Relypsa, Sanofi marketing teams revved up and waiting for FDA nod on patiromer

Relypsa ($RLYP) is raring to go on its treatment for hyperkalemia, patiromer. It needs to get going, considering a competitor med might hit the market in mid-2016. All it needs is an FDA approval, and that decision is expected today.

If the agency comes through, the California-based company will cross the final Ts on its salesforce hiring and launch the med within two months, spokeswoman Charlotte Arnold told TheStreet. The company has said it will field 120 reps on the drug.

It won't be launching alone, either. Sanofi ($SNY) signed up to co-market patiromer, using its kidney-disease sales reps to promote the med. That veteran force has been marketing Revela and Renagel, which fight high levels of phosphate in patients with kidney disease, to nephrologists and dialysis clinics.

Relypsa's 120 reps will focus on outreach to nephrologists, cardiologists and hospitals and a small number of primary care doctors, while Sanofi will detail patiromer to its nephrology customers and potentially some cardiologists. Already, the two companies have been laying the groundwork with "disease-state education," Relypsa said in an SEC filing earlier this year. The two companies will train Sanofi's reps on the drug together.

As Sanofi's involvement suggests, Relypsa will focus its marketing on patients with hyperkalemia--abnormally high potassium levels in the blood--because of chronic kidney disease. That's 3 million patients in the U.S., Relypsa says, and a significant number of those people are hospitalized every year.

There are other treatment approaches to hyperkalemia, Relypsa said in a statement about the pending approval, including an older med Kayexalate. That drug is "a poorly tolerated therapy that was developed more than 50 years ago," the company says.

Still, some analysts figure it will be tough to persuade doctors to abandon that treatment and other approaches--and to persuade payers to cover a newer, presumably more expensive drug--TheStreet notes. They've set peak sales forecasts below $200 million.

Others see patiromer as a potential blockbuster, provided prices hold up and the drug grabs market share ahead of another new treatment from ZS Pharma, due for an FDA decision next May.

"We recognize that the patiromer commercial launch requires us to build the market and educate doctors" about a new way to treat hyperkalemia, Arnold told TheStreet. The company intends to keep prices at or below $600 per month, she said.

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