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Fairview Specialty Pharmacy Signs Contract With BioMarin for Distribution of Kuvan(TM)
Date:1/8/2008

ctor that works in conjunction with phenylalanine hydroxylase (PAH) to metabolize Phe. BioMarin and Merck Serono estimate that Kuvan could be a potential treatment option for approximately 30 percent to 50 percent of the estimated 50,000 identified PKU patients in the developed world.

Kuvan has received orphan drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). Kuvan has received seven years of market exclusivity in the United States. In November 2007, Merck Serono submitted a Marketing Authorization Application (MAA) to the EMEA for sapropterin dihydrochloride as an oral treatment for patients suffering from HPA due to PKU or BH4 deficiency. If approved in the EU, it will receive 10 years of market exclusivity for this indication.

About PKU

PKU, a genetic disorder affecting approximately 50,000 diagnosed patients in the developed world, is caused by a deficiency of the enzyme phenylalanine hydroxylase. PAH is required for the metabolism of phenylalanine, an essential amino acid found in most protein-containing foods. If the active enzyme is not present in sufficient quantities, Phe accumulates to abnormally high levels in the blood and becomes toxic to the brain, resulting in a variety of complications including severe mental retardation and brain damage, mental illness, seizures, tremors, and limited cognitive ability. To learn more about PKU, please visit http://www.PKU.com.

About Fairview Specialty Pharmacy

Fairview Specialty Pharmacy provides personal medication management services to patients who take high-cost or self-injected drugs for chronic conditions. Fairview Specialty Pharmacy ensures that patients receive their medications safely and on time via services including medication management and monitoring, free shipping anywhere in the US, and monthly refill reminder phone calls. All calls are answered by "live" pha
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SOURCE Fairview Specialty Pharmacy
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