Aralez Pharmaceuticals Inc., a global specialty pharmaceutical company, announced that it acquired the US and Canadian rights to Zontivity (vorapaxar), pursuant to an asset purchase agreement entered into between Merck, known as MSD outside the United States and Canada, and Aralez Pharmaceuticals Trading DAC, a subsidiary of Aralez, based in Ireland.
Zontivity is the first and only approved therapy shown to inhibit the protease-activated receptor-1 (PAR-1), the primary receptor for thrombin, which is considered to be the most potent activator of platelets. In the US, Zontivity is indicated for the reduction of thrombotic cardiovascular events in patients with a history of heart attack (myocardial infarction) or in patients with narrowing of leg arteries, called peripheral arterial disease (PAD), and should be used in combination with daily aspirin and/or clopidogrel according to their indications or standard of care. In Canada, Zontivity (vorapaxar sulfate) co-administered with aspirin with or without clopidogrel, according to their standard of care, is indicated for the reduction of atherothrombotic events in adult high-risk patients with a history of myocardial infarction (MI).
The asset purchase agreement included an initial upfront payment of $25 million, which was paid from cash on hand. The transaction also includes graduated royalties and potential added future consideration in the form of payments for achieving certain aggregate annual sales-based milestones. In addition to the Asset Purchase Agreement, the parties simultaneously entered into a Supply Agreement, a License Agreement with respect to trademarks and certain proprietary know-how and a Transition Services Agreement. Under the terms of the Transition Services Agreement, Merck will continue to distribute the product on behalf of Aralez for up to twelve months while the product rights, packaging and labeling and other responsibilities are transferred to Aralez Pharmaceuticals Trading DAC.
The US prescribing information for Zontivity includes a boxed warning regarding bleeding risk. Zontivity is not for use in patients with a history of stroke, transient ischemic attack (TIA) or intracranial hemorrhage (ICH), or active pathological bleeding. Antiplatelet agents, including Zontivity, increase the risk of bleeding, including ICH and fatal bleeding.
Zontivity is a once-daily tablet containing 2.08 mg of vorapaxar, equivalent to 2.5 mg of vorapaxar sulfate. There is no experience with use of Zontivity as the only administered antiplatelet agent, because Zontivity was studied only as an addition to aspirin and/or clopidogrel.
"Zontivity represents a revenue-generating asset with NCE regulatory data exclusivity and patent protection potentially extending to 2027. It is an excellent strategic fit with our anchor therapeutic position in cardiovascular disease targeting high prescribing cardiologists alongside Yosprala, pending FDA approval, and Fibricor," said Adrian Adams, chief executive officer of Aralez. "This transaction is consistent with our business model designed to build value organically through the approval and commercialization of Yosprala, currently pending FDA approval with a September 14, 2016 PDUFA date, and through seizing high potential growth opportunities through aggressive business development and licensing in our anchor positions in cardiovascular disease, pain management and other specialty therapeutic areas."
Heart attacks are generally caused by atherosclerotic plaque disruption and thrombus (blood clot) formation in a coronary artery. Each year, about 750,000 Americans have a new (550,000) or recurrent (200,000) heart attack.
Peripheral arterial disease (PAD) is generally defined as obstruction of arteries supplying the lower or upper extremities, most commonly due to atherosclerosis and much more commonly involving the lower extremities.
Zontivity is contraindicated in patients with a history of stroke, TIA, or ICH and in patients with active pathological bleeding such as ICH or peptic ulcer. Discontinue Zontivity in patients who experience a stroke, TIA, or ICH.
Antiplatelet agents, including Zontivity, increase the risk of bleeding, including ICH and fatal bleeding. Zontivity increases the risk of bleeding in proportion to the patient's underlying bleeding risk. Physicians should consider the underlying risk of bleeding before initiating Zontivity.
Aralez Pharmaceuticals Inc. is a global specialty pharmaceutical company focused on delivering meaningful products to improve patients' lives while creating shareholder value by acquiring, developing and commercializing products primarily in cardiovascular, pain and other specialty areas.