View:
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 14,1998
ENZON, INC.
(Exact name of registrant as specified in its charter)
Delaware 0-12957 22-237286
(State or other jurisdiction (Commission (IRS Employer
of 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
________________________________________________________________________________
(Former name or former address, if changed since last report)
Item 5. Other Events
Company Hires Vice President of Business Development
Enzon, Inc. (the "Company") announced the appointment of Richard P. Voss to
the newly created position of Vice President, Business Development.
Prior to joining the Company, Mr. Voss was Executive Director, Strategic
Planning & Corporate Development at Corange/Boehringer Mannheim Corporation,
Therapeutics ("BMCT"). While at BMCT, Mr. Voss was instrumental in negotiating,
among other transactions, product co-promotion agreements with E.I. du Pont de
Nemours and Company, Merck & Co., Inc., Roche Capital Corp. and SmithKline
Beecham Corp., as well as a major restructuring of BMCT's product development
and commercialization agreement with Gensia. Mr. Voss also spear-headed BMCT's
product licensing activities. Previously, Mr. Voss was Director, Mergers &
Acquisitions for Bogart Delafield Ferrier, Inc., Director, Corporate Development
for Warner-Lambert Company in its Planning, Investment & Development Group, and
Senior Product Manager with Abbott Laboratories.
Mr. Voss holds an MBA from the University of Chicago in International
Business, Finance and Accounting, and a B.S.B.A. from Marquette University.
John Caruso, Vice President, Administration and General Counsel, will
continue to be involved in the Company's business development efforts. He will
continue to manage the Company's strategic alliances with Schering-Plough
Corporation, Rhone-Poulenc Rorer Pharmaceuticals, Inc. and Medac GmbH among
others. Mr. Caruso will also be responsible for Human Resources, Regulatory
Affairs and Patents.
Green Cross Arbitration
The Company has two research and license agreements with The Green Cross
Corporation ("Green Cross") regarding the development of recombinant Human Serum
Albumin ("rHSA"), a blood expander. The Company and Yoshitomi Pharmaceuticals
Industries, Ltd. ("Yoshitomi"), the successor to the Green Cross business, have
been unable to resolve their dispute over the royalties payable to the Company
once commercial sales of rHSA begin. In January 1998, the Company commenced an
arbitration in Maryland which seeks a declaratory judgment that Green Cross will
owe royalties to the Company in accordance with the terms of the first of two
research and license agreements between Genex Corporation, a company which the
Company acquired in 1991, and Green Cross, once commercial sales of the rHSA
begin. In April 1998, Yoshitomi instituted arbitration proceedings in Los
Angeles seeking a declaratory judgment that no royalties would be due to the
Company under either agreement. On April 27, 1998, Yoshitomi filed a petition
against the Company in the United States District Court for the Central District
of California (the "California District Court") seeking to compel the Company to
submit to the arbitration proceeding filed by Yoshitomi. On May 12, 1998, the
Company filed a petition in the United States District Court for the District of
Maryland (the "Maryland District Court") to compel arbitration in Maryland and
for other related relief. After the Maryland District Court and the California
District Court conferred, it was determined that the California District Court
would be the first to review the issue of where the arbitration should proceed.
On May 27, 1998, the Company filed a motion in the California District Court
seeking to stay the arbitration proceedings in Los Angeles and to transfer the
arbitration proceedings to Maryland. The motions by Yoshitomi and the Company
are still pending.
Although the Company believes that royalties are payable by Yoshitomi under the
first research and license agreement, there can be no assurance the Company will
receive a favorable decision in the arbitration. An unfavorable decision in
these proceedings could result in a material adverse effect to the Company's
future business, financial condition and results of operations.
Notice of Allowance for Patent on Pro-Drug Technology
The Company has received a Notice of Allowance from the U.S. Patent and
Trademark Office for a patent on its newest generation of polyethylene glycol
("PEG") technology: Pro Drug/Transport technology. This third generation of PEG
technology may provide increased solubility and other drug delivery enhancements
to certain small molecule therapeutics. The claims in the allowed patent
application will cover certain PEG-modified small molecules, such as certain
anti-cancer, anti-fungal, antibiotic and other compounds. The key feature of the
Pro Drug/Transport technology is the linker joining PEG to the therapeutic
compound, which controls the rate of release of the compound in vivo to
potentially increase its efficacy and reduce its toxicity.
The new Pro Drug/Transport technology makes it possible to "pegylate" small
molecules, which has not been commercially feasible with earlier generations of
PEG technology. Many small molecules have known therapeutic efficacy, but also
have delivery problems. One well known example is camptothecin, a topoisomerase
I inhibitor. Camptothecin has been known as an effective anti-cancer agent for
some time, but has been difficult to deliver without serious side effects. The
Company is developing PROTHECAN(TM), a Pro/Drug/Transport version of
camptothecin. The Company's pre-clinical results with PROTHECAN suggest improved
efficacy in animal models of human cancers when compared to the products
currently on the market. The Company intends to file an Investigational New Drug
Application for PROTHECAN during the third calendar quarter of 1998.
Company Enters into Agreements to Raise $19 Million in Private Placement
On June 25, 1998, the Company announced that a small group of institutions
had agreed to purchase in a private placement an aggregate of approximately $19
million of the Company's unregistered Common Stock. The private placement was
priced on June 24, 1998 at $4.75 per share. Funding for the private placement
will be received at closing, which is expected immediately after notice from the
Securities and Exchange Commission (the "SEC") that a shelf registration
statement for the resale of the securities is effective.
The proceeds of the private placement will be used for general corporate
purposes, including further development of the Company's second and third
generation PEG (polyethylene glycol) products in an effort to create more value
before such products are licensed out to strategic partners. Proceeds will also
be used to develop a number of additional high potential PEG and Single-Chain
Antigen Binding (SCA) Protein compounds. The proceeds from this private
placement, along with the Company's current cash reserves, should be sufficient
to meet the Company's future capital and operational requirements for the
foreseeable future, based on currently planned research and development
activities and related costs. The securities being sold in the private placement
have not been registered under the Securities Act of 1933 and may not be offered
or sold in the United States absent registration or an applicable exemption from
the registration requirements.
Except for the historical information herein, the matters discussed herein
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 the Company's Form 10-K, Form 10-Q and Form 8-K
on file with the SEC, including without limitation, risks in obtaining and
maintaining regulatory approval for expanded indications, market acceptance of
and continuing demand for the Company'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: June 30, 1998
ENZON, INC.
(Registrant)
By: /s/ KENNETH J. ZUERBLIS
---------------------------
Kenneth J. Zuerblis
Vice President, Finance
and Chief Financial
Officer