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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): January 14, 2002
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 or organization) File Number) Identification No.)
371 Bel Marin Keys Boulevard,
Suite 210, Novato, California 94949
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (415) 884-6700
Not Applicable
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(Former name or former address, if changed since last report)
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Item 5. Other Events.
On January 14, 2002, BioMarin Pharmaceutical Inc. (the "Registrant")
announced that it has reached a definitive agreement to acquire Synapse
Technologies Inc. ("Synapse"). The Registrant intends to use Synapse's
proprietary technology to deliver therapeutic enzymes and other drugs across the
blood-brain barrier by means of traditional intravenous injections.
Under the terms of the agreement, the Registrant will purchase all of
the outstanding shares of Synapse for approximately US$10.18 million by
exchanging 885,275 shares of the Registrant's common stock at a value of
US$11.50 per share. The Registrant will also make contingent payments
post-closing to Synapse stockholders in either cash or the Registrant's stock of
up to approximately US$5.10 million upon reaching certain development
milestones.
The boards of directors of the Registrant and Synapse have approved the
transaction, which is subject to approval of the shareholders of Synapse,
approval of the Supreme Court of British Columbia after a hearing on the
fairness of the terms and conditions of the acquisition, and customary closing
conditions. The transaction is expected to close in the first quarter of 2002.
The Registrant's press release issued on January 14, 2002 is attached
hereto as Exhibit 99.1.
Item 7. 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 Registrant dated January 14, 2002
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: January 14, 2002 By: /s/ Fredric D. Price
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Fredric D. Price
Chairman and Chief Executive Officer
EXHIBIT INDEX
Exhibit No. Description
Exhibit 99.1 Press Release of the Registrant dated January 14, 2002
Exhibit 99.1
Press Release
SOURCE: BioMarin Pharmaceutical Inc.
BioMarin to Acquire Developer of Unique Brain Delivery Technology
Technology Pioneered by Synapse Transports Enzymes Across the Blood-Brain
Barrier via Traditional IV Injection Conference Call and Webcast to be Held
Today at 4:15 PM ET (2215 CET)
NOVATO, Calif., Jan. 14 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq and
Swiss SWX New Market: BMRN) today announced that it has reached a definitive
agreement to acquire Synapse Technologies Inc., a privately held
biopharmaceutical company based in Vancouver, British Columbia. BioMarin intends
to use Synapse's proprietary technology to deliver therapeutic enzymes and other
drugs across the blood- brain barrier by means of traditional intravenous
injections. BioMarin will evaluate opportunities in lysosomal storage disorders
using the Synapse technology to deliver enzyme replacement therapies to brain
cells in order to treat the neurological effects of these genetic diseases.
Terms of the Agreement
Under the terms of the agreement, BioMarin will purchase 100% of the outstanding
shares of Synapse for approximately US$10.18 million by exchanging 885,275
shares of BioMarin common stock at a value of US$11.50 per share. BioMarin will
also make contingent payments post-closing to Synapse stockholders in either
cash or BioMarin stock of up to approximately US$5.1 million upon reaching
certain development milestones.
The boards of directors of BioMarin and Synapse have approved the transaction,
which is subject to approval of the shareholders of Synapse, approval of the
Supreme Court of British Columbia after a hearing on the fairness of the terms
and conditions of the acquisition, and customary closing conditions. The
transaction is expected to close in the first quarter of 2002.
Fredric D. Price, BioMarin's Chairman and Chief Executive Officer, said, "At
present, intravenously administered biotechnology-based protein drugs
(including enzymes, hormones, and peptides) and certain small molecule drugs
(including many anti-cancer agents) cannot penetrate the blood-brain barrier,
the body's natural brain defense mechanism. If Synapse's brain delivery
technology demonstrates safety and efficacy in human clinical trials, it will
enable BioMarin to develop enzyme replacement therapies for the currently
untreatable central nervous system effects of many lysosomal storage disorders.
"The acquisition of Synapse, along with the recent addition of Neutralase (TM)
and Phenylase to our pipeline, enhances our enzyme technology base and opens up
larger patient market opportunities for BioMarin. Equally important, this
technology supports our strategic focus of developing novel enzyme therapies for
significant, unmet medical needs."
Z. Sam Ruttonsha, President and Chief Executive Officer of Synapse, added, "This
transaction provides an endorsement of our technology, which was originally
developed by Dr. Wilfred Jefferies at the University of British Columbia, and
subsequently has been financed, in part, by several leading Canadian venture
capital firms. Now with the addition of BioMarin's development capabilities, we
envision more rapid progress towards the commercialization of this technology."
