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): January 19, 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)
Item 5. Other Events
Enzon Pharmaceuticals, Inc. ("Enzon"; NASDAQ: ENZN) and Inex Pharmaceuticals
Corporation ("INEX"; TSX: IEX) today announced a strategic partnership to
develop and commercialize INEX's proprietary oncology product Onco TCS.
Under the terms of the agreement, Enzon receives the exclusive North American
commercialization rights for Onco TCS for all indications. The lead indication
is relapsed aggressive non-Hodgkin's lymphoma (NHL) for which INEX is in the
process of submitting a "rolling" New Drug Application (NDA) to the United
States Food and Drug Administration (FDA), which is expected to be completed
during the first quarter of calendar year 2004. The product is also in numerous
phase II clinical trials for several other cancer indications, including
first-line NHL.
INEX receives a US$10 million up-front payment and will receive up to a US$20
million payment upon Onco TCS receiving approval from the FDA. Additional
development milestones and sales based bonus payments could total US$43.75
million, of which US$10 million is payable upon annual sales first reaching
US$125 million and US$15 million is payable upon annual sales first reaching
US$250 million. INEX will also receive a percentage of commercial sales of Onco
TCS and this percentage will increase as sales reach certain predetermined
thresholds.
INEX has the option of complementing Enzon's sales efforts by co-promoting Onco
TCS through the formation of a dedicated North American sales and medical
science liaison force. The costs of building INEX's co-promotion force would be
shared equally by both companies and Enzon will record all sales in the licensed
territories.
Enzon and INEX will share equally the future development costs designed to
obtain and maintain marketing approvals in North America for Onco TCS, while
Enzon will pay all sales and marketing costs and certain other post-approval
clinical development costs typically associated with commercialization
activities. Enzon plans to market Onco TCS through its entire North American
sales force of approximately 60 people, which currently markets ABELCET(R),
ONCASPAR(R), and DEPOCYT(R) to the oncology market.
INEX retains manufacturing rights and will initially manufacture and supply the
drug and be reimbursed by Enzon. INEX and Enzon are discussing the potential of
transferring manufacturing to Enzon's sterile injectable manufacturing facility
in Indianapolis, Indiana where Enzon manufacturers its commercial drug
ABELCET(R) (Amphotericin B Lipid Complex Injection) and where MYOCET(TM)
(liposome encapsulated doxorubicin citrate complex) is manufactured for Elan
Corporation, plc.
The companies will also explore the acquisition and joint development of other
cancer drugs.
About Onco TCS
Onco TCS is a proprietary drug comprised of the widely used off-patent cancer
drug vincristine encapsulated in INEX's TCS (liposomal) drug delivery
technology. The TCS technology provides prolonged blood circulation, tumor
accumulation and extended drug release at the cancer site. These characteristics
are designed to increase the effectiveness and reduce the side effects of the
encapsulated drug.
INEX has completed a pivotal phase II/III clinical trial treating relapsed
aggressive NHL with Onco TCS. Currently, there is no effective treatment for
patients with aggressive NHL that have relapsed following first-line and
second-line treatment.
INEX's multi-center pivotal phase II/III trial treated 119 NHL patients who had
not responded to their previous therapy or had responded and subsequently
relapsed. After treatment with Onco TCS, an overall response rate of 25% was
attained. The results of this pivotal trial were released in June 2003 and
presented in December 2003 at the American Society of Hematology annual
conference along with interim results from two ongoing phase II trials in
relapsed Hodgkin's disease and relapsed B-cell lymphoma.
INEX has submitted two major sections of its "rolling" NDA to the FDA seeking
marketing approval for Onco TCS as a treatment for relapsed aggressive NHL. The
first section was submitted September 30, 2003 and included nonclinical, safety
and pharmacology data. The second section was submitted December 3, 2003 and
included data on manufacturing process, stability of the drug, composition of
the drug and other chemistry and related information. INEX expects the third and
final section, containing data from clinical trials, to be submitted during the
first quarter of calendar year 2004.
