Navigation Links
Patents Issued Covering Stable Tablet Formulation and Once Daily Dosing Regimen for Kuvan
Date:7/30/2009

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.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. 90 Brain Fitness Patents for Posit Science
2. Misonix Announces the Purchase of Patents From ProRhythm, Inc.
3. Orexigen(R) Therapeutics Announces In-Licensing of Key Patents to Further Strengthen its Intellectual Property Estate for Contrave(R)
4. Impliant Granted Two New U.S. Patents and Successfully Defends European Patent Opposition Case
5. CAP Joins Landmark Lawsuit Challenging Legality of Myriad Genetics Gene Patents
6. ACMG Joins Lawsuit Challenging Patents on Breast Cancer Genes; Genes Are Naturally Occurring Substances and Should Not Be Patented, Says American College of Medical Genetics
7. ACLU Challenges Patents on Breast Cancer Genes
8. MMR Information Systems, Inc. Announces 250,000 Membership Milestone and Granting of International Patents
9. German Federal Patent Court Invalidates Wake Forest NPWT Patents Licensed to KCI
10. United States Patent Office Rejects KCIs Patents
11. ALSIUS CORPORATION PREPARED TO INVALIDATE ZOLL TEMPERATURE MANAGEMENT PATENTS
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... (PRWEB) , ... December 08, 2016 , ... ... accreditation with distinction by the Undersea and Hyperbaric Medical Society (UHMS), the leading ... advanced care and patient safety. Only a few hospitals and facilities have earned ...
(Date:12/8/2016)... Virginia (PRWEB) , ... December 08, 2016 , ... ... services company offering Medication Therapy Management (MTM), adherence, and other pharmacist-delivered patient care ... operations and general counsel and Eric Hoessel to vice president of sales. ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... access for customers and employees that are both engaging and easy to use. ... Smart Technology, the software company revealed today its plans to roll out new ...
(Date:12/8/2016)... ... 2016 , ... California Senate Bill (SB) 863, signed into law in 2012, ... and 2014, according to CompScope™ Medical Benchmarks for California, 17th Edition , a ... study, medical payments per claim in California decreased 4 percent in 2013 and then ...
(Date:12/8/2016)... ... December 08, 2016 , ... The Dianne Michael Insurance ... in Hamilton County, is embarking on a charity drive with the aim of ... homes for orphaned or neglected senior dogs in the Cincinnati region, and LuvFurMutts ...
Breaking Medicine News(10 mins):
(Date:12/8/2016)... , Dec. 8, 2016 Allergy Diagnostics ... products and tests that are used to determine ... peanuts, milk, or drugs etc. in the samples ... the immune system. The report on global allergy ... of the market. The report consists of an ...
(Date:12/8/2016)... CAMBRIDGE, Mass. , Dec. 8, 2016 /PRNewswire/ ... today that Nationwide Children,s Hospital signed ... enhance and accelerate the development of new cures. ... healthcare organizations representing over 57 million patients globally, ... are working together to improve protocol design, site ...
(Date:12/8/2016)... True Health Diagnostics today announced a ... and management expertise to hospital systems throughout ... doctors and patients to benefit from state-of-the-art biomarker ... Logo - http://photos.prnewswire.com/prnh/20161208/447162LOGO ... to contain costs, have struggled to keep up ...
Breaking Medicine Technology: