Amgen Denied Full Fed. Circ. Hearing On Repatha Patents By Kelly Knaub February 23, 2018, 8:42 PM EST The full Federal Circuit will not review a panel decision that revived a challenge to Amgen’s patents for Repatha, an antibody-based cholesterol treatment, according to a decision issued by the appeals court Friday. In a per curiam decision, the appeals court’s 12 active judges denied Amgen Inc.’s petition for a panel rehearing or rehearing en banc, more than two months after the drugmaker had argued that in nullifying its patent win over Sanofi and Regeneron Pharmaceuticals Inc., a three-judge panel abandoned precedent
Amgen Statement on January 9, 2017, U.S. District Court Decision THOUSAND OAKS, Calif., Jan. 9, 2017/PRNewswire/ -- Amgen(NASDAQ:AMGN) issued the following statement regarding the U.S. District Court of Delaware's denial of Sanofi and Regeneron's motion to stay the injunction pending the appeal in the ongoing PCSK9 patent litigation: Today, the U.S. District Court of Delawaredenied Sanofi and Regeneron's motion to stay the injunction pending the appeal in the ongoing PCSK9 patent litigation. By this ruling, the Court has extended the time before the injunction will be imposed by 15 days (from 30 days to 45 days) to allow Sanofi and Regeneron to seek appellate review of the Court's orders on injunction and denial of stay pending appeal. Amgen respects the court's thoughtful deliberations in a situation where a competitor made the choice to launch at risk during the pendency of a patent lawsuit within months of an expedited trial date. The Company remains confident in the validity of its patents.
That is horrible news for Repatha! I think the two MT’s from Astra Zeneca brought not only a shitty culture with them, but also some bad bad mojo!
YEP...AZ stands a AZZ-holes...get it. Repatha works but needs to be around $400/month...sorry you idiots!
Net price needs to be around $8-$10 a day or less than $3600 a year. The benefits are less than what branded statins were a decade ago.
Praluent's CV outcomes trial -ODYESSY- will readout at ACC next week. Dr Gluckman expects comparable efficacy and safety to Repatha's CV outcomes study (FOURIER), despite having almost 10,000 fewer patients. This is because ODYESSY is in a higher risk population, and it is being studied for 30% longer than FOURIER. If ODYSSEY were to show high 20-30% relative risk reduction in CV death, non-fatal MI and non-fatal stroke this would be "eye-opening" for the doctor, and would change his prescribing habits to favour Praluent over Repatha (his current use is 75-80% Repatha because of the outcomes data, apparent payer preference, and monthly dosing). However, even if the data are impressive, he describes this as a pyrrhic victory, he notes use of the class will remain low as the out-of-pocket spend for PCSK9's remains too high for patients, and payers will continue to limit the prescription given the high price
