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.
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.
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.
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.
Pete De Spain
Director, Investor Relations
& Corporate Communications
Prometheus Laboratories Inc.