(Source: Enzon Pharmaceuticals, Inc.)
Enzon Acquires Global Rights from NatImmune for
Oncology Product
Monday October 3, 1:00 am ET
BRIDGEWATER, N.J. & COPENHAGEN, Denmark--(BUSINESS WIRE)--Oct. 3, 2005--Enzon
Pharmaceuticals, Inc. (Nasdaq: ENZN - News) and the Danish biotech company,
NatImmune A/S today announced that they have entered into a license agreement
for NatImmune's lead development product, recombinant human Mannan-Binding Lectin
(rhMBL), a protein therapeutic being developed for the prevention of severe
infections in MBL-deficient individuals undergoing chemotherapy. Under the agreement,
Enzon receives exclusive worldwide rights, excluding the Nordic countries, and
is responsible for the development, manufacture, and marketing of rhMBL. NatImmune
will receive an upfront payment of $10 million and is eligible to receive additional
payments upon the successful completion of certain clinical development, regulatory,
and sales-based milestones. NatImmune is also eligible to receive royalties
from any future product sales of rhMBL by Enzon and retains certain rights to
develop a non-systemic formulation for topical administration of MBL.
Mannan-Binding Lectin (MBL) is a naturally occurring human
plasma protein that plays a key role in the immune system's first-line defense
against infections. MBL binds to a wide range of invading organisms, including
bacteria, fungi, viruses, and parasites and activates the lectin pathway of
the complement system, an important defense mechanism of the immune system.
Numerous studies have found a strong correlation between MBL-deficiency and
an increased susceptibility to infections in patients with a suppressed immune
system, such as cancer patients undergoing treatment with chemotherapy. In addition,
a number of publications have also highlighted the potentially important future
role of MBL replacement therapy in preventing serious infections in other critical
care areas associated with immunodeficiency.
"Today's announcement underscores our commitment to rebuilding our clinical
pipeline with promising product development opportunities," said Jeffrey
H. Buchalter, Enzon's chairman and chief executive officer. "Given the
vital role MBL plays in the immune system, this compound represents an exciting
opportunity for us to bring a substantial clinical advantage to patients who
are susceptible to serious infections."
"We believe Enzon's extensive experience in developing and commercializing
therapeutics for patients with cancer and other immunodeficiency disorders makes
them an ideal partner to advance this high-potential therapeutic," said
Dr. Martin Bonde NatImmune's chief executive officer. "Further, we will
also work together to leverage Enzon's long-standing skills in developing optimized
versions of protein-based therapeutics through PEGylation to potentially explore
a next-generation compound."
In December 2004, NatImmune completed Phase 1 clinical trials that evaluated
the safety and pharmacokinetic profile of single and multi dose intravenous
administration of rhMBL in 28 MBL-deficient volunteers. Results from the Phase
1 trials demonstrated that rhMBL replacement therapy is safe and has an attractive
pharmacokinetic profile. NatImmune has also completed a prospective correlation
study of 250 hematological cancer patients that documented MBL-deficient patients
have a significantly higher risk of severe infections following chemotherapy
compared to patients with sufficient MBL levels. These results confirmed previous
clinical correlation studies published in the Lancet in August 2001.
About Enzon
Enzon Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to the
development and commercialization of therapeutics to treat patients with cancer
and other life-threatening diseases. Enzon's specialized sales force markets
ABELCET®, ONCASPAR®, ADAGEN®, and DEPOCYT® in North America.
In addition, Enzon also receives royalties on sales of PEG-INTRON®, marketed
by Schering-Plough Corporation, and MACUGEN®, marketed by Eyetech Pharmaceuticals
and Pfizer Inc. Enzon's product-driven strategy includes an extensive drug development
program that leverages its proprietary technologies, including a next-generation
PEGylation platform that utilizes linkers designed to release compounds at a
controlled rate. Enzon complements its internal research and development efforts
with strategic initiatives, such as partnerships designed to broaden its revenue
base or provide access to promising new technologies or product development
opportunities. Further information about Enzon and this press release can be
found on the Company's web site at www.enzon.com.
About NatImmune
NatImmune A/S is a biotech company focused on the development of therapeutic
proteins. Based in Symbion Science Park, the Company was founded in 2000 and
has 22 employees. NatImmune's lead product, Mannan Binding Lectin (MBL), has
completed Phase 1 clinical trials and is being developed under a global licensing
agreement with the U.S. biopharmaceutical company, Enzon Pharmaceuticals, Inc.
NatImmune has retained certain rights to develop a non-systemic formulation
for the topical administration of MBL. In addition, the Company's pipeline also
includes antibodies for the treatment of colorectal cancer (COU-I) and cardiovascular
diseases (MASP-2). Further information about NatImmune can be found at the Company's
web site at www.natimmune.com.
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, but are
not limited to the timing of, success, and cost of clinical studies; the ability
to obtain regulatory approval of products; and those described in Enzon's Form
10-K and Forms 10-Q on file with the United States Securities and Exchange Commission
and NatImmune's publicly filed reports. 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 October 3, 2005 and
Enzon and NatImmune undertake no duty to update this information.
________________________________________
Contact:
Enzon Pharmaceuticals, Inc.
Craig Tooman, 908-541-8759
or
Susan M. Mesco, 908-541-8777
or
NatImmune A/S
Martin Bonde, +45 39 17 94 44
________________________________________
Source: Enzon Pharmaceuticals, Inc.