Navigation Links
BioMarin Receives Notice of Allowance for Once Daily Dosing Patent for Kuvan
Date:3/30/2009

NOVATO, Calif., March 30 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that it has received a notice from the United States Patent Office reporting allowance of claims covering once daily dosing methods for Kuvan(R) (sapropterin dihydrochloride) in the treatment of phenylketonuria (PKU). The company expects that the patent will be officially issued later this year, and if issued, the patent's initial 20-year term would expire in 2024. The company has a number of other pending patent applications covering various aspects of Kuvan compositions and dosing.

"We believe the issuance of this patent will be significant in strengthening our proprietary position on Kuvan," said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. "This patent would prevent potential competitors from using or copying Kuvan's approved dosing regimen. Based on the claims allowed by the USPTO, we believe that the once daily dosing regimen will prevent therapeutically equivalent generic competition to Kuvan while the patent is in force."

About Kuvan

Kuvan (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, 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 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 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: expected action by the United States Patent and Trademark Office, 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: actions by the United States Patent and Trademark Office, 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 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.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. BioMarin to Present at the 4th Annual Citi Biotech Day
2. BioMarins Clinical Trial Application for GALNS for Morquio A Syndrome Accepted by the MHRA
3. BioMarin Announces Fourth Quarter and Full Year 2008 Financial Results
4. BioMarin to Host Fourth Quarter and Full Year 2008 Financial Results Conference Call and Webcast on Wednesday, February 18 at 5:00 p.m. ET (23:00 CET)
5. BioMarin to Present at the Piper Jaffray Healthcare Conference
6. BioMarin Announces the Planned Retirement of Dr. Emil Kakkis, Chief Medical Officer
7. BioMarin to Present at the Credit Suisse Healthcare Conference
8. BioMarin Announces Third Quarter 2008 Financial Results
9. BioMarin Corrects Information Included in Bloomberg Article
10. BioMarin to Present at the Merrill Lynch Global Pharmaceutical Conference
11. BioMarin to Present at the Morgan Stanley Global Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/6/2016)... Souderton, PA (PRWEB) , ... ... ... Technologies, part of the Almac Group, the world’s largest privately-held contract pharmaceutical ... partnership with inVentiv Health, a leading biopharma outsourcing company combining a leading ...
(Date:12/6/2016)... Colorado (PRWEB) , ... December 06, 2016 , ... ... dynamic aqueous plasma technology platforms, announced today that the company has engaged in ... Research and Development Agreement (MRDA) with the CSU Office of the Vice President ...
(Date:12/6/2016)... , Dec. 6, 2016 Zimmer Biomet Holdings, ... announced the pricing terms of its previously-announced cash ... aggregate purchase price (excluding accrued and unpaid interest ... and excluding fees and expenses related to the ... securities identified in the table below (collectively, the ...
(Date:12/6/2016)... ... December 06, 2016 , ... ... management solutions headquartered in Aurora, Ohio, announced the opening of their new office ... the newly constructed facility is home to 200 employees focused on providing sales, ...
Breaking Biology Technology:
(Date:12/6/2016)... 2016  Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) ... of €500.0 million principal amount of its 1.414% senior unsecured ... 2.425% senior unsecured notes due 2026. The ... 2016, subject to the satisfaction of customary closing conditions.  The ... The Company intends to use the net ...
(Date:12/5/2016)... Dec. 5, 2016  The Office of Justice ... "Can CT Scans Enhance or Replace Medico Legal ... of supporting or replacing forensic autopsies with postmortem ... In response to recommendations made by ... using CT scans as a potential component of ...
(Date:11/30/2016)... , Nov. 30, 2016 Not many of us realize that we spend ... recovery so we need to do it well. Inadequate sleep levels have been found ... pressure, stroke, diabetes, and even cancer. Maybe now is the best time ... could help them to manage their sleep quality? Continue ... ...
Breaking Biology News(10 mins):