AFFY - Affymax Inc. PDUFA 03/27/12

[Superfly]

Affymax, Inc. is a biopharmaceutical company developing drugs to improve the treatment of serious and often life-threatening conditions. Its product candidate, Hematide (peginesatide), is designed to treat anemia associated with chronic renal failure. Hematide is a synthetic peptide-based erythropoiesis stimulating agent (ESA) designed to stimulate production of red blood cells. The Company completed treatment and follow up of patients with anemia associated with chronic renal failure in the Phase III clinical program for Hematide. Its Phase III clinical program included four open-label, randomized controlled clinical trials. Of these trials, two trials, called PEARL 1 and PEARL 2, were conducted in pre-dialysis patients and designed to evaluate the safety and efficacy of Hematide compared to darbepoetin alfa to correct anemia and maintain hemoglobin in a corrected range over time

Affymax, Inc.: NASDAQ:AFFY quotes & news - Google Finance



I dont have time to look really hard into this right now, but its down 70% on "met endpoints" for its phase 3 trial this morning. They say in the PR that they are looking forward to NDA + pre NDA discussions with the FDA, so there may be a play here for a bounce.

Company has 167 million in cash as of last quarter, (~7.00 a share), so it is trading at cash levels pretty much, there WERE some differences in the trial or something than was expected, I will look later tonight.

Insiders were exercising options pre-data release, so I would venture that they knew something was up.

AFFY Insider Trading - Affymax Inc - Form 4 SEC Filings



Bounce play for now at 7.38

Affymax and Takeda Announce Phase 3 Trials Meet Primary Endpoints for Investigational Drug, Hematide™/peginesatide, to Treat Anemia in Chronic Renal Failure With Some Differences Noted in Secondary Analyses

Affymax and Takeda Announce Phase 3 Trials Meet Primary Endpoints for Investigational Drug, Hematide?/peginesatide, to Treat Anemia in Chronic Renal Failure With Some Differences Noted in Secondary Analyses | Business Wire

[ChuckD]

Can one of you medical types decipher this please. If they have $7 in cash per share, may be a real opportunity here.


Affymax and Takeda Announce Phase 3 Trials Meet Primary Endpoints for Investigational Drug, Hematide(TM)/peginesatide, to Treat Anemia in Chronic Renal Failure With Some Differences Noted in Secondary Analyses
5:00a ET June 21, 2010 (Business Wire) Affymax, Inc. (Nasdaq:AFFY) and Takeda Global Research & Development Center, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE, 4502), today announced preliminary top-line results from the Phase 3 clinical program for the investigational drug, Hematide(TM)/peginesatide, for the treatment of anemia in chronic renal failure patients. The primary efficacy endpoint, the mean change in hemoglobin (Hb) from baseline, in each of the four Phase 3 studies (EMERALD 1, EMERALD 2, PEARL 1 and PEARL 2) met the statistical criteria for non-inferiority, when Hematide was compared to epoetin and darbepoetin, in correcting and/or maintaining Hb in the target range. Hematide also met the statistical criterion for non-inferiority in the combined four studies for the adjudicated cardiovascular composite safety endpoint (CSE), which was composed of death, stroke, myocardial infarction, congestive heart failure, unstable angina, and arrhythmia (hazard ratio (HR) 1.06, 90 percent confidence interval (CI) 0.91 -- 1.22). The median duration of follow-up for patients on study drug in the four trials was 1.3 years.
In a subgroup analysis of CSE events in the EMERALD studies in maintenance treatment of anemia in dialysis patients, the frequency of CSE events was balanced between Hematide and the comparator (HR 0.95, 90 percent CI 0.79 -- 1.13).
A difference in CSE events was noted, however, when a subgroup analysis was conducted in non-dialysis patients. In the PEARL trials, which evaluated correction and maintenance treatment of anemia in non-dialysis patients, the frequency of CSE events was higher in the Hematide group (21.6 percent) versus the comparator (17.1 percent) (HR 1.34, 90 percent CI 1.03 -- 1.73).
The Hematide Phase 3 program, which involved 2,609 randomized patients, consisted of four open-label, randomized active-controlled clinical trials in the U.S. and Europe, including two studies in non-dialysis patients (PEARL 1 and 2) and two others in dialysis patients (EMERALD 1 and 2). In all studies, Hematide was dosed once every four weeks while comparator drugs were dosed more frequently according to their product labels. In these studies, epoetin was dosed one-to three-times per week and darbepoetin was dosed every two weeks. The Hb target range was 11-12 g/dL for non-dialysis patients and 10-12 g/dL for those on dialysis.
"Completion of these four Phase 3 studies is a key milestone and we look forward to pre-NDA discussions with the FDA," said Arlene M. Morris, chief executive officer of Affymax, Inc. "We are continuing to evaluate the data, in particular the non-dialysis studies, and the impact on the timing of an NDA submission."
"The focus of Takeda and Affymax is patients' needs, which are paramount in drug development. Together, we are working to bring this treatment option to patients with chronic renal failure and to physicians who treat them," said Azmi Nabulsi, M.D., M.P.H, president of Takeda Global Research & Development Center.
EMERALD 1 & 2 (Dialysis)
In the EMERALD studies, patients were randomized two to one to receive Hematide or epoetin. The starting dose of Hematide was based on a conversion from the prior epoetin dose.
The primary efficacy endpoint of these two studies was a mean change in Hb between baseline and the evaluation period, which was between weeks 29 and 36 following entry into the study. This endpoint was met in both studies. The secondary endpoints of the two studies were the proportion of patients who received red blood cell (RBC) transfusions and the proportion of patients who maintained Hb within the target range during the evaluation period.
E
MERALD 1
--------------------------------------
Primary Endpoint H E
ematide poetin
Q4W 1-3x/week
-------------------------------------- ------- -----------
Number of patients 524 269
-------------------------------------- ------- -----------
Mean change from baseline in Hb (g/dL) -0.24 -0.09
-------------------------------------- ------- -----------
Treatment difference (CI)* -0.15 (-0.29, -0.01)
-------------------------------------- ---------------------
* Lower limit of the 95 percent two-sided confidence interval for the difference from epoetin (Hematide -- epoetin) met the pre-specified criterion for non-inferiority (lower bound of confidence interval > - 1.0 g/dL)
Regarding the secondary endpoints, the proportion of patients who received RBC transfusions was similar between groups (10.3 percent in the Hematide group and 8.6 percent in the epoetin group). The proportion of patients with a mean Hb within the target range during the evaluation period was statistically significantly lower in the Hematide group (63.0 percent) compared to the epoetin group (71.7 percent).
The mean Hb level during the evaluation period was 11.1 g/dL for Hematide and 11.3 g/dL for epoetin. Serious adverse events (SAEs) occurred in 58 percent of Hematide patients and in 63 percent of epoetin patients.
E
MERALD 2
--------------------------------------
Primary Endpoint H E
ematide poetin
Q4W 1-3x/week
-------------------------------------- ------- ---------
Number of patients 542 273
-------------------------------------- ------- ---------
Mean change from baseline in Hb (g/dL) -0.07 -0.17
-------------------------------------- ------- ---------
Treatment difference (CI)* 0.10 (-0.05, 0.26)
-------------------------------------- -------------------
* Lower limit of the 95 percent two-sided confidence interval for the difference from epoetin (Hematide -- epoetin) met the pre-specified criterion for non-inferiority (lower bound of confidence interval > - 1.0 g/dL)
Regarding the secondary endpoints, the proportion of patients who received RBC transfusions was similar (7.6 percent in the Hematide group and 9.9 percent in the epoetin group). The proportion of patients with a mean Hb within the target range during the evaluation period was also similar (63.5 percent in the Hematide group vs 65.9 percent in the epoetin group).
The mean Hb level during the evaluation period was 11.1 g/dL for Hematide and 11.1 g/dL for epoetin. SAEs occurred in 49 percent of Hematide patients and in 52 percent of epoetin patients.
PEARL 1 & 2 (Non-dialysis)
In the PEARL studies, patients were randomized into one of three treatment groups: Hematide starting dose of 0.025 mg/kg administered once every four weeks, Hematide starting dose of 0.04 mg/kg administered once every four weeks and darbepoetin starting dose of 0.75 mcg/kg administered every two weeks.
The primary endpoint for these two studies was a mean change in Hb between baseline and the evaluation period, which was between weeks 25 and 36 following entry into the study. This endpoint was met in both studies. The secondary endpoints of the two studies were the proportion of patients who received RBC transfusions and the proportion of patients who responded during the correction and evaluation periods.
P
EARL 1
-------------------------------------------------------------------------------------
Primary Endpoint H H D
ematide ematide arbepoetin
Q4W Q4W Q2W
(0.025 mg/kg (0.04 mg/kg (0.75 mcg/kg
starting starting starting
dose) dose) dose)
-------------------------------------- ------------------ ----------------- ------------
Number of patients 161 165 164
-------------------------------------- ------------------ ----------------- ------------
Mean change from baseline in Hb (g/dL) 1.39 1.64 1.37
-------------------------------------- ------------------ ----------------- ------------
Treatment difference (CI)* 0.03 (-0.19, 0.26) 0.26 (0.04, 0.48)
-------------------------------------- ------------------ -----------------
* Lower limit of the 97.5 percent two-sided confidence interval for the difference from darbepoetin (Hematide -- darbepoetin) met the pre-specified criterion for non-inferiority (lower bound of confidence interval > - 1.0 g/dL)
Regarding the secondary endpoints, the proportion of patients who received RBC transfusions was 6.2 percent in the Hematide 0.025 mg/kg group, 7.3 percent in the Hematide 0.04 mg/kg group and 4.9 percent in the darbepoetin group. These were not statistically different. The proportions of patients with a mean Hb within the target range during the evaluation period were similar (93 percent in the 0.025 mg/kg Hematide group, 94 percent in the 0.04 mg/kg Hematide group compared to 94 percent in the darbepoetin group).
The mean Hb levels during the evaluation period were 11.5 g/dL for 0.025 mg/kg Hematide, 11.6 g/dL for 0.04 mg/kg Hematide and 11.5 g/dL for darbepoetin. SAEs occurred in 48 percent of patients in the 0.025 mg/kg Hematide group, 46 percent in the 0.04 mg/kg Hematide group and 43 percent in darbepoetin patients.
P
EARL 2
-------------------------------------------------------------------------------------
Primary Endpoint H H D
ematide ematide arbepoetin
Q4W Q4W Q2W
(0.025 mg/kg (0.04 mg/kg (0.75 mcg/kg
starting starting starting
dose) dose) dose)
-------------------------------------- ------------------ ----------------- ------------
Number of patients 167 163 163
-------------------------------------- ------------------ ----------------- ------------
Mean change from baseline in Hb (g/dL) 1.50 1.68 1.35
-------------------------------------- ------------------ ----------------- ------------
T 0.14 (-0.09, 0.36) 0.31 (0.08, 0.54)
reatment difference (CI)*
-------------------------------------- ------------------ -----------------
* Lower limit of the 97.5 percent two-sided confidence interval for the difference from darbepoetin (Hematide -- darbepoetin) met the pre-specified criterion for non-inferiority (lower bound of confidence interval > - 1.0 g/dL)
Regarding the secondary endpoints, the proportions of patients who received RBC transfusions was higher in the Hematide groups (11.4 percent in the 0.025 mg/kg, 10.4 percent in the 0.04 mg/kg) than the darbepoetin group (4.9 percent). The difference between the 0.025 mg/kg Hematide group and the darbepoetin group was statistically significant. The proportions of patients with a mean Hb within the target range during the evaluation period were similar (91 percent in the 0.025 mg/kg Hematide group and 93 percent in the 0.04 mg/kg Hematide group compared to 95 percent in the darbepoetin group).
The mean Hb levels during the evaluation period were 11.6 g/dL for 0.025 mg/kg Hematide, 11.7 g/dL for 0.04 mg/kg Hematide and 11.4 g/dL for darbepoetin. SAEs occurred in 52 percent of patients in the 0.025 mg/kg Hematide group, 49 percent in the 0.04 mg/kg Hematide group and 43 percent in darbepoetin patients.
Analysis of Cardiovascular Composite Endpoint
The CSE was evaluated in a pooled analysis of all four Phase 3 pivotal trials. The CSE was defined as time to first event, consisting of death from any cause or a cardiovascular event (myocardial infarction, stroke, or a serious adverse event of congestive heart failure, unstable angina, or arrhythmia). The criterion for non-inferiority required the upper limit of the two-sided 90% confidence interval for the estimated HR to be less than 1.3. CSE events were adjudicated by a prospectively-established, independent, blinded Event Review Committee.
For the CSE from the pooled EMERALD and PEARL studies, 22.4 percent of patients in the Hematide group and 21.6 percent of patients in the control group (epoetin or darbepoetin) experienced at least one CSE event. The pre-specified criterion for non-inferiority was met with a HR of 1.06, 90 percent CI (0.91, 1.22).
In a subgroup analysis of dialysis patients (EMERALD studies), 22.8 percent of patients in the Hematide group and 24.4 percent in the epoetin group experienced at least one CSE event, HR 0.95, 90 percent CI (0.79, 1.13).
Of note, in a subgroup analysis of non-dialysis patients (PEARL studies), 21.6 percent of patients receiving Hematide and 17.1 percent of patients receiving darbepoetin experienced at least one CSE event, HR 1.34, 90 percent CI (1.03, 1.73). The HR in the non-dialysis patients was primarily driven by higher rates of death, unstable angina, and arrhythmia events in the Hematide treated patients. The percentages of patients experiencing stroke, myocardial infarction, and congestive heart failure were similar between treatment groups.
Further investigation into these data is ongoing.
Affymax, Inc. Conference Call Details
Affymax will hold a conference call today, Monday, June 21, 2010 at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time) to discuss this announcement. To participate in the live call via phone, please dial 877-354-4057 from the United States and Canada or +1-224-357-2391 internationally. The conference ID is 83101977. Please dial in approximately ten minutes prior to the start of the call. Individuals interested in listening to the live call via webcast may do so by visiting www.Affymax.com and clicking on the "Investor Relations" section. A replay of the webcast will be available on Affymax's website for 30 days.
About Hematide
Hematide is a novel investigational 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 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 the United States (in 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). According to the National Kidney Foundation, 26 million Americans - 1 in 9 U.S. adults - have CKD.(1,2) 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.(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)
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 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 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 timing, scope and results of an NDA filing for Hematide and the likelihood and timing of the commercialization of Hematide. The companies' actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties, including the FDA's interpretation of the data from the Phase 3 studies, in particular with respect to the subgroup analyses in the non-dialysis groups, the risks relating to the continued safety and efficacy of Hematide in clinical development, the potential for once per month dosing and room temperature stability, 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 quarterly report on Form 10-Q filed with the Securities and Exchange Commission. The scientific information discussed in this release related to Hematide is preliminary and investigative. Hematide has not been approved by the U.S. Food and Drug Administration or any other regulatory body, and no conclusion can be drawn regarding the safety or effectiveness of Hematide to treat anemia associated with chronic renal failure in dialysis or non dialysis patients. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The companies undertake no obligation to update any forward-looking statement in this press release.
SOURCE: Affymax, Inc.