A "rolling" NDA is a process used by the FDA to expedite the review of a drug
intended for the treatment of a serious or life threatening condition and that
demonstrates the potential to address an unmet medical need. This allows the FDA
to begin to review sections of the NDA as they are submitted, as opposed to the
normal approval process, which requires the entire NDA to be submitted at one
time. In order to be eligible to submit a rolling NDA, a company will usually
have been granted Fast Track designation by the FDA, which INEX received in
August 2000.
Subject to acceptance of the full NDA for review, INEX expects to have a
response from the FDA within six months. If approved, it is anticipated that
Onco TCS could be introduced to the marketplace before the end of calendar year
2004 or early in 2005.
Although INEX has chosen to file an NDA for relapsed aggressive NHL as the first
route to approval for Onco TCS, Enzon and INEX intend to develop Onco TCS for
use as a stand-alone drug and/or in combination therapy for several cancers in
which vincristine is now used. Onco TCS is being evaluated in several phase II
clinical trials as a treatment for first-line NHL, relapsed small cell lung
cancer, relapsed Hodgkin's disease, relapsed acute lymphoblastic leukemia,
relapsed pediatric malignancies, relapsed NHL in combination with the approved
cancer drug Rituxan(R) (rituximab), and relapsed NHL in combination with the
approved cancer drug etoposide.
About Non-Hodgkin's Lymphoma (NHL)
NHL is the fifth-leading cause of cancer deaths in the United States (23,400
estimated in 2003) and the sixth-leading cause of cancer deaths in Canada (2,800
estimated in 2003), according to estimates of the American Cancer Society and
the Canadian Cancer Society. Approximately 53,400 and 6,400 new cases were
diagnosed in the U.S. and Canada respectively in 2003.
Enzon Conference Call
Company management of Enzon will be hosting a conference call on Tuesday,
January 20, 2004 at 7:30 AM EST regarding the agreement. All interested parties
can access the call using the following information:
Domestic dial-in number 888-423-3274
International dial-in number 612-332-0345
Access Code 717868
Enzon's conference call will also be webcast in a "listen only" mode via the
internet at http://www.vcall.com. Additionally, for those parties unable to
listen at the time of Enzon's conference call, a rebroadcast will be available
following the call from Tuesday, January 20, 2004 at approximately 11:00 AM.
This rebroadcast will end on Tuesday, January 27, 2004 at 11:59PM. The
rebroadcast may be accessed using the following information:
Domestic Dial-In Number: 800-475-6701
International Dial-In Number: 320-365-3844
Access Code: 717868
INEX Conference Call
Company management of INEX will be hosting a conference call on Wednesday,
January 14, 2004 at 8:30 AM EST regarding the formation of the partnership. All
interested parties can access the call using the following information:
Dial-In Number: 416-405-9328
North American toll free access: 800-387-6216
INEX's conference call will also be webcast via the internet at
www.inexpharm.com.
Additionally, for those parties unable to listen at the time of INEX's
conference call, a replay will be available shortly following the completion of
the call. This rebroadcast will end on January 20, 2004 at 11:59 PM. The
rebroadcast may be accessed using the following information:
Dial-In Number: 416-695-5800
North American toll free access: 800-408-3053
Access Code: 1520395
About INEX
INEX is a Canadian biopharmaceutical company developing and commercializing
proprietary drugs and drug delivery systems to improve the treatment of cancer.
INEX entered into the partnership with Enzon through agreements entered into by
its wholly owned U.S. subsidiary, Inex Pharmaceuticals, Inc.
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), which are all marketed in North America
by Enzon's hospital and oncology sales forces. Enzon's science-focused 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 products, projects, and technologies. Enzon has several drug
candidates in various stages of development, independently and with partners.
There are forward-looking statements contained herein that are not based on
historical fact, including without limitation statements containing the words
"believes," "may," "plans," "will," "estimate," "continue," "anticipates,"
"intends," "expects," and similar expressions. Such forward-looking statements
involve 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. Such factors include the
risk that Onco-TCS may not receive regulatory approval from the FDA, as well as
those described in Enzon's Form 10-K and Forms 10-Q on file with the SEC and
INEX's publicly filed periodic reports and others, such as, (i) as to Enzon,
Enzon's ability to successfully launch and market Onco-TCS, Enzon's ability to
sustain profitability, and positive cash flow; risks in obtaining and
maintaining regulatory approval for indications and expanded indications for
Enzon's products; market acceptance of and continuing demand for Enzon's
products; timing and results of clinical trials and the impact of competitive
products and pricing and (ii) as to INEX, INEX's stage of development, lack of
product revenues, additional capital requirements, risks associated with the
completion of clinical trials and obtaining regulatory approval to market INEX's
products, risks associated with the failure to secure all necessary intellectual
property from third parties, the ability to protect its intellectual property
and dependence on collaborative partners. These factors should be considered
carefully and readers are cautioned not to place undue reliance on such
forward-looking statements. All information in this press release is as of
January 20, 2004, and Enzon and INEX undertake no duty to update this
information.
