappointed by the interim results we
are encouraged by the positive trends seen in the trial. If these trends
do not achieve statistical significance at the end of the trial it will
take us longer to complete the development of oral Copaxone. The sales
of Copaxone in its injectable form continue to grow very nicely. The results
of additional clinical and MRI data released recently show why Copaxone
is well on the way to becoming the premier therapy for MS."
Mr. Hurvitz added further: "Out of
respect for the terrible tragedy that occurred last week, Teva decided
to postpone its 100 Anniversary events and celebration. Teva wishes to
convey its deepest condolences to the American people and to all of its
friends, clients, employees and their families in the United States.
Teva Pharmaceutical Industries Ltd.,
headquartered in Israel, is among the top 40 pharmaceutical companies and
among the largest generic pharmaceutical companies in the world. 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.
A conference call to discuss this
release will be hosted today at 08:30 AM EST. Details in a separate release.
Safe Harbor Statement under the U.S.
Private Securities Litigation Reform Act of 1995: This release contains
forward-looking statements, which express the beliefs and expectations
of management. Such statements are based on current plans, estimates and
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 a strategy of acquiring companies and on strategic alliances, exposure
to product liability claims, dependence on patent and other protections
for our innovative products, fluctuations in currency, exchange and interest
rates, operating results, 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. Forward-looking statements speak only
as of the date on which they are made, and the Company undertakes no obligation
to update publicly or revise any forward-looking statement, whether as
a result of new information, future developments or otherwise.
CONTACT: Teva Pharmaceutical
Industries Ltd., Jerusalem
Copyright (C) 2001 Business Wire
Source: Business Wire
Dan Suesskind, (011) 972-55-231-310
http://www.tevapharm.com
or
Teva North America
William Fletcher, 215/591-8800