[ChuckD]

Bought some at $7.15

[wy3134]

tried to buy an october $7.50 call but couldnt get it to hit...wasnt gonna pay more then the bid at $1.30, should have upped it to $1.35

[tape660]

Chuck, This may be the reason for the drop...

AFFY – Affymax, Inc. – Shares of the biopharmaceutical company plunged 68.7% to an intraday low of $7.20 today after data showed that non-dialysis patients taking Affymax’s anemia drug, Hematide, have a higher rate of heart attacks, chest pain, heart failure, arrhythmia, strokes and death than patients taking a similar drug made by Amgen Inc. The Hematide safety concerns inspired a downgrade of Affymax to ‘underperform’ from ‘outperform’ with a 12-month target share price of $7.00 by an analyst at RBC Capital this morning. Bearish options investors populating AFFY today initiated trades implying the price of the underlying stock will not recover in the next several months. Pessimistic players sold short roughly 2,800 calls at the July $10 strike to pocket an average premium of $0.37 apiece. Investors short the calls keep the full $0.37 premium received today as long as Affymax’s shares trade below $10.00 through July expiration. Call-selling spread to the October $10 strike where approximately 1,600 calls were shed for an average premium of $0.80 per contract. Investors keep the full $0.80 premium per contract if shares of the underlying stock fail to rally above $10.00 ahead of October expiration.

http://www.fxstreet.com/fundamental/...06-21.v02.html

[Superfly]

Well, it appears here that AFFY has a drug that works reasonably well, perhaps as good or better than the ONLY drug on the market for this disease, "Epogen" by Amgen.

Epogen : http://www.epogen.com/

The problem is though as tape showed, there were "unexpected" events that occurred in one of the Non dialysis arms of the (emerald?) trial, and now the drug poses the possibility of cardiac health risks.


If you look at Epogen though, it appears to an uneducated eye like my own that it has quite its own share of health risks attached to it. Could help AFFY's case.

Yes, it was found that Epogen could be superior to AFFY's drug in the health dept.



Sounds like they are really analyzing the non dialysis problem arms before going too much further, but an analyst posed the possibility of filing solely on dialysis. Management didnt say no to this, so I guess it could be possible.


I think (at this time), there is a trade with this one, they have lots of cash, only 20-25 million shares outstanding, and a drug that appears to be fairly effective, but has health risks. Sounds to me that higher doses may cause more problems than lower doses to for the cardiac problems in the non dialysis arm too, time will tell.

FDA may want another trial in that questionable subset, or approval might get held up because of it. I dont really see a valid reason (saying this somewhat lightly) for a 70% haircut to the shareprice though, here's a good article from last winter....Amgen's drug has a bunch of health problems too as I said before.

Affymax Targets Amgen Anemia Drug Aided by U.S. Rules (Update3)
February 16, 2010, 4:12 PM EST

By Rob Waters
Feb. 16 (Bloomberg) -- Affymax Inc., a 10-year-old company with no marketed products, may get help from the U.S. government in grabbing market share from Amgen Inc.’s $2.6 billion anemia drug Epogen with a treatment in line to be approved next year.

New rules for Medicare, the U.S. plan for the elderly and disabled, will cap fees for kidney dialysis, including the cost of anemia drugs, at about $250 per treatment starting on Jan. 1, 2011, and combine all services under one bill or “bundle,” said Yaron Werber, a Citibank analyst in New York.

The regulations may push dialysis clinics to use smaller amounts of cheaper drugs, Werber said. While Affymax hasn’t yet announced a price for its treatment, called Hematide, it’s given only once a month while Epogen is usually administered three times a week. Affymax expects Hematide to be approved as early as next year, Chief Executive Officer Arlene Morris said in an interview. If so, sales may hit $1.1 billion by 2015, said Phil Nadeau, a Cowen & Co. analyst in New York.

“When we go under the bundle, everything’s going to be about money,” said Julia Inrig, a kidney specialist at UT Southwestern Medical Center in Dallas, in a telephone interview. If Hematide is cheaper to buy and use than Epogen, “its use could significantly increase, and it could potentially drive Epogen out of the market.”

Affymax, of Palo Alto, California, rose 21 cents, or 1.1 percent, to $20.07 at 4 p.m. New York time in Nasdaq Stock Exchange composite trading. Thousand Oaks, California-based Amgen rose 51 cents to $56.99.



Sales Decline



Sales of Amgen’s anemia drugs Epogen and Aranesp have declined for four straight years after studies linked them to heart attacks and strokes at high doses.

Anemia is a condition in which the body does not have enough healthy, red blood cells to carry oxygen to other body tissues. It is common in people with kidney disease who use dialysis, and Amgen’s drugs remain the only ones now used in dialysis clinics. The company sells Epogen for about $8,445 per patient per year, Citibank’s Werber said.

