CAMBRIDGE, Mass. and BETHESDA, Md., March 23 /PRNewswire-FirstCall/ --
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Cystic Fibrosis
Foundation Therapeutics, Inc. (CFFT) today announced that they have entered
into a new collaboration to accelerate clinical development of VX-770, a
novel, oral drug candidate for the treatment of cystic fibrosis (CF). CFFT is
the nonprofit drug discovery and development affiliate of the Cystic Fibrosis
Foundation.
As part of the agreement, CFFT will pay Vertex approximately $13.3 million
in development support through the fourth quarter of 2007. Vertex plans to
initiate clinical development of VX-770 in the second quarter of 2006 and to
progress to clinical studies in patients with CF in the second half of the
year. VX-770 is the first of a new class of oral agents that specifically
target a key mechanism underlying CF. Vertex retains worldwide rights to
develop and commercialize VX-770.
"VX-770 represents a novel approach to addressing the progression of
cystic fibrosis and is the first clinical drug candidate to emerge from our
innovative CF research efforts," said Joshua Boger, Ph.D., Chairman, President
and Chief Executive Officer of Vertex. "We appreciate CFFT's continued
support for the development of VX-770, and we look forward to initiating the
first clinical study of this novel compound in patients with CF later in
2006."
"We are excited to continue to work with Vertex on this exciting small
molecule drug candidate. Our support should accelerate the clinical
development of VX-770, a compound that holds great potential for changing the
course of this disease," said Robert J. Beall, Ph.D., President and Chief
Executive Officer of the Cystic Fibrosis Foundation and CFFT. "The
collaboration announced today offers hope that together we may one day soon
provide a new treatment option to patients with CF. Our common goal to
accelerate the clinical development of VX-770 represents yet another example
of the productive collaborative history we share with Vertex in CF research."
About VX-770
VX-770 was advanced into preclinical development based on a successful
five-year research collaboration with CFFT that incorporated capabilities and
proprietary research from Vertex's San Diego research site. VX-770 may act to
restore the function of the cystic fibrosis transmembrane conductance
regulator (CFTR) protein, the defective cell membrane protein responsible for
the progression of CF. Defects in the CFTR protein affect the transport of
chloride and other ions across cells, and lead to the accumulation of thick,
sticky mucus in the lungs of patients with CF. This mucus fosters chronic
infection and inflammation, and results in irreversible lung damage.
Potentiator compounds such as VX-770 are designed to increase the probability
that the CFTR channel is open, which could result in an increase in chloride
transport across the cell surface in some patients. In laboratory
experiments, using cells from patients with CF where CFTR proteins are present
on the cell surface, VX-770 has restored the function of defective CFTR
channels.
Potentiator Collaboration
Under the new collaboration announced today, CFFT and Vertex will share
certain costs associated with clinical development of VX-770. CFFT will
provide to Vertex approximately $13.3 million to support clinical development
of VX-770 through the fourth quarter of 2007. Vertex retains worldwide rights
to develop and commercialize VX-770. Upon commercialization, Vertex would pay
CFFT certain royalties and sales milestones based on specific net sales
thresholds.
Collaborative History with CFFT
Vertex initiated its CF research program in May 2000 as part of a
collaboration with CFFT, and expanded the agreement in May 2004. In addition
to the new collaboration announced today, in January 2006, Vertex and CFFT
entered into an expanded research collaboration to discover novel compounds
known as correctors, which may work by increasing the number of CFTR channels
on the cell surface. To date, CFFT has provided to Vertex more than $40
million for CF research.
About Cystic Fibrosis and the Cystic Fibrosis Foundation
Cystic fibrosis is a genetic disease affecting approximately 30,000 people
in the United States. A defect in the CFTR gene causes the body to produce
abnormally thick, sticky mucus that leads to chronic, life-threatening lung
infections and impairs digestion. When the CF Foundation was established in
1955, few children lived to attend elementary school. Today, because of
research and care supported by the CF Foundation -- with money raised through
donations from families, corporations and foundations -- the median predicted
age of survival for people with CF is in the mid-30s.
The Cystic Fibrosis Foundation, headquartered in Bethesda, MD, is a
donor-supported, nonprofit organization committed to finding therapies and
ultimately a cure for CF, and to improving the lives of those with the
disease. For more information on CF and the programs of the CF Foundation,
call (800) FIGHT CF or visit http://www.cff.org.
About Vertex
Vertex Pharmaceuticals Incorporated is a global biotechnology company
committed to the discovery and development of breakthrough small molecule
drugs for serious diseases. The Company's strategy is to commercialize its
products both independently and in collaboration with major pharmaceutical
companies. Vertex's product pipeline is principally focused on viral
diseases, inflammation, autoimmune diseases and cancer. Vertex co-promotes
the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.
Lexiva is a registered trademark of the GlaxoSmithKline group of
companies.
Vertex Safe Harbor Statement
This press release may contain forward-looking statements, including
statements that Vertex expects that (i) CFFT will pay Vertex approximately
$13.3 million in development support for VX-770 through the end of the fourth
quarter of 2007; (ii) it will initiate clinical development of VX-770 in the
second quarter of 2006 and progress to studies in patients with CF in the
second half of 2006; (iii) the development support of CFFT will accelerate the
clinical development of VX-770; (iv) VX-770 may change the course of cystic
fibrosis; (v) a new treatment option may one day soon be provided to patients
with CF; and (vi) VX-770 may act to restore the function of the cystic
fibrosis transmembrane conductance regulator (CFTR) protein by increasing the
probability that the CFTR channel is open, which could result in an increase
in chloride transport across the cell surface in some patients. While
management makes its best efforts to be accurate in making forward-looking
statements, such statements are subject to risks and uncertainties that could
cause Vertex's actual results to vary materially. These risks and
uncertainties include, among other things, the possibility that CFFT could
terminate its financial support under its agreements with Vertex early, risks
that efforts to develop VX-770 may not proceed due to financial, technical,
scientific, commercial or other reasons, that clinical trials may not proceed
as planned due to technical, scientific, supply or patient enrollment issues,
that actual clinical studies of VX-770 will not reflect the results obtained
in pre-clinical and nonclinical testing, and other risks listed under Risk
Factors in Vertex's Form 10-K filed with the Securities and Exchange
Commission on March 16, 2006.
Vertex's press releases are available at http://www.vrtx.com.
Vertex Contacts:
Lynne Brum, Vice President, Strategic Communications, (617) 444-6614
Michael Partridge, Director, Corporate Communications, (617) 444-6108
Lora Pike, Manager, Investor Relations, (617) 444-6755
Zachry Barber, Specialist, Media Relations, (617) 444-6470
CFFT/Cystic Fibrosis Foundation Contact:
Carolyn Habbersett, Director, Medical Communications, (301) 907-2542
SOURCE Vertex Pharmaceuticals Incorporated
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Related links:
http://www.vrtx.com
Company News On-Call:
http://www.prnewswire.com/comp/938395.html
CONTACT:
Lynne Brum, Vice President, Strategic
Communications, +1-617-444-6614, Michael Partridge, Director,
Corporate Communications, +1-617-444-6108, or Lora Pike, Manager,
Investor Relations, +1-617-444-6755, or Zachry Barber,
Specialist, Media Relations, +1-617-444-6470, all of Vertex
Pharmaceuticals Incorporated; or Carolyn Habbersett, Director,
Medical Communications, of Cystic Fibrosis Foundation Contact,
(301) 907-2542
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