Reata Pharmaceuticals

Reata Pharmaceuticals, Inc. is a biopharmaceutical company based in Irving, Texas. Founded in 2002, Reata is currently developing oral anti-inflammatory drugs targeting Nrf2, a master regulator of the antioxidant response in humans. Through its control of the body's production of antioxidants, Nrf2 protects against a broad range of inflammation and oxidative stress related diseases, including renal disease,[1][2][3] cancer,[4] cardiovascular diseases,[5][6] and neurological diseases (eg: multiple sclerosis,[7][8] amyotrophic lateral sclerosis,[9][10] alzheimer's disease.[11]

Contents

Bardoxolone Methyl

Reata's lead program, bardoxolone methyl, is the first antioxidant inflammation modulator (AIM) to enter clinical trials. The drug has been shown to significantly increase estimated glomerular filtration rate (GFR), and improve several other markers of kidney function in patients with chronic kidney disease (CKD).[12] Bardoxolone methyl has been advanced to late-stage, pivotal clinical trials in patients with chronic kidney disease and type 2 diabetes.

Data from Phase 2 clinical studies of bardoxolone methyl have demonstrated that the drug is:

About Chronic Kidney Disease

Chronic Kidney Disease (CKD) is a common complication of diabetes and hypertension that affects over 26 million Americans.[14] It is a progressive condition that ultimately leads to End Stage Renal Disease (ESRD) and the need for dialysis or transplant, and is associated with dramatic increase in the risk of cardiovascular disease.[15] Current standard of care can slow the progression of the disease,[16] but no treatments are currently available to stop it. Due to the high prevalence of the condition, and absence of disease modifying therapy, CKD represents an area of significant unmet medical need.

Pipeline

Reata is developing a series of other antioxidant inflammation modulators (AIMs) with activity against a variety of intractable diseases. These unique drugs help to restore the balance between pro-oxidant and antioxidant signaling molecules within the cell by mimicking the body's own natural regulators of inflammation.[17][18] By increasing the production of enzymes that maintain the antioxidant buffering system within the cell, they prevent harmful inflammation and the associated oxidative stress and organ/DNA damage caused by high concentrations of oxygen and nitrogen radicals. Also, by activating enzymes that maintain the antioxidant buffering system, they increase the body's ability to protect against tissue damage from toxic insults, chronic health problems, and aging.

Partnerships

January 7, 2010 - Reata announced that they entered into a licensing agreement with Kyowa Hakko Kirin Co., Ltd. The agreement provided Kyowa Hakko Kirin with the exclusive rights to develop and commercialize bardoxolone methyl for CKD and related indications in Japan, China, Taiwan, Korea, and other select Southeast Asian countries. In return, Reata is eligible to receive up to $272 million in up-front fees and milestone payments, in addition to escalating double-digit royalties from sales in the licensed territories.[19][20][21]

September 23, 2010 - Abbott and Reata announced that they entered into a collaboration agreement to develop and commercialize bardoxolone methyl. Under the agreement, Reata granted Abbott exclusive rights to develop and commercialize bardoxolone methyl outside the U.S., excluding Asian markets outlined in the January 7th agreement with Kyowa Hakko Kirin. In exchange, Reata received upfront and near-term cash payments of $450 million for the licensing rights and a minority equity stake in the company. Additionally, Reata will receive milestone payments upon completion of certain development and approval objectives for bardoxolone in the licensed territories.[22][23][24]

