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Affymax and Takeda to Present Peginesatide Data at the American Society of Nephrology Kidney Week 2011

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

PALO ALTO, Calif. & DEERFIELD, Ill.--(BUSINESS WIRE)--Oct 10, 2011 - Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceuticals Global Research & Development Center, Inc., U.S., today announced data from multiple studies of peginesatide (formerly known as Hematide™) have been accepted for presentation at the American Society of Nephrology (ASN) Kidney Week 2011 taking place November 8-13, 2011 in Philadelphia, Pa.

Peginesatide is an investigational agent in development by Affymax and Takeda for the treatment of anemia in chronic kidney disease patients on dialysis. The companies and investigators will present seven posters, including clinical data on dosing, hemoglobin stability and safety in hemodialysis patients. Details of the poster presentations at ASN Kidney Week 2011 follow:

Friday, November 11, 2011:

 

  • Relationship Between Peginesatide and Epoetin Doses in Hemodialysis (HD) Patients (Fishbane, et al.)
    Poster Board # FRˆ’PO1579: 10 a.m.-12 p.m.
  • Rate of Hemoglobin (Hb) Decline Following Peginesatide Dose Interruption (Besarab, et al.)
    Poster Board # FRˆ’PO1570: 10 a.m.-12 p.m.
  • Hemoglobin (Hb) Stability During Peginesatide Versus Epoetin Treatment in Hemodialysis (HD) Patients (Provenzano, et al.)
    Poster Board # FRˆ’PO1607: 10 a.m.-12 p.m.
  • Safety Results From Two Phase 3 Studies of Peginesatide Treatment for Anemia in Hemodialysis (HD) Patients (Locatelli, et al.)
    Poster Board # FRˆ’PO1571: 10 a.m.-12 p.m.
  • IV Versus SC ESA Dosing Requirements in U.S. and Non-U.S. Hemodialysis (HD) Patients (Schiller, et al.)
    Poster Board # FRˆ’PO1601: 10 a.m.-12 p.m.

Saturday, November 12, 2011:

 

  • Peginesatide Stimulation Allows for a Longer Lifespan of the Activated Erythropoietin Receptor (Green, et al.)
    Poster Board # SA-PO2417: 10 a.m.-12 p.m.
  • In Vivo Erythropoietic Activity of Peginesatide Correlates with Erythropoietin Receptor Residence Time and Plasma Half Life (Green, et al.)
    Poster Board # SA-PO2416: 10 a.m.-12 p.m.

*Note: All times are listed in Eastern Time

About Peginesatide

Peginesatide is a synthetic, PEGylated peptidic compound that binds to and stimulates the erythropoietin receptor and thus acts as an erythropoiesis stimulating agent or ESA.

Affymax and Takeda are collaborating on the development of peginesatide and plan to co-commercialize the product if approved in the United States. A New Drug Application for peginesatide was submitted in May 2011 and the companies recently announced that the application was accepted for review by the U.S. Food and Drug Administration and assigned a Prescription Drug User Fee Act (PDUFA) action date of March 27, 2012.

About Anemia in Chronic Kidney Disease (CKD)

Anemia is a common complication in chronic kidney disease (also referred to as CKD), because the impaired kidneys are not able to produce enough erythropoietin, the hormone that promotes the production of oxygen-carrying red blood cells.1 Research has shown that anemia impacts the overall health and well being of CKD and dialysis patients and is associated with increased rates of hospitalization and mortality.2 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.3,4

Anemia often develops in the early stages of CKD and worsens as patients progress toward total kidney failure and need dialysis (also referred to as end-stage renal disease).1 ESAs, which stimulate red blood cell production, are commonly prescribed to treat anemia in CKD.3,4 According to the Center for Medicaid Services, more than 95 percent of patients on dialysis in the U.S. are currently receiving ESA treatment for anemia in CKD.5

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, gastroenterology and cardiovascular disease treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com.

This press release contains forward-looking statements. Forward-looking statements include statements regarding Takeda's plans, outlook, strategies, results for the future, and other statements that are not descriptions of historical facts. Forward-looking statements may be identified by the use of forward-looking words such as "may," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "assume," "continue," "seek," "pro forma," "potential," "target," "forecast," "guidance," "outlook" or "intend" or other similar words or expressions of the negative thereof. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors are cautioned not to unduly rely on such forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to, (1) the economic circumstances surrounding Takeda's business, including general economic conditions in Japan, the United States and worldwide; (2) competitive pressures and developments; (3) applicable laws and regulations; (4) the success or failure of product development programs; (5) actions of regulatory authorities and the timing thereof; (6) changes in exchange rates; (7) claims or concerns regarding the safety or efficacy of marketed products or product candidates in development; and (8) integration activities with acquired companies.

The forward-looking statements contained in this press release speak only as of the date of this press release, and Takeda undertakes no obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If Takeda does update or correct one or more of these statements, investors and others should not conclude that Takeda will make additional updates or corrections.

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 continuation and success of Affymax's collaboration with Takeda, milestones expected to be accomplished, timing, design and progress of the peginesatide development program and the timing and potential regulatory approval and commercialization of peginesatide. Affymax's actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties, including risks relating to the approvability and completeness of the New Drug Application (NDA) filing, risks relating to regulatory requirements and approvals, in particular the FDA's interpretation and review of the data in the NDA including issues related to the subgroup analyses in non-dialysis, data quality and integrity particularly in non-inferiority designed trials, the continued safety and efficacy of peginesatide in clinical development, the timing of patient accrual in ongoing and planned clinical studies, research and development efforts, industry and competitive environment, intellectual property rights and disputes and potential for costs, disruptions and consequences of litigation, financing requirements and ability to access capital and other matters that are described in Affymax's Quarterly Report on Form 10-Q 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. Affymax undertakes no obligation to update any forward-looking statement in this press release.

References

1. National Kidney and Urologic Diseases Information Clearinghouse. “Anemia in Kidney Disease and Dialysis.” http://kidney.niddk.nih.gov/kudiseases/pubs/anemia.

2. Astor et al “Association of Kidney Function with Anemia: The Third National Health and Nutrition Examination Survey (1988-1992). Archives of Internal Medicine 2002; 162: 1401-1408

3. National Kidney Foundation. “Anemia and Chronic Kidney Disease.” http://www.kidney.org/Atoz/pdf/anemia.pdf.

4. National Heart Lung Blood Institute “What is Anemia.” http://www.nhlbi.nih.gov/health/dci/Diseases/anemia/anemia_what is.html.

5. Centers for Medicare and Medicaid Services. “MEDCAC Meeting 3/24/2010 - Erythopoiesis Stimulating Agents (ESA) in Anemia Related to Kidney Disease.” http://www.cms.gov/medicare-coverage-database/details/medcac-meeting-details.aspx?MEDCACId=52.

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50022653&lang=en

Contact: Affymax, Inc.
Sylvia Wheeler, 650-812-8861
Vice President, Corporate Communications
or
Takeda Pharmaceuticals North America, Inc.
Jocelyn Gerst, 224-554-5422
Corporate Communications

 

 

Posted: October 2011

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