Business News
BioMarin Announces Roll-Out of National PKU Registry
2008-08-21 15:00:00
Conference Call and Webcast to Be Held Today at 4:30 p.m. ET (21:30 CET)
NOVATO, Calif., Aug. 21 /EMWNews/ -- BioMarin
Pharmaceutical Inc. (Nasdaq: BMRN) announced today the roll-out of the
national PKU Demographics, Outcomes and Safety Registry (PKUDOS). The
registry is open to all PKU clinics within the United States, and all
patients screened for Kuvan responsiveness are eligible for enrollment in
the registry. Also, from September 1, 2008 until December 31, 2008, to
facilitate enrollment in the registry, new patients at clinics
participating in the registry will be able to receive 45 days of free drug
while individual insurance coverage is secured.
"We are excited to initiate the first PKU patient registry and believe
that it will substantially strengthen the available data on a variety of
PKU patient populations, including some less studied, such as children
under four years of age and maternal PKU patients," said Jean-Jacques
Bienaime, Chief Executive Officer of BioMarin. "Approximately half of the
PKU clinics have already expressed interest in participating in the
registry program.
"Moreover, at a very minimal cost to BioMarin, we will be able to
bypass the current two- to eight-week processing time between BPPS referral
and initiation of commercial therapy, by providing an initial supply of
Kuvan at no cost to patients. This will allow physicians to test for
responsiveness to Kuvan without the need to first secure insurance
coverage. We have also received numerous requests to support PKU clinics
planning patient information days to further stimulate interest in Kuvan
screening, and we are pleased to help advance education in the PKU
community," added Mr. Bienaime.
BioMarin will host a conference call and webcast to discuss details of
the national PKU registry roll-out and provide a company update today,
Thursday, August 21, at 4:30 p.m. ET (21:30 CET). This event can be
accessed on the investor section of the BioMarin website at
http://www.BMRN.com.
Date: August 21, 2008
Time: 4:30 p.m. ET (21:30 CET)
U.S. / Canada Dial-in Number: 866.713.8565
International Dial-in Number: 617.597.5324
Participant Code: 39040728
Replay Dial-in Number: 888.286.8010
Replay International Dial-in Number: 617.801.6888
Replay Code: 15294001
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, a product for the treatment of phenylketonuria
(PKU), developed in partnership with Merck Serono, a division of Merck KGaA
of Darmstadt, Germany. Other product candidates include 6R-BH4 for
cardiovascular indications, which is currently in Phase 2 clinical
development for the treatment of peripheral arterial disease and sickle
cell disease, and PEG-PAL (PEGylated recombinant phenylalanine ammonia
lyase), which is currently in Phase 1 clinical development for the
treatment of PKU. For additional information, please visit
http://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: the continued development and
commercialization of Kuvan and BioMarin's other products and product
candidates and actions by regulatory authorities. 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: our success in the continued
commercialization of Kuvan; the content and timing of decisions by the U.S.
Food and Drug Administration, the European Commission and other regulatory
authorities concerning each of the described products and product
candidates; 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 2007
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 a registered trademarks of
BioMarin Pharmaceutical Inc.
Aldurazyme(R) is a registered trademark of BioMarin/Genzyme LLC.
Investors Media
Eugenia Shen Susan Berg
BioMarin Pharmaceutical Inc. BioMarin Pharmaceutical Inc.
(415) 506-6570 (415) 506-6594
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