The debut of Hematide could give the clinics more bargaining power, Affymax’s Morris said.

Now, “Amgen can do what they want because they’re the only game in town,” Morris said during an interview in San Francisco. “A second company makes the playing field level and gives a second choice” to dialysis providers.



Labor Costs, Supplies



Even if the company doesn’t charge less for a once-a-month injection of Hematide than Amgen does for Epogen given three times a week, dialysis centers could save money on labor costs and supplies with a less frequently used drug, said Sylvia Wheeler, an Affymax spokeswoman.

Emma Hurley, an Amgen spokeswoman, said in an e-mail that while it’s too early to draw conclusions about the prospects for Hematide, “Amgen strongly believes the dialysis and pre- dialysis markets are already well-served.”

Affymax will market Hematide with Takeda Pharmaceuticals Inc., Japan’s largest drugmaker. The companies will share U.S. profits equally and Affymax will get a share of revenue from sales outside the U.S., Wheeler said.

Hematide’s prospects may be strongest if Affymax can negotiate a deal with either of the companies that operate most of the dialysis centers in the U.S. -- Germany’s Fresenius Medical Care AG and Lakewood, Colorado-based DaVita Inc. -- said Werber.



Capturing a Chain



“Their goal is to capture one of the big dialysis chains from Amgen,” Werber said in a telephone interview. “If they can sign a contract with one of them, they wouldn’t need a big sales force.”

Neither dialysis company responded to repeated requests for comment.

People with kidney disease often don’t produce enough erythropoietin, a hormone that stimulates production of the red blood cells. The result is anemia, a condition that leaves people fatigued and impairs the work of the heart and brain.

Some people’s kidneys deteriorate so badly they go to dialysis centers and have machines filter waste from their blood. Nearly all patients on dialysis are anemic.

Epogen, a synthetic version of erythropoietin, boosts the depleted red-blood cells and is used primarily by dialysis patients, who take it with most treatments.



Introduced in 1989



Epogen was introduced in 1989 and seven years later topped $1 billion in sales. Combined sales of Epogen and Aranesp, a longer-acting version approved in 2001, soared to $6.6 billion in 2006, helping Amgen become the world’s largest biotechnology company. They plummeted 21 percent from 2006 to 2009 as studies documented the side effects caused by high doses of the drugs.

Amgen said today that a new requirement from the FDA starting March 24 will require all cancer doctors to enroll online and take a training course before prescribing Epogen or Aranesp. Fears by investors that this will slow prescribing may be overstated, said Michael Yee, a biotechnology analyst at RBC Capital Markets in San Francisco, in a note today to clients.

“It doesn’t look too bad,” he said.

Worldwide sales of anemia drugs for the one-year period ended Sept. 30 totaled $10.7 billion, according to IMS Health, a Norwalk, Connecticut, company that tracks prescriptions. Aranesp and Epogen combined have 55 percent of those sales.

Hematide is a synthetic peptide, a smaller version of a protein, and is easier to produce than a biologically engineered drug like Epogen, said Anne-Marie Duliege, Affymax’s chief medical officer.



More Testing



It’s being tested in kidney disease patients who don’t yet need dialysis, as well as those who do. Affymax and Takeda could grab market share from Amgen in both parts of the kidney disease market, said Cowen’s Nadeau in a telephone interview.

Affymax and Takeda said Jan. 25 they had completed four large studies testing the drug in 2,600 patients with kidney disease and will release results by the end of June. They plan to submit a marketing application to U.S. regulators by the end of the year, Morris said.

In a previous study, 114 dialysis patients were given Epogen three times a week or Hematide in low or high doses once a month. After 12 weeks, all three groups had achieved the same increase in their levels of hemoglobin, the iron-bearing protein in red blood cells, Affymax said in an Oct. 30 statement.

On average, hemoglobin rose from 9.2 grams per deciliter of blood to the target range of 11 to 12, Affymax said. The most common side effect was high blood pressure, which occurred in 8 percent of patients getting Epogen or high-dose Hematide and 3 percent of those getting the lower Hematide dose, according to the company.



Monthly Dosing



Hematide’s once-monthly dosing will appeal to patients who now get Epogen three times a week or Aranesp once a week, said Iain Macdougall, a kidney specialist at Kings College in London.

Hematide also may not require refrigeration, said Macdougall, who has led trials of the drug for Affymax. As a peptide, it’s cheaper to make than a protein drug, Macdougall said in a Jan. 22 telephone interview.

“We’re hoping we’ll get much cheaper anemia therapy,” Macdougall said. “I don’t know what the marketers at Affymax will do. There will be a bit of pressure to pass that on to the consumer.”

Affymax’s Wheeler said the company was thinking about how to price the drug.

“We recognize that we are launching Hematide into a price- and cost-sensitive marketplace,” she said.

http://www.businessweek.com/news/201...-update1-.html

Affymax Shares Plunge After Trial Raises Heart Safety Concern for Medicine
By Elizabeth Lopatto and Rob Waters - Jun 21, 2010

Affymax Inc. fell 69 percent, the most ever in Nasdaq trading, after the company released results showing greater heart risks among some kidney patients taking its investigational anemia drug Hematide than among users of Amgen Inc.’s Aranesp.

