Antitrust suit involving generic Lipitor, Effexor XR back on
A United States appeals court has revived an antitrust lawsuit against four drug makers, alleging that they hamstrung generics for Lipitor and Effexor XR.
The plaintiffs, a coalition of labor unions and retailers, including Rite Aid and Walgreens, accused four drug makers of reverse settlement payment deals, in which a drug’s patent holder pays the accused infringer not to produce the patented item. The plaintiffs allege Ranbaxy accepted such payments from Pfizer to delay generics for Lipitor, while Wyeth accepted payments from Teva to delay Effexor XR.
A federal judge earlier dismissed the claims, but this week the U.S. Court of Appeals for the Third Circuit in Philadelphia reversed the ruling.
Study suggests statin therapy may lower risk of breast cancer
BARCELONA, Spain — A 14 year study in more than one million people has found that women with high cholesterol have significantly lower rates of breast cancer and improved mortality. The research, presented earlier this week at ESC Congress, suggests that statins are associated with lower rates of breast cancer and subsequent mortality.
"This is the most conclusive and direct evidence as yet to confirm the link between high cholesterol and breast cancer, a topic that has been fascinating researchers for the past few years," stated Rahul Potluri, senior author and founder of the ACALM Study Unit at Aston Medical School, Aston University, Birmingham. "We previously found an association between having high cholesterol and developing breast cancer so we designed this study to follow up patients longitudinally and address the relationship more robustly," he said. "Showing that patients with high cholesterol have a lower risk of developing breast cancer and subsequent mortality in a longitudinal study like this provides the strongest evidence for a protective effect, which is likely related to statins."
The current study followed-up women aged 40 or more with, and without, a diagnosis of high cholesterol and compared the development of breast cancer and subsequent mortality rates in the two groups. Patients admitted to U.K. hospitals with high cholesterol between Jan. 1 2000 and March 31 2013 were recruited from the Algorithm for Comorbidities, Associations, Length of stay and Mortality clinical database.
The researchers found that those with high cholesterol were 45% less likely to develop breast cancer than those without high cholesterol. After adjusting for factors which might influence mortality, including age, sex, ethnicity and the 10 most common causes of death in the U.K., the researchers found that patients who developed breast cancer were 40% less likely to die if they had high cholesterol than if they did not.
"Compared to those without high cholesterol, patients with high cholesterol had a 45% reduced risk of breast cancer, and if they did develop breast cancer, a 40% reduced chance of death," Potluri said. "If a diagnosis of high cholesterol leads to lower breast cancer rates this must either relate to something inherent in the condition or affected patients, or more likely, to treatment with widely used cholesterol lowering interventions such as statins."
"Our research confirms that women with a diagnosis of high cholesterol have strikingly lower rates of breast cancer with improved death rates and survival," commented Paul Carter, lead author of this study and researcher at the ACALM Study Unit. "Building on previous research by us and other groups, including animal studies in which statins reduced the risk of breast cancer, this gives a strong indication that statins produce this protective effect in breast cancer."
Allergan settles Restasis suit, grants authorized generic to Family Care
DUBLIN — Allergan and its subsidiaries on Monday announced that it has reached a settlement regarding its litigation with Famy Care Limited relating to Allergan's Restasis (cyclosporine ophthalmic emulsion) 0.05%.
The patents relative to Restasis are listed in the Orange Book and expire on Aug. 27, 2024, Allergan stated.
However, as a result of the settlement, all Famy Care litigation regarding Restasis patents will be dismissed and Famy Care will terminate its pending petitions for Inter Parties Review. Allergan will grant Famy Care a license to market a generic version of Restasis in the United States beginning on Feb. 27, 2024, or earlier under certain circumstances.
Additional details regarding the settlement were not disclosed.