This release is also available at http://www.enzon.com and
http://www.inexpharm.com
Contacts for Enzon Pharmaceuticals, Contacts for Inex Pharmaceuticals
Inc. Corporation
Investors Investors
Susan M. Mesco Ian Mortimer
Director, Investor Relations Senior Director, Investor Relations
Phone: 908-541-8678 Phone: 604-419-3200
Media Media
Euro RSCG Life NRP James Hoggan & Associates Inc.
Mark Vincent Karen Cook Boas
Phone: 212-845-4239 Phone: 604-739-7500
Enzon's common shares are traded on NASDAQ under the trading symbol "ENZN".
INEX's common shares are traded on the Toronto Stock Exchange under the trading
symbol "IEX".
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 20, 2004
By: /s/ Kenneth J. Zuerblis
---------------------------
Kenneth J. Zuerblis
Vice President, Finance and
Chief Financial Officer
Exhibit 99.1
Enzon and INEX Sign Commercialization Partnership for
Oncology Drug Onco TCS
Bridgewater, NJ, and Vancouver, Canada - January 20, 2004 - Enzon
Pharmaceuticals, Inc. ("Enzon"; NASDAQ: ENZN) and Inex Pharmaceuticals
Corporation ("INEX"; TSX: IEX) today announced a strategic partnership to
develop and commercialize INEX's proprietary oncology product Onco TCS.
Under the terms of the agreement, Enzon receives the exclusive North American
commercialization rights for Onco TCS for all indications. The lead indication
is relapsed aggressive non-Hodgkin's lymphoma (NHL) for which INEX is in the
process of submitting a "rolling" New Drug Application (NDA) to the United
States Food and Drug Administration (FDA), which is expected to be completed
during the first quarter of calendar year 2004. The product is also in numerous
phase II clinical trials for several other cancer indications, including
first-line NHL.
INEX receives a US$12 million up-front payment and will receive up to a US$20
million payment upon Onco TCS receiving approval from the FDA. Additional
development milestones and sales based bonus payments could total US$43.75
million, of which US$10 million is payable upon annual sales first reaching
US$125 million and US$15 million is payable upon annual sales first reaching
US$250 million. INEX will also receive a percentage of commercial sales of Onco
TCS and this percentage will increase as sales reach certain predetermined
thresholds.
INEX has the option of complementing Enzon's sales efforts by co-promoting Onco
TCS through the formation of a dedicated North American sales and medical
science liaison force. The costs of building INEX's co-promotion force would be
shared equally by both companies and Enzon will record all sales in the licensed
territories.
Arthur Higgins, Enzon's chairman and chief executive officer, said, "This
transaction is highly complementary to our R&D and manufacturing infrastructure,
is an excellent fit with the therapeutic focus of our field force and most
importantly, offers the potential to significantly increase Enzon's product
revenues beginning as soon as fiscal 2005."
David Main, INEX's president and chief executive officer, said the agreement
meets INEX's objectives for a commercialization partnership. "It rewards our
company for successfully taking Onco TCS through clinical trials and through to
an NDA, it gives us a strong partner dedicated to oncology with which to share
costs of commercializing Onco TCS and expanding its potential uses. It also lets
us benefit from future sales with a formula for capturing an increasing share of
commercial sales."
"Enzon has expertise in the development, manufacturing and marketing of
liposomal drugs and has the motivation to make Onco TCS sales an important part
of its future," Main said. "This deal also provides a cost-effective means for
us to build our own commercial infrastructure to work alongside Enzon's, which
is important for our future growth strategy and pipeline activities."
