Bayer HealthCare AG and Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the first patient
has been dosed in the VIEW 2 trial, a second Phase 3 clinical study in a
development program evaluating VEGF Trap-Eye for the treatment of the
neovascular form of Age-related Macular Degeneration (wet AMD), a leading
cause of blindness in adults.
VIEW 2 (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD)
will enroll approximately 1,200 patients in up to 200 centers in Europe,
Asia Pacific, Japan and Latin America. The first Phase 3 trial, VIEW 1,
began enrolling patients in August 2007 in the United States and Canada.
Both VIEW 1 and VIEW 2 are designed to evaluate the efficacy and safety of
VEGF Trap-Eye administered by intravitreal injection, at dosing intervals
of 4 and 8 weeks. The development program will include visual acuity
endpoints and anatomical endpoints, including retinal thickness, a measure
of disease activity. The trial is intended to establish non-inferiority of
VEGF Trap-Eye with Lucentis(R)* (ranibizumab), an antiangiogenic agent
approved for use in wet AMD in major markets globally.
Wet AMD accounts for about 90 percent of all severe AMD-related vision
loss. It occurs when abnormal blood vessels in the eye leak fluid and blood
into the macula, the area of the retina that allows for vision of fine
details. This can lead to a rapid loss of central vision with continued
progression.
“Results from the Phase 2 study have shown that VEGF Trap-Eye has the
potential to significantly reduce retinal thickness and improve vision,”
said Kemal Malik, MD, Head of Global Development and member of the Bayer
HealthCare Executive Committee. “Dosing of the first patient in this
confirmatory Phase 3 trial is an important milestone for this compound
intended to treat a devastating ocular disease that impacts millions of
people worldwide.”
“New therapies are still needed to provide optimal care to those
patients with wet AMD,” said George D. Yancopoulos, M.D., Ph.D., President
of Regeneron Research Laboratories. “This global Phase 3 clinical program
will provide additional data to further evaluate the efficacy and safety of
VEGF Trap-Eye using different dosing regimens.”
Bayer HealthCare and Regeneron are collaborating on the global
development of VEGF Trap-Eye for treatment of wet AMD, diabetic eye
diseases, and other ocular diseases and disorders. Once approved, Bayer
HealthCare will market VEGF Trap-Eye outside the U.S., where the parties
will share equally in profits from any future sales of VEGF Trap-Eye.
Regeneron maintains exclusive rights to VEGF Trap-Eye in the U.S. VIEW 2
primary analysis results are anticipated in 2011.
About VIEW 2
In the first year, the VIEW 2 (VEGF Trap-Eye: Investigation of Efficacy
and Safety in Wet AMD) study will evaluate the safety and efficacy of VEGF
Trap-Eye at doses of 0.5 milligrams (mg) and 2.0 mg administered at 4-week
intervals and 2.0 mg at an 8-week dosing interval, including one additional
2.0 mg dose at week four. Patients randomized to the ranibizumab arm of the
trial will receive a 0.5 mg dose every 4 weeks. After the first year of
treatment, patients will continue to be followed and treated for another
year on a flexible, criteria-based extended regimen with a dose
administered at least every 12 weeks, but not more often than every 4 weeks
until the end of the study.
The primary endpoint of the study is the proportion of patients treated
with VEGF Trap-Eye who maintain vision at the end of one year, compared to
ranibizumab patients. Visual acuity is defined as the total number of
letters read correctly on the Early Treatment Diabetic Retinopathy Study
(ETDRS) chart, a standard chart used in research to measure visual acuity.
Maintenance of vision is defined as losing fewer than three lines
(equivalent to 15 letters) on the ETDRS chart. Key secondary endpoints
include the mean change from baseline in visual acuity as measured by ETDRS
and the proportion of patients who gained at least 15 letters of vision at
week 52.
Phase 2 Clinical Data
In a Phase 2 trial in 157 patients, announced in October 2007 at the
Retina Society Conference in Boston, VEGF Trap-Eye met both primary and
secondary key endpoints: a statistically significant reduction in retinal
thickness (a measure of disease activity) after 12 weeks of treatment
compared with baseline and a statistically significant improvement from
baseline in visual acuity (ability to read letters on an eye chart).
Following the initial 12-week fixed-dosing phase of the trial, patients
continued to receive therapy at the same dose on a PRN (as needed) dosing
schedule based upon the physician assessment of the need for re-treatment
in accordance with pre-specified criteria. At the 2008 meeting of the
Association for Vision and Ophthalmology (ARVO), it was reported that, on
average, patients on the PRN dosing schedule maintained the gain in visual
acuity and decrease in retinal thickness achieved at week 12 through week
32 of the study.
