Eyetech (NASDAQ:EYET)
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Eyetech Raises Full-Year Sales Forecast for Macugen(R)
(pegaptanib sodium injection)
Company shares research and development program to expand Macugen franchise and
develop pipeline of compounds for ocular diseases
NEW YORK, June 22 /PRNewswire-FirstCall/ -- Eyetech Pharmaceuticals, Inc.
(NASDAQ:EYET) announced today that it revised its 2005 forward-looking guidance
for net product revenue from the sale of Macugen(R) (pegaptanib sodium
injection), the only FDA-approved therapy for the treatment of all types of
neovascular age-related macular degeneration (neovascular AMD). Eyetech now
expects net product revenue from the sale of Macugen to be in a range of $175 -
$190 million for the full fiscal year ending December 31, 2005. This revised
guidance compares with previous company estimates of $135 - $150 million for
the full year. The company plans to provide a full financial update during its
second quarter earnings call in late July. Eyetech and Pfizer Inc launched
Macugen in the United States on January 20, 2005.
(Logo: http://www.newscom.com/cgi-bin/prnh/20050407/EYETLOGO )
"Macugen's launch has exceeded our initial expectations and we are pleased that
Macugen is quickly establishing itself as a foundation therapy for neovascualar
AMD," said David R. Guyer, M.D., Chief Executive Officer of Eyetech. "The
strong Macugen sales to date represent continued growth in new accounts
combined with larger and more frequent re-orders, which demonstrates that
retinal specialists are adopting Macugen even faster than we previously
anticipated."
Macugen's pioneering technology and early success in treating patients with
neovascular AMD has paved the way for Eyetech and its strategic partners to
initiate research programs on a number of exciting compounds, specifically
aptamers, for use in the treatment of various eye diseases and certain cancers.
A key component of Eyetech's development program is to investigate E10030, a
compound being developed with Archemix Corp. that suppresses platelet- derived
growth factor-B (PDGF-B), another key protein that regulates cell growth and
plays a role in many eye diseases. Eyetech plans to study E10030 both as a
single agent and in combination with Macugen for neovascular AMD and plans to
initiate clinical trials in mid-2006. Separately, Eyetech and Pfizer are
collaborating on clinical trial programs to expand the Macugen franchise to
additional disease areas with unmet medical needs. The companies plan to begin
a Phase 2/3 trial for Macugen in diabetic macular edema (DME) in the second
half of 2005, and already initiated a Phase 2 trial in 2004 to determine the
safety, efficacy and pharmacokinetics of Macugen in patients with central
retinal vein occlusion (RVO). Additional research is focusing on the use of
Macugen as part of combination therapy with photodynamic therapy (PDT) for the
treatment of neovascular AMD as well as a sustained-release drug delivery
system for Macugen.
"Our research plans for Macugen reflect our commitment to meeting unmet medical
needs in ophthalmology and the important role we believe we can play in helping
people whose lives have been devastated by eye diseases," said Anthony P.
Adamis, M.D., Chief Scientific Officer of Eyetech. "We are leveraging
Macugen's anti-VEGF capabilities and exploring an enhanced drug delivery
program for Macugen for the possible treatment of certain cancers such as
glioblastoma. In addition, our drug development pipeline is identifying
several aptamer-based compounds that target exciting new areas including TGF
beta for ocular scarring, a condition that follows glaucoma surgery, retinal
detachment surgery and chronic neovascular AMD, and the ICAM cascade, which
plays a role in the progression of diabetic retinopathy."
A complete overview of the research and development programs for Macugen as
well as Eyetech's plans to discover new compounds will be presented to
investors, analysts and media this afternoon at Eyetech Vision Day in New York.
For details about the event, including a live audio web cast, please visit the
Investor Relations section of our corporate web site, http://www.eyetech.com/.
In addition, Eyetech also recently adopted new initiatives to lower future
expenses and realign incentives for employees. One initiative allows for the
acceleration of the vesting of certain out-of-the-money stock options. Based
on current assumptions, the acceleration of the affected options has the effect
of reducing the charge related to the expensing of unvested options by as much
as $61 million over the 40 months following the required implementation of a
new accounting rule, SFAS No. 123(R), in 2006. Another initiative provides for
the grant of new shares of restricted stock to holders of such out-of-the-money
options to realign incentives. The company anticipates that there will be a
non-cash income statement charge over the next 12-months in the range of $17 to
$19 million based on current assumptions resulting from these new grants.
"The Board recognizes the need to address the effect of market events on our
equity incentives. Taken together, the decision to accelerate the vesting of
certain out-of-the-money stock options and grant new shares of restricted stock
provides a future financial statement benefit and keeps our employees invested
in the future success of Eyetech," said Glenn Sblendorio, Chief Financial
Officer of Eyetech.
About Macugen
Macugen is a pegylated anti-VEGF aptamer, which binds to vascular endothelial
growth factor (VEGF). VEGF is a protein that plays a critical role in
angiogenesis (the formation of new blood vessels) and increased permeability
(leakage from blood vessels), two of the primary pathological processes
responsible for the vision loss associated with neovascular AMD. Macugen works
by binding to the specific isoform VEGF165, which is believed to be responsible
for the pathological blood vessel growth and leakage in ocular
neovascularization. Studies suggest that this selectivity is the reason why no
physical destruction of vasculature has been observed in connection with use of
Macugen.
Macugen is administered in a 0.3 mg dose once every six weeks by intravitreal
injection. It is not approved for the treatment of DME or RVO at this time.
Macugen also is approved for neovascular AMD in Canada and Brazil and is
expected to be available in both countries later this year. Macugen has been
filed for approval in the European Union, Australia and Switzerland.
For full prescribing information about Macugen, please visit
http://www.macugen.com/.
Important Safety Information
Macugen is contraindicated in patients with ocular or periocular infections.
Intravitreal injections including those with Macugen have been associated with
endophthalmitis. Proper aseptic injection technique - which includes use of
sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent)
- should always be utilized when administering Macugen. In addition, patients
should be monitored during the week following the injection to permit early
treatment, should an infection occur.
Increases in intraocular pressure (IOP) have been seen within 30 minutes of
injection with Macugen. Therefore, IOP as well as the perfusion of the optic
nerve head should be monitored and managed appropriately.
Serious adverse events related to the injection procedure occurring in