Upon the closing of the divestment, Grünenthal will make an upfront, non-contingent payment to AstraZeneca of $320 million.
Photo courtesy of AstraZeneca.
AstraZeneca announced today that it has agreed to sell the rights to Crestor (rosuvastatin) and its associated medicines in more than 30 countries in Europe (with the exception of the UK and Spain) to Grünenthal, a German pharmaceutical company. The divestment is expected to close in the first quarter of 2021.
AstraZeneca will continue to manufacture and supply Crestor to Grünenthal during the transition period. In addition, it will continue selling the product in other countries. Upon the closing of the divestment, Grünenthal will make an upfront, non-contingent payment to AstraZeneca of $320 million. It may also make additional future milestone payments of up to $30 million.
“This agreement supports the management of our mature medicines to enable reinvestment into the pipeline and bringing new, innovative treatments to patients,” said Ruud Dobber, executive vice president of AstraZeneca’s biopharmaceuticals business unit. “Grünenthal previously acquired the rights to several established AstraZeneca medicines and is well placed to ensure continued access to Crestor for patients across Europe.”
Crestor is a statin and lipid-lowering medication that it is used to treat blood lipid disorders and prevent cardiovascular events. The drug produces its lipid-modifying effects in two ways: first, it blocks an enzyme in the liver, causing the liver to make less cholesterol. Secondly, it increases the uptake and breakdown by the liver of cholesterol already in the blood. Crestor is approved for use in more than 100 countries.
Back in April 2016, the U.S. Food and Drug Administration (FDA) approved the first generic version of Crestor (rosuvastatin calcium) tablets. Specifically, it was approved for use in combination with diet for the treatment of hypertriglyceridemia in adults; in combination with diet for the treatment of Type III Hyperlipoproteinemia; and either alone or in combination with other cholesterol treatments for adults with homozygous familial hypercholesterolemia.
“The FDA is working hard to get first-time generic drugs approved as quickly as possible so patients can have increased access to needed treatments,” said Kathleen Uhl, M.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research, at the time of the announcement. “The FDA requires that generic drugs meet rigorous scientific and quality standards.”
Watson Pharmaceuticals, Inc. was initially given approval to market the generic version of Crestor in multiple strengths. However, Allergan announced just days later that it had also received FDA approval on its Abbreviated New Drug Application for rosuvastatin calcium 5, 10, 20 and 40 mg tablets as well.
“This first-to-market launch demonstrates the talent of our Generics team in developing, manufacturing and bringing to market high-quality, affordable versions of widely used medications like Crestor,” said Robert Stewart, Allergan’s Executive Vice President & President, Generics and Global Operations, at the time of the announcement. “This is expected to be the largest generic launch in 2016, benefiting patients and reducing cost for U.S. health systems.”
Crestor was also notably approved by the FDA back in 2009 for use in children between the ages of 10 and 17 who are living with heterozygous familial hypercholesterolemia. Specifically, it could be prescribed when diet alone failed to reduce elevated cholesterol.
In July 2009, AstraZeneca announced that the FDA had granted an additional six-month period of exclusivity to market Crestor for its approved cholesterol and atherosclerosis indications up through July 2016. The decision at the time was based a supplemental New Drug Application submitted by the company.
