MINNEAPOLIS, Jan. 8 /PRNewswire/ -- Fairview Specialty Pharmacy today announced that it has been selected by BioMarin Pharmaceutical, Inc. to be a participating pharmacy in the specialty pharmacy limited distribution network for Kuvan(TM) (sapropterin dihydrochloride) Tablets, the first specific drug therapy approved for the treatment of phenylketonuria (PKU).
Kuvan was approved by the U.S. Food and Drug Administration (FDA) on December 13 and is now available through Fairview Specialty Pharmacy for patients who are prescribed this treatment by their physicians.
Kari Amundson, Fairview Specialty Pharmacy Director, commented, "We are pleased to be selected by BioMarin to launch this new drug therapy. This distributor agreement is critical to our growth strategy and our ability to provide comprehensive care to patients across the Midwest and at the University of Minnesota Medical Center, Fairview."
"Kuvan is an important breakthrough in the treatment of PKU," said Chester Whitley, Ph.D, M.D., Director of Advanced Therapy Services at the University of Minnesota Medical Center, Fairview. "We are fortunate to have Fairview Specialty Pharmacy as one of the limited specialty distribution providers for this drug."
"We are extremely pleased to be working with specialty pharmacies like Fairview to make this promising new treatment option available to PKU patients and their families," said Stephen Aselage, Senior Vice President of Global Commercial Operations for BioMarin Pharmaceutical.
About Kuvan
Kuvan(TM) (sapropterin dihydrochloride) Tablets is indicated to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive phenylketonuria (PKU). Kuvan is to be used in conjunction with a Phe-restricted diet.
The active ingredient in Kuvan, sapropterin dihydrochloride, is the synthetic form of 6R-BH4 (tetrahydrobiopterin), a naturally occurring enzyme cofactor 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" pharmacists, and Patient Financial Advocates(SM) are available to help patients with insurance and billing issues. To learn more, visit http://www.FairviewSpecialtyPharmacy.org.
About BioMarin
BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises three approved products and multiple clinical and preclinical product candidates. Approved products include Naglazyme(R) (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme(R) (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; and Kuvan(TM) (sapropterin dihydrochloride) Tablets, a product for the treatment of phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany. For additional information, please visit http://www.BMRN.com.
CONTACT: Steve Green, +1-612-672-7058, for Fairview Specialty Pharmacy
Web site: http://www.fairviewspecialtypharmacy.org/
http://www.BMRN.com/
