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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