Healthcare Industry News:  OSI Pharmaceuticals 

Biopharmaceuticals Ophthalmology Regulatory

 News Release - February 2, 2006

European Commission Approves Macugen for Treatment of All Types of Wet Age-Related Macular Degeneration; First Treatment to Target Underlying Disease Process of Wet AMD

"Each year there are an estimated 500,000 new cases of Wet AMD worldwide, so new treatment options are crucially important"

NEW YORK, Feb. 2 (HSMN NewsFeed) -- Pfizer Inc said today that the European Commission has granted marketing authorization for MacugenŽ (pegaptanib sodium injection) for the treatment of neovascular (wet) age- related macular degeneration (AMD), an age-related eye disease that destroys central vision critical to reading, driving and color vision.

Macugen is the first treatment to target the underlying disease process and has been proven to help preserve visual acuity in patients with wet AMD. Clinical studies showed that Macugen prevented severe vision loss at twice the rate of standard care, which included photodynamic therapy.

"Macugen represents an important treatment advance for this leading cause of irreversible vision loss," said Dr. Joseph Feczko, Pfizer's chief medical officer. "Macugen is the first therapy indicated in Europe for the treatment of all types of wet AMD, regardless of lesion subtype, size or visual acuity. Pfizer is committed to bringing innovative medicines to patients facing the loss of vision caused by wet AMD, glaucoma, diabetic retinopathy and other diseases of the eye."

Wet AMD is a chronic, progressive disease of the macula, the central portion of the retina responsible for sight that allows people to see faces, walk stairs and engage in daily activities. Central vision is impaired when abnormal blood vessel growth beneath the macula, known as choroidal neovascularization (CNV), causes bleeding and other fluid accumulation in the retina.

"While the problem of wet AMD is a global one, it hits particularly hard in areas with rapidly aging populations, such as Europe," said Steve Winyard, chairman of the AMD Alliance International. "Each year there are an estimated 500,000 new cases of wet AMD worldwide, so new treatment options are crucially important."

About Macugen

Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration.

Macugen is the first of a new type of ophthalmic drug that targets vascular endothelial growth factor (VEGF 165), a protein that acts as a signal in triggering CNV, the single disease process underlying all subtypes of wet AMD. By selectively binding to VEGF 165, Macugen reduces blood vessel growth and leakage, thereby limiting the progression of vision loss and helping patients preserve the vision they have.

The approval was based on the results of two pivotal clinical trials involving 1,186 patients with all subtypes of wet AMD. The primary efficacy endpoint was the proportion of patients protected from a three-line loss of visual acuity on the eye chart by week 54. Seventy percent of patients who had 0.3 mg of Macugen every six weeks lost fewer than three lines of vision on the eye chart, compared with 55 percent of patients in the control group -- a 27 percent treatment benefit. After one year, patients were randomized to continue or discontinue treatment for another year. Two-year clinical data from the studies demonstrated a continued treatment benefit with Macugen and that treatment should be initiated as early as possible.

Overall, Macugen was well tolerated. Patients on Macugen for two years received over 90 percent of possible injections, indicating strong compliance and acceptance to therapy. Most of the adverse events reported over the two years were mild in severity, transient and attributed by investigators to the injection procedure rather than the study drug.

Macugen is contraindicated in patients with active or suspected ocular or periocular infection or with known hypersensitivity to the active or inactive substances.

Rare post-marketing cases of an allergic reaction have been reported in patients within several hours after injection with Macugen, although a direct relationship to Macugen or other factors has not been established.

The safety and efficacy of Macugen beyond two years have not been demonstrated.

Macugen has been approved by regulatory authorities in the U.S., Canada, Brazil, Argentina, Peru, Pakistan and the Philippines, with filings submitted in 15 other countries. More than 50,000 patients with wet AMD have been treated with Macugen in the United States last year. Macugen is an important addition to a Pfizer ophthalmology portfolio that includes market-leading glaucoma medications Xalatan/Xalacom.

Pfizer has an exclusive license from OSI Pharmaceuticals, Inc., to develop and market Macugen outside of the United States. Pfizer and OSI jointly develop and market Macugen in the United States.


Source: Pfizer

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