Cardiovascular problems are “a major concern” for the U.S. Food and Drug Administration, Aaron Reames, a Wachovia analyst, wrote today in a note to investors. “There is a good possibility that another trial is required.”

The data may delay the Palo Alto, California-based company’s bid to win regulatory approval for its first marketed product and challenge Amgen in treating anemia in kidney patients, said Arlene Morris, the company’s chief executive officer. The results also may prompt U.S. regulators to require additional studies, Reames said.

“We need time to reconsider our regulatory strategy,” Morris said today in an interview. “The key issue is just the uncertainty right now, not being able to tell people what we’re going to do and when we’re going to do it.”

Affymax fell $15.83 to $7.18, at 4 p.m. New York time in Nasdaq Stock Market composite trading.

Study Results

In the results released today, 22 percent of non-dialysis patients taking Hematide had a cardiovascular complication, compared with 17 percent of those taking the Amgen drug. The biggest difference was in the portion of patients who died of a heart-related problem -- 8.8 percent among the Hematide users compared with 6.7 percent of those taking Aranesp.

In a separate study of dialysis patients, heart-related complications struck 23 percent of Hematide users and 24 percent of patients taking another Amgen drug, Epogen, said Anne-Marie Duliege, Affymax’s chief medical officer.

The dialysis market is about three times larger than the non-dialysis market, Morris said.

“Our data are promising in the dialysis area so we think there’s a nice fit with the dialysis market,” Morris said.

The results are good for Amgen, wrote Geoffrey Meacham, an analyst for JPMorgan, in a note today to investors. Hematide was considered a major competitor to Amgen’s anemia drugs, and today’s data make it less of a threat, Meacham wrote.

Amgen, based in Thousand Oaks, California, rose $1.32, or 2.4 percent, to $56.52, also in Nasdaq trading.

Amgen’s View

It’s too early to say how the results may affect sales of Aranesp, Amgen spokeswoman Emma Hurley said today in an interview. Aranesp generated sales of $2.7 billion in 2009.

Affymax is developing Hematide with Osaka-based Takeda Pharmaceutical Co. Takeda can terminate the collaboration with six months written notice or in the event of “certain specified clinical development events or failures,” according to Affymax’s annual report for 2009.

Takeda’s “collaboration with Affymax is strong and we remain committed to continue developing Hematide,” said Josephine Zammuto, a U.S. spokeswoman for Takeda, in a telephone interview today.

The drug was as effective as Epogen or Aranesp in four studies released by Affymax and Takeda. The average follow-up for patients in all four trials was 1.3 years. Hematide was given once every four weeks; both Amgen drugs require more frequent dosing.

http://www.bloomberg.com/news/2010-0...y-concern.html

[Superfly]

Credit Suisse owns 10% of the shares....80% institution owned (or used to own lol).

http://moneycentral.msn.com/ownership?Symbol=AFFY

[Superfly]

Lots of nice news, I think I'm going to hold my shares for a little bit and see if we get a bigger bounce. Very rough (no calculators or balance sheets) math suggests to me that they have approx. 8$ a share in cash, as they had 167 million in cash last Q, plus the new 30 mil payment = 197 mil. Subtract say 7 mil for expenses this Q and 190 mil / 24 mil = 7.92.


I think they will need to run an abbreviated trial for non dialysis with a lower dose just to show that Hematide is safe...similar to what RPRX wants to do. The efficacy data is there, just need to get around the safety data. IF they get it fixed, (IF), I would think it will return to 20$ a share.

Affymax® Receives $30 Million Milestone Payments for Database Lock of Phase 3 Clinical Trials for Hematide™/peginesatide
Affymax (MM) (NASDAQ:AFFY)

Today : Tuesday 22 June 2010

Affymax, Inc. (Nasdaq:AFFY) today announced that it has received $30 million in development milestone payments from Takeda Pharmaceutical Company as part of the companies’ exclusive global agreement to develop and commercialize Hematide™/peginesatide, Affymax’s investigational drug for the treatment of anemia in chronic renal failure patients. The payments were triggered by the achievement of database lock in the PEARL and EMERALD Phase 3 clinical trials, which evaluated Hematide to treat anemia in chronic renal failure patients.

Affymax and Takeda are collaborating on the development of Hematide and will co-commercialize the product in the United States upon approval. Takeda holds an exclusive license to develop and commercialize Hematide outside the United States, including Japan.

Affymax Announces Hematide Successfully Restores Hemoglobin in Patients with Prca
21/06/2010 15:07 (1 Day 15:50 minutes ago)

The FINANCIAL -- Affymax, Inc. (Nasdaq: AFFY) and Takeda Pharmaceutical Company Limited (TSE: 4502) on June 21 announced results from a Phase 2 clinical trial of Hematide to treat anemia in dialysis and predialysis chronic kidney disease (CKD) patients with pure red cell aplasia (PRCA, Anti-erythropoietin antibody-mediated).

Results showed that Hematide could restore hemoglobin to the target range in these patients and eliminate the need for red blood cell transfusions in the patients studied.

