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Schering-Plough to acquire exclusive United States marketing rights for INTEGRILIN from Millennium.

Schering-Plough Corporation (Kenilworth, NJ) and Millennium Pharmaceuticals, Inc. (Cambridge, MA) announced an agreement to restructure their collaboration for cardiovascular drug INTEGRILIN to optimize the growth potential of this United States market-leading GP IIb-IIIa inhibitor. Under the new relationship, Schering-Plough will acquire exclusive development and commercialization rights to INTEGRILIN in the United States. Schering-Plough and Millennium have been co-promoting INTEGRILIN in the United States and sharing profits since 2002.

Under the terms of the agreement, Schering-Plough will pay to Millennium an upfront payment of $35.5 million and royalties over the United States lifespan of INTEGRILIN. In 2006 and 2007, minimum royalty payments for each year are set at $85 million, with some extraordinary conditions that could reduce these minimums. In addition, Schering-Plough will pay to Millennium approximately $45-50 million for the purchase of existing INTEGRILIN inventories. The agreement is subject to federal antitrust review under the Hart-Scott-Rodino Act and should become effective September 1, 2005.

"Acquiring the balance of United States rights to INTEGRILIN will give us direct control of this important therapy in its largest market. This is yet another long-term action we are taking to increase our importance to health providers and patients and to become a global leader in the very important area of cardiac care," said Fred Hassan, Schering-Plough chairman and CEO. "We have said before that building strength in our cardiovascular portfolio would be a key driver of our Action Agenda to transform Schering-Plough into a high-performance company for the long term. Our announcement on INTEGRILIN today comes as we continue to see growth of the cholesterol-lowering agents VYTORIN and ZETIA, and as our innovative thrombin receptor antagonist continues in early-stage trials. We are moving steadily toward our goal."

"For Millennium, this new agreement allows the company to focus its commercial infrastructure on oncology while providing a significant revenue stream from INTEGRILIN to support development of VELCADE and other molecules in the company's pipeline," said Mark Levin, retiring chief executive officer, Millennium. "This transaction demonstrates our continued commitment to making strategic business decisions in the best interest of patients and shareholders."

Schering-Plough said the near-term impact of the new agreement on its earnings is expected to be relatively neutral. Schering-Plough's current expectations under the agreement include:

* A stronger foundation on which to build and expand Schering-Plough's cardiovascular portfolio, and to increase the company's long-term relevance to customers in this large sector;

* More effective and direct control over the management of the United States INTEGRILIN (eptifibatide) INJECTION franchise, allowing for greater efficiencies;

* Increased flexibility to optimize sales force effectiveness for INTEGRILIN and other cardiovascular products, and to gain additional product promotion; and

* The potential for improved INTEGRILIN profitability over time, with the product under the management of one company rather than under two.

In assuming these exclusive United States commercialization responsibilities, Schering-Plough also plans to integrate into its United States Acute Coronary Syndrome field force a significant number of Millennium United States sales representatives and managers currently assigned to INTEGRILIN (eptifibatide) Injection. Schering-Plough will continue to be responsible for commercializing the product in Canada and other international markets excluding Europe. Schering-Plough has been co-promoting INTEGRILIN in the United States and sharing profits since 1998, initially with COR Therapeutics, Inc. and then with Millennium when COR merged with Millennium in 2002.

INTEGRILIN and Schering-Plough's thrombin receptor antagonist (TRA) represent potentially complementary therapies in cardiovascular treatment. INTEGRILIN is most often used as an acute treatment in the hospital setting, in interventional cardiology, catheterization labs and emergency rooms for early use for patients with acute coronary syndrome. TRA, a potential oral agent for chronic therapy, is under development for use in the hospital and primary care setting as a once-daily anti-platelet agent to prevent thrombotic vascular events in patients with atherosclerosis that could be administered in combination with other anti-platelet or anti-thrombotic agents, such as INTEGRILIN, in treating acute coronary syndrome.

Schering-Plough reported INTEGRILIN sales of $325 million in 2004, of which $301 million were in the United States. In June 2004, Millennium reacquired European marketing rights to INTEGRILIN from Schering-Plough and licensed those rights to GlaxoSmithKline plc.

INTEGRILIN has played an important role in the company's transition to a fully integrated R&D and commercial biopharmaceutical company. The product provided the capabilities and revenue that helped Millennium establish and grow the critical commercial infrastructure that ensured the successful launch of VELCADE (bortzeomib) Injection in 2003.

Millennium expects the upfront payment and anticipated royalties from the restructured relationship, combined with the associated cost savings, will be at least equivalent to the value of the current profit share arrangement. Strategically, Millennium expects to:

* Continue to receive a substantial revenue stream while eliminating the need to further invest its resources into INTEGRILIN sales and marketing and development activities;

* Capture the opportunity for more efficient management of INTEGRILIN in the United States by placing responsibility with one company; and

* Streamline and focus resources on VELCADE and its pipeline, which are both critical to the continued success of Millennium. Conference Call Advisory.

INTEGRILIN is indicated for the treatment of patients with acute coronary syndrome (unstable angina/non-ST-segment-elevation myocardial infarction), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI). It is also indicated in the United States 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 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.

Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world.

Millennium markets VELCADE (bortzeomib) Injection, a novel cancer 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, inflammation, and cardiovascular. 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.

Schering-Plough Corporation


Millennium Pharmaceuticals, Inc.

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Publication:BIOTECH Patent News
Geographic Code:1USA
Date:Aug 1, 2005
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