Abstract
Rosuvastatin (Crestor) is a fully synthetic statin that was discovered by Shionogi and commonly referred to as a “super statin,” because of its high potency, together with atorvastatin (Lipitor). Relative to the earlier statins, rosuvastatin was a very late entrant into the market. However, Crestor became a highly successful global blockbuster drug. In the global competition to discover synthetic statins with stronger efficacy than the statins from natural products, Shionogi succeeded by taking advantage of the company’s wealth of experience and expertise in the field chemical synthesis, particularly with respect to sulfonamide additions. The superior characteristics of rosuvastatin are well illustrated by the ability of Crestor to expand and maintain its sales, despite the entry of generic drugs to the statin market following the expiration of patents for earlier statins. Crestor was launched only because AstraZeneca was able to resume its clinical development after Shionogi abandoned it. In doing so, AstraZeneca expanded the scale and diversity of clinical trials with the intention of a global launch of rosuvastatin. It also engaged in extensive comparative clinical trials with leading statins. This case illustrates the critical role of the complementary asset for turning a great drug invention into a successful innovation as well as the importance of combining capabilities across firms for such an objective.
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Notes
- 1.
Trade name in the USA.
- 2.
Medical Interview Form: CRESTOR Tablets 2.5 mg/CRESTOR Tablets 5 mg (in Japanese).
References
Beck, G., Kesselar, K., Baader, E., Bartmann, W., Bergmann, A., Granzer, E., et al. (1990). Synthesis and biological activity of new HMG-CoA reductase inhibitors 1. Lactones of pyridine- and pyrimide-substituted 3,5-dihydroxy-6-heptenoic(-heptanoic) Acids. Journal of Medicinal Chemistry, 33(1), 52–60.
Black, D. M., Bakker-Arkema, R. G., & Nawrocki, J. W. (1998). An overview of the clinical safety profile of atorvastatin (Lipitor), a new HMG-CoA reductase inhibitor. Archives of Internal Medicine, 158(6), 577–584.
Blasetto, J. W., Stein, E. A., Brown, W. V., Chitra, R., & Raza, A. (2003). Efficacy of rosuvastatin compared with other statins at selected starting doses in hypercholesterolemic patients and in special population groups. The American Journal of Cardiology, 91(5), 3–10.
Brewer, H. B. (2003). Benefit-risk assessment of rosuvastatin 10 to 40 milligrams. The American Journal of Cardiology, 92(4), 23–29.
Jones, P. H., Davidson, M. H., Stein, E. A., Bays, H. E., McKenney, J. M., Miller, E., et al. (2003). Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR* Trial). The American Journal of Cardiology, 92(2), 152–160.
Li, J. J. (2009). Triumph of the heart: The story of statins. Oxford University Press.
Mukhtar, R. Y. A., & Reckless, J. P. D. (2005). Pitavastatin. International Journal of Clinical Practice, 59(2), 239–252.
Nawrocki, J. W., Weiss, S. R., Davidson, M. H., Sprecher, D. L., Schwartz, S. L., Lupien, P. J., et al. (1995). Reduction of LDL cholesterol by 25% to 60% in patients with primary hypercholesterolemia by atorvastatin, a new HMG-CoA reductase inhibitor. Arteriosclerosis, Thrombosis, and Vascular Biology, 15(5), 678–682.
Ohfuji, K., Yano, S., Yamaguchi, M., Smith, G., Hirata, M., Shimada, H., et al. (2005). Pharmacological action and clinical effects of the new HMG-CoA reductase inhibitor rosuvastatin calcium (crestol). Japanese Pharmacology Journal, 126, 213–219.
Roth, B. D., Bocan, T. M. A., Blankley, C. J., Chuchlowski, A. W., Creger, P. L., Creswell, M. W., et al. (1991). Relationship between tissue selectivity and lipophilicity for inhibitors of HMG-CoA reductase. Journal of Medicinal Chemistry, 34(1), 463–466.
Shook, R. L. (2007). Miracle medicines: Seven lifesaving drugs and the people who created them. Portfolio Hardcover.
Watanabe, M., Koide, H., Ishiba, T., Okada, T., Seo, S., & Hirai, K. (1997). Synthesis and biological activity of methanesulfonamide primide- and N-methanesulfonyl pyrrole-substituted 3,5-dihydroxy-6-heptenoates, a novel series of HMG-CoA reductase inhibitors. Bioorganic & Medicinal Chemistry, 5(2), 437–444.
Yamamoto, A. (2005). Characteristics of new statin rosuvastatin. Pharmacy, 56(1), 149–159.
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Hara, Y., Nagaoka, S., Genda, K. (2019). Rosuvastatin (Crestor). In: Nagaoka, S. (eds) Drug Discovery in Japan. Springer, Singapore. https://doi.org/10.1007/978-981-13-8906-1_4
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DOI: https://doi.org/10.1007/978-981-13-8906-1_4
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