Navigation Links
United States Patent Office Allows Claims Covering the Approved Administration of Kuvan with Food

NOVATO, Calif., Sept. 30 /PRNewswire-FirstCall/ --BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that the United States Patent and Trademark Office has allowed claims covering the approved administration of Kuvan® (sapropterin dihydrochloride) with food, based on the discovery that food increases the bioavailability of Kuvan. The company expects that the patent, which expires in 2024, will officially issue later this year.

"This food effect patent, along with the patents issued for once daily dosing and stable tablet formulation, continues to strengthen our proprietary position on Kuvan and provides protection that extends approximately ten years beyond orphan drug exclusivity," said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. "We believe these patents will create significant barriers to therapeutically equivalent generic competition prior to their expiration."

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 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® (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme® (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; and Kuvan® (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 Phase II clinical 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 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®, Naglazyme® and Kuvan® are registered trademarks of BioMarin Pharmaceutical Inc.

Aldurazyme® 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

SOURCE BioMarin Pharmaceutical Inc.

SOURCE BioMarin Pharmaceutical Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
2. R-CALF United Stockgrowers of America: Fighting for the U.S. Cattle Producer
3. United States, Canada and Mexico Agree to Mutual Assistance During Public Health Emergencies
4. Parker Waichman Alonso LLP and Affiliated Lawfirms Have Filed a Class Action Lawsuit in the United States District Court for the Eastern District of New York Against Merck & Co., Inc. and Schering-Plough Corporation
5. Peptimmune Announces Grant of United States Patent for PI-2301 Peptide Copolymer for Multiple Sclerosis
6. A First-Line Therapy for Renal Cell Carcinoma that can Increase Overall Survival when Compared with Sutent Would Earn a Higher Patient Share in the United States Than in Europe
7. American Oriental Bioengineering to Initiate a Phase One Clinical Trial in the United States of AOBO-001 Oral Capsule
8. Premier Research Expands its Medical Device Operations to the United States
9. Watson Announces United States Availability of RAPAFLO(TM) (silodosin), a Novel New Treatment in Benign Prostatic Hyperplasia (BPH)
10. United States Patent and Trademark Office Publishes Stemedicas Patent Application for the Treatment of Diabetic Retinopathy
11. EMD Serono Submits Application for Cladribine Tablets as a Potential Oral Short-Course Multiple Sclerosis Therapy in the United States
Post Your Comments:
(Date:11/26/2015)... 2015 ) has ... of High Viscosity Drugs" report to their ... the addition of the "Self Administration of ... --> Research and Markets ( ... "Self Administration of High Viscosity Drugs" report ...
(Date:11/26/2015)... , November 26, 2015 /PRNewswire/ ... announced the addition of the  "2016 ... the European Cell Surface Marker Testing ... Opportunities"  report to their offering.  ... the addition of the  "2016 Future ...
(Date:11/25/2015)... Calif. , Nov. 25, 2015  Amgen (NASDAQ: ... Biologics License Application (BLA) with the United ... for ABP 501, a biosimilar candidate to Humira ® ... adalimumab biosimilar application submitted to the FDA and represents ... Sean E. Harper , M.D., executive vice ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... November 28, 2015 , ... There is only one major question facing ... last year? , This question has not been an easy question to answer. Especially ... age and the younger workforce don’t share the same discipline around working long hours. ...
(Date:11/27/2015)... Angeles, CA (PRWEB) , ... November 27, 2015 , ... ... study carried out by the University of Toronto and the University of British Columbia ... of hospitalizations for head injuries. The article explains that part of the reason for ...
(Date:11/27/2015)... ... November 27, 2015 , ... The ... in America. As people age, more care is needed, especially with Alzheimer’s, dementia ... medical professionals are being overworked. The forgotten part of this equation: 80 percent ...
(Date:11/27/2015)... ... November 27, 2015 , ... An inventor, ... to dispense prescription medications at home, so he invented the patent-pending ELECTRONIC M.D. ... dispense prescription medications. In doing so, it could help to prevent potential overdose ...
(Date:11/27/2015)... CA (PRWEB) , ... November 27, 2015 , ... Lizzie’s ... , The company is offering customers 10% off of their purchase of lice treatment ... treatment at full price. According to a company spokesperson. “Finding lice is a sure ...
Breaking Medicine News(10 mins):