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News and Press Releases

April 28, 2011


Affymax and Takeda Report Additional Phase 3 Clinical Trial Data for Peginesatide in Dialysis Patients at the National Kidney Foundation Spring Clinical Meetings



Las Vegas, Nevada, and Osaka, Japan, April 28, 2011, Affymax, Inc. (Nasdaq: AFFY) and Takeda Pharmaceutical Company Limited (TSE:4502, “Takeda”), today announced results of additional analyses from two Phase 3 studies (EMERALD 1 and 2) of the investigational agent, peginesatide (formerly known as Hematide™) in chronic renal failure (CRF) patients on dialysis with anemia.  Building on the primary analysis of the EMERALD studies, which showed that once-monthly peginesatide was comparable to epoetin given up to 13 times a month in maintaining hemoglobin (Hb) levels with a generally similar adverse event rate, these data provide additional information on the maintenance of Hb within treatment targets over time (up to 100 weeks), as well as cardiovascular safety results of this once-monthly agent in the dialysis patients studied.1,2  These data, along with a demographic analysis from the dialysis studies, were part of three poster presentations at the National Kidney Foundation’s (NKF) Spring Clinical Meetings in Las Vegas, Nevada.   

            Peginesatide is in development for the treatment of anemia in CRF patients on dialysis.  The EMERALD studies were part of the largest Phase 3 clinical program to support initial registration of an erythropoiesis stimulating agent (ESA) in the treatment of anemia in CRF.  The trials evaluated the efficacy and safety of peginesatide administered once-monthly, compared to epoetin alfa or epoetin beta dosed up to 13 times a month, in maintaining Hb levels within the current recommended target range (between 10-12 g/dL), a goal of anemia management.  Epoetin alfa or beta were dosed according to their product labels.  Dialysis patients randomized to the peginesatide arm were switched from epoetin alfa or epoetin beta to peginesatide. 

“The Phase 3 EMERALD program was particularly interesting because the studies evaluated the efficacy and safety of peginesatide in patients who were stable on an epoetin dose and then switched to peginesatide,” said Anne-Marie Duliege, M.D., chief medical officer, Affymax.  “We look forward to submitting our New Drug Application and reviewing our findings with the FDA.”

 “Evaluating cardiovascular safety is important in patients receiving dialysis because they typically have several co-existing conditions, such as diabetes and heart disease,” said Darryl Sleep, M.D., vice president, Clinical Science, Takeda Global Research & Development Center Inc., a wholly-owned subsidiary of Takeda.  “The EMERALD trials were the first Phase 3 registration studies to prospectively evaluate the cardiovascular safety of an erythropoiesis stimulating agent through an adjudicated composite safety analysis.  We believe our results provide important information on anemia treatment in this population.”

 

Safety and Efficacy of Peginesatide for Treatment of Anemia in Hemodialysis Patients Previously on Epoetin Alfa or Epoetin Beta (Poster #s 217 and 63), April 27, 2011

The peginesatide data presented at NKF were from two Phase 3 clinical trials known as EMERALD 1 and EMERALD 2.  The primary efficacy endpoint for both studies was the comparison of the mean change in Hb levels from baseline to the evaluation period across both treatment groups.1,2  In both Phase 3 trials, peginesatide had similar results to epoetin in maintaining Hb levels within target range.1,2  Specific study results presented at the meeting based on key secondary analyses are as follows:

 

·         EMERALD 1: The percentage of patients whose Hb levels remained within the target range during four-week periods in the initial titration period (weeks 1-28) was 60 to 69 percent in patients who were switched to peginesatide and 65 to 74 percent in those who were maintained on epoetin.  Hb levels during four-week periods in the evaluation and long-term follow up periods (weeks 29-52) were maintained in 67 to 75 percent of peginesatide patients and 68 to 75 percent of epoetin patients.  In this study, Hb levels were maintained without increasing the need for red blood cell transfusions (10 percent in the peginesatide group versus 9 percent in the epoetin group).1 

 

·         The overall adverse event profile of peginesatide was consistent with that of epoetin and the most commonly reported adverse events in the peginesatide and epoetin arms were diarrhea (20 percent versus 14 percent), cough (19 percent versus 20 percent), dyspnea (19 percent versus 20 percent) and nausea (17 percent versus 19 percent).1 

 

·         A similar frequency of serious adverse events was observed across groups.  Further, a similar frequency of the following cardiovascular events was reported in both treatment groups: death (11.1 percent versus 11.2 percent), stroke (2.3 percent versus 4.5 percent), myocardial infarction (4.8 percent versus 5.9 percent), unstable angina (2.7 percent versus 2.6 percent), congestive heart failure (11.3 percent versus 9.7 percent) and arrhythmia (6.9 percent versus 6.7 percent).

