Navigation Links
Patents Issued Covering Stable Tablet Formulation and Once Daily Dosing Regimen for Kuvan

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 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 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.


    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
Post Your Comments:
(Date:11/27/2015)... ... November 27, 2015 , ... Dr. Thomas Dunlap and ... and Dr. Tucker Bierbaum with Emergency Medicine at St., Joseph Health System’s Santa ... and Sepsis conditions present in similar ways and require time-critical intervention to avoid large ...
(Date:11/26/2015)... ... November 26, 2015 , ... Inevitably when people think Thanksgiving, ... choose to buy during the Black Friday and Cyber Monday massage chair sales ... search the Internet high and low to find the best massage chair deals, they ...
(Date:11/26/2015)... ... , ... Jobs in hospital medical laboratories and in the imaging field lead ... Aureus Medical Group . These fields, as well as travel nursing, ... healthcare jobs through the company’s website, , The leading healthcare staffing ...
(Date:11/26/2015)... ... November 26, 2015 , ... ... for mental health and wellness consultation, has collaborated with Women’s Web – ... their reader’s queries on topics on mental and emotional well-being relationship, life ...
(Date:11/25/2015)... , ... November 25, 2015 , ... ... where preparing the perfect dish and pleasing the palates of attendees is of ... bringing a dish to a seasonal get-together, give these recipes a try this ...
Breaking Medicine News(10 mins):
(Date:11/25/2015)... 2015  Amgen (NASDAQ: AMGN ) today announced ... the United States (U.S.) Food ... candidate to Humira ® (adalimumab). Amgen believes this ... the FDA and represents Amgen,s first BLA submission using ... , M.D., executive vice president of Research and Development ...
(Date:11/25/2015)... , Nov. 25, 2015  Linden Care, LLC, a ... treatment outcomes for patients suffering from chronic pain, said ... a Temporary Restraining Order (TRO) enjoining Express Scripts from ... companies. --> --> ... of its legal options. --> ...
(Date:11/25/2015)... ATLANTA , Nov. 25, 2015 ... the first federal bellwether trial against Wright Medical ... relating to their Conserve metal-on-metal hip implant device, ... Christiansen.  Following a two week trial and three ... Conserve metal-on-metal hip device was defectively designed and ...
Breaking Medicine Technology: