24.02.2006 13:10:00
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Systemic Safety Profile of Macugen(R) (pegaptanib sodium injection) Maintained Throughout Two Years with No Increased Risk of Cardiovascular Events
OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) and Pfizer Inc (NYSE:PFE) announced today that the systemic safety profile of Macugen(R)(pegaptanib sodium injection), already established in data from Year 1of the VISION trials, was maintained over 2 years of treatment with noevidence of an association with hypertension, serious hemorrhagic(excessive bleeding) events, or thromboembolic (blood clots) events ascompared to the control group. Such events have been noted with theclinical use of other VEGF inhibitors. Furthermore, a preliminaryanalysis of a third year of data suggests that the safety of Macugenis maintained throughout three years of treatment. These data werepresented at the annual Macula Society meeting on February 22-25, 2006in Carlsbad, California.
"These long-term safety data are of utmost importance because wetAMD afflicts people over the age of 65, an age group already atincreased risk of cardiovascular disease, including heart attack andstroke," said Larry Singerman, M.D., Clinical Professor ofOphthalmology at Case University School of Medicine and President ofRetina Associates of Cleveland. "Macugen's proven systemic safetyprofile over 2 years is encouraging because many of our patientsrequire long-term treatment since AMD is a chronic, progressivedisease."
Macugen is the only VEGF inhibitor with long-term safety data inneovascular AMD, and the only VEGF inhibitor that specifically targetsVEGF 165, the isoform primarily responsible for promoting the bloodvessel growth and leakage associated with neovascular AMD.
About the Studies
Data presented at the Macula Society meeting are from the twoMacugen trials, jointly named VISION, that were concurrentmulticenter, double-masked, randomized controlled studies, whichenrolled 1,190 patients. At the beginning of Year 2, patientsreceiving Macugen (0.3 mg, 1 mg or 3 mg) were re-randomized (1:1) toeither continue treatment for an additional 48 weeks, or todiscontinue treatment. Sham-treated patients also were re-randomizedto receive one of the three Macugen doses, continue in the sham group,or discontinue treatment. The two-year systemic safety data examinedthe 425 patients (0.3 mg, N=128; 1 mg, N=126; 3 mg, N=120; sham, N=51)who continued the same treatment in the second year as in the first.
These patients received a total of 2,663 intravitreous injectionsof Macugen and 388 sham injections. The systemic safety profile ofMacugen established in Year 1 was sustained in Year 2, with noevidence that Macugen was associated with an increased incidence ofadverse events, such as systemic hypertension, serious hemorrhagicevents, or thromboembolic events compared to the control group. Suchevents have been noted with the clinical use of other VEGF inhibitors.
Preliminary Year 3 Results
After two years (week 102), patients receiving 0.3 mg or 1 mg ofMacugen continued on the same dose for a third year; all remainingsubjects were re-randomized either to 0.3 or to 1 mg for a third year.A total of 422 patients entered into the third year of the VISIONtrials. Of these, 161 patients received Macugen for three years. Thesafety profile of Macugen was maintained over three years. There wereno new ocular or systemic safety concerns, such as increased incidenceof systemic hypertension, bleeding, or thromboembolic events, notedwith continuous Macugen treatment for three years.
About Age-Related Macular Degeneration
AMD is a chronic, progressive disease of the central portion ofthe retina called the macula, resulting in the loss of central vision.The most common symptoms are a central blurred or blank spot,distortion of objects or simply blurred vision. Peripheral visionusually remains intact. AMD is classified into two forms: dry AMD andneovascular or wet AMD.
In neovascular AMD, abnormal blood vessels grow and leak into themacula, resulting in loss of vision. Neovascular AMD is the moresevere form of the disease and progresses more rapidly than the drytype. Although it accounts for only about 10-15% of all maculardegeneration cases, neovascular AMD is responsible for 90% ofblindness caused by the disease.
About Macugen
Macugen is indicated in the United States for the treatment ofneovascular age-related macular degeneration (neovascular AMD) and isadministered in a 0.3-mg dose once every six weeks by intravitrealinjection. Macugen is a pegylated anti-VEGF aptamer, which binds tovascular endothelial growth factor (VEGF). VEGF is a protein thatplays a critical role in angiogenesis (the formation of new bloodvessels) and increased permeability (leakage from blood vessels), twopathological processes that contribute to the vision loss associatedwith neovascular AMD.