Brain Delivery: A Significant Unmet Medical Need
The blood-brain barrier is the brain's first line of defense against potentially
harmful compounds and pathogens. It is also the major obstacle to developing
drugs for the brain. Synapse's research involves the proprietary use of a
natural human blood protein known as p97 that is being developed to transport
both large and small molecule drugs as "payloads" across the blood- brain
barrier and into brain cells. BioMarin is developing enzyme replacement
therapies for lysosomal storage disorders and intends to use p97 to transport
therapeutic enzymes across the blood-brain barrier into the brain for the
treatment of the central nervous system effects -- such as delayed mental
development -- that are associated with many lysosomal storage disorders.
Synapse has conducted preclinical studies using intravenously administrated
p97-enzyme conjugates that have demonstrated successful delivery of enzymes to
the brain. Most importantly, the experiments have shown that these p97-enzyme
conjugates remain active in brain tissue and appear within the brain cells in as
little as 15 minutes after intravenous administration.
In addition, Synapse has demonstrated in animal models that it can deliver
therapeutic doses of doxorubicin, an approved small molecule cancer drug that
currently does not penetrate the blood-brain barrier on its own, to the brain
using the p97 delivery system. Richard Beliveau, Ph.D., Professor at the
University of Quebec at Montreal and Director of the Laboratory of Molecular
Medicine, Ste. Justine Hospital in Montreal, Quebec, Canada, said, "Since every
brain cell is within a few microns of a blood capillary, the most effective way
of achieving uniform drug
distribution throughout the brain is via the brain's extensive vasculature.
Therefore, the most efficient and convenient means of achieving brain delivery
of enzymes and other drugs would be via the traditional intravenous injection
into the bloodstream. Synapse's work is promising and, if confirmed in human
clinical trials, could lead to a breakthrough in the treatment of central
nervous system disorders."
Christopher M. Starr, Ph.D., BioMarin's co-founder and Senior Vice President,
Research and Development, said, "While BioMarin's primary focus for p97 will be
on treating the neurological problems associated with many lysosomal storage
disorders, we also recognize that this technology platform may offer BioMarin
additional business opportunities in the delivery of small molecule, hormone and
peptide therapeutics across the blood-brain barrier. Our intention is to invest
in these kinds of small molecule programs only to the extent that we can
demonstrate proof of principle that we can deliver such compounds to the brain.
After that time, we would then seek to form partnerships with other companies
that would assume further development and commercialization responsibilities."
Synapse's employees will remain in Vancouver under the direction of Reinhard
Gabathuler, Ph.D., who is currently Vice President, Research at Synapse and who
will become BioMarin's Vice President, Brain Research.
Dr. Gabathuler added, "The expertise of BioMarin in enzyme replacement therapies
is a near perfect fit with Synapse's brain delivery technology. Our
collaborative efforts in the past few months have been fruitful and we look
forward to building on this work and contributing to the future success of
BioMarin." Additional information on the Synapse p97 brain delivery technology
can be found on the BioMarin website by visiting:
www.biomarinpharm.com/BM_ClinicalAndDevelopmentPrograms_BrainResearch.html
BioMarin will host a conference call and webcast to discuss this acquisition
today at 4:15 PM EST (2215 CET). This event can be accessed on the BioMarin
website at: http://investor.biomarinpharm.com.
Date: January 14th, 2002
Time: 4:15 PM ET (2215 CET)
U.S. & Canada Toll-free Dial in #: 1-800-360-9865
International Dial in #: 1-973-694-6836
Replay Toll-free Dial in #: 1-800-428-6051
Replay International Dial in #: 1-973-709-2089
Replay Code #: 225408
BioMarin specializes in the development and commercialization of therapeutic
enzyme products to treat serious, life-threatening diseases and conditions.
Synapse Technologies Inc. is a biotechnology company specializing in the
research and development of new technologies for therapeutic drug delivery to
the brain across the blood-brain barrier and the identification of new drug
targets in neurodegenerative diseases.
This press release contains forward-looking statements about the business
prospects of BioMarin Pharmaceutical Inc., and the acquisition of the assets to
be acquired from Synapse and the technologies of Synapse. 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 completion of the acquisition, progress of
BioMarin's product programs, including the ability to integrate the technologies
being acquired from Synapse, the actual results of the current and proposed
clinical trials, actions of regulatory authorities, future availability of
capital, future actions in the pharmaceutical market and developments by
competitors, and those factors detailed in BioMarin's filings with the
Securities and Exchange Commission such as 10Q, 10K and 8K reports. 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.
Contacts:
Jeremy T. Price
Manager, Investor Relations
BioMarin Pharmaceutical Inc.
(415) 884-6777
Sharon Karlsberg
Vice President
Feinstein Kean Healthcare
(617) 577-8110
SOURCE: BioMarin Pharmaceutical Inc.