- The Food and Drug Administration approved a generic copy of AstraZeneca’s blockbuster cholesterol drug Crestor, marking the fifth time a generic statin has been made available in the U.S.
- Made by Watson Pharmaceuticals, generic rosuvastatin will likely hurt sales of Crestor, one of several older AstraZeneca drugs facing patent expiry. CEO Pascal Soriot recently warned of the effect generic competition may have on the company’s earnings this year.
- Crestor was originally approved in 2007, and was one of the top prescribed medications in 2015, generating almost $5 billion in revenues for AstraZeneca.
Generic rosuvastatin will join four other generic statins already on the U.S. market: simvastatin, atorvastatin, pravastatin and lovastatin. However, not all statins are created equal, and Crestor has consistently outsold other statins, including generic options.
"Crestor is a more potent statin and has the added effect of raising HDL-C," explained Barry Mennen, a Washington, DC-based physician.
Allergan (Watson Pharma's parent company) expects rosuvastatin to be the largest generic launch this year. Under a 2013 agreement with AstraZeneca, the drug is launching 67 days ahead of July 8, the data Crestor's patent exclusivity officially expires.
AstraZeneca's shifting fortunes
While the approval of Actavis’ copy of Crestor will hurt sales, generic competition has been anticipated for some time. AstraZeneca has been investing heavily in R&D, focusing particularly on oncology in hopes of offsetting the new competition.
Additionally, Soriot said the company would aim to trim annual costs by a little over $1 billion by 2017, cutting back on selling and administration expenses.
Overall, first-quarter core profits fell 12% to $1.2 billion, from $1.37 billion in Q1 2015. The patent expiration of Crestor did not affect first-quarter earnings, but will most likely be felt later this year.
Despite the challenges, Soriot is bullish on AstraZeneca’s long-term outlook and sticks by his forecast of $45 billion in revenues by 2023. The company has high hopes for its immuno-oncology drug durvalumab. It recently added a hyperkalemia drug and several development cancer treatments through two acquisitions last year.
What about PCSK9 inhibitors?
When the new PCSK9 cholesterol drugs were first approved in the U.S. last year, hopes were high the drugs would rapidly become a mainstay treatment for patients who are either intolerant of statins, or have hard-to-treat hypercholesterolemia.
However, both Sanofi/Regeneron’s Praluent and Amgen’s Repatha have seen slow uptake as insurers and pharmacy benefit managers have balked at high prices.
At this point, generic Crestor appears unlikely to further impact uptake of PSCK9 drugs.
"Generic Crestor will pull business away from generic Lipitor, but I cannot see it having an effect on initial PSCK9 uptake,” according to Mennen. “It would seem to be that in order for a patient to get an OK for a PCSK9 drug from their insurer or PBM, they would need to show a special need---such as having failed on statins to achieve target lipid levels.”