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) December 18, 2000
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
N/A
(Former name or former address, if changed since last report)
Item 5. Other Events
Enzon Files Investigational New Drug Application for PEG-paclitaxel
Enzon, Inc. (the "Company") announced on December 18, 2000 that it has
submitted an Investigational New Drug (IND) application to the Food and Drug
Administration (FDA) for PEG-paclitaxel. PEG-paclitaxel is a PEG modified
version of paclitaxel. Preclinical animal studies have demonstrated that
PEG-paclitaxel can be dosed at higher levels than TAXOL(R) (paclitaxel), the
world's best selling cancer drug. The ability to dose PEG-paclitaxel at higher
levels may allow increased efficacy compared to TAXOL.
TAXOL is a powerful chemotherapeutic agent with delivery limitations. TAXOL
is used to treat various types of cancers, including ovarian, breast, non-small
cell lung, and AIDS-related Kaposi's sarcoma. In 1999, sales of TAXOL were
reported to be $1.5 billion.
Using the Company's proprietary PEG technology, scientists at the Company
have modified paclitaxel through the chemical attachment of PEG using a linker
designed to deteriorate over time, giving PEG-paclitaxel prodrug attributes.
PEG-paclitaxel was designed to be delivered without the need for solubilizing
agents or premedications. TAXOL, a commercial formulation of paclitaxel,
contains the solubilizing agent CREMOPHOR(R) and patients are required to take
premedications prior to treatment to reduce the potential for serious allergic
reactions, which may be caused by CREMOPHOR.
To date, the Company's PEG technology has been used to create three
approved protein therapeutics, including PEG-INTRON(R), currently being marketed
in Europe by Schering-Plough. PEG-paclitaxel is the second application of the
Company's PEG technology to deliver small organic chemical molecules.
PROTHECAN(R), a PEG modified version of the topoisomerase inhibitor
camptothecin, is currently in two Phase I clinical trials.
The Company's proprietary PEG technology can significantly increase the
efficacy of compounds that suffer from delivery limitations allowing them to
become improved therapeutics. The Company's proprietary PEG technology may
improve a wide range of drugs on the market, as well as enhance those in
development, including chemotherapy agents, antibiotics, anti-fungals and
immunosuppressants. The attachment of PEG has the potential to temporarily mask
the active mechanisms of some chemotherapeutics, allowing the drug to circulate
in the bloodstream longer and direct accumulation of the drug towards the tumor
site. After accumulation in the tumor, the bond is designed to break down,
allowing the compound to resume its normal tumor killing activity and achieve
targeted efficacy with possibly reduced systemic toxicity. The Company is
currently applying its PEG technology to several additional compounds in
preclinical development.
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-Qs 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 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: December 18, 2000
ENZON, INC.
--------------------------
(Registrant)
By: /s/ Kenneth J. Zuerblis
------------------------------
Kenneth J. Zuerblis
Vice President, Finance and
Chief Financial Officer