Patents Issued Covering Stable Tablet Formulation and Once Daily Dosing Regimen for...

Patents Issued Covering Stable Tablet Formulation and Once Daily Dosing
Regimen for Kuvan

NOVATO, Calif., July 30, /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical
Inc. (Nasdaq: BMRN) announced today that the United States Patent Office has
issued patents covering stable tablet formulation and the approved once daily
dosing regimen for Kuvan(R) (sapropterin dihydrochloride) for the treatment of
phenylketonuria (PKU). The patent for stable tablet formulation expires in
2025, and the patent for the once daily dosing regimen expires in 2024.

"We believe the issuance of these two patents is significant in strengthening
our proprietary position on Kuvan," said Jean-Jacques Bienaime, Chief
Executive Officer of BioMarin. "These patents provide coverage for Kuvan's
formulation and approved dosing regimen that extends approximately ten years
beyond orphan drug protection and we believe will prevent therapeutically
equivalent competition from entering the market."

About Kuvan
Kuvan(R) (sapropterin dihydrochloride) Tablets are indicated in the United
States 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.

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 orphan exclusivity in the United States and ten years
of market exclusivity in the E.U.

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. As a result of
newborn screening efforts implemented in the 1960s and early 1970s, virtually
all PKU patients under the age of 40 in developed countries have been
diagnosed at birth. To learn more about PKU, please visit www.PKU.com.
Information on this website is not incorporated by reference into this press
release.

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 pre-clinical 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(R)( )(sapropterin
dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership
with Merck Serono, a division of Merck KGaA of Darmstadt, Germany. Other
product candidates include PEG-PAL (PEGylated recombinant phenylalanine
ammonia lyase), which is currently in development for the treatment of PKU and
GALNS (N-acetylgalactosamine 6-sulfatase), which is currently in Phase I/II
clinical development for the treatment of MPS IVA. For additional information,
please visit www.BMRN.com. Information on BioMarin's website is not
incorporated by reference into this press release.

Forward-Looking Statement
This press release contains forward-looking statements about the business
prospects of BioMarin Pharmaceutical Inc., including, without limitation,
statements about: expectations related to patents associated with Kuvan. These
forward-looking statements are predictions and involve risks and uncertainties
such that actual results may differ materially from these statements. These
risks and uncertainties include, among others: possible actions by others to
challenge, invalidate or design around the patents; and those factors detailed
in BioMarin's filings with the Securities and Exchange Commission, including,
without limitation, the factors contained under the caption "Risk Factors" in
BioMarin's 2008 Annual Report on Form 10-K, as amended, and the factors
contained in BioMarin's reports on Form 10-Q and Form 8-K. Stockholders are
urged not to place undue reliance on forward-looking statements, which speak
only as of the date hereof. BioMarin is under no obligation, and expressly
disclaims any obligation to update or alter any forward-looking statement,
whether as a result of new information, future events or otherwise.

BioMarin(R), Naglazyme(R) and Kuvan(R) are registered trademarks of BioMarin
Pharmaceutical Inc.

Aldurazyme(R) is a registered trademark of BioMarin/Genzyme LLC.
Contact:

Investors Media
Eugenia Shen Susan Berg
BioMarin Pharmaceutical Inc. BioMarin Pharmaceutical Inc.
(415) 506-6570 (415) 506-6594

SOURCE BioMarin Pharmaceutical Inc.

Investors, Eugenia Shen, +1-415-506-6570, or Media, Susan Berg,
+1-415-506-6594, both of BioMarin Pharmaceutical Inc.