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): October 10, 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 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
(Former name or former address, if changed since last report)
Item 5. Other Events.
On October 10, 2001, the Registrant announced that it has reached a
definitive agreement with IBEX Technologies Inc. ("IBEX") to acquire the rights
to all IBEX pharmaceutical assets. IBEX's portfolio of enzyme therapeutics will
complement the Registrant's existing pipeline of products for serious,
life-threatening diseases and conditions.
Under the terms of the two asset purchase agreements which govern the
transactions, the Registrant will acquire IBEX's pharmaceutical assets for
approximately US$10.5 million, with all but approximately US$2.0 million payable
in shares of the Registrant's common stock. The Registrant will also make
contingent payments of up to US$9.5 million to IBEX shareholders upon U.S. FDA
approval of products acquired from IBEX.
The boards of directors of the Registrant and IBEX have approved the
transactions, which is subject to customary closing conditions. The transactions
are expected to close in the fourth quarter of this year.
The Registrant's press release on the transactions 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 October 10, 2001
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: October 10, 2001 By: /s/ Fredric D. Price___________________
Fredric D. Price
Chairman and Chief Executive Officer
EXHIBIT INDEX
Exhibit No. Description
Exhibit 99.1 Press Release of the Registrant dated October 10, 2001
Exhibit 99.1
Press Release
Contacts:
Jeremy T. Price Sharon Karlsberg
Financial and Investor Relations Director
BioMarin Pharmaceutical Inc. Feinstein Kean Healthcare
(415) 884-6777 (617) 577-8110
BioMarin To Acquire Enzyme Products From IBEX Technologies
Neutralase(TM) to Enter Phase III Clinical Program for Coronary Artery Bypass
Graft;Phenylase in Preclinical Development for Phenylketonuria
Conference Call and Webcast to be Held Today at 4:15 PM EDT (2215 CET)
Novato, California, October 10, 2001 - BioMarin Pharmaceutical Inc. (Nasdaq
and SWX New Market: BMRN) today announced that it has reached a definitive
agreement with IBEX Technologies Inc. (Toronto Stock Exchange: IBT) to acquire
the rights to all IBEX pharmaceutical assets. IBEX's portfolio of enzyme
therapeutics will complement BioMarin's existing pipeline of products for
serious, life-threatening diseases and conditions.
New Product Additions to the BioMarin Pipeline
IBEX's lead product, NeutralaseTM, is an injectable heparinase
that reverses the anticoagulation of blood by heparin and other new heparin-like
anticoagulants. Neutralase is a carbohydrate-modifying enzyme that cleaves
heparin, a glycosaminoglycan (GAG), in a manner similar to the activity of
BioMarin's two enzyme replacement therapies: AldurazymeTM for the treatment of
MPS I and rhASB for the treatment of MPS VI. Based on positive safety and
efficacy data from IBEX's clinical trials of Neutralase, BioMarin plans to
initiate a Phase III trial of Neutralase in Coronary Artery Bypass Graft (CABG)
surgery in 2002.
In addition, IBEX has an early development stage program for Phenylase, an
orally active enzyme with the potential to treat Phenylketonuria (PKU), a
genetic disease caused by an enzyme deficiency that can lead to progressive,
severe, and irreversible mental retardation.
Terms of the Agreement
Under the terms of the agreement, BioMarin will acquire IBEX's
pharmaceutical assets for US$10.5 million, with all but US$2 million payable in
shares of BioMarin common stock.
BioMarin will also make contingent payments of up to US$9.5 million to IBEX
upon U.S. FDA approval of products acquired from IBEX.
The boards of directors of BioMarin and IBEX have approved the
transaction, which is subject to customary closing conditions. The transaction
is expected to close in the fourth quarter of this year. Leerink Swann & Co.
acted as financial advisor to BioMarin with regard to this transaction.
Fredric D. Price, BioMarin's Chairman and Chief Executive Officer said,
"Neutralase and Phenylase represent novel approaches to solving
medically-important problems that affect hundreds of thousands of patients in
North America and Europe. The acquisition of these promising compounds further
expands BioMarin's portfolio of treatments developed through our enzyme and
carbohydrate chemistry expertise.
"Neutralase is a unique late-stage product with the potential to
significantly reduce the serious problems associated with heparin reversal. With
the addition of Neutralase, BioMarin will have five drug candidates in clinical
trials next year: Aldurazyme, rhASB, Vibriolysin, Neutralase, and a fifth
product that will advance from our internal development pipeline."
