UNITED STATES
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 22, 2004
ENZON PHARMACEUTICALS, 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)
685 Route 202/206, Bridgewater, New Jersey 08807
(Address of principal executive offices) (Zip Code)
(Registrant's telephone number, including area code: (908) 541-8600
----------------------------------------------------------------------
(Former name or former address, if changed since last report)
|_| Written communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
|_| Soliciting material pursuant to Rule 14a-12 under the Securities Act (17
CFR 240.14a-12)
|_| Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
|_| Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
Item 8.01 Other Events
Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) reported today that Schering-Plough
Corporation (NYSE: SGP) announced today that its subsidiary in Japan, has
received marketing approval for PEG-INTRON(R) (peginterferon alfa-2b) Powder for
Injection for use in combination with REBETOL(R) (ribavirin) Capsules for the
treatment of chronic hepatitis C. PEG-INTRON and REBETOL combination therapy is
the first and only pegylated interferon-based combination therapy approved in
Japan. An estimated 1 to 2 million Japanese are chronically infected with
hepatitis C. PEG-INTRON is a longer-acting form of INTRON(R) A (interferon
alfa-2b, recombinant) Injection that uses proprietary PEG technology developed
by Enzon. Under the Company's licensing agreement with Schering-Plough, Enzon is
entitled to royalties on worldwide sales of PEG-INTRON. Schering-Plough holds an
exclusive worldwide license to PEG-INTRON.
The approval by the Ministry of Health, Labor and Welfare (MHLW) follows a
priority review. PEG-INTRON will become available in Japan upon National Health
Insurance Reimbursement price listing.
PEG-INTRON, which is administered once weekly in combination with REBETOL daily
for 48 weeks, is indicated in patients chronically infected with hepatitis C
virus (HCV) genotype 1 (genotype 1a or 1b) and high viral load. HCV genotype 1
is considered the most difficult-to-treat form of hepatitis C and is the most
common form in Japan, accounting for approximately 60 percent of all HCV
infections there.
Importantly, PEG-INTRON is the only peginterferon product approved in Japan for
which a blood test is not required before every injection.
In the Japanese clinical study supporting the approval, 48 weeks of PEG-INTRON
and REBETOL combination therapy achieved a sustained virologic response (SVR)(1)
rate of 48% in patients with HCV genotype 1 and high viral loads. An SVR rate of
63 percent was achieved with PEG-INTRON and REBETOL in the portion of these
patients who had relapsed following previous interferon treatment.
Hepatitis C is the leading cause in Japan of chronic liver disease, cirrhosis,
and hepatocellular carcinoma, which is associated with more than 30,000 deaths
there annually. Hepatitis C is the most common reason for liver transplant in
major world markets, including Japan, according to the World Health Organization
(WHO).
PEG-INTRON, recombinant interferon alfa-2b linked to a 12,000 dalton
polyethylene glycol (PEG) molecule, is a once-weekly therapy dosed according to
patient body weight that is designed to achieve an effective balance between
antiviral activity and elimination half-life. PEG-INTRON is a longer-acting form
of INTRON(R) A (interferon alfa-2b, recombinant) Injection.
REBETOL is an oral formulation of ribavirin, a synthetic nucleoside analog with
broad-spectrum antiviral activity. Schering-Plough K.K. currently markets
REBETOL in Japan for use in combination with INTRON A for chronic hepatitis C.
In the United States, PEG-INTRON and REBETOL combination therapy is indicated
for the treatment of chronic hepatitis C in patients with compensated liver
disease who have not been previously treated with interferon alpha and are at
least 18 years of age.
About Enzon
Enzon Pharmaceuticals is a biopharmaceutical company dedicated to the discovery,
development and commercialization of therapeutics to treat life-threatening
diseases. The Company has developed or acquired a number of marketed products,
including PEG-INTRON(R), marketed by Schering-Plough, and ABELCET(R),
ONCASPAR(R), ADAGEN(R), and DEPOCYT(R), marketed in North America by Enzon's
specialized sales force. Enzon's science-driven strategy includes an extensive
drug development program that leverages the Company's macromolecular engineering
technology platforms, including PEG modification and single-chain antibody
(SCA(R)) technologies. Internal research and development efforts are
complemented by strategic transactions that provide access to additional
marketed products and promising clinical compounds. Enzon has several drug
candidates in various stages of development, independently and with partners,
including Marqibo(R) (formerly referred to as Onco TCS), for which a U.S.
marketing application is currently being reviewed by the FDA for the treatment
of relapsed aggressive non-Hodgkin's lymphoma. Further information about Enzon
can be found on the Company's web site at www.enzon.com.
The statements above regarding the regulatory process in Japan and the
availability of PEG-INTRON in Japan are forward looking statements, not based on
historical or current fact. Such forward-looking statement are subject to known
and unknown risks, uncertainties and other factors that may cause actual
results, events or developments to be materially different from the future
results, events or developments discussed above.
All information in this press release is as of October 22, 2004 and the Company
undertakes no duty to update this information.
(1) SVR is defined as the sustained undetectability of the hepatitis C virus for
six months following therapy.
