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PR Pharmaceuticals, Inc. Announces Collaboration With OSI Pharmaceuticals, Inc. (OSIP) To Develop Sustained Release Formulation Of Macugen(R)


1/11/2006 10:24:10 AM

FORT COLLINS, Colo., Jan. 11 /PRNewswire/ -- PR Pharmaceuticals, Inc. announced today an exclusive agreement with OSI Pharmaceuticals to collaborate on the development of a sustained release formulation of Macugen® (pegaptanib sodium injection), a novel treatment for neovascular age-related macular degeneration (neovascular AMD), using PRP's proprietary ProPhase(TM) encapsulation technology.

Under the terms of the collaboration, PRP grants OSI Pharmaceuticals an exclusive license to use PRP's ProPhase(TM) technology with respect to Macugen in the treatment of eye diseases. The agreement gives OSI and its development and marketing partner Pfizer access to a proprietary method for encapsulating Macugen for use in ophthalmology. PRP is responsible for developing the formulations and manufacturing the test article for non-clinical and clinical trials. OSI, through its eye disease unit (OSI) Eyetech, is responsible for clinical development activities and has the right to manufacture and commercialize any resulting product.

"This collaboration brings together the scientific and technical expertise to develop a sustained release formulation of Macugen, our breakthrough medicine for neovascular AMD," said David Guyer, M.D., chief executive officer of (OSI) Eyetech and executive vice president of OSI Pharmaceuticals. "Dosing convenience is important for retina specialists and patients who are fighting age-related blindness."

"For PRP, this agreement demonstrates the value of our broad intellectual property estate and expertise in the formulation of sustained release large molecules," said Steve Howe, chief executive officer of PRP. "We are proud to partner with OSI."

PRP received an undisclosed upfront payment from (OSI) Eyetech and also will receive payments for achieving certain milestones and royalties on net sales of any products resulting from the collaboration. OSI will reimburse PRP for efforts carried out by PRP in support of the collaboration.

About Macugen

Macugen is indicated in the United States for the treatment of neovascular age-related macular degeneration (neovascular AMD) and is administered in a 0.3-mg dose once every six weeks by intravitreal injection. 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 pathological processes that contribute to the vision loss associated with neovascular AMD.

For full prescribing information about Macugen, please visit 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 <1% of intravitreal injections included endophthalmitis, retinal detachment, and iatrogenic traumatic cataract.

Most frequently reported adverse events in patients treated for up to two years were anterior chamber inflammation, blurred vision, cataract, conjunctival hemorrhage, corneal edema, eye discharge, eye irritation, eye pain, hypertension, increased IOP, ocular discomfort, punctate keratitis, reduced visual acuity, visual disturbance, vitreous floaters, and vitreous opacities. These events occurred in approximately 10% to 40% of patients.

About OSI Pharmaceuticals

OSI Pharmaceuticals is committed to "shaping medicines and changing lives" by discovering, developing and commercializing high-quality and novel pharmaceutical products that extend life or improve 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 focused on developing molecular targeted therapies designed to change the paradigm of cancer care. (OSI) Eyetech specializes in the development and commercialization of novel therapeutics to treat diseases of the eye. (OSI) Prosidion is committed to the generation of novel, targeted therapies for the treatment of type 2 diabetes and obesity. OSI's flagship product, Tarceva® (erlotinib), is the first drug discovered and developed by OSI to obtain FDA approval and the only EGFR inhibitor to have demonstrated the ability to improve survival in both non-small cell lung cancer and pancreatic cancer patients. OSI markets Tarceva through partnerships with Genentech, Inc. in the U.S. and with Roche throughout the rest of the world. Macugen® (pegaptanib sodium injection) is approved in the United States for the treatment of neovascular age-related macular degeneration. OSI commercializes Macugen in partnership with Pfizer Inc. For additional information about OSI, please visit http://www.osip.com.

About PR Pharmaceuticals, Inc.

PRP is a Fort Collins, CO based privately held Biopharmaceutical Company. The company has unique sustained release injectable technologies and uses these primarily to develop its own proprietary products. PRP's lead products under development are InsuLAR(TM), a once-a-week basal insulin injection and PulmoLAR(TM), a sustained release preparation for the treatment of Pulmonary Arterial Hypertension.

PRP collaborates with other pharmaceutical companies who desire to enhance the benefits of their proprietary molecules through PRP's sustained release technologies. More information about PRP on our website www.prpharm.com

Source: PR Pharmaceuticals, Inc.



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