About VEGF Trap-Eye
Vascular Endothelial Growth Factor (VEGF) is a naturally occurring
protein in the body whose normal role is to trigger the formation of new
blood vessels (angiogenesis) to support the growth of the body’s tissues
and organs. It has also been associated with the abnormal growth and
fragility of new blood vessels in the eye, which lead to the development of
wet AMD. VEGF Trap-Eye is a fully human, soluble VEGF receptor fusion
protein that binds all forms of VEGF-A along with the related placental
growth factor (PIGF) and VEGF-B. VEGF Trap-Eye is a specific and highly
potent blocker of these growth factors. Blockade of VEGF can prevent
abnormal blood vessel formation as well as vascular leak and has proven
beneficial in the treatment of wet AMD.
About Wet AMD
Age-related Macular Degeneration (AMD) is a leading cause of acquired
blindness. Macular degeneration is diagnosed as either dry (non-exudative)
or wet (exudative). In wet AMD, new blood vessels grow beneath the retina
and leak blood and fluid. This leakage causes disruption and dysfunction of
the retina creating blind spots in central vision, and it can account for
blindness in wet AMD patients. Wet AMD is the leading cause of blindness
for people over the age of 65 in the U.S. and Europe.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the
fields of health care, nutrition and high-tech materials. Bayer HealthCare,
a subsidiary of Bayer AG, is one of the world’s leading, innovative
companies in the healthcare and medical products industry and is based in
Leverkusen, Germany. The company combines the global activities of the
Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions.
The pharmaceuticals business operates under the name Bayer Schering Pharma
AG. Bayer HealthCare’s aim is to discover and manufacture products that
will improve human and animal health worldwide. Find more information at
bayerhealthcare.
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical
company. Its research and business activities are focused on the following
areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women’s
Healthcare. With innovative products, Bayer Schering Pharma aims for
leading positions in specialized markets worldwide. Using new ideas, Bayer
Schering Pharma aims to make a contribution to medical progress and strives
to improve the quality of life. Find more information at
bayerscheringpharma.de.
About Regeneron
Regeneron is a fully integrated biopharmaceutical company that
discovers, develops, and commercializes medicines for the treatment of
serious medical conditions. In addition to ARCALYST(TM) (rilonacept)
Injection for Subcutaneous Use, its first commercialized product, Regeneron
has therapeutic candidates in clinical trials for the potential treatment
of cancer, eye diseases, and inflammatory diseases, and has preclinical
programs in other diseases and disorders. Additional information about
Regeneron and recent news releases are available on Regeneron’s Web site at
regeneron.
Bayer HealthCare Forward Looking Statement
This release may contain forward-looking statements based on current
assumptions and forecasts made by Bayer Group or subgroup management.
Various known and unknown risks, uncertainties and other factors could lead
to material differences between the actual future results, financial
situation, development or performance of the company and the estimates
given here. These factors include those discussed in Bayer’s public reports
which are available on the Bayer website at bayer. The
company assumes no liability whatsoever to update these forward-looking
statements or to conform them to future events or developments.
Regeneron Forward Looking Statement
This news release discusses historical information and includes
forward-looking statements about Regeneron and its products, development
programs, finances, and business, all of which involve a number of risks
and uncertainties, such as risks associated with preclinical and clinical
development of Regeneron’s drug candidates, determinations by regulatory
and administrative governmental authorities which may delay or restrict
Regeneron’s ability to continue to develop or commercialize its product and
drug candidates, competing drugs that are superior to Regeneron’s product
and drug candidates, uncertainty of market acceptance of Regeneron’s
product and drug candidates, unanticipated expenses, the availability and
cost of capital, the costs of developing, producing, and selling products,
the potential for any collaboration agreement, including Regeneron’s
agreements with the sanofi-aventis Group and Bayer HealthCare, to be
cancelled or to terminate without any product success, risks associated
with third party intellectual property, and other material risks. A more
complete description of these and other material risks can be found in
Regeneron’s filings with the United States Securities and Exchange
Commission (SEC), including its Form 10-Q for the quarter ended March 31,
2008. Regeneron does not undertake any obligation to update publicly any
forward-looking statement, whether as a result of new information, future
events, or otherwise unless required by law.
Bayer HealthCare
bayer