References

  1. ^ Cachofeiro, Victoria; Goicochea, Marian; De Vinuesa, Soledad García; Oubiña, Pilar; Lahera, Vicente; Luño, José (2008). "Oxidative stress and inflammation, a link between chronic kidney disease and cardiovascular disease". Kidney International 74: S4–9. doi:10.1038/ki.2008.516. 
  2. ^ Sela, S.; Shurtz-Swirski, R; Cohen-Mazor, M; Mazor, R; Chezar, J; Shapiro, G; Hassan, K; Shkolnik, G et al. (2005). "Primed Peripheral Polymorphonuclear Leukocyte: A Culprit Underlying Chronic Low-Grade Inflammation and Systemic Oxidative Stress in Chronic Kidney Disease". Journal of the American Society of Nephrology 16 (8): 2431–8. doi:10.1681/ASN.2004110929. PMID 15987755. 
  3. ^ Vaziri, Nosratola D (2004). "Roles of oxidative stress and antioxidant therapy in chronic kidney disease and hypertension". Current Opinion in Nephrology and Hypertension 13 (1): 93–9. doi:10.1097/00041552-200401000-00013. PMID 15090865. 
  4. ^ Klaunig, JE; Xu, Y; Isenberg, JS; Bachowski, S; Kolaja, KL; Jiang, J; Stevenson, DE; Walborg Jr, EF (1998). "The role of oxidative stress in chemical carcinogenesis". Environmental health perspectives 106 Suppl 1: 289–95. PMC 1533298. PMID 9539021. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=1533298. 
  5. ^ Dhalla, Naranjan; Temsah, Rana; Netticadan, Thomas (2000). "Role of oxidative stress in cardiovascular diseases.". Journal of Hypertension 18 (6): 655–73. doi:10.1097/00004872-200018060-00002. PMID 10872549. 
  6. ^ Madamanchi, N. R. (2004). "Oxidative Stress and Vascular Disease". Arteriosclerosis, Thrombosis, and Vascular Biology. doi:10.1161/01.ATV.0000150649.39934.13. 
  7. ^ Offen, Daniel; Gilgun-Sherki, Yossi; Melamed, Eldad (2004). "The role of oxidative stress in the pathogenesis of multiple sclerosis: the need for effective antioxidant therapy". Journal of Neurology 251 (3): 261–8. doi:10.1007/s00415-004-0348-9. PMID 15015004. 
  8. ^ Syburra, C; Passi, S (1999). "Oxidative stress in patients with multiple sclerosis". Ukrainskii biokhimicheskii zhurnal 71 (3): 112–5. PMID 10609336. 
  9. ^ Simpson, Ericka P.; Yen, Albert A.; Appel, Stanley H. (2003). "Oxidative Stress: a common denominator in the pathogenesis of amyotrophic lateral sclerosis". Current Opinion in Rheumatology 15 (6): 730–6. doi:10.1097/00002281-200311000-00008. PMID 14569202. 
  10. ^ Ferrante, Robert J.; Browne, Susan E.; Shinobu, Leslie A.; Bowling, Allen C.; Baik, M. Jay; MacGarvey, Usha; Kowall, Neil W.; Brown, Robert H. et al. (2002). "Evidence of Increased Oxidative Damage in Both Sporadic and Familial Amyotrophic Lateral Sclerosis". Journal of Neurochemistry 69 (5): 2064–74. doi:10.1046/j.1471-4159.1997.69052064.x. PMID 9349552. 
  11. ^ Markesbery, W (1997). "Oxidative Stress Hypothesis in Alzheimer's Disease". Free Radical Biology and Medicine 23 (1): 134–47. doi:10.1016/S0891-5849(96)00629-6. PMID 9165306. 
  12. ^ "Reata to Present at Jefferies 2010 Global Life Sciences Conference" (Press release). Reata Pharmaceuticals. June 9, 2010. http://www.reatapharma.com/news_detail.asp?id=60. Retrieved October 28, 2010. 
  13. ^ http://www.reatapharma.com/pip_rta402.asp#clinical
  14. ^ Centers for Disease Control and Prevention (2007). "Prevalence of chronic kidney disease and associated risk factors—United States, 1999–2004". Morbidity and Mortality Weekly Report 56 (8): 161–5. PMID 17332726. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5608a2.htm. 
  15. ^ Anavekar, Nagesh S.; Pfeffer, Marc A. (2004). "Cardiovascular risk in chronic kidney disease". Kidney International 66: S11–5. doi:10.1111/j.1523-1755.2004.09203.x. PMID 9573568. 
  16. ^ "Use of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers in CKD". National Kidney Foundation. http://www.kidney.org/professionals/kdoqi/guidelines_bp/guide_11.htm.  in Kidney Disease Outcomes Quality Initiative (K/DOQI) (2004). "K/DOQI clinical practice guidelines on hypertension and antihypertensive agents in chronic kidney disease". American journal of kidney diseases 43 (5 Suppl 1): S1–290. PMID 15114537. 
  17. ^ "Two Studies Support AIMs Development" (Press release). Reata Pharmaceuticals. July 8, 2009. http://www.dddmag.com/news-Two-Studies-Support-AIMs-Development-070809.aspx. Retrieved October 28, 2010. 
  18. ^ http://www.natap.org/2009/HIV/062109_03.htm
  19. ^ http://www.biospace.com/news_story.aspx?NewsEntityId=167221
  20. ^ http://www.fiercebiotech.com/special-reports/emerging-drug-developer-reata-pharmaceuticals
  21. ^ http://www.medicalnewstoday.com/articles/175571.php
  22. ^ http://www.biospace.com/news_story.aspx?NewsEntityId=195321
  23. ^ http://www.marketwatch.com/story/abbott-and-reata-pharmaceuticals-announce-agreement-to-develop-and-commercialize-bardoxolone-methyl-for-chronic-kidney-disease-outside-the-us-2010-09-23
  24. ^ Hethcock, Bill (October 3, 2010). "Reata adding jobs, stays in Dallas". http://www.bizjournals.com/dallas/stories/2010/10/04/story4.html. 

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