"The data were presented yesterday by Iain C. Macdougall, M.D., Hematide clinical trial investigator, consultant nephrologist and honorary senior lecturer at King's College Hospital in London during an oral presentation at the American Society of Nephrology Renal Week 2007 in San Francisco. In addition, Phase 2 clinical trial results of Hematide in patients with anemia due to CKD were presented during the poster session," Takeda informs.

PRCA, a rare autoimmune disorder, occurs when the body produces neutralizing antibodies to the currently marketed recombinant human erythropoietin (EPO), thus suppressing the production of red blood cells by the bone marrow. In contrast, Hematide, Affymax’s lead drug in development for the treatment of anemia, is a novel synthetic, pegylated peptidic compound with no structural homology with human EPO.

“PRCA is a treatment complication resulting when a patient develops antibodies to recombinant EPO products. While rare, PRCA is a serious disease that prohibits further treatment with recombinant EPO and requires patients undergo regular blood transfusions and immunosuppressive therapy to suppress antibody production in an attempt to correct anemia and manage hemoglobin levels,” said Dr. Macdougall, consultant nephrologist in the Department of Renal Medicine at King’s College Hospital in London, U.K. “These trial results provide important information about the safety profile of Hematide.”

“Hematide is immunologically distinct from EPO. In preclinical studies, Hematide addressed hemoglobin deficiencies caused by EPO-specific antibodies, and antibodies generated to recombinant EPO have not been shown to cross-react with Hematide,” added Robert B. Naso, Ph.D., executive vice president of research and development at Affymax. “The PRCA data presented at ASN are intriguing findings which support the differentiation of Hematide. At some point in the future, Affymax and Takeda may decide to pursue further development of the product in the area of PRCA, but for now our development priorities are focused on anemia in chronic renal failure and chemotherapy-induced anemia.”

“We are pleased with this data presentation, which suggests the difference of Hematide,” said Masaomi Miyamoto, Ph.D., general manager of pharmaceutical development division at Takeda. “With our partner Affymax, we will vigorously continue development activities of this scientifically interesting product as a potential new treatment option for patients with anemia in both chronic renal failure and chemotherapy-induced anemia.”



PRCA Study Results


The open-label, multi-center trial in 10 dialysis and predialysis CKD patients with PRCA evaluated the effectiveness and safety of Hematide administered subcutaneously every four weeks. The primary endpoint was the change in hemoglobin from baseline over time. Secondary endpoints included safety and the effectiveness of Hematide in reducing the frequency of red blood cell transfusions over time.

Results showed that by six months of treatment, median hemoglobin had increased from 9.7 g/dL to 11.6 g/dL and transfusion requirements were eliminated. Three patients, who had their hemoglobin levels increased with Hematide, improved sufficiently to undergo kidney transplant surgery. Hematide was generally well tolerated. Some adverse events, including bone pain, hypertension, injection site hematoma, and increased blood pressure, were considered possibly related to Hematide.



Hematide Phase 2 Trial Results Also Presented at ASN Conference


In addition to the oral presentation on PRCA trial results, two posters from two separate Phase 2 clinical trials of Hematide in dialysis and predialysis CKD patients were presented at the ASN conference. These data showed that Hematide increased hemoglobin in treatment-naive, predialysis patients when administered monthly at an appropriate dose. Similarly, the data in dialysis patients previously treated with three-times weekly Epoetin alfa demonstrated that mean hemoglobin levels were maintained at target levels following a switch to once-monthly dosing of Hematide at an appropriate dose.

http://www.finchannel.com/news_flash...nts_with_Prca/

[ChuckD]

I sold my $7.15 shares at $7.65 this morning, rebought $7.25, sold at $7.53 set my re-buy at $7.15 again but it did not drop that low. I'm not going heavy because I don't know them that well, so only made about $300 If it behaves like other big drops, I think we will see some more volatility tomorrow, then a slow rise up a few bucks. Just my opinion, dont bank on it. lol

[ChuckD]

I bought back into AFFY this afternoon (7.29), it has had 3 full days to shake out with pretty heavy volume and has managed to hold above 7 The last two days it has peaked around 9:45 AM My target sell is $7.79 tomorrow, but I am considering holding some till next week.

[ChuckD]

AFFY surprised me a little this morning, took a dip down to $6.77, it has come back up close to $7 now. I am holding my $7.29 shares. I still have not done DD yet, but they seem cheap trading below their cash.

[ChuckD]

Looks like I guessed wrong on AFFY, it continues to bleed out, as low as $6.19 this morning on light volume. I am just holding 300 shares,but down 14-15% at the moment. I am going to hold on for now.

[ChuckD]

I bailed on AFFY at $6.39, lost the $300 I made on it the other day, watching for another entry, they are trading well below their cash.