Robert Heft, Ph.D., Co-founder, President, and Chief Operating Officer of
IBEX, added, "BioMarin's expertise in enzyme research, production, quality
control and assurance, process development, and clinical trials management will
greatly enhance the ability to effectively advance Neutralase and Phenylase
through their next stages of development. I am looking forward to assuming my
new position as Vice President, Product Development at BioMarin and
contributing, with my team here in Montreal, to BioMarin's success."
Background on Neutralase and Phenylase Markets
There are approximately 300,000 CABG procedures and 725,000 angioplasties
each year in the United States that could potentially benefit from heparin
reversal. Estimates for the European markets are projected to be as large as
those in the U.S. In addition, preclinical studies have shown that Neutralase
may be effective as a reversal agent for the low molecular weight heparins
(LMWHs) that are used in many surgeries such as hip and knee replacements as
well as for a new class of drugs, pentasaccharides, that are also being
developed for these indications.
Currently, protamine is the only product available for the reversal of
heparin anticoagulation. Protamine has been known to cause significant problems
during the reversal of heparin anticoagulation, but it has continued to be used
in the absence of an appropriate alternative. According to numerous published
articles, risks associated with protamine usage include: sudden decreases in
blood pressure, depression of heart function, pulmonary hypertension, acute
allergic reactions, complement activation, and strokes. IBEX's clinical trials
have demonstrated that Neutralase adequately reverses heparin anticoagulation
and improves blood pressure characteristics when compared to protamine.
Additional data suggest that Neutralase may address other serious problems that
have been linked to protamine usage as well.
Jeffrey Borer, M.D., Chief, Division of Cardiovascular Pathophysiology,
Weill Medical College of Cornell University, noted, "Protamine complications
during heart surgery are well known, but currently there are no other heparin
antidotes. In clinical testing during open heart surgery, Neutralase has
demonstrated the potential of being an effective alternative to protamine
without its unwanted hemodynamic complications."
Jean-Francois Tanguay, M.D., Montreal Heart Institute, and principal
investigator for IBEX's Phase II trial of Neutralase in angioplasty, commented,
"Heparin reversal following angioplasty is uncommon because of the lack of a
suitable drug. Initial clinical evaluation in patients undergoing angioplasty
demonstrated that Neutralase has the ability to significantly reduce the time to
sheath removal and the time required for safe patient ambulation."
PKU affects approximately 50,000 patients in North America and Europe.
There are no drugs currently approved for treatment of PKU, and patients are
required to adhere to strict, protein avoiding diets. The special formulas and
foods are estimated to cost more than $5,000 per patient per year over normal
food requirements. Many patients over five to ten years of age have difficulty
maintaining this dietary regimen, and their elevated phenylalanine levels lead
to a variety of problems with brain function. Phenylase is an oral enzyme
therapy that has the potential to reduce phenylalanine levels while allowing a
less restricted, more palatable diet.
Charles R. Scriver, M.D., Alva Professor of Human Genetics, McGill
University, said, "Up to now, treatment of thousands of PKU patients has been
accomplished by changing lifestyle, diet and the intake of protein and
phenylalanine. Almost fifty years of dietary treatment reveal how arduous and
difficult it is. Oral enzyme substitution therapy with Phenylase has been
demonstrated in a PKU animal model. It is time to move Phenylase forward so that
it can be studied and used in the human patient."
BioMarin will host a conference call and webcast to discuss this
acquisition today at 4:15 PM EDT (2215 CET). This event can be accessed on the
BioMarin website at: http://investor.biomarinpharm.com.
Date: Wednesday, October 10, 2001
Time: 4:15 PM EDT (2215 CET)
U.S. & Canada Toll-free Dial in #: 1-800-997-8642
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 #: 212381
Questions and Answers Related to the Transaction
In order to provide comprehensive information to all investors regarding
this transaction, BioMarin is taking this opportunity to present questions and
answers related to this transaction on the accompanying pages.
BioMarin specializes in the development and commercialization of
therapeutic enzyme products to treat serious, life-threatening diseases and
conditions.
IBEX is a biopharmaceutical company developing enzyme-based therapeutics
for a variety of applications, particularly cardiovascular disease and diseases
of genetic origin.
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 IBEX and the products of IBEX. 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 programs being acquired from IBEX, 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 undo 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.
The securities to be issued in connection with this acquisition have not been
registered under the Securities Act of 1933, as amended, or state securities
laws and may not be offered or sold in the United States absent registration or
an applicable exemption from the registration requirements. The Company has
agreed to use its best efforts to register all of the common stock relating to
this transaction with the SEC following the closing of this acquisition.