Macugen has been approved by regulatory authorities in the UnitedStates, European Union, Canada, Brazil, Argentina, Peru, Pakistan, thePhilippines, and Switzerland, with filings submitted in 14 othercountries. OSI and Pfizer co-promote Macugen in the United States. OSIhas granted Pfizer exclusive rights to commercialize Macugen incountries outside the United States pursuant to a royalty-bearinglicensing agreement.
For full prescribing information about Macugen, please visithttp://www.macugen.com/.
Important Safety Information
Macugen is contraindicated in patients with ocular or periocularinfections.
Intravitreal injections including those with Macugen have beenassociated with endophthalmitis. Proper aseptic injection technique --which includes use of sterile gloves, a sterile drape, and a sterileeyelid speculum (or equivalent) -- should always be utilized whenadministering Macugen. In addition, patients should be monitoredduring the week following the injection to permit early treatment,should an infection occur.
Increases in intraocular pressure (IOP) have been seen within 30minutes of injection with Macugen. Therefore, IOP as well as theperfusion of the optic nerve head should be monitored and managedappropriately. Rare post-marketing cases of allergic reactions havebeen reported in patients following the Macugen intravitrealadministration procedure, although a direct relationship to Macugen orother factors has not been established.
Most frequently reported adverse events in patients treated for upto two years were anterior chamber inflammation, blurred vision,cataract, conjunctival hemorrhage, corneal edema, eye discharge, eyeirritation, eye pain, hypertension, increased IOP, ocular discomfort,punctate keratitis, reduced visual acuity, visual disturbance,vitreous floaters, and vitreous opacities. These events occurred inapproximately 10% to 40% of patients.
About OSI Pharmaceuticals
OSI Pharmaceuticals is committed to "shaping medicines andchanging lives" by discovering, developing and commercializinghigh-quality and novel pharmaceutical products that extend life orimprove the quality of life for patients with cancer, eye diseases,and diabetes. The Company operates through three business teams, (OSI)Oncology, (OSI) Eyetech and (OSI) Prosidion. (OSI) Oncology is focusedon developing molecular targeted therapies designed to change theparadigm of cancer care. (OSI) Eyetech specializes in the developmentand commercialization of novel therapeutics to treat diseases of theeye. (OSI) Prosidion is committed to the generation of novel, targetedtherapies for the treatment of type 2 diabetes and obesity. OSI'sflagship product, Tarceva(R) (erlotinib), is the first drug discoveredand developed by OSI to obtain FDA approval and the only EGFRinhibitor to have demonstrated the ability to improve survival in bothnon-small cell lung cancer and pancreatic cancer patients. OSI marketsTarceva through partnerships with Genentech, Inc. in the United Statesand with Roche throughout the rest of the world. Macugen(R)(pegaptanib sodium injection) is approved in the United States for thetreatment of neovascular age-related macular degeneration. OSIcommercializes Macugen in partnership with Pfizer Inc. For additionalinformation about OSI, please visit http://www.osip.com.
This news release contains forward-looking statements. Thesestatements are subject to known and unknown risks and uncertaintiesthat may cause actual future experience and results to differmaterially from the statements made. Factors that might cause such adifference include, among others, the completion of clinical trials,the FDA review process and other governmental regulation, OSI's andits collaborators' abilities to successfully develop and commercializedrug candidates, competition from other pharmaceutical companies, theability to effectively market products, and other factors described inOSI Pharmaceuticals' filings with the Securities and ExchangeCommission.
About Pfizer Inc
Pfizer Inc discovers, develops, manufactures and markets leadingprescription medicines for humans and animals as well as many of theworld's best-known consumer brands. Pfizer Ophthalmics, a division ofPfizer Inc., is committed to preserving sight and eliminatingpreventable blindness. Pfizer Ophthalmics discovers, develops andprovides leading treatments in ophthalmology to support patients whoare at risk of blindness or suffering from vision impairment, and toserve the health care professionals who treat them. Its currentproduct line includes the most prescribed treatment to lower elevatedeye pressure in patients with ocular hypertension (abnormally high eyepressure) or open-angle glaucoma. In collaboration with OSIPharmaceuticals, the division also includes a treatment forneovascular age-related macular degeneration.
For more information about Pfizer, please visithttp://www.pfizer.com.
PFIZER DISCLOSURE NOTICE
The information contained in this release is as of February 24,2006. The Company assumes no obligation to update any forward-lookingstatements contained in this release as a result of new information orfuture events or developments.
This release contains forward-looking information regardingMacugen that involves substantial risks and uncertainties. Adescription of these risks and uncertainties can be found in theCompany's Annual Report on Form 10-K for the fiscal year endedDecember 31, 2004 and in its reports on Forms 10-Q and 8-K.
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