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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) April 10, 2002
ENZON, INC.
(Exact name of registrant as specified in its charter)
Delaware 0-12957 22-2372868
(State or other jurisdiction of (Commission (IRS Employer
incorporation) File Number) Identification)
20 Kingsbridge Road, Piscataway, New Jersey 08854
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (732) 980-4500
NA
(Former name or former address, if changed since last report)
Item 5. Other Events
On April 10, 2002, Enzon, Inc. ("Enzon") announced a multi-year strategic
collaboration with Micromet AG ("Micromet") to identify and develop the next
generation of antibody-based therapeutics.
Under the terms of the agreement, Enzon and Micromet (collectively, the
"Partners") will combine their significant patent estates and complementary
expertise in single-chain antibody ("SCA") technology to create a leading
platform of therapeutic products based on antibody fragments. The collaboration
will also benefit from a non-exclusive, royalty-bearing license from Enzon for
PEGylated SCA products. The companies will establish a new R&D Unit located at
Micromet's research facility in Germany. The R&D Unit will be staffed initially
with 25 scientists and plans to be fully operational by the end of 2002. During
the first phase of the collaboration, covering a 30-month period beginning in
the third quarter of calendar 2002, the new R&D Unit will focus on the
generation of at least two clinical product candidates in therapeutic areas of
common strategic interest. The Partners will share equally the costs of research
and development, and plan to share the revenues generated from technology
licenses and from future commercialization of any developed products. Because
the R&D activities will now be located at Micromet's headquarters in Germany,
Enzon will be re-deploying its SCA group, which is operating out of Enzon's New
Jersey R&D facility. To that end, Enzon anticipates that during the fourth
quarter of fiscal year 2002, it will be taking a one-time charge of
approximately $750,000. Enzon does not expect total anticipated R&D expenditures
to materially change as a result of this alliance. Additional R&D costs arising
from this alliance will be in line with the current projected R&D growth
incorporated in current estimates.
In addition to the R&D collaboration, Enzon will make a US$8 million
investment into Micromet in the form of a loan convertible into common stock of
Micromet.
SCAs combine the antigen binding regions of antibodies on a single
polypeptide chain. They are considerably smaller in size than conventional
antibodies, and can be produced conveniently on a commercial scale in microbial
protein expression systems, providing significant cost savings when compared to
monoclonal antibodies. SCAs are highly versatile and can readily be genetically
engineered to work in a variety of formats. These formats include: SCAs specific
for cell-surface receptors for application as biological antagonists and
agonists; SCAs designed to block the activity of cytokines and other soluble
biological mediators; and,
SCA-fusion proteins, where cell-specific SCAs are "armed" with toxins,
radionuclides, enzymes, or cytotoxic drugs for selective elimination of
particular cell types, for example in cancer. The variety of SCA formats make
them attractive products potentially suitable for a broad range of therapeutic
applications, beyond the reach of conventional monoclonal antibodies in areas
such as cancer, central nervous system disorders, transplantation, inflammation
and autoimmunity. The ability to deliver SCAs by alternative routes of
administration, e.g., by pulmonary delivery, and to predictably extend the
biological half-life of SCAs by PEGylation, further expands the clinical utility
of SCA products beyond the range of monoclonal antibodies.
Enzon holds core intellectual property in SCAs. These fundamental patents,
combined with Micromet's key patents in SCA linkers and fusion protein
technology, generate a compelling technology platform for SCA product
development. The Partners have renewed their cross-license agreement to their
respective SCA intellectual property ("IP") and have decided to jointly market
their combined SCA IP to third parties. Micromet will be the exclusive marketing
partner and will institute a comprehensive licensing program on behalf of the
partnership, for which the parties will share equally in the costs and revenues.
Current licensees to Enzon and Micromet IP include Alexion, Bristol-Myers
Squibb, Cambridge Antibody Technologies, Cell Genesys, Celltech, Crucell, Eli
Lilly, Seattle Genetics and Xoma. Several SCA molecules are in clinical trials.
Alexion Pharmaceuticals, Inc. is currently in Phase III clinical studies in
cardiopulmonary bypass surgery.
Antibodies are proteins produced naturally by the body's immune system, in
response to infection, and specifically recognize target molecules known as
antigens, present on virus-infected cells or located on the surface of microbial
pathogens. Hybridoma technology has enabled the generation of specific
monoclonal antibodies (antibodies derived from a single clone of cells) directed
to a range of biological targets of therapeutic interest. Subsequent technical
advances have also addressed issues such as commercial-scale manufacturing and
the production of "humanized" mouse monoclonal antibodies, and totally human
monoclonal antibodies, to overcome immunogenicity problems associated with
first-generation products. Several monoclonal antibodies have been approved and
commercialized for human therapeutic use, creating a multibillion dollar market
that is expected to grow significantly in the next several years. Monoclonal
antibodies generally have a long circulating half-life, making them suitable for
particular types of therapy.
Except for the historical information herein, the matters discussed in this
news release include forward-looking statements that may involve a number of
risks and uncertainties. Actual results may vary significantly based upon a
number of factors, which are described in Enzon's Form 10-K, Form 10-Q's and
Form 8-K's on file with the SEC, including without limitation, risks in
obtaining and maintaining regulatory approval for indications and expanded
indications, market acceptance of and continuing demand for Enzon's products and
the impact of competitive products and pricing.
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.
Dated: April 10, 2002
ENZON, INC.
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(Registrant)
By: /s/ KENNETH J. ZUERBLIS
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Kenneth J. Zuerblis
Vice President, Finance, Chief Financial
Officer and Corporate Secretary