Enzon and INEX will share equally the future development costs designed to
obtain and maintain marketing approvals in North America for Onco TCS, while
Enzon will pay all sales and marketing costs and certain other post-approval
clinical development costs typically associated with commercialization
activities. Enzon plans to market Onco TCS through its entire North American
sales force of approximately 60 people, which currently markets ABELCET(R),
ONCASPAR(R), and DEPOCYT(R) to the oncology market.
INEX retains manufacturing rights and will initially manufacture and supply the
drug and be reimbursed by Enzon. INEX and Enzon are discussing the potential of
transferring manufacturing
to Enzon's sterile injectable manufacturing facility in Indianapolis, Indiana
where Enzon manufacturers its commercial drug ABELCET(R) (Amphotericin B Lipid
Complex Injection) and where MYOCET(TM) (liposome encapsulated doxorubicin
citrate complex) is manufactured for Elan Corporation, plc.
The companies will also explore the acquisition and joint development of other
cancer drugs.
About Onco TCS
Onco TCS is a proprietary drug comprised of the widely used off-patent cancer
drug vincristine encapsulated in INEX's TCS (liposomal) drug delivery
technology. The TCS technology provides prolonged blood circulation, tumor
accumulation and extended drug release at the cancer site. These characteristics
are designed to increase the effectiveness and reduce the side effects of the
encapsulated drug.
INEX has completed a pivotal phase II/III clinical trial treating relapsed
aggressive NHL with Onco TCS. Currently, there is no effective treatment for
patients with aggressive NHL that have relapsed following first-line and
second-line treatment.
INEX's multi-center pivotal phase II/III trial treated 119 NHL patients who had
not responded to their previous therapy or had responded and subsequently
relapsed. After treatment with Onco TCS, an overall response rate of 25% was
attained. The results of this pivotal trial were released in June 2003 and
presented in December 2003 at the American Society of Hematology annual
conference along with interim results from two ongoing phase II trials in
relapsed Hodgkin's disease and relapsed B-cell lymphoma.
INEX has submitted two major sections of its "rolling" NDA to the FDA seeking
marketing approval for Onco TCS as a treatment for relapsed aggressive NHL. The
first section was submitted September 30, 2003 and included nonclinical, safety
and pharmacology data. The second section was submitted December 3, 2003 and
included data on manufacturing process, stability of the drug, composition of
the drug and other chemistry and related information. INEX expects the third and
final section, containing data from clinical trials, to be submitted during the
first quarter of calendar year 2004.
A "rolling" NDA is a process used by the FDA to expedite the review of a drug
intended for the treatment of a serious or life threatening condition and that
demonstrates the potential to address an unmet medical need. This allows the FDA
to begin to review sections of the NDA as they are submitted, as opposed to the
normal approval process, which requires the entire NDA to be submitted at one
time. In order to be eligible to submit a rolling NDA, a company will usually
have been granted Fast Track designation by the FDA, which INEX received in
August 2000.
Subject to acceptance of the full NDA for review, INEX expects to have a
response from the FDA within six months. If approved, it is anticipated that
Onco TCS could be introduced to the marketplace before the end of calendar year
2004 or early in 2005.
Although INEX has chosen to file an NDA for relapsed aggressive NHL as the first
route to approval for Onco TCS, Enzon and INEX intend to develop Onco TCS for
use as a stand-alone drug and/or in combination therapy for several cancers in
which vincristine is now used. Onco TCS is being evaluated in several phase II
clinical trials as a treatment for first-line NHL, relapsed small cell lung
cancer, relapsed Hodgkin's disease, relapsed acute lymphoblastic leukemia,
relapsed pediatric malignancies, relapsed NHL in combination with the approved
cancer drug Rituxan(R) (rituximab), and relapsed NHL in combination with the
approved cancer drug etoposide.
About Non-Hodgkin's Lymphoma (NHL)
NHL is the fifth-leading cause of cancer deaths in the United States (23,400
estimated in 2003) and the sixth-leading cause of cancer deaths in Canada (2,800
estimated in 2003), according to estimates of the American Cancer Society and
the Canadian Cancer Society. Approximately 53,400 and 6,400 new cases were
diagnosed in the U.S. and Canada respectively in 2003.
