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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 25, 2001 (June 25, 2001)
BioMarin Pharmaceutical Inc.
(Exact name of registrant as specified in its charter)
Delaware 000-26727 68-0397820
(State or other jurisdiction of (Commission (IRS Employer
incorporation) File Number) Identification No.)
371 Bel Marin Keys Boulevard, Suite 94949
210 (Zip Code)
Novato, California
(Address of principal executive
offices)
(415) 884-6700
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(Registrant's telephone number, including area
code)
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Item 5. Other Events
Filing of Clinical Trial Exemption To Conduct Clinical Trial of Vibriolysin
Topical
On June 25, 2001, we announced the filing of a Clinical Trial Exemption
application with the Medicines Control Agency in the United Kingdom for
permission to conduct a human clinical trial of Vibriolysin Topical in patients
with serious burns. Vibriolysin Topical has displayed promising efficacy in
numerous preclinical studies related to the debridement (cleaning) of dead
tissue resulting from serious burns. Pending approval of the Clinical Trial
Exemption by the Medicines Control Agency, the Company anticipates initiating a
clinical trial of Vibriolysin Topical in the United Kingdom. If the application
is approved, Vibriolysin Topical will represent our third enzyme-based product
to be tested in humans.
Treatment of an acute burn injury requires the removal of dead tissue to enable
healing. Depending on the depth and location of the wound, debridement may be
attempted by topical drug treatment or manual methods that have been devised to
reduce the blood loss and pain inherent in surgery. Vibriolysin Topical's
propensity for selectively breaking down dead tissue without digesting healthy
tissue, as observed in preclinical studies, suggests that Vibriolysin Topical
may offer physicians treating burns a safe and effective alternative to surgery
and other less effective topical drugs for the debridement of burn wounds.
This foregoing information contains forward-looking statements about our
business prospects and products, including Vibriolysin Topical. These
forward-looking statements are predictions and involve risks and uncertainties
such that actual results may differ materially from these statements. Results
may differ materially depending on the progress of our product programs, the
results of current and proposed clinical trials, actions of regulatory
authorities, including the Medicines Control Agency's actions on the Clinical
Trial Exemption application, and those factors detailed in our other filings
with the Securities and Exchange Commission such as 10Q, 10K and 8K reports.
Stockholders are urged not to place undo reliance on forward-looking statements,
which speak only as of the date hereof. We are under no obligation, and
expressly disclaim any obligation, to update or alter any forward-looking
statement, whether as a result of new information, future events or otherwise.
Item 7. Financial Statements and Exhibits
None.
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.
By: /s/ Fredric D. Price
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Fredric D. Price
Chief Executive Officer and
Chairman of the Board
Date: June 25, 2001
Exhibit Index
None.