Millennium Achieves Milestone Payments of Approximately $40 Million
-- INTEGRILIN(R) (eptifibatide) Injection and VELCADE(R) (bortezomib) for Injection Milestones Achieved --
3/7/2005 4:01:09 PM
CAMBRIDGE, Mass., March 7, 2005 /PRNewswire-FirstCall via COMTEX/ -- Millennium Pharmaceuticals, Inc. (MLNM) today announced it will receive licensing fees and milestone payments based on the success of collaborations with the GlaxoSmithKline Group (GSK) and Johnson & Johnson Pharmaceutical Research and Development L.L.C. (J&JPRD) totaling approximately $40 million. Marsha Fanucci, chief financial officer and senior vice president, Millennium, will discuss these milestones in more detail in the Company's presentation at the SG Cowen & Co. 25th Annual Health Care Conference on March 17, 2005 which will be webcast and accessible through the Millennium website at millennium.com.
A milestone payment of $19.9 million in cash from GSK was triggered by the successful transfer of the central marketing authorization of INTEGRILIN in Europe to GSK and related activities. This payment is expected to be received during the first quarter of 2005 and will be recognized as strategic alliance revenue throughout the remainder of 2005. In addition, Millennium will receive two $10.0 million cash milestone payments based on the success of its collaboration with J&JPRD, following the achievement of thresholds in year-to- date VELCADE sales outside the United States and worldwide. Both payments will be recognized as strategic alliance revenue during the first quarter of 2005.
"These anticipated one-time payments represent the realization of our strategy to create collaborations to fully maximize the value of our market- leading products, INTEGRILIN and VELCADE, and are a component of growth in strategic alliance revenue in 2005," said Fanucci. "We are delighted to work with our collaborators to deliver our breakthrough products to patients around the world."
In June 2004, Millennium and GSK entered into an agreement in which GSK exclusively markets INTEGRILIN in Europe. The commercialization alliance was designed to provide significant sales and marketing support to capitalize on growth opportunities for INTEGRILIN in Europe and enhance the GSK cardiovascular critical care portfolio and presence in the European acute care market. Under the terms of the agreement, Millennium is entitled to license fees, milestone payments and royalties from GSK on INTEGRILIN sales in Europe upon the achievement of certain objectives.
INTEGRILIN is the U.S. market-leading therapy in a class of blood-clot inhibitors known as glycoprotein (GP) IIb-IIIa inhibitors. INTEGRILIN was launched in the U.S. in 1998 and in Europe in 1999. In the European Union (EU), INTEGRILIN is indicated for the prevention of early myocardial infarction in patients presenting with unstable angina or non-Q-wave myocardial infarction, also known as acute coronary syndromes, with the last episode of chest pain occurring within 24 hours and with ECG changes and/or elevated cardiac enzymes. Patients most likely to benefit from INTEGRILIN are those at high risk of developing myocardial infarction within the first three to four days after onset of acute angina symptoms including, for instance, those that are likely to undergo an early Percutaneous transluminal coronary angioplasty (PTCA). In the United States, INTEGRILIN can also be used to treat patients undergoing percutaneous coronary intervention (PCI).
In June 2003, Millennium entered into an agreement with Ortho Biotech Products, L.P. and its research affiliate, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., to collaborate on the commercialization and continued clinical development of VELCADE(R) (bortezomib). Under the terms of the agreement, Ortho Biotech and its affiliate, Janssen-Cilag, commercialize VELCADE outside of the U.S. and Millennium receives royalties on sales outside the U.S. In addition, Millennium may receive payments for achieving clinical, development and regulatory approvals and sales milestones outside of the U.S.
VELCADE is currently approved in approximately 40 countries around the world, including the United States for treatment of multiple myeloma (MM) patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. On September 29, 2004, Millennium filed a sNDA for VELCADE as a treatment for patients with MM who have received at least one prior therapy. The sNDA is currently under Priority Review at the U.S. Food and Drug Administration (FDA). Millennium and J&JPRD continue to investigate VELCADE globally in phase I, II and III clinical trials in both hematologic and solid tumors, including frontline MM, non-Hodgkin's lymphoma, and lung, prostate and ovarian cancers.
About INTEGRILIN(R) (eptifibatide) Injection
In the United States, INTEGRILIN is indicated for the treatment of patients with acute coronary syndrome (unstable angina/non-ST-segment myocardial infarction), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI). It is also indicated for the treatment of patients at time of PCI, including in patients undergoing intracoronary stenting.
INTEGRILIN is contraindicated in patients with a history of bleeding diathesis, or evidence of abnormal bleeding within the previous 30 days; severe hypertension (systolic blood pressure greater than 200 mm Hg or diastolic blood pressure greater than 110 mm Hg) not adequately controlled on antihypertensive therapy; major surgery within the preceding six weeks; history of stroke within 30 days, or any history of hemorrhagic stroke; current or planned administration of another parenteral glycoprotein (GP) IIb- IIIa inhibitor; dependency on renal dialysis; or known hypersensitivity to any component of the product.
Bleeding is the most common complication encountered during INTEGRILIN therapy. In the registration trials, the majority of excess major bleeding events were localized at the femoral artery access site. Oropharyngeal, genitourinary, gastrointestinal and retroperitoneal bleeding were also seen more commonly with INTEGRILIN compared to placebo.
INTEGRILIN is co-promoted and co-developed by Millennium Pharmaceuticals, Inc. and Schering-Plough Corporation in the U.S. and is marketed by the GlaxoSmithKline Group of companies in Europe. INTEGRILIN is also marketed by Schering-Plough Corporation in other countries.
About VELCADE(R) (bortezomib) for Injection
VELCADE is approved for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. The effectiveness of VELCADE is based on response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in survival. VELCADE(R) (bortezomib) for Injection is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol.
VELCADE is being co-developed by Millennium and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S.; Ortho Biotech and Janssen-Cilag are responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for Japan.
Risks associated with VELCADE therapy include new or worsening peripheral neuropathy, orthostatic hypotension, congestive heart failure, gastrointestinal adverse events, thrombocytopenia, and tumor lysis syndrome. Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE.
In 228 patients who were treated with VELCADE 1.3 mg/m2/dose in phase II studies, the most commonly reported adverse events were asthenic conditions (65%), nausea (64%), diarrhea (51%), decreased appetite including anorexia (43%), constipation (43%), thrombocytopenia (43%), peripheral neuropathy (37%), pyrexia (36%), vomiting (36%), and anemia (32%). Fourteen percent of patients experienced at least one episode of Grade 4 toxicity, with the most common toxicities being thrombocytopenia (3%) and neutropenia (3%). A total of 113 (50%) of the 228 patients experienced Serious Adverse Events (SAEs) during studies. The most commonly reported SAEs included pyrexia (7%), pneumonia (7%), diarrhea (6%), vomiting (5%), dehydration (5%), and nausea (4%).
For more information about VELCADE clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-(866)-VELCADE.
About Millennium
Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a novel cancer product, co- promotes INTEGRILIN(R) (eptifibatide) Injection, a market-leading cardiovascular product, and has a robust clinical development pipeline of product candidates. The Company's research, development and commercialization activities are focused in three therapeutic areas: oncology, cardiovascular, and inflammation. By applying its knowledge of the human genome, its understanding of disease mechanisms, and its industrialized drug discovery platform, Millennium is seeking to develop breakthrough products. |
