Fairview Specialty Pharmacy Signs Contract With BioMarin for Distribution of
Kuvan(TM)
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.
SOURCE Fairview Specialty Pharmacy
Steve Green, +1-612-672-7058, for Fairview Specialty Pharmacy
