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Prometheus Acquires Exclusive Rights to
PROLEUKIN® (aldesleukin) in the U.S.
Company to distribute, promote and sell Proleukin under
long-term commercialization agreement with Novartis
San Diego, January 26, 2010 – Prometheus Laboratories Inc., a
specialty pharmaceutical and diagnostic company, today announced
the execution of a commercialization agreement with Novartis
under which Prometheus acquired exclusive rights to distribute,
promote and sell PROLEUKIN® (aldesleukin) in the United States.
Proleukin is a recombinant human interleukin-2 for treatment in
adults with metastatic melanoma and metastatic kidney cancer.
Net sales for Proleukin were approximately $75 million in the
U.S. in 2009.
Under the terms of the agreement, Novartis received an upfront
fee and will receive royalties on net sales of Proleukin in the
U.S. Novartis is also eligible to receive potential sales
milestone payments. Prometheus will have the option to extend
the initial six-year term on an annual basis for up to an
additional six years. In addition, the companies will have an
option to amend the agreement to include the rest of the world
upon the completion of certain conditions.
“This represents a transformational event for Prometheus as we
continue to build our oncology presence and execute on our
integrated therapeutics and diagnostics business model,” said
Joseph M. Limber, President and Chief Executive Officer of
Prometheus. “We have established ourselves as a leader in the
gastroenterology market by offering a complementary portfolio of
pharmaceutical and diagnostic products promoted via Prometheus’
highly trained sales force. Now, following the recent launch of
our three ProOncDx microRNA-based diagnostic tests and the
continued development of our emerging and proprietary
diagnostics platform, we are well positioned to repeat this
success in the oncology market.”
A portion of the proceeds from Prometheus’ previously announced
$260 million Senior Secured Credit Facility was used to finance
this transaction.
About Proleukin
PROLEUKIN® (aldesleukin) for injection is a recombinant human
interleukin-2 for treatment in adults with metastatic melanoma
and metastatic kidney cancer. Proleukin therapy is a form of
immunotherapy that enhances the body’s natural immune system to
help fight these types of cancer. Proleukin has been used for
over 10 years in the treatment of metastatic melanoma and over
15 years in the treatment of metastatic kidney cancer (renal
cell carcinoma). For complete prescribing information, please
visit
http://www.proleukin.com/.
Important Safety Information
Therapy with PROLEUKIN® (aldesleukin) for injection should be
restricted to patients with normal cardiac and pulmonary
functions as defined by thallium stress testing and formal
pulmonary function testing. Extreme caution should be used in
patients with a normal thallium stress test and a normal
pulmonary function test who have a history of cardiac or
pulmonary disease.
Proleukin should be administered in a hospital setting under the
supervision of a qualified physician experienced in the use of
anticancer agents. An intensive care facility and specialists
skilled in cardiopulmonary or intensive care medicine must be
available.
Proleukin administration has been associated with capillary leak
syndrome (CLS) which is characterized by a loss of vascular tone
and extravasation of plasma proteins and fluid into the
extravascular space. CLS results in hypotension and reduced
organ perfusion which may be severe and can result in death. CLS
may be associated with cardiac arrhythmias (supraventricular and
ventricular), angina, myocardial infarction, respiratory
insufficiency requiring intubation, gastrointestinal bleeding or
infarction, renal insufficiency, edema, and mental status
changes.
Proleukin treatment is associated with impaired neutrophil
function (reduced chemotaxis) and with an increased risk of
disseminated infection, including sepsis and bacterial
endocarditis. Consequently, preexisting bacterial infections
should be adequately treated prior to initiation of Proleukin
therapy. Patients with indwelling central lines are particularly
at risk for infection with gram positive microorganisms.
Antibiotic prophylaxis with oxacillin, nafcillin, ciprofloxacin,
or vancomycin has been associated with a reduced incidence of
staphylococcal infections.
Proleukin administration should be withheld in patients
developing moderate to severe lethargy or somnolence; continued
administration may result in coma.
About Interleukin-2
Interleukin-2 (IL-2) is a protein that occurs naturally in the
body and plays an important role in activating the immune
system. The immune system protects the body from foreign
substances, cells, and tissues by responding to and resisting
diseases. Proleukin therapy is a genetically engineered or
recombinant version of IL-2. Proleukin therapy possesses the
same properties as naturally occurring IL-2 and helps activate
the immune system to recognize and eliminate certain kinds of
cancer cells.
About Prometheus
Prometheus Laboratories Inc. is committed to improving lives
through the development and commercialization of novel
pharmaceutical and diagnostic products that enable physicians to
provide greater individualized patient care. Prometheus is a
leader in applying the principles of personalized medicine to
the diagnosis and treatment of gastrointestinal diseases and is
applying these principles to oncology. Its strategy includes the
marketing and delivery of pharmaceutical products complemented
by proprietary diagnostic testing services. By integrating
therapeutics and diagnostics, Prometheus believes it can provide
physicians with a comprehensive solution to treat chronic
diseases. Prometheus’ corporate offices are located in San
Diego, California.
PROLEUKIN is a registered trademark of Novartis.
ProOncDx is a trademark of Prometheus Laboratories Inc.
Contact
Pete De Spain
Director, Investor Relations
& Corporate Communications
Prometheus Laboratories Inc.
(858) 587-4117
pdespain @prometheuslabs.com
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