Item 9.01 Financial Statements and Exhibits
Exhibit 99.1 Press Release dated October 22, 2004
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: October 22, 2004
By: /s/ Kenneth J. Zuerblis
----------------------------
Kenneth J. Zuerblis
Vice President, Finance and
Chief Financial Officer
Exhibit 99.1
ENZON
PHARMACEUTICALS For Immediate Release
================================================================================
PRESS RELEASE
Contact: Susan Mesco
Director, Investor Relations
908-541-8678
Euro RSCG Life NRP
Mark R. Vincent, Media Relations
212-845-4239
ENZON REPORTS THAT SCHERING-PLOUGH ANNOUNCES PEG-INTRON(R)
APPROVED IN JAPAN FOR USE IN COMBINATION WITH REBETOL(R) FOR
CHRONIC HEPATITIS C
First and Only Peginterferon Combination Therapy Approved in Japan
More Than 1 Million Japanese Infected With Hepatitis C Virus
Bridgewater, New Jersey, October 22, 2004 - Enzon Pharmaceuticals, Inc. (Nasdaq:
ENZN) reported today that Schering-Plough Corporation (NYSE: SGP) announced
today that its subsidiary in Japan, has received marketing approval for
PEG-INTRON(R) (peginterferon alfa-2b) Powder for Injection for use in
combination with REBETOL(R) (ribavirin) Capsules for the treatment of chronic
hepatitis C. PEG-INTRON and REBETOL combination therapy is the first and only
pegylated interferon-based combination therapy approved in Japan. An estimated 1
to 2 million Japanese are chronically infected with hepatitis C. PEG-INTRON is a
longer-acting form of INTRON(R) A (interferon alfa-2b, recombinant) Injection
that uses proprietary PEG technology developed by Enzon. Under the Company's
licensing agreement with Schering-Plough, Enzon is entitled to royalties on
worldwide sales of PEG-INTRON. Schering-Plough holds an exclusive worldwide
license to PEG-INTRON.
The approval by the Ministry of Health, Labor and Welfare (MHLW) follows a
priority review. PEG-INTRON will become available in Japan upon National Health
Insurance Reimbursement price listing.
PEG-INTRON, which is administered once weekly in combination with REBETOL daily
for 48 weeks, is indicated in patients chronically infected with hepatitis C
virus (HCV) genotype 1 (genotype 1a or 1b) and high viral load. HCV genotype 1
is considered the most difficult-to-treat form of hepatitis C and is the most
common form in Japan, accounting for approximately 60 percent of all HCV
infections there.
Importantly, PEG-INTRON is the only peginterferon product approved in Japan for
which a blood test is not required before every injection.
-more-
================================================================================
685 Route 202/206
Phone: (908) 541-8600 Fax: (908) 575-9457
http://www.enzon.com
Japan PEG-INTRON/Page 2
In the Japanese clinical study supporting the approval, 48 weeks of PEG-INTRON
and REBETOL combination therapy achieved a sustained virologic response (SVR)(1)
rate of 48% in patients with HCV genotype 1 and high viral loads. An SVR rate of
63 percent was achieved with PEG-INTRON and REBETOL in the portion of these
patients who had relapsed following previous interferon treatment.
Hepatitis C is the leading cause in Japan of chronic liver disease, cirrhosis,
and hepatocellular carcinoma, which is associated with more than 30,000 deaths
there annually. Hepatitis C is the most common reason for liver transplant in
major world markets, including Japan, according to the World Health Organization
(WHO).
PEG-INTRON, recombinant interferon alfa-2b linked to a 12,000 dalton
polyethylene glycol (PEG) molecule, is a once-weekly therapy dosed according to
patient body weight that is designed to achieve an effective balance between
antiviral activity and elimination half-life. PEG-INTRON is a longer-acting form
of INTRON(R) A (interferon alfa-2b, recombinant) Injection.
REBETOL is an oral formulation of ribavirin, a synthetic nucleoside analog with
broad-spectrum antiviral activity. Schering-Plough K.K. currently markets
REBETOL in Japan for use in combination with INTRON A for chronic hepatitis C.
In the United States, PEG-INTRON and REBETOL combination therapy is indicated
for the treatment of chronic hepatitis C in patients with compensated liver
disease who have not been previously treated with interferon alpha and are at
least 18 years of age.
About Enzon
Enzon Pharmaceuticals is a biopharmaceutical company dedicated to the discovery,
development and commercialization of therapeutics to treat life-threatening
diseases. The Company has developed or acquired a number of marketed products,
including PEG-INTRON(R), marketed by Schering-Plough, and ABELCET(R),
ONCASPAR(R), ADAGEN(R), and DEPOCYT(R), marketed in North America by Enzon's
specialized sales force. Enzon's science-driven strategy includes an extensive
drug development program that leverages the Company's macromolecular engineering
technology platforms, including PEG modification and single-chain antibody
(SCA(R)) technologies. Internal research and development efforts are
complemented by strategic transactions that provide access to additional
marketed products and promising clinical compounds. Enzon has several drug
candidates in various stages of development, independently and with partners,
including Marqibo(R) (formerly referred to as Onco TCS), for which a U.S.
marketing application is currently being reviewed by the FDA for the treatment
of relapsed aggressive non-Hodgkin's lymphoma. Further information about Enzon
can be found on the Company's web site at www.enzon.com.
-more-
================================================================================
685 Route 202/206
Phone: (908) 541-8600 Fax: (908) 575-9457
http://www.enzon.com
Japan PEG-INTRON/Page 3
The statements above regarding the regulatory process in Japan and the
availability of PEG-INTRON in Japan are forward looking statements, not based on
historical or current fact. Such forward-looking statement are subject to known
and unknown risks, uncertainties and other factors that may cause actual
results, events or developments to be materially different from the future
results, events or developments discussed above.
All information in this press release is as of October 22, 2004 and the Company
undertakes no duty to update this information.
(1) SVR is defined as the sustained undetectability of the hepatitis C virus for
six months following therapy.
###
================================================================================
685 Route 202/206
Phone: (908) 541-8600 Fax: (908) 575-9457
http://www.enzon.com