Affymax banks $50M milestone on ESA drug approval

Posted under Affymax, Amgen, Anemia drugs, Blog, Companies, Diagnostics, Epogen, Funding, Medical Devices, Medical Supply, Omontys, Partnering, peginesatide, Pharmaceuticals, Regulatory, Startups, Takeda, Universities, Videos by john

Affymax ($AFFY) has banked a $50 million check from its partner Takeda Pharmaceutical after they won FDA approval for peginesatide, an anemia treatment that will now compete with Amgen ($AMGN) for market share. The biotech will co-promote the treatment in the U.S., which will be sold as Omontys. Analysts expect it to earn upward of $700 million a year, much of it taken from Amgen's Epogen franchise. Release

Affymax breaks Amgen’s anemia drug monopoly with ESA approval

Posted under Affymax, Amgen, Anemia drugs, Blog, Companies, Diagnostics, Epogen, Funding, Medical Devices, Medical Supply, Omontys, peginesatide, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Amgen has finally lost control of the U.S. market for anemia drugs needed to treat dialysis patients. In the middle of the day the FDA announced that it had handed Affymax ($AFFY) an approval for peginesatide--an ESA therapy that will be sold as Omontys. The approval paves the way to the entry of a rival for Epogen, Amgen's ($AMGN) longtime anemia blockbuster, which will offer patients a much easier dosing schedule.

Peginesatide's biggest advantage is that patients will only need once-monthly injections, compared to up to 12 times a month for Epogen patients. That is likely to open lots of doors in the market of some 400,000 patients. And the FDA was acutely aware of the lack of competition in the market when it announced the news of the approval.

"Omontys represents the first new FDA-approved and marketed ESA for this condition since 2001," said Richard Pazdur, M.D., CDER's director of the Office of Hematology and Oncology Products. "This new drug offers patients and health care providers the convenience of receiving ESA therapy just once per month instead of more frequent injections."

The approval marks a big victory for Affymax, which had to battle back from the cardiovascular risk signals seen in 2010 to win over regulators. Takeda will split the U.S. market with Affymax. The news is also good for Nektar ($NKTR), which helped on the delivery side of the program. Nektar wins a single-digit royalty stream with the approval.

Amgen has been digging a deep defensive position for itself in the anemia market. It has an exclusive supplier relationship with DaVita which covers the bulk of its anemia drug needs for seven years. And Fresenius struck a nonexclusive supply deal. That still leaves a large chunk of the marketplace for small- and medium-sized dialysis centers, which analysts note are particularly price sensitive. Peginesatide is expected to bring in $700 million a year, with much of that money redirected from the Epogen franchise.

- here's the press release
- read the story from Bloomberg
- get the Xconomy story

Related Articles:
Affymax spikes after expert panel backs new anemia drug rival to Amgen
Potential rival to Amgen's anemia drug faces big day with FDA advisers
Affymax gets $10M milestone, PDUFA date on anemia drug

Affymax spikes after expert panel backs new anemia drug rival to Amgen

Posted under Affymax, Amgen, Anemia drugs, Blog, Companies, Diagnostics, Dr. Steven Nissen, Epogen, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Takeda, Universities, Videos by John Carroll

Shares of Affymax spiked more than 25% this morning as investors got a chance to show their enthusiasm for the big support FDA experts provided Wednesday afternoon for the biotech's experimental anemia drug peginesatide. The panelists voted 15 to 1 to endorse the treatment, with the Cleveland Clinic's Steven Nissen providing the sole ‘nay' and one other expert sticking to the sidelines.

The vote immediately had everyone in the business buzzing about the potential showdown looming between Affymax ($AFFY) and its partner Takeda with the giant Amgen ($AMGN), which has shepherded a blockbuster anemia drug market for years. Peginesatide is dosed only once a month, giving it a big advantage over Epogen, which earned $2.5 billion last year. Affymax would also compete with J&J's ($JNJ) Procrit, with sales close to $2 billion.

"I think the compelling evidence today is that we don't have a reason to say no to this drug in the dialysis setting," noted Dr. Wyndham Wilson, chair of the panel, according to a Reuters report.

Affymax posted noninferior data on its new treatment, another erythropoiesis-stimulating agent that boost red blood cell counts. And it came in with a safety profile quite similar to the current blockbusters, setting the stage for a possible new entry that could disrupt the market if they set out to entice patients and physicians with easier dosing schedules and a competitive price. Due to cardiovascular risks seen in trials, Affymax is seeking approval to limit use to patients in dialysis.

While no guarantee of success, the big vote in its favor makes Affymax a likely winner at the FDA, unless regulators are persuaded by Nissen's lone vote against the treatment.

"The time has come to search our souls and decide how much risk are we willing to take for the convenience factor," said Nissen. "Will we in five years come back and find out that there was something going on here that we were learning in the non-dialysis population, that will emerge in the dialysis population?

That's a standard few drug developers can ever meet and not likely to persuade the FDA to stand in the way at this point.

- read the report from Reuters
- get the Bloomberg story

Related Articles:
Affymax investors bullish on FDA review of Amgen anemia drug rival
Potential rival to Amgen's anemia drug faces big day with FDA advisers
Affymax gets $10M milestone, PDUFA date on anemia drug

Affymax investors bullish on FDA review of Amgen anemia drug rival

Posted under Affymax, Amgen, Aranesp, Blog, Companies, Diagnostics, Epogen, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Facing an expert panel review for peginesatide on Wednesday, FDA staffers gave Affymax ($AFFY) a solid boost in confidence this morning with an agency review that backed the once-monthly anemia treatment as equivalent to Amgen's ($AMGN) blockbuster treatments Epogen and Aranesp. And investors quickly picked up on the positive spin, boosting the biotech's stock more than 25% this morning.

"Data from the clinical program support the efficacy of peginesatide administered once monthly for the treatment of anemia of CKD in dialysis patients," the staffers noted in a detailed review of the data. "The Phase III Dialysis Studies 12 and 14 demonstrated peginesatide could be used to maintain stable Hb levels as successfully as epoetin."

The agency has its reservations about the drug's safety, though, and wants the committee to take a close look at the benefits and risks for patients with chronic kidney disease, "given the safety findings and in light of the prior history with agents that stimulate the erythropoietin receptor." Affymax and its partner Takeda are seeking approval of the drug for CKD patients on dialysis. But as Adam Feuerstein at The Street noted this morning, the FDA's safety concerns appear relatively muted in the report, which helped to further ignite the biotech's share price.

Agency reviews typically contain a sharp focus on any safety or efficacy concerns for a new drug. And investors have been acutely sensitive to some late-stage data on the drug's cardio risks seen in a group of patients. Today they seem to be at least temporarily satisfied that Affymax has taken one more step toward a potential approval for the first direct competitor to Amgen's more frequently administered treatments.

- get the FDA review (.pdf)
- here's the story from The Street
- read the Bloomberg report

Special Report: Amgen - Biotech's Biggest Spenders 2011

Related Articles:
Potential rival to Amgen's anemia drug faces big day with FDA advisers
Affymax readies blockbuster alternative to Epogen
Medicare affirms rule expected to erode Epogen sales
Affymax gets $10M milestone, PDUFA date on anemia drug