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 22, 2001
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)
1
Item 5. Other Events
FIRST PEGYLATED INTERFERON APPROVED FOR MARKETING IN THE UNITED STATES
Enzon, Inc. announced today that Schering-Plough Corporation has received U.S.
Food and Drug Administration (FDA) approval for PEG-INTRON(TM) (peginterferon
alfa-2b) Powder for Injection as once-weekly monotherapy for the treatment of
chronic hepatitis C in patients not previously treated with alpha interferon who
have compensated liver disease and are at least 18 years of age. PEG-INTRON is
the first and only pegylated interferon approved for marketing in the United
States. The product is expected to be available nationwide in early February
2001.
PEG-INTRON is a longer acting form of Schering-Plough Corporation's
INTRON(R) A that uses proprietary PEG technology developed by Enzon. Under
Enzon's licensing agreement with Schering-Plough Corporation, Enzon is entitled
to royalties on worldwide sales of PEG-INTRON and milestone payments. This
approval triggers the final milestone payment of $2 million under the licensing
agreement.
PEG-INTRON is administered subcutaneously once weekly for one year. The
dose should be administered on the same day of each week and may be
self-administered by patients.
The safety and efficacy of PEG-INTRON has been demonstrated in a
randomized, controlled clinical study involving 1,219 adult patients with
chronic hepatitis C who were not previously treated with alpha interferon. The
study compared PEG-INTRON (0.5, 1.0 or 1.5 mcg/kg) administered subcutaneously
once weekly to Schering-Plough's INTRON(R) A (interferon alfa-2b, recombinant)
Injection (3 MIU) administered subcutaneously three times weekly. Patients were
treated for 48 weeks and were followed for 24 weeks post-treatment. In the
study, patients receiving the 1.0 mcg/kg dose of PEG-INTRON achieved a 24
percent treatment response rate of sustained virologic response and ALT(1)
normalization as compared to a 12 percent treatment response rate in patients
receiving INTRON A. The safety and efficacy of PEG-INTRON in combination with
ribavirin have not been established.
Nearly all study patients experienced one or more adverse events. The
incidence of serious adverse events was similar (about 12 percent) in all
treatment groups. The most common adverse events associated with PEG-INTRON were
"flu-like" symptoms, which occurred in approximately 50 percent of patients;
injection site irritation or inflammation, seen in 47 percent of patients; and
depression, seen in 29 percent of patients.
- --------------------------------------------------------------------------------
WARNING
Alpha interferons, including PEG-INTRON, cause or aggravate fatal or
life-threatening neuropsychiatric, autoimmune, ischemic, and infectious
disorders. Patients should be monitored closely with periodic clinical and
laboratory evaluations. Patients with persistently severe or worsening signs or
symptoms of these conditions should be withdrawn from therapy. In many but not
all cases these disorders resolve after stopping PEG-INTRON therapy.
- --------------------------------------------------------------------------------
PEG-INTRON, recombinant interferon alfa-2b linked to a 12,000 dalton
polyethylene glycol (PEG) molecule, is a once-weekly product designed to
optimize the balance between antiviral activity and elimination half-life.
Schering-Plough holds an exclusive worldwide license to PEG-INTRON.
Schering-Plough markets the product as PEGINTRON(TM) in the European Union,
where it received marketing approval in May 2000.
INTRON A is a recombinant version of naturally occurring alpha interferon,
which has been shown to exert both antiviral and immunomodulatory effects.
Schering-Plough markets INTRON A, the world's largest-selling alpha interferon,
for 16 major antiviral and anticancer indications worldwide.
Some 4 million Americans are infected with the hepatitis C virus (HCV) and
approximately 70 percent of infected patients go on to develop chronic liver
disease, according to the Centers for Disease Control and Prevention (CDC).
Hepatitis C infection contributes to the deaths of an estimated 8,000 to 10,000
Americans each year. This toll is expected to triple by the year 2010 and exceed
the number of annual deaths due to AIDS, according to the CDC. The CDC has
reported that HCV-associated end-stage liver disease is the most frequent
indication for liver transplantation among adults.
Except for the historical information herein, the matters discussed in this
Form 8-K 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 on
file with the SEC, including without limitation, risks in obtaining and
maintaining regulatory approval for Enzon's products and expanded indications
for such products, market acceptance of and continuing demand for Enzon's
products and the impact of competitive products and pricing. The forward-looking
statements included in this news release provide the information included in
such statements as of the date of this news release and Enzon disclaims any duty
to update any of such statements.
(1)ALT: alanine aminotransferase, an enzyme that indicates ongoing liver
inflammation.
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: January 22, 2000
ENZON, INC.
-----------------------------------
(Registrant)
By: /s/ KENNETH J. ZUERBLIS
-----------------------------------
Kenneth J. Zuerblis
Vice President, Finance and Chief
Financial Officer