The first rival treatment to Amgen’s portfolio of anaemia drugs has been approved in the US.

Omontys (peginesatide) has been developed by Affymax and Takeda to treat anaemia in adult dialysis patients who have chronic kidney disease (CKD). This makes it a rival for Amgen’s Epogen, which was first approved in 1989 and has been a blockbuster earner for many years.

Omontys is administered just once a month, giving it a major advantage over Epogen, which needs to be taken up to 12 times a month.

The drug is a new erythropoiesis-stimulating agent (ESA), that aids in the formation of red blood cells by stimulating the bone marrow to produce more red blood cells, and thereby reduce the need for transfusions.

The approval is a long-awaited victory for the marketing partners, who have fought to overcome FDA concerns about cardiovascular risk seen in clinical trials since 2010.

Analysts believe that the drug could hit peak sales $700 million or more, but is unlikely to reach the multi-billion dollar figures reached by Epogen.

Safety concerns about Epogen and Amgen’s other anaemia drugs have seen sales drop significantly in recent years, and the market is now a fraction of its size five years ago.

The FDA retains its own concerns about the safety of Omontys. Two trials of the drugs showed patients with CKD not on dialysis experienced increased specific cardiovascular events, and for this reason the FDA has blocked its use in these patients, and in patients with cancer-related anaemia. 

The drug’s label also states that it should not be used as a substitute for red blood cell transfusions in patients who require immediate correction of anaemia. This restricts the size of the market in which it can compete with Epogen, which is approved in these patients.

Amgen has also anticipated the competition by striking a deal with the biggest US provider of dialysis services, DaVita.  The companies recently signed an exclusive long-term contract a few months ago to include use of Epogen, and a similar but non-exclusive deal with Fresenius Medical Care has also been signed. 

Takeda is to market the product outside the US, and will share the US market with Affymax, which has never brought a product to market before.

The approval comes with a Risk Evaluation and Mitigation Strategy (REMS), which includes a post-marketing requirements to conduct an observational study and a randomised controlled trial to evaluate cardiovascular safety and safety of long-term use in adult patients on dialysis, in particular in the incident patient population.

These two studies must be completed with final reports submitted in 2018 and 2019, respectively.

The companies will also have to carry out of paediatric studies with target dates for completion between 2016 and 2027. Letters will be sent to nephrology healthcare providers as part of a Risk Evaluation and Mitigation Strategy (REMS), to inform them that Omontys is not indicated in patients with CKD not on dialysis.

Takeda has filed a European marketing application for the drug with the EMA.

The FDA approval is also welcome news for Nektar, which will earn single-digit royalties for its contribution to the drug delivery technology.

Andrew McConaghie

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LOWVILLE ? Despite some delays, Lewis County General Hospital officials hope a long-awaited renal dialysis center will be in place later this year or early next year.

The state Department of Health has approved a certificate of need for DaVita Inc., Buffalo, to operate a dialysis clinic on the hospital?s North State Street campus. However, the county-owned hospital is waiting for the company to sign on a Utica-based doctor as the clinic?s medical director before entering a lease agreement, hospital CEO Eric R. Burch said Monday during a joint meeting of county legislators and hospital managers.

?They were confident they were going to get him signed,? he said.

Hospital officials plan to build a roughly $1 million addition off the Medical Arts Building?s first floor and basement to accommodate the dialysis center. However, they want to have a signed lease with DaVita before sending requests for construction bids, Mr. Burch said.

Even if there isn?t enough time to complete construction this year, the hope is that at least a shell of the addition is done, allowing interior work to be done next winter, he said.

Hospital officials tentatively plan a groundbreaking ceremony May 12 in conjunction with their annual Community Health Awareness Day.

Mr. Burch also said Watertown nephrologist Dr. Khalid P. Sindhu plans to have office hours here one day per week and use the dialysis clinic, if and when it is completed.

Legislator Philip C. Hathway, R-Harrisville, asked if DaVita?s lease payments would cover the cost of construction. Mr. Burch said they would.

Martinsburg resident Edward Ingersoll in 2005 presented to county legislators a petition signed by more than 2,000 people requesting dialysis services here.

Legislators in both 2006 and 2007 supported certificate of need submissions that would have allowed Renal Care of Northern New York, Watertown, to set up a dialysis operation here, but those plans never came to fruition.

Faxton-St. Luke?s Healthcare, Utica, in fall 2009 submitted another certificate of need application. However, by the time the project received state approval, Faxton-St. Luke?s officials had decided not to move forward, leaving local officials searching for another partner. They found one last year in DaVita, a company based in Denver that operates similar centers throughout the country.

Up to 30 Lewis County residents receive dialysis treatments in either Watertown or Utica, Mr. Burch has said. Dialysis patients typically undergo four-hour treatments three days each week.

The Lewis County Hospital Foundation over the past two Saturdays held its third annual bowling tournament to benefit the dialysis project. The tournament, held at Lewis Lanes, raised about $2,900, and proceeds are expected to total nearly $4,000 when money from an accompanying auction is figured in, according to foundation Executive Director Timothy W. O?Connor.

Mr. Burch also reported Monday that the hospital is awaiting state approval on certificates of need to take over operation of the Harrisville medical clinic now run by Carthage Area Hospital and to take over hospice and home health care programs from the Lewis County Public Health Agency.

Hospital officials also continue to work on a plan to convert three unused classrooms at Copenhagen Central School for a health clinic and hope to meet soon with Dierdre K. Scozzafava, deputy secretary of state for local government, to see if state funding would be available, Mr. Burch said. Given all the needed approvals, however, that project probably would not come to fruition until at least next year, he said.

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