[ChuckD]

Looks like I made the right call by bailing the other day, it was down to $5.60 today. Watching it to get my revenge. lol

[ChuckD]

Affymax(R) Receives $10.4M in Settlement of Auction Rate Securities with UBS

- Proceeds Used to Pay Outstanding Debt -


PALO ALTO, Calif., Jul 20, 2010 (BUSINESS WIRE) -- Affymax, Inc. /quotes/comstock/15*!affy/quotes/nls/affy (AFFY 6.00, 0.00, 0.00%) today announced the completion of the sale at par value of all auction rate securities (ARS) held by UBS AG and its affiliates (UBS) in a transaction which generated net proceeds of $5.0 million to Affymax, after payment of $5.4 million from the proceeds to retire a loan due to UBS. From April 1, 2010 through June 30, 2010, $3.7 million of the UBS ARS were settled at par value resulting in a corresponding reduction in the balance of UBS ARS and related loan since the first quarter 2010. The company now has no debt liability on its balance sheet.
In connection with settlement arrangements between UBS and various U.S. regulatory agencies, including the Securities and Exchange Commission relating to sales and marketing practices of ARS, in November 2008, the company accepted an offer from UBS AG of Series C-2 ARS Rights relating to the ARS that were purchased through UBS. These ARS Rights provided the company the option to require UBS to repurchase, at par, the ARS beginning on June 30, 2010, or prior to such date, UBS had the option to buy, at par, the ARS. In connection with the settlement, UBS offered a loan which the company accepted in December 2009. The loan was secured by the ARS and ARS Rights as collateral and was subject to collateral maintenance requirements.
After the sale to UBS, the company continues to hold ARS with a fair value of $3.8 million that remain classified as long-term securities. These remaining ARS are comprised of a municipal issuance collateralized by student loans guaranteed by the U.S. government under the Federal Family Education Loan Program and a closed end preferred issuance.
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. Affymax's product candidate, Hematide(TM)/peginesatide, completed Phase 3 clinical trials for the treatment of anemia associated with chronic renal failure. For additional information, please visit www.affymax.com.
SOURCE: Affymax, Inc.

[Superfly]

Time to start watching again...NDA filing expected by mid year. Company just did a share offering too, they arent trading much over their cash level (if that). Ground level pricing if you are patient and think the NDA will be accepted.

March 18, 2011 08:30 AM Eastern Daylight Time
Affymax Announces Pricing of Public Offering of Common Stock

PALO ALTO, Calif.--(BUSINESS WIRE)--Affymax, Inc. (Nasdaq:AFFY), today announced the pricing of an underwritten public offering of 8,474,576 shares of its common stock at a price to the public of $5.90 per share. The gross proceeds to Affymax from this offering are expected to be approximately $50.0 million, before deducting underwriting discounts and commissions and other estimated offering expenses. The offering is expected to close on or about March 23, 2011, subject to customary closing conditions. Affymax has also granted the underwriters a 30-day option to purchase up to 1,271,186 additional shares of common stock to cover over-allotments, if any. All of the shares in the offering are to be sold by Affymax.

Lazard Capital Markets LLC is acting as sole book-running manager in the offering, with Stifel Nicolaus Weisel acting as co-manager. A shelf registration statement on Form S-3 relating to the shares was filed with the Securities and Exchange Commission and is effective. A preliminary prospectus supplement relating to the offering has been filed with the SEC and is available on the SEC's web site at U.S. Securities and Exchange Commission (Home Page). Copies of the final prospectus supplement relating to the offering, when available, may be obtained from the offices of Lazard Capital Markets LLC at 30 Rockefeller Plaza, 60th Floor, New York, NY, 10020 or via telephone at (800) 542-0970, or from the above-mentioned SEC website.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

Affymax Announces Pricing of Public Offering of Common Stock | Business Wire

[Adam]

Maintained previous guidance that they intend to file their NDA this quarter.

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

[Superfly]

Time to start watching again...NDA filing expected by mid year. Company just did a share offering too, they arent trading much over their cash level (if that). Ground level pricing if you are patient and think the NDA will be accepted.

+15% later, still watching...this is pretty high on my list for later this year, going to buy if NDA gets accepted. Remember, they are also partnered with Takeda and Nektar Therapeutics (NKTR), pretty sure there's a future for Hematide if 3 of them are involved with it. The reason it tanked last year was for some safety issues in one of the trial populations, they are submitting the NDA for the safe populations.

[Superfly]

There will be a FDA panel for Affymax on December 7th for its anemia drug peginesatide. Being that there is the possibility of cardiovascular risks being discussed in the briefing documents I would not be long into their release (3 business days ahead of time). If AFFY can get peginesatide approved for kidney dialysis patients, it will compete with only Epogen (Amgen), which sold 2.5 billion dollars worth last year. Peginesatide is cheaper to produce, and there would be no other competitors until at least 2014.

110 million cash w/ low debt, 175mm market cap.

Affymax Hires New CEO, Former Genentecher, to Complete FDA Push With Anemia Drug | Xconomy

Affymax Lives to Fight Another Day, In Bid to Challenge Amgen’s Monopoly | Xconomy

Affymax Gears Up for its Make-or-Break Moment, As Anemia Drug Faces FDA Scrutiny | Xconomy

[wy3134]

docs released this morning, dont have a link to them but appears to be good as its up 30% premarket... thoughts on trading this superfly??