Chiron Compound Enters Clinical Trials Through the Global Alliance for TB Drug Development; Phase I Studies to Begin for First T
14 Giugno 2005 - 2:01PM
Business Wire
Chiron Corporation (Nasdaq:CHIR) today announced that the Global
Alliance for TB Drug Development (TB Alliance) has initiated Phase
I clinical trials for the tuberculosis (TB) drug candidate PA-824.
Chiron granted the TB Alliance exclusive worldwide rights to PA-824
and related compounds in 2002, with a commitment to make the TB
technology available royalty-free in endemic countries. Clinical
trials are scheduled to begin this month. The TB Alliance is a
public-private partnership developing affordable, new drug regimens
for TB, and PA-824 is the first TB drug from the TB Alliance
pipeline to enter clinical study. After licensing PA-824 from
Chiron, the TB Alliance directed and funded the drug's preclinical
development. The U.S. National Institute of Allergy and Infectious
Diseases of the National Institutes of Health also provided in-kind
support and technical assistance. More than 40 years have elapsed
since the last novel compound was introduced for the treatment of
TB. "Chiron's relationship with the TB Alliance is an example of
how public-private partnerships can enable drug research and
development in areas of critical unmet need," said Craig Wheeler,
President, Chiron Biopharmaceuticals. "Since acquiring PA-824 from
Chiron, the TB Alliance has done exceptional work in moving the
compound from the laboratory to the clinic. As a company committed
to protecting people through innovative science, Chiron is proud to
be associated with the alliance's efforts to develop new treatments
for TB." Under the 2002 license agreement in which Chiron granted
the TB Alliance rights to PA-824, provisions were made for possible
further collaboration between Chiron and the TB Alliance at later
stages of development, including a grant-back option to Chiron for
manufacture and commercialization of products in developed markets.
The parties have agreed that no royalties will be due under this
agreement for drugs marketed in less developed economies, including
impoverished countries with a high burden of tuberculosis.
"Reaching this milestone greatly enhances the chances of improved
TB treatment and is an important advance in the TB community's
drive for a faster cure," said Dr. Maria C. Freire, President and
CEO, TB Alliance. "We worked creatively and smartly with our
partners, donors and contractors. The result is that an extremely
promising TB compound moved from lead identification into human
trials in near record time." PA-824 was first identified in 1995 by
researchers at PathoGenesis Corporation, a Seattle-based
biotechnology company. The drug was in preclinical development when
Chiron acquired PathoGenesis in 2000. About Tuberculosis
Tuberculosis (TB) is a highly contagious, airborne disease that
attacks the respiratory system and is presently treated with a
four-drug combination that imposes a lengthy six- to eight-month
treatment course. According to a 2002 report published by the Stop
TB Partnership, between 2000 and 2020 it is estimated that nearly 1
billion people will be newly infected from TB, 200 million will
become sick, and 35 million will die. TB is a leading cause of
death among people living with HIV/AIDS. New treatments are
necessary to combat the TB epidemic because current treatment
regimens utilizing approved drugs are long and cumbersome and fail
to treat resistant strains. About Chiron Chiron delivers innovative
and valuable products to protect human health by advancing
pioneering science across the landscape of biotechnology. The
company works to deliver on the limitless promise of science and
make a positive difference in people's lives. For more information
about Chiron, please visit www.chiron.com. This news release
contains forward-looking statements, including statements regarding
research and development, product development initiatives, new
product indications, new product marketing, and clinical trials
that involve risks and uncertainties and are subject to change.
Forward-looking statements often address our expected future
performance and often contain words such as "expects,"
"anticipates," "intends," "plans," "believes," "seeks" or "will." A
discussion of the company's operations and financial condition,
including factors that may affect its business and future prospects
that could cause actual results and developments to differ
materially from those expressed or implied by forward-looking
statements, is contained in documents the company has filed with
the SEC, including the Form 10-K for the year ended December 31,
2004, and the Form 10-Q for the quarter ended March 31, 2005, and
will be contained in all subsequent periodic filings made with the
SEC. These documents identify important factors that could cause
the company's actual performance to differ from current
expectations, including, among others, the outcome of clinical
trials, regulatory review and approvals, manufacturing
capabilities, intellectual property protections and defenses,
litigation, and marketing effectiveness. In addition, the company
may engage in business opportunities, the successful completion of
which is subject to certain risks, including approval by Novartis
AG, regulatory approvals, and the integration of operations. Chiron
does not undertake an obligation to update the forward-looking
information the company is giving today.
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