PRAECIS PHARMACEUTICALS INCORPORATED Announces German Regulatory Approval for Plenaxis(R); Schering AG Collaboration Terminated
September 28 2005 - 8:00PM
Business Wire
PRAECIS PHARMACEUTICALS INCORPORATED (NASDAQ: PRCS) today announced
that it has received marketing authorization for Plenaxis(R)
(abarelix 100 mg powder for an injectable suspension) from the
German competent authority, Bundesinstitut fur Arzneimittel und
Medizinprodukte (BfArM). In Germany, Plenaxis(R) is indicated to
initiate hormonal castration in patients with advanced or
metastatic, hormone-dependent prostate cancer, if androgen
suppression is appropriate. PRAECIS also announced that it received
notice today from Schering AG of Germany that it was exercising its
right to terminate the parties' license, supply and distribution
agreement due to PRAECIS not having received marketing
authorization for Plenaxis(R) in Germany with a requisite label by
June 30, 2005. In connection with the termination notice, Schering
AG advised PRAECIS that since the parties differed significantly in
their interpretation of the label for Plenaxis(R) approved by the
BfArM, and the consequences for the commercial potential of the
product, Schering AG would not continue with the collaboration
under the terms of the existing agreement. Schering AG had
requested that the parties reconsider the scope of Schering AG's
commercialization obligations in Europe, and indicated that it
expected a substantial reduction in the milestone payments provided
for in the existing agreement upon PRAECIS obtaining marketing
authorizations in various European countries. Kevin F. McLaughlin,
President and Chief Executive Officer of PRAECIS, stated, "We are
disappointed with Schering AG's decision to terminate our
collaboration, especially in light of our receipt of German
registration approval which we believe fulfills the contractual
requirements for the Plenaxis(R) label under our agreement. We
intend to explore various opportunities for this product, including
a license or sale transaction that would enable commercialization
of the product in Europe and other territories." About Plenaxis(R)
In Germany, Plenaxis(R) is indicated to initiate hormonal
castration in patients with advanced or metastatic,
hormone-dependent prostate cancer, if androgen suppression is
appropriate. When the duration of therapy is longer than 3 months,
the response of the patient to the Plenaxis(R) therapy must be
closely monitored, because in some patients the efficacy decreases
between 3 and 12 months and has not been established beyond 12
months. Response to Plenaxis(R) therapy may be monitored by
clinical parameters and by periodically measuring serum
testosterone and PSA levels. Following each injection of
Plenaxis(R), patients should be observed for at least 30 minutes
and, in the event of an immediate-onset allergic reaction, managed
appropriately (e.g. leg elevation, oxygen, intravenous fluids,
antihistamines, corticosteroids, and epinephrine, alone or in
combination). About Prostate Cancer Prostate cancer is one of the
most common cancers in men. While effective treatments for prostate
cancer include either surgical removal of the prostate gland or
radiation treatments, a substantial proportion of patients will
require treatment with hormonal therapy. Prostate cancer can grow
under the influence of the male hormone, testosterone. Hormonal
therapy is utilized in the treatment of prostate cancer to reduce
the levels of testosterone. Plenaxis(R) is the first available GnRH
antagonist that immediately reduces testosterone levels and
represents a novel class of hormonal therapy. Currently available
treatments, known as LHRH agonists, cause an immediate increase in
testosterone levels which can worsen the cancer. Plenaxis(R) was
developed to avoid these consequences and clinical studies
demonstrated the complete absence of these testosterone increases
following Plenaxis(R) treatment. About PRAECIS PRAECIS
PHARMACEUTICALS INCORPORATED is a biopharmaceutical company focused
on the discovery, development and commercialization of innovative
therapies that either address unmet medical needs or offer
improvements over existing therapies. PRAECIS has a novel MetAP-2
inhibitor in clinical development for non-Hodgkin's lymphoma and
solid tumors, as well as an innovative drug discovery technology,
Direct Select(TM), which enables the generation and practical use
of ultra-large libraries for the discovery of orally active
compounds for drug development. PRAECIS has received approval to
market Plenaxis(R) in Germany. This news release contains
forward-looking statements, including statements regarding the
Company's intention to explore various opportunities for the
commercialization of Plenaxis(R) in Europe and other territories.
These statements are based on the Company's current beliefs and
expectations as to future outcomes and are not guarantees of future
events or performance. These statements are subject to numerous
risks, uncertainties and assumptions that could cause actual events
and results to differ from those anticipated or projected,
including, but not limited to, the timing and content of decisions
made by European and non-European regulatory authorities regarding
Plenaxis(R) under the Mutual Recognition Procedure and otherwise,
unexpected results in ongoing and future clinical or preclinical
trials, the need for additional research and testing, including as
a result of unanticipated determinations by regulatory authorities,
the interest of, and financial and other terms required by, other
parties with respect to a possible transaction with the Company for
the commercialization of Plenaxis(R) in Europe and other
territories, the Company's ability to manage operating expenses,
unexpected expenditures, as well as the risks set forth from time
to time in the Company's filings with the Securities and Exchange
Commission, including but not limited to various risks discussed in
the Company's Quarterly Report on Form 10-Q for the quarter ended
June 30, 2005. The Company undertakes no obligation to update any
forward-looking statement made in this press release to reflect new
information, events or circumstances after the date of this
release. Plenaxis(R) is a registered trademark of PRAECIS
PHARMACEUTICALS INCORPORATED.
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