8-K

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): June 21, 2005

BioMarin Pharmaceutical Inc.

(Exact name of registrant as specified in its charter)

Delaware	000-26727	68-0397820
(State or other jurisdiction of incorporation or organization)	(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 (see General Instruction A.2. below):

¨ 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 8.01. Other Events.

On June 21, 2005, BioMarin Pharmaceutical Inc. (the “Company”) issued two press releases. One release related to the U.S. launch of Naglazyme for MPS VI and the second related to the appointment of Stephen Aselage as the Company’s Senior Vice President of Global Commercial Operations. The Company’s press releases issued on June 21, 2005 are attached hereto as Exhibits 99.1 and 99.2, respectively. The initial wholesale acquisition price for Naglazyme in the United States is $1,450 per 5mg vial.

Item 9.01. Financial Statements, Pro Forma 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 of the Company dated June 21, 2005 regarding the U.S. launch of Naglazyme for MPS VI.
Exhibit 99.2	Press Release of the Company dated June 21, 2005 regarding the appointment of Stephen Aselage as the Company’s Senior Vice President of Global Commercial Operations.

SIGNATURE

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
Date: June 22, 2005	By:	/s/ G. Eric Davis
		G. Eric Davis Vice President, Corporate Counsel

EXHIBIT INDEX

Exhibit No.	Description
Exhibit 99.1	Press Release of the Company dated June 21, 2005 regarding the U.S. launch of Naglazyme for MPS VI.
Exhibit 99.2	Press Release of the Company dated June 21, 2005 regarding the appointment of Stephen Aselage as the Company’s Senior Vice President of Global Commercial Operations.

EX-99.1

Exhibit 99.1

Contacts:

Investors	Media
Joshua A. Grass	Susan Ferris
Director, Business Development & Finance	Manager, Corporate Communications
BioMarin Pharmaceutical Inc.	BioMarin Pharmaceutical Inc.
415.506.6777	415.506.6701

For Immediate Release:

BioMarin Announces U.S. Launch of Naglazyme for MPS VI

Novato, CA, June 21, 2005 – BioMarin Pharmaceutical Inc. (Nasdaq and SWX: BMRN) announced today that Naglazyme^™ (galsulfase) is now available in the United States as the first specific therapy approved for the treatment of individuals with mucopolysaccharidosis VI (MPS VI), a rare and life-threatening genetic disease. Naglazyme was approved on May 31, 2005 by the U.S. Food and Drug Administration (FDA) and was shipped to distributors on Monday, June 20. The drug is being shipped to physicians this week. Naglazyme was developed by BioMarin and will be commercialized by the company’s U.S.-based sales force. Naglazyme is indicated for patients with MPS VI. Naglazyme has been shown to improve walking and stair-climbing capacity.

“With the commercial launch of Naglazyme, individuals with MPS VI now have an approved treatment option that specifically addresses the underlying cause of this progressive and debilitating disease,” stated Jean-Jacques Bienaimé, Chief Executive Officer and Director of BioMarin. “Naglazyme is the second product developed by BioMarin to receive FDA approval and the first such product that we are commercializing on our own. We have prepared extensively for this moment and are optimistic that our preparation will result in a robust product launch.”

In a separate release issued today, BioMarin announced the appointment of Stephen Aselage to the position of Senior Vice President, Global Commercial Operations, effective July 1, 2005. BioMarin’s commercial team includes four medical science liaisons who will be responsible for providing support to infusion centers and physicians who administer Naglazyme. The BioMarin sales force has mounted a disease awareness campaign targeted toward pediatricians and sub-specialists who are involved in the multi-disciplinary care of patients with MPS disorders to help drive new patient identification. Additionally, BioMarin has launched BioMarin Physician and Patient Support (BPPS), a free and confidential service established to assist patients and caregivers in their effort to receive insurance reimbursement for treatment with Naglazyme.

Naglazyme is administered once weekly via intravenous infusion and is dosed at 1 milligram of drug per kilogram of body weight. The annual cost of treatment will vary considerably according to each patient’s weight.

ATU Program Under Way in France

In advance of product approval, BioMarin has received temporary use authorization (ATU) from regulatory authorities in France for named patient basis sales. Three patients who met certain selection criteria have begun to receive Naglazyme treatment. BioMarin expects to book revenue from these named patient basis sales and will continue to assist patients in Europe wherever possible prior to product approval in the European Union.

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About Naglazyme

Naglazyme is an enzyme replacement therapy for the treatment of MPS VI. As the first therapy approved for MPS VI, the FDA has granted Naglazyme orphan drug status, which confers seven years of market exclusivity.

