-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, SbkVZeFGLWCAZ8pzBewF19D9UFY92SIwfhEB81/Pn2/hng/zzCvojX1sT03lj2KM LiouDwP68UVwQ/w98JmdEg== 0001193125-05-097672.txt : 20050505 0001193125-05-097672.hdr.sgml : 20050505 20050505172213 ACCESSION NUMBER: 0001193125-05-097672 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20050505 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050505 DATE AS OF CHANGE: 20050505 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIOMARIN PHARMACEUTICAL INC CENTRAL INDEX KEY: 0001048477 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 680397820 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-26727 FILM NUMBER: 05804652 BUSINESS ADDRESS: STREET 1: 105 DIGITAL DRIVE CITY: NOVATO STATE: CA ZIP: 94949 BUSINESS PHONE: 4155066700 MAIL ADDRESS: STREET 1: 105 DIGITAL DRIVE CITY: NOVATO STATE: CA ZIP: 94949 8-K 1 d8k.htm FORM 8-K Form 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 8-K

 


 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): May 5, 2005

 


 

BioMarin Pharmaceutical Inc.

(Exact name of registrant as specified in its charter)

 


 

Delaware   000-26727   68-0397820

(State or other jurisdiction

of incorporation)

  (Commission File Number)  

(IRS Employer

Identification No.)

 

105 Digital Drive, Novato, California   94949
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (415) 506-6700

 

 

(Former name or former address, if changed since last report.)

 


 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 



Item 1.01 Entry Into a Material Definitive Agreement.

 

In connection with a license agreement entered into on May 2, 2005, BioMarin Pharmaceutical Inc. (the “Company”) issued a press release on May 5, 2005 announcing that it has licensed from Daiichi Suntory Pharma Co., Ltd. the exclusive worldwide rights (excluding Japan) to certain patent applications for the use of tetrahydrobiopterin (6R-BH4) to treat endothelial dysfunction that causes vascular complications in diabetes, cardiovascular and other diseases. The Company’s press release issued on May 5, 2005 is attached hereto as Exhibit 99.1.

 

Item 9.01 Financial Statements and Exhibits.

 

  (a) Financial Statements of Business Acquired.

 

Not Applicable.

 

  (b) Pro Forma Financial Information.

 

Not Applicable.

 

  (c) Exhibits.

 

Exhibit 99.1 – Press Release dated May 5, 2005.


SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

   

BioMarin Pharmaceutical Inc., a Delaware corporation

   

(Registrant)

Date: May 5, 2005

       
   

By:

 

/s/ Jeffrey H. Cooper


       

Jeffrey H. Cooper,

Chief Financial Officer


EXHIBIT INDEX

 

99.1    Press Release dated May 5, 2005.

EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

 

LOGO

 

Contacts:

 

Investors

  

Media

Joshua A. Grass

  

Susan Ferris

BioMarin Pharmaceutical Inc.

  

BioMarin Pharmaceutical Inc.

(415) 506-6777

  

(415) 506-6701

 

For Immediate Release:

 

BioMarin Acquires Rights to 6R-BH4 for Treating Vascular Dysfunction in Diabetes and Cardiovascular Disease

 

Novato, CA, May 5, 2005 – BioMarin Pharmaceutical Inc. (Nasdaq and SWX: BMRN) announced today that it has licensed from Daiichi Suntory Pharma Co., Ltd. the exclusive worldwide rights (excluding Japan) for the use of tetrahydrobiopterin (6R-BH4) to treat the endothelial dysfunction that causes vascular complications in diabetes, cardiovascular and other diseases. These rights are covered by U.S., European and other foreign patents and patent applications. The newly acquired rights expand BioMarin’s market opportunity for 6R-BH4 well beyond phenylketonuria (PKU).

 

In November 2004, BioMarin announced two separate agreements with Daiichi Suntory Pharma relating to 6R-BH4 for genetic diseases including PKU: a license to intellectual property, preclinical and clinical data, and a manufacturing and supply agreement. 6R-BH4 is the active pharmaceutical ingredient in Phenoptin (sapropterin hydrochloride), BioMarin’s investigational Phase 3 product candidate for the treatment of PKU. The new license extends BioMarin’s exclusive rights to Daiichi Suntory Pharma’s patents and data related to 6R-BH4 for all indications.

 

Emil Kakkis, M.D., Ph.D., Senior Vice President of Business Operations at BioMarin, commented, “Vascular endothelial dysfunction is an important underlying cause of morbidity and mortality in diabetes, cardiovascular and other diseases. 6R-BH4 is an essential cofactor required for the production of nitric oxide, which regulates vascular endothelial function. Researchers have established that a deficiency of 6R-BH4 contributes to endothelial dysfunction, and in limited academic studies, have demonstrated that 6R-BH4 administration improves vascular endothelial function in animal models and patients with diabetes and other cardiovascular diseases.”

 

In exchange for the exclusive rights to the intellectual property and data for all indications, in all territories outside of Japan, BioMarin will pay Daiichi Suntory Pharma an upfront payment, an undisclosed royalty on sales of 6R-BH4, and developmental milestones for up to two indications.

 

About BioMarin

 

BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company’s product portfolio is comprised of two approved products, Aldurazyme® (laronidase) for mucopolysaccharidosis I (MPS I), and Orapred® (prednisolone sodium phosphate oral solution) for severe asthma, and multiple investigational product candidates including rhASB (galsulfase), a BLA/MAA-stage product candidate for the treatment of mucopolysaccharidosis VI (MPS VI), and Phenoptin (sapropterin hydrochloride), a Phase 3 product candidate for the treatment of phenylketonuria (PKU). For additional information, please visit www.BMRN.com. Information on BioMarin’s website is not incorporated by reference into this press release.

 

Page 1 of 2


Forward-Looking Statement

 

This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including, without limitation, statements about: the development of its product candidate Phenoptin; expectations related to the possible use of Phenoptin for the treatment of indications other than PKU; and the scope, impact and validity of intellectual property licensed from Daiichi Suntory Pharma Co., Ltd. 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: the results of preclinical and clinical trials related to Phenoptin for the treatment of indications other than PKU; results and timing of current and planned clinical trials of Phenoptin for the treatment of PKU; the content and timing of decisions by the U.S. Food and Drug Administration, the European Medicines Agency and other regulatory authorities concerning Phenoptin; current and possible future challenges to the patents and patent applications licensed from Daiichi Suntory Pharma Co., Ltd.; and those factors detailed in BioMarin’s filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption “Factors That May Affect Future Results” in BioMarin’s 2004 Annual Report on Form 10-K and the factors contained in BioMarin’s reports on Forms 10-Q and 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.

 

Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC.

 

Orapred® is a registered trademark of Medicis Pediatrics, Inc., and is used under license.

 

# # #

 

Page 2 of 2

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-----END PRIVACY-ENHANCED MESSAGE-----