Enzon Conference Call
Company management of Enzon will be hosting a conference call on Tuesday,
January 20, 2004 at 7:30 AM EST regarding the agreement. All interested parties
can access the call using the following information:
Domestic dial-in number 888-423-3274
International dial-in number 612-332-0345
Access Code 717868
Enzon's conference call will also be webcast in a "listen only" mode via
the internet at http://www.vcall.com. Additionally, for those parties unable to
listen at the time of Enzon's conference call, a rebroadcast will be available
following the call from Tuesday, January 20, 2004 at approximately 11:00 AM.
This rebroadcast will end on Tuesday, January 27, 2004 at 11:59PM. The
rebroadcast may be accessed using the following information:
Domestic Dial-In Number: 800-475-6701
International Dial-In Number: 320-365-3844
Access Code: 717868
INEX Conference Call
Company management of INEX will be hosting a conference call on Wednesday,
January 14, 2004 at 8:30 AM EST regarding the formation of the partnership. All
interested parties can access the call using the following information:
Dial-In Number: 416-405-9328
North American toll free access: 800-387-6216
INEX's conference call will also be webcast via the internet at
www.inexpharm.com.
Additionally, for those parties unable to listen at the time of INEX's
conference call, a replay will be available shortly following the completion of
the call. This rebroadcast will end on January 20, 2004 at 11:59 PM. The
rebroadcast may be accessed using the following information:
Dial-In Number: 416-695-5800
North American toll free access: 800-408-3053
Access Code: 1520395
About INEX
INEX is a Canadian biopharmaceutical company developing and commercializing
proprietary drugs and drug delivery systems to improve the treatment of cancer.
INEX entered into the partnership with Enzon through agreements entered into by
its wholly owned U.S. subsidiary, Inex Pharmaceuticals, Inc.
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), which are all marketed in North America
by Enzon's hospital and oncology sales forces. Enzon's science-focused 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 products, projects, and technologies. Enzon has several drug
candidates in various stages of development, independently and with partners.
There are forward-looking statements contained herein that are not based on
historical fact, including without limitation statements containing the words
"believes," "may," "plans," "will," "estimate," "continue," "anticipates,"
"intends," "expects," and similar expressions. Such forward-looking statements
involve known and unknown risks, uncertainties and other factors that may cause
the actual results, events or developments to be materially different from
actual future results, events or developments. Such factors include the risk
that Onco-TCS may not receive regulatory approval from the FDA, as well as those
described in Enzon's Form 10-K and Forms 10-Q on file with the SEC and INEX's
publicly filed periodic reports and others, such as, (i) as to Enzon, Enzon's
ability to successfully launch and market Onco-TCS, Enzon's ability to sustain
profitability, and positive cash flow; risks in obtaining and maintaining
regulatory approval for indications and expanded indications for Enzon's
products; market acceptance of and continuing demand for Enzon's products;
timing and results of clinical trials and the impact of competitive products and
pricing and (ii) as to INEX, INEX's stage of development, lack of product
revenues, additional capital requirements, risks associated with the completion
of clinical trials and obtaining regulatory approval to market INEX's products,
risks associated with the failure to secure all necessary intellectual property
from third parties, the ability to protect its intellectual property and
dependence on collaborative partners. These factors should be considered
carefully and readers are cautioned not to place undue reliance on such
forward-looking statements. All information in this press release is as of
January 20,,2004, and Enzon and INEX undertake no duty to update this
information.
This release is also available at http://www.enzon.com and
http://www.inexpharm.com
Contacts for Enzon Pharmaceuticals, Contacts for Inex Pharmaceuticals
Inc. Corporation
Investors Investors
Susan M. Mesco Ian Mortimer
Director, Investor Relations Senior Director, Investor Relations
Phone: 908-541-8678 Phone: 604-419-3200
Media Media
Euro RSCG Life NRP James Hoggan & Associates Inc.
Mark Vincent Karen Cook Boas
Phone : 212-845-4239 Phone: 604-739-7500
Enzon's common shares are traded on NASDAQ under the trading symbol "ENZN".
INEX's common shares are traded on the Toronto Stock Exchange under the trading
symbol "IEX".