Affymax and Takeda to Present Hematide/peginesatide Phase 2 Data at the National Kidney Foundation 2010 Spring Meeting

Update: Omontys (peginesatide) Now FDA Approved - March 27, 2012

PALO ALTO, Calif., & DEERFIELD, Ill.--(BUSINESS WIRE)--Mar 30, 2010 - Affymax, Inc. (Nasdaq: AFFY) and Takeda Pharmaceuticals Global Research & Development Center, Inc., U.S., today announced multiple posters on Hematide™/peginesatide have been accepted for presentation at the National Kidney Foundation (NKF) 2010 Spring Clinical Meeting taking place April 13-17, 2010 in Orlando, Florida. Hematide is an investigational agent for the treatment of anemia in chronic renal failure (also referred to as renal anemia).


 

Affymax and investigators will present six posters highlighting Phase 2 data on Hematide in renal anemia. Details of the poster presentations at NKF follow:


 

Wednesday, April 14 2010:


 

 


 


  • Long-Term Clinical Experience With Hematide (Schiller, et al.): 6:00PM
     
  • Hemoglobin Decline Following Hematide Dose Interruption (Besarab, et al.): 6:00PM
     
  • Hematide Dose Adjustments in the Maintenance of Hb in Hemodialysis Patients (Whittier, et al.): 6:00PM
     
  • Analysis of Hemoglobin Stability With Hematide in Hemodialysis Patients (Kaplan, et al.): 6:00PM
     
  • EPO and Hematide Requirements Differ in ESA Hyporesponsive HD Patients (Kotanko, et al.): 6:00PM
     
  • Evaluation of the Maintenance of Hb Control in HD Patients Both During and After Hospitalization With Once-Monthly Hematide (Zabaneh, et al.): 6:00PM
     


 

*Note: All times are listed in Eastern Time


 

About Hematide


 

Hematide is a novel synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an ESA. Peginesatide is the USAN (or nonproprietary) name for the compound.


 

Affymax and Takeda are collaborating on the development of Hematide and plan to co-commercialize the product once approved in the United States. Phase 3 clinical trials investigated the potential for Hematide to treat anemia associated with chronic renal failure. The product, upon approval, will be commercialized outside of the United States (the European Union and Japan) by Takeda.


 

About Anemia in Chronic Renal Failure (CRF)


 

Anemia in CRF affects many individuals with Chronic Kidney Disease (CKD).1 According to the National Kidney Foundation, 26 million Americans - 1 in 9 U.S. adults - have CKD.2,3 Anemia develops in the early stages of CKD and worsens as patients progress towards total kidney failure and need a dialysis machine to eliminate waste and water from their blood.1 In severe or prolonged cases of anemia, the lack of oxygen in the blood can cause serious and sometimes fatal damage to the heart and other organs.4


 

About Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.


 

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com.


 

About Affymax, Inc.


 

Affymax, Inc. is a biopharmaceutical company committed to developing novel drugs to improve the treatment of serious and often life-threatening conditions. For additional information, please visit www.affymax.com.


 

This release contains forward-looking statements, including statements regarding the success of the collaboration, timing, design and results of the Company's clinical trials and drug development program and the timing and likelihood of the commercialization of Hematide. The Company's actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties, including risks relating to the continued safety and efficacy of Hematide in clinical development, the potential for once per month dosing and room temperature stability, the cardiovascular event rate in our Phase 3 program, the timing of patient accrual in ongoing and planned clinical studies, regulatory requirements and approvals, research and development efforts, industry and competitive environment, intellectual property rights and disputes and other matters that are described in Affymax's annual report on Form 10-K filed with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update any forward-looking statement in this press release.


 


     
1.   National Institute of Diabetes and Digestive and Kidney Diseases. http://kidney.niddk.nih.gov/kudiseases/pubs/anemia.

 


 
2.   National Kidney Foundation. http://www.kidney.org/kidneydisease/ckd/index.cfm.

 


 
3.   National Kidney Foundation. “Anemia and Chronic Kidney Disease.”

http://www.kidney.org/Atoz/pdf/anemia.pdf.


 


 
4.   National Heart Lung Blood Institute.

http://www.nhlbi.nih.gov/health/dci/Diseases/anemia/anemia_whatis.html.


 


 

 


 


 

Contact: Affymax, Inc.

Sylvia Wheeler, 650-812-8861

Executive Director, Corporate Communications

or

Takeda Global Research & Development, Inc., U.S.

Julia Ellwanger, 224-554-7681

Corporate Communications


 

 


 

 

Posted: March 2010

View comments

Hide
(web3)