Data from the Phase 3 clinical trial and extension study indicate that Naglazyme was generally safe. The most common adverse events observed in clinical trials in Naglazyme-treated patients were headache, fever, arthralgia, vomiting, upper respiratory infections, abdominal pain, diarrhea, ear pain, cough, and otitis media. Over 95 percent of the infusion-related adverse events were considered mild or moderate and were easily managed. Infusion-related adverse events commonly included fever, chills/rigors, headache, rash, and mild to moderate urticaria. Severe reactions included angioneurotic edema, hypotension, dyspnea, bronchospasm, respiratory distress, apnea, and urticaria. No patients discontinued Naglazyme infusions for adverse events and all patients that completed the double-blind portion of the trial continue to receive weekly infusions of Naglazyme. Nearly all patients developed antibodies as a result of treatment, but the level of the immune response did not correlate with adverse events or impact the improvements experienced in endurance. Evaluation of airway patency should be considered prior to the initiation of treatment. Consideration to delay Naglazyme infusion should be given when treating patients who present with an acute febrile or respiratory illness. Naglazyme is available by prescription only. Full prescribing information is available at www.naglazyme.com.

About MPS VI

MPS VI (also known as Maroteaux-Lamy syndrome) is a debilitating, life-threatening genetic disease caused by a deficiency of the enzyme N-acetylgalactosamine 4-sulfatase. This enzyme deficiency leads to the accumulation of certain complex carbohydrates, glycosaminoglycans (GAGs), in the lysosomes, giving rise to progressive cellular, tissue and organ system dysfunction. Enzyme replacement therapy with Naglazyme addresses the underlying cause of the disease by providing individuals with MPS VI the enzyme they are naturally lacking. An estimated 1,100 individuals in the developed world have MPS VI. The majority of individuals with MPS VI die from disease-related complications between childhood and early adulthood. Additional information about MPS VI can be found at www.mpsvi.com.

About BioMarin

BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company’s product portfolio is comprised of three approved products and multiple product and preclinical 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), and Orapred^® (prednisolone sodium phosphate oral solution) for severe asthma. Investigational product candidates include 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 websites, including www.BMRN.com, www.mpsvi.com and www.naglazyme.com, 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: the development and commercialization of Naglazyme; expectations related to post-marketing commitments for Naglazyme; 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: slow market penetration following launch; the content and timing of decisions by the European Commission and other regulatory authorities concerning Naglazyme; issues or complications associated with post-

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marketing commitments; 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.

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EX-99.2

Exhibit 99.2

Contacts:

Investors	Media
Joshua A. Grass	Susan Ferris
Director, Business Development & Finance	Manager, Corporate Communications
BioMarin Pharmaceutical Inc.	BioMarin Pharmaceutical Inc.
415.506.6777	415.506.6701

For Immediate Release:

BioMarin Announces Appointment of Stephen Aselage

as Senior Vice President of Global Commercial Operations

Novato, CA, June 21, 2005 – BioMarin Pharmaceutical Inc. (Nasdaq and SWX: BMRN) announced today that it has appointed Stephen Aselage to the position of Senior Vice President, Global Commercial Operations, effective July 1, 2005. Mr. Aselage joins BioMarin from Cell Therapeutics, Inc. where he served as Executive Vice President, Global Commercial Operations.

“I am pleased to welcome Mr. Aselage to BioMarin and look forward to the leadership he will bring to the commercial arm of our business,” stated Jean-Jacques Bienaimé, Chief Executive Officer and Director of BioMarin. “Mr. Aselage’s significant experience in building and developing commercial organizations and past involvement in launching over a dozen new products in the biotechnology and pharmaceutical industries, will undoubtedly prove to be useful as we move forward with our U.S. launch of Naglazyme^™ for MPS VI and evaluate ex-U.S. commercialization strategies in anticipation of European approval in early 2006.”

Mr. Aselage, 54, joins BioMarin with more than 25 years of experience in medical sales and marketing in the biotechnology and pharmaceutical industries. In February 2004, Mr. Aselage was appointed Executive Vice President of Global Commercial Operations at Cell Therapeutics, a biotechnology company focused on cancer therapeutics. While there, he led efforts to streamline the company’s United States and European commercial operations. Prior to Cell Therapeutics, Mr. Aselage served as Senior Vice President of North American Sales and Marketing for Genzyme Corporation following Genzyme’s September 2003 acquisition of Sangstat Medical Corporation where he had worked since February 1999. While at Sangstat, Mr. Aselage restructured the company’s sales, marketing and medical affairs groups and led the successful effort to make Thymoglobulin^® the top selling product in its class. From 1996 through 1999, Mr. Aselage served as Director of Sales and Marketing at Advanced Tissue Sciences where he established the company’s first sales and customer service groups. Earlier in his career, Mr. Aselage held a variety of sales and sales management positions at biotechnology and pharmaceutical companies including Rhone-Poulenc Rorer Pharmaceuticals (now Sanofi-Aventis), Genentech, Inc., and Bristol Laboratories. Mr. Aselage holds a Bachelor of Science in biology from the University of Notre Dame.

About BioMarin

BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company’s product portfolio is comprised of three approved products and multiple product and preclinical product candidates. Approved products include Naglazyme^™ (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and

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commercialized by BioMarin, Aldurazyme® (laronidase) for mucopolysaccharidosis I (MPS I), and Orapred® (prednisolone sodium phosphate oral solution) for severe asthma. Investigational product candidates include 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.

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 and commercialization of Naglazyme; expectations related to post-marketing commitments for Naglazyme; 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: slow market penetration following launch; the content and timing of decisions by the European Commission and other regulatory authorities concerning Naglazyme; issues or complications associated with post-marketing commitments; 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.

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