 

·         EMERALD 2: In this trial, 58 to 68 percent of patients switched to peginesatide were within Hb target range during four-week periods in weeks 1-28, compared to 67 to 78 percent who were maintained on epoetin.  The number of patients within target range during four-week periods in the evaluation and long-term follow up periods (weeks 29-52) was comparable between treatment groups, with 64 to 70 percent of peginesatide patients within range, versus 65 to 74 percent of those in the epoetin arm.  The proportion of patients who received a red blood cell transfusion was similar between peginesatide and the epoetin control (8 percent versus 10 percent).2 

 

·         The overall adverse event profile of peginesatide was consistent with that of epoetin and the most commonly reported adverse events in the peginesatide and epoetin arms were muscle spasm (20 percent versus 19 percent), dyspnea (18 percent versus 18 percent), nausea (18 percent versus 20 percent) and diarrhea (17 percent versus 18 percent).2 

 

·         A similar frequency of serious adverse events was observed across groups.  Also, a similar frequency of the following cardiovascular events was reported in both treatment groups: death (10.5 percent versus 12.5 percent), stroke (2.6 percent versus 2.9 percent), myocardial infarction (4.4 percent versus 4.8 percent), unstable angina (1.8 percent versus 1.8 percent), congestive heart failure (8.1 percent versus 8.4 percent) and arrhythmia (5.0 percent versus 6.2 percent).

 

Peginesatide Phase 3 Trial Subjects vs. a Random Sample of U.S. Hemodialysis Patients (Poster #163) – April 27, 2011

In addition to the safety and efficacy data, a demographic comparison presented at NKF showed that U.S. patients included in the EMERALD trials had baseline characteristics that are consistent with patients from a random sample of the U.S. adult hemodialysis population (n=8,731).3  Age, severity of chronic kidney disease and medical history of patients in the trials were generally reflective of the real-world population, as captured through Medicare claims data.3 

 

About the EMERALD Studies and the Peginesatide Phase 3 Program

The EMERALD trials were open-label, randomized active-controlled Phase 3 clinical studies that involved over 1,600 dialysis patients.  EMERALD 1 included 803 U.S. dialysis patients who were receiving hemodialysis (≥3 months) and were being treated with intravenous (IV) epoetin alfa (≥8 weeks).1  In this trial, patients were randomized to receive once-monthly peginesatide or epoetin alfa one-to-three times a week.1  EMERALD 2 enrolled 823 U.S. and European dialysis patients who were receiving hemodialysis (≥3 months) and were being treated with IV or subcutaneous (SC) injection of epoetin alfa or beta (≥8 weeks).  EMERALD 2 patients were randomized to receive once-monthly peginesatide (by IV or SC administration) or epoetin one-to-three times a week.2  These studies were part of the peginesatide Phase 3 program that also included two studies in non-dialysis patients (PEARL 1 and 2).  Based on the results of the peginesatide Phase 3 program, the companies are not pursuing an indication in non-dialysis in the U.S.  However, while not in our immediate plans, we will continue to evaluate our strategy in the non-dialysis indication.  A New Drug Application submission in the U.S. for peginesatide for the treatment of anemia in CRF patients on dialysis is anticipated in the second quarter of 2011.  

 

About Peginesatide

Peginesatide is a novel synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an ESA.  Affymax and Takeda are collaborating on the development of peginesatide and plan to co-commercialize the product if approved in the U.S.  The Phase 3 clinical trials were designed to investigate the potential for peginesatide to treat anemia associated with CRF.  The product, upon approval, would be commercialized outside the U.S. (in the European Union and Japan) by Takeda.

 

About Anemia in Chronic Renal Failure

Anemia is a common complication in chronic kidney disease (also referred to as CKD or chronic renal failure).4  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.5  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.6,7   ESAs are medications commonly prescribed to treat anemia and stimulate red blood cell production.6,7  According to the Center for Medicaid Services (CMS), nearly 95 percent of patients on dialysis in the U.S. are currently receiving ESA treatment for anemia in CRF.8

 

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 our ability to submit a New Drug Application (NDA) in the second quarter, the completeness of the NDA filing, risks relating to 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, regulatory requirements and approvals, 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 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. Affymax undertakes no obligation to update any forward-looking statement in this press release.

 

About Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals.  As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine.  Additional information about Takeda is available through its corporate website, www.takeda.com.

 

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.

 

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References

1.     Schiller, et al. “Safety and Efficacy of Peginesatide for Treatment of Anemia in Hemodialysis Patients Previously on Epoetin Alfa.” NKF 2011 Abstract. 

2.     Besarab, et al.  “Safety and Efficacy of Peginesatide for Treatment of Anemia in Hemodialysis Patients Previously on Epoetin Alfa or Beta.” NKF 2011 Abstract. 

3.     Yang, et al. “Peginesatide Phase 3 Trial Subjects vs. a Random Sample of United States Hemodialysis Patients.” NKF 2011 Abstract. 

4.     National Kidney and Urologic Diseases Information Clearinghouse. “Anemia in Kidney Disease and Dialysis.”  http://kidney.niddk.nih.gov/kudiseases/pubs/anemia.  Accessed March 3, 2011

5.     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

6.     National Kidney Foundation.  “Anemia and Chronic Kidney Disease.” http://www.kidney.org/Atoz/pdf/anemia.pdf.  Accessed March 2, 2011.

7.     National Heart Lung Blood Institute “What is Anemia.” http://www.nhlbi.nih.gov/health/dci/Diseases/anemia/anemia_what is.html. Accessed March 2, 2011.

8.     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.  Accessed March 4, 2011.

Contacts:

Josephine Zammuto
Corporate Communications
Takeda Global Research & Development Center, Inc.
224-554-2795
 
Mihoko Shinomiya
Corporate Communications Dept.
Takeda Pharmaceutical Company Limited
+81- 3- 3278- 2037
 
Sylvia Wheeler
Vice President, Corporate Communications
Affymax